AzTrials
AzTrials

Yellow FeverPhase 1NCT02743455

A Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of MVA-BN Yellow Fever Vaccine With and Without Montanide ISA-720 Adjuvant in 18-45 Year Old Healthy Volunteers

A Phase 1 study testing ISA-720, MVA Smallpox Vaccine and MVA-BN Yellow Fever Vaccine in people with Yellow Fever and Yellow Fever Immunisation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a multi-center, double-blind, placebo-controlled, Phase I study to evaluate the safety, reactogenicity, tolerability, and immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic-Yellow Fever (MVA-BN-YF) in Flavivirus-naive healthy male and non-pregnant female adult subjects. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Yellow Fever, Yellow Fever Immunisation
What is being tested?
ISA-720, MVA Smallpox Vaccine and MVA-BN Yellow Fever Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
92 participants
Where
2 sitesUnited States
Study dates
5 Jul 2016to 22 Mar 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Must be a male or female at least 18 to < / = 45 years old at the time of screening.
  • Must be able to read and provide written consent and complete the Informed Consent.
  • Must have a body mass index (BMI) > / = 18.5 and < 35.0 kg/m^2.
  • Must be in good health on the basis of physical examination, vital signs*, medical history, safety laboratories, and the investigator's clinical judgment. *Safety laboratory normal ranges will be those used by the reference clinical lab. Protocol-specific criteria for individual subjects are listed in criteria #6
  • The clinical laboratory evaluations that will be graded as laboratory Adverse Events (AEs) and be considered for the Study or Individual Halting Rules are those which are included in the laboratory toxicity grading scales.
  • Vital signs must be in normal ranges. If a subject has elevated systolic or diastolic blood pressure, subject may rest for 10 minutes in a quiet room and then the blood pressure may be retaken once.
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  • For Group 6: subjects must have documented previous vaccination with MVA-BN*. *In order to be enrolled, a subject has to have received two 1x10^8 TCID50 doses of MVA-BN 19-45 days apart subcutaneous (SC) or intramuscular (IM) as part of participation in DMID vaccine trials 11-0021 or 09-0002. First dose must have been administered no earlier than 2010.
  • Must have acceptable* laboratory criteria within 28 days before enrollment.
  • Acceptable lab parameters include:
  • Hemoglobin: women: > 11.0 g/dL; men > 12.5 g/dL
  • White blood cell count: > 3,700 cells/mm^3 but < 11,000 cells/mm^3
  • Platelets: > 125,000 but < 375,000 per mm^3
  • Urine dipstick (clean urine sample): protein < 1+, glucose negative
  • Alanine aminotransferase and aspartate aminotransferase (ALT, AST) < 1.25 x institutional upper limit of normal
  • Blood urea nitrogen (BUN) < / = 1 x institutional upper limit of normal
  • Total bilirubin < 1.25x institutional upper limit of normal.
  • Serum creatinine < / = 1 x institutional upper limit of normal
  • If laboratory screening tests are out of range, repeat of screening tests is permitted once, provided there is an alternative explanation for the out of range value.
  • Women of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy tests prior to each vaccination.
  • Women of childbearing potential must have an acceptable method of contraception* from 28 days prior to the 1st vaccination until at least 60 days after the 2nd vaccination.
  • Acceptable methods of contraception include the following:
  • -Prescription oral contraceptives, contraceptive injections, intrauterine device (IUD), implants, vaginal ring, double-barrier method, contraceptive patch, male partner sterilization, abstinence (defined as refraining from heterosexual intercourse during participation in the study [from 28 days before the first vaccination until at least 60 days after the last vaccination]). Women of non-childbearing potential, defined as postmenopausal (any age with amenorrhea for = / > 12 months without other known or suspected cause for amenorrhea, or surgically sterile (hysterectomy, bilateral tubal ligation, obilateral oophorectomy, or successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with documented confirmation test at least 3 months after the procedure), are not required to use the birth control methods.
  • Female subjects must agree to not donate eggs (ova, oocytes) from the start of screening onwards until at least 60 days after the last vaccination.
  • Male subjects who have not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use an acceptable measure of birth control* from 28 days prior to 1st vaccination until at least 60 days after the last vaccination.
  • Acceptable methods of birth control include the following:
  • Abstinence (defined as refraining from heterosexual intercourse with a female partner of childbearing potential during participation in the study [from 28 days before the first vaccination until at least 60 days after the last vaccination].
  • A double-barrier method of birth control, such as condom with spermicidal foam/gel/film/cream/suppository and partner with occlusive cap (diaphragm, cervical/vault caps).
  • In case the female partner is using an acceptable method of birth control (see Inclusion Criterion #8), a single-barrier method of birth control for the male subject is acceptable.
  • Male subjects must agree to not donate sperm from the start of screening onwards until at least 60 days after the last vaccination.
  • Must be available and willing to participate for the duration of the study visits and follow-up.
  • Must have a means to be contacted by telephone.

Who cannot join

  • Was ever vaccinated with a licensed or investigational YF vaccine or was diagnosed with YF infection or disease*.
  • Includes YF-VAX, Stamaril, or Bio-Manguinhos yellow fever vaccine. Subject's verbal history will suffice.
  • Was ever vaccinated with a licensed or investigational Flavivirus vaccine*.
  • Including Japanese encephalitis virus (JEV) vaccine or an investigational Flavivirus vaccine including dengue virus (DENV) or West Nile virus vaccine, or has been diagnosed with an illness caused by a Flavivirus including DENV, West Nile virus (WNV), JEV, St. Louis encephalitis, or tick-borne encephalitis virus (TBEV). Subject's verbal history will suffice.
  • Positive serology for HIV, Hepatitis C virus, or Hepatitis B surface antigen.
  • Positive serology to Dengue, Yellow Fever, or West Nile virus.
Show all 58Show fewer
  • Plans to travel to a Yellow-Fever endemic area during the course of the study* or travel to a Yellow-Fever endemic area within 30 days of screening.
  • Subjects who have a recent travel to a Yellow Fever endemic area may screen if they have returned to the U.S. 30 or more days prior to the screening visit. Refer to the CDC Yellow Fever map for countries/regions at risk for Yellow Fever virus infection. http://www.cdc.gov/yellowfever/maps/
  • Was ever vaccinated with a licensed or investigational smallpox vaccine* with the exception of subjects in Group 6.
  • Includes Dryvax, Acam2000, LC 16 m8, MVA-based vaccine candidate or licensed vaccines, and Imvamune or Imvanex.
  • -EXCEPTION: Group 6 should have had two 1 x 10^8 TCID 50 doses of MVA-BN 19-45 days apart SC or IM as part of participation in DMID vaccine trials 11-0021 or 09-0002. First dose must have been administered no earlier than 2010.
  • Has known allergy or history of anaphylaxis or other serious adverse reaction to a vaccine or vaccine products*.
  • Including egg products, aminoglycosides, gelatin, sorbitol, tris (hydroxymethyl)-amino methane (THAM), or any of the constituents of the study vaccines.
  • Has severe allergy or anaphylaxis to latex*.
  • Participants in Group 6 will not be exposed to latex and so may have history of severe allergy or anaphylaxis to latex.
  • Has an acute illness or temperature > / = 38.0 degrees Celsius on Day 1 or Day 29*.
  • Subjects with fever or acute illness on the Day of vaccination may be re-assessed and enrolled if healthy or only minor residual symptoms remain within 3 days.
  • Female subjects who are pregnant or breast-feeding, or planning to become pregnant while enrolled in the study.
  • Has history of chronic or acute severe neurologic condition*.
  • Including history of seizure disorder or epilepsy, history of Guillain-Barre syndrome, Bell's palsy, meningitis, or disease with any focal neurologic deficits.
  • Has history of thymus disorder including myasthenia gravis, thymoma or prior thymectomy.
  • Has history of autoimmune disease, or clinically significant cardiac, pulmonary, hepatic, rheumatologic, or renal disease by history, physical examination, and/or laboratory studies*.
  • Includes the conditions and diagnoses defined as AESI.
  • Has history of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure*.
  • Subjects with a history of skin cancer must not be vaccinated at the previous tumor site.
  • Has known or suspected congenital or acquired immunodeficiency, or recent history or current use of immunosuppressive therapy*.
  • Anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 0.5 mg/kg/day). Intranasal or topical prednisone (or equivalent) are allowed.
  • Is post-organ and/or stem cell transplant whether or not on chronic immunosuppressive therapy.
  • Had major surgery (per the investigator's judgment) within the 4 weeks prior to study entry or planned major surgery during the course of the study.
  • Has personal history of recurring migraines (every 6 months or more often) or on prescription medication for treatment of recurring headaches or migraines.
  • Has history of cardiac disease*.
  • Myocarditis, pericarditis, cardiomyopathy, transient ischemic attack or stroke, myocardial infarction, angina, coronary artery disease, congestive heart failure, clinically significant arrhythmia. Includes any arrhythmia requiring medication, treatment, or clinical follow-up.
  • Has electrocardiogram (ECG) with clinically significant findings, or features that would interfere with the assessment of myocarditis/pericarditis*.
  • Including any of the following:
  • Conduction disturbance (complete left or complete right bundle branch block or nonspecific intraventricular conduction disturbance with QRS = / > 120 ms, PR interval > 219 ms, any second-or third-degree atrioventricular block, or prolongation of the QT interval corrected according to Bazett's formula [QTcB] [> 450 ms]).
  • Significant repolarization (ST-segment or T-wave) abnormality.
  • Significant atrial or ventricular arrhythmia; frequent atrial or ventricular ectopy (e.g., frequent premature atrial contractions, 2 premature ventricular contractions in a row).
  • ST-elevation consistent with ischemia or evidence of past or evolving myocardial infarction.
  • Has history of diabetes mellitus type 1 or type 2, including cases controlled with diet alone.
  • -Note: history of isolated gestational diabetes is not an exclusion criterion.
  • Has history of thyroidectomy, or thyroid disease requiring medication during the last 12 months.
  • Has history of hypertension even if medically controlled.
  • -Note: Vital signs must be normal by protocol toxicity grading scale or determined to be normal-variant by investigator. In the event of an abnormal heart rate or blood pressure due to physiological variation or activity, the subject may rest for 10 minutes in a quiet room, and then blood pressure and/or heart rate may be re-measured. Repeated vital signs may be used to determine eligibility.
  • Received live attenuated vaccines from 30 days before Day 1 until 30 days after the 2nd vaccination.
  • Received killed or inactivated vaccines from 14 days before Day 1 until 14 days after the 2nd vaccination.
  • Received experimental therapeutic agents within 3 months prior to the first study vaccination or plans to receive any experimental therapeutic agents during the course of the study.
  • Is currently participating or plans to participate in another clinical study which would involve receipt of the following*:
  • An investigational product, blood drawing, or an invasive medical procedure that would require administration of anesthetics or intravenous dyes or removal of tissue during the study.
  • -Includes endoscopy, bronchoscopy, or administration of IV contrast.
  • Received blood products or immunoglobulin in the 3 months before study entry or planned use during the course of the study.
  • Donated a unit of blood within 8 weeks before Day 1 or plans to donate blood during the course of the study.
  • Has major psychiatric illness during the past 12 months that in the opinion of the investigator would preclude participation.
  • Has current alcohol use or current or past abuse of recreational or narcotic drugs by history as judged by the investigator to potentially interfere with study adherence.
  • Has a history of chronic urticaria (recurrent hives).
  • Has tattoos, scars, or other marks on both deltoid areas which would, in the opinion of the investigator, interfere with assessment of the vaccination site.
  • Is a study site employee* or staff who are paid entirely or partially by/through the OCRR contract for the trial, or staff who are supervised by the PI or Sub-Investigators.
  • Including the Principal Investigator (PI), sub-Investigators listed in Form FDA 1572 or Investigator of Record Form.
  • In the opinion of the investigator cannot communicate reliably, is unlikely to adhere to the requirements of the study, or has any condition which would limit the subject's ability to complete the study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Iowa - Vaccine Research and Education Unit

    Iowa City, Iowa, 52242-2600

  • Saint Louis University Center for Vaccine Development

    St Louis, Missouri, 63104-1015

Other trials in United States

About this study

Official title: A Phase I, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Reactogenicity, and Immunogenicity of MVA-BN Yellow Fever Vaccine With and Without Montanide ISA 720 Adjuvant in 18-45 Year Old Healthy Adults

This study is a multi-center, double-blind, placebo-controlled, Phase I study to evaluate the safety, reactogenicity, tolerability, and immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic-Yellow Fever (MVA-BN-YF) in Flavivirus-naive healthy male and non-pregnant female adult subjects. There are six dose groups in this study. Subjects who have never received a licensed or investigational smallpox vaccine will be randomized to Groups 1-5 and vaccine administration and follow-up will be conducted in a double-blinded fashion. Subjects who have previously received two, 1 x 10^8 TCID50 doses of Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) between 19 and 45 days apart by s ubcutaneous (SC) or intramuscular (IM) routes will be enrolled in Group 6 and will be dosed open-label. Since this is a first in human, phase I study, a sentinel cohort will be utilized. The first two subjects (1st sentinel group) one at each clinical site will be randomized to Group 2 or 3 and vaccinated with MVA-BN-YF with or without Montanide ISA 720 adjuvant (ISA 720). Subjects and study personnel will be blinded as to whether ISA 720 was administered. The primary objectives are the: 1) assessment of the safety, tolerability, and reactogenicity of MVA-BN-YF vaccine administered with or without ISA 720; 2) comparison of the safety, tolerability, and reactogenicity of MVA-BN-YF vaccine administered with or without ISA 720 with Yellow Fever Vaccine (YF-VAX) and MVA-BN.

Read the detailed description

This study is a multi-center, double-blind, placebo-controlled, Phase I study to evaluate the safety, reactogenicity, tolerability, and immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic-Yellow Fever (MVA-BN-YF) in Flavivirus-naive healthy male and non-pregnant female adult subjects. There are six dose groups in this study. Subjects who have never received a licensed or investigational smallpox vaccine will be randomized to Groups 1-5 and vaccine administration and follow-up will be conducted in a double-blinded fashion. Subjects who have previously received two, 1 x 10^8 TCID50 doses of Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) between 19 and 45 days apart by subcutaneous (SC) or intramuscular (IM) routes will be enrolled in Group 6 and will be dosed open-label. Since this is a first in human, phase I study, a sentinel cohort will be utilized. The first two subjects (1st sentinel group) one at each clinical site will be randomized to Group 2 or 3 and vaccinated with MVA-BN-YF with or without Montanide ISA 720 adjuvant (ISA 720). Subjects and study personnel will be blinded as to whether ISA 720 was administered. Subjects will be monitored for safety for one day, and if no pre-defined halting rule is met then two additional subjects (2nd sentinel group) one at each clinical site will be assigned to the group the previous subject was not assigned to. These subjects will be vaccinated and monitored as above. A total of 4 sentinel subjects will be vaccinated. The primary objectives are the: 1) assessment of the safety, tolerability, and reactogenicity of MVA-BN-YF vaccine administered with or without ISA 720; 2) comparison of the safety, tolerability, and reactogenicity of MVA-BN-YF vaccine administered with or without ISA 720 with Yellow Fever Vaccine (YF-VAX) and MVA-BN. The secondary objectives are the: 1) assessment of the immunogenicity against the MVA-BN backbone and Yellow Fever Virus (YF) antigen insert of MVA-BN-YF with and without ISA 720 as assessed by kinetics of the immune responses, seroconversion rates, and peak Geometric Mean Titer (GMT); 2) assessment of the impact of previous MVA-BN vaccination on peak immune responses to YF antigen in MVA-BN-YF; 3) comparison of the peak immunogenicity against YF antigen of 1 or 2 doses of MVA-BN-YF with or without ISA 720 with YF-VAX; 4) comparison of the peak immunogenicity against the MVA-BN backbone of 1 or 2 doses of MVA-BN-YF with or without ISA 720 with MVA-BN; 5) assessment of durability of immune response to YF antigen and MVA-BN at 6 months after 2nd vaccination or placebo administration.

Being tested
ISA-720, MVA Smallpox Vaccine, MVA-BN Yellow Fever Vaccine, Placebo, YF Vax 17D Strain
Keywords
Fever, Immunogenicity, MVA-BN, Reactogenicity, Vaccine, Yellow
Medical subject headings
Yellow Fever, Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ISA-720Drug

    The vaccine adjuvant ISA 720 will be used with Modified Vaccinia Ankara-Bavarian Nordic-Yellow Fever (MVA-BN-YF) as vaccine adjuvant with a depot effect. This comprises slow release of antigen at the injection site, protection of antigen against degradation and strong stimulation of the immune response.

  • MVA Smallpox VaccineBiological

    Modified Vaccinia Ankara-Bavarian Nordic Smallpox Vaccine (MVA BN(R)) is a purified live vaccine will be used as an active comparator.

  • MVA-BN Yellow Fever VaccineBiological

    Modified Vaccinia Ankara-Bavarian Nordic-Yellow Fever (MVA-BN-YF) clinical trial material is manufactured in CEF cells derived from Specific Pathogen Free (SPF) eggs in a bioreactor culture using serum free medium.

  • PlaceboOther

    0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection.

  • PlaceboOther

    0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection.

  • YF Vax 17D StrainBiological

    Yellow Fever Vaccine (YF-VAX) is a vaccine prepared by culturing the 17D-204 strain of yellow fever virus in living avian leucosis virus-free (ALV-free) chicken embryos. Will be used as an active comparator.

Study groups in NCT02743455
Study groupRoleWhat they receive
Group 1Active comparatorSubjects will receive 1.0x10^8 TCID50 of MVA-BN as two doses subcutaneously on Day 1 and Day 29. N=15
Receives: Biological: MVA Smallpox Vaccine
Group 2ExperimentalSubjects will receive 1.0x10^8 TCID50 of MVA-BN-YF as two doses intramuscularly on Day 1 and Day 29. N=15
Receives: Biological: MVA-BN Yellow Fever Vaccine
Group 3ExperimentalSubjects will receive 1.0x10^8 TCID50 of MVA-BN-YF + ISA 720 as two doses intramuscularly on Day 1 and Day 29. N=15
Receives: Drug: ISA-720; Biological: MVA-BN Yellow Fever Vaccine
Group 4ExperimentalSubjects will receive 1.0x10^8 TCID50 of MVA-BN-YF + ISA 720 as a single dose intramuscularly on Day 1 and matching placebo on Day 29. N=15
Receives: Drug: ISA-720; Biological: MVA-BN Yellow Fever Vaccine; Other: Placebo
Group 5Active comparatorSubjects will receive = / > 4.74 log10 PFU of YF-Vax as a single dose subcutaneously on Day 1 and matching placebo on Day 29. N=15
Receives: Other: Placebo; Biological: YF Vax 17D Strain
Group 6ExperimentalSubjects with prior receipt of MVA-BN will receive 1.0x10^8 TCID50 of MVA-BN-YF as two doses intramuscularly on Day 1 and Day 29. N=15
Receives: Biological: MVA-BN Yellow Fever Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of Grade 3 local, systemic or laboratory toxicities, continuous Grade 2 or greater local reactogenicity

    Measured: Day 1 through Day 8

  2. Comparison of Grade 3 local, systemic or laboratory toxicities, continuous Grade 2 or greater local reactogenicity

    Measured: Day 29 through Day 36

  3. Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 1

    Measured: Day 1 through Day 394

  4. Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 2

    Measured: Day 1 through Day 394

  5. Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 3

    Measured: Day 1 through Day 394

  6. Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 4

    Measured: Day 1 through Day 394

  7. Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 5

    Measured: Day 1 through Day 394

  8. Number of adverse events of special interest (AESIs) considered related to study vaccination in Group 6

    Measured: Day 1 through Day 394

  9. Number of adverse events of special interest (AESIs) considered related to study vaccination overall

    Measured: Day 1 through Day 394

  10. Number of related adverse events of special interest (AESIs)

    Measured: Day 1 through Day 394

  11. Number of related serious adverse events (SAEs)

    Measured: Day 1 through Day 394

  12. Number of serious adverse events (SAEs) considered related to study vaccination in Group 1

    Measured: Day 1 through Day 394

  13. Number of serious adverse events (SAEs) considered related to study vaccination in Group 2

    Measured: Day 1 through Day 394

  14. Number of serious adverse events (SAEs) considered related to study vaccination in Group 3

    Measured: Day 1 through Day 394

  15. Number of serious adverse events (SAEs) considered related to study vaccination in Group 4

    Measured: Day 1 through Day 394

  16. Number of serious adverse events (SAEs) considered related to study vaccination in Group 5

    Measured: Day 1 through Day 394

  17. Number of serious adverse events (SAEs) considered related to study vaccination in Group 6

    Measured: Day 1 through Day 394

  18. Number of serious adverse events (SAEs) considered related to study vaccination overall

    Measured: Day 1 through Day 394

  19. Number of subjects with new onset of a chronic medical condition in Group 1

    Measured: Day 1 through Day 394

  20. Number of subjects with new onset of a chronic medical condition in Group 2

    Measured: Day 1 through Day 394

  21. Number of subjects with new onset of a chronic medical condition in Group 3

    Measured: Day 1 through Day 394

  22. Number of subjects with new onset of a chronic medical condition in Group 4

    Measured: Day 1 through Day 394

  23. Number of subjects with new onset of a chronic medical condition in Group 5

    Measured: Day 1 through Day 394

  24. Number of subjects with new onset of a chronic medical condition in Group 6

    Measured: Day 1 through Day 394

  25. Number of subjects with new onset of a chronic medical condition overall

    Measured: Day 1 through Day 394

  26. Number of subjects with unsolicited vaccine-related adverse events (AEs) in Group 1

    Measured: Day 1 through Day 57

  27. Number of subjects with unsolicited vaccine-related adverse events (AEs) in Group 2

    Measured: Day 1 through Day 57

  28. Number of subjects with unsolicited vaccine-related adverse events (AEs) in Group 3

    Measured: Day 1 through Day 57

  29. Number of subjects with unsolicited vaccine-related adverse events (AEs) in Group 4

    Measured: Day 1 through Day 57

  30. Number of subjects with unsolicited vaccine-related adverse events (AEs) in Group 5

    Measured: Day 1 through Day 57

  31. Number of subjects with unsolicited vaccine-related adverse events (AEs) in Group 6

    Measured: Day 1 through Day 57

  32. Number of subjects with unsolicited vaccine-related adverse events (AEs) overall

    Measured: Day 1 through Day 57

  33. Number of vaccine-related laboratory adverse events (AEs) in Group 1

    Measured: Day 1 through Day 57

  34. Number of vaccine-related laboratory adverse events (AEs) in Group 2

    Measured: Day 1 through Day 57

  35. Number of vaccine-related laboratory adverse events (AEs) in Group 3

    Measured: Day 1 through Day 57

  36. Number of vaccine-related laboratory adverse events (AEs) in Group 4

    Measured: Day 1 through Day 57

  37. Number of vaccine-related laboratory adverse events (AEs) in Group 5

    Measured: Day 1 through Day 57

  38. Number of vaccine-related laboratory adverse events (AEs) in Group 6

    Measured: Day 1 through Day 57

  39. Number of withdrawals or discontinuation of vaccinations due to any reason

    Measured: Day 1 through Day 394

  40. Occurrence of solicited injection site reactogenicity events in Group 1

    Measured: Day 1 through Day 8

  41. Occurrence of solicited injection site reactogenicity events in Group 1

    Measured: Day 29 through Day 36

  42. Occurrence of solicited injection site reactogenicity events in Group 2

    Measured: Day 1 through Day 8

  43. Occurrence of solicited injection site reactogenicity events in Group 2

    Measured: Day 29 through Day 36

  44. Occurrence of solicited injection site reactogenicity events in Group 3

    Measured: Day 1 through Day 8

  45. Occurrence of solicited injection site reactogenicity events in Group 3

    Measured: Day 29 through Day 36

  46. Occurrence of solicited injection site reactogenicity events in Group 4

    Measured: Day 1 through Day 8

  47. Occurrence of solicited injection site reactogenicity events in Group 4

    Measured: Day 29 through Day 36

  48. Occurrence of solicited injection site reactogenicity events in Group 5

    Measured: Day 1 through Day 8

  49. Occurrence of solicited injection site reactogenicity events in Group 5

    Measured: Day 29 through Day 36

  50. Occurrence of solicited injection site reactogenicity events in Group 6

    Measured: Day 1 through Day 8

  51. Occurrence of solicited injection site reactogenicity events in Group 6

    Measured: Day 29 through Day 36

  52. Occurrence of solicited injection site reactogenicity events overall

    Measured: Day 1 through Day 8

  53. Occurrence of solicited injection site reactogenicity events overall

    Measured: Day 29 through Day 36

  54. Occurrence of solicited systemic reactogenicity events in Group 1

    Measured: Day 1 through Day 8

  55. Occurrence of solicited systemic reactogenicity events in Group 1

    Measured: Day 29 through Day 36

  56. Occurrence of solicited systemic reactogenicity events in Group 2

    Measured: Day 1 through Day 8

  57. Occurrence of solicited systemic reactogenicity events in Group 2

    Measured: Day 29 through Day 36

  58. Occurrence of solicited systemic reactogenicity events in Group 3

    Measured: Day 1 through Day 8

  59. Occurrence of solicited systemic reactogenicity events in Group 3

    Measured: Day 29 through Day 36

  60. Occurrence of solicited systemic reactogenicity events in Group 4

    Measured: Day 1 through Day 8

  61. Occurrence of solicited systemic reactogenicity events in Group 4

    Measured: Day 29 through Day 36

  62. Occurrence of solicited systemic reactogenicity events in Group 5

    Measured: Day 1 through Day 8

  63. Occurrence of solicited systemic reactogenicity events in Group 5

    Measured: Day 29 through Day 36

  64. Occurrence of solicited systemic reactogenicity events in Group 6

    Measured: Day 1 through Day 8

  65. Occurrence of solicited systemic reactogenicity events in Group 6

    Measured: Day 29 through Day 36

  66. Occurrence of solicited systemic reactogenicity events overall

    Measured: Day 1 through Day 8

  67. Occurrence of solicited systemic reactogenicity events overall

    Measured: Day 29 through Day 36

Secondary outcomes (262)

  1. Comparison of geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 1 and Group 2

    Measured: Day 211

  2. Comparison of geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 1 and Group 3

    Measured: Day 211

  3. Comparison of geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 1 and Group 4

    Measured: Day 211

  4. Comparison of geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 1 and Group 2

    Measured: Day 211

  5. Comparison of geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 1 and Group 3

    Measured: Day 211

  6. Comparison of geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 1 and Group 4

    Measured: Day 211

  7. Comparison of geometric mean titer (GMT) (as measured by PRNT) to YF between Group 5 and Group 2

    Measured: Day 211

  8. Comparison of geometric mean titer (GMT) (as measured by PRNT) to YF between Group 5 and Group 3

    Measured: Day 211

  9. Comparison of geometric mean titer (GMT) (as measured by PRNT) to YF between Group 5 and Group 4

    Measured: Day 211

  10. Comparison of geometric mean titer (GMT) (as measured by PRNT) to YF between Group 5 and Group 6

    Measured: Day 211

  11. Comparison of geometric mean titer (GMT) (as measured by PRNT) to YF between Group 6 and Group 2

    Measured: Day 211

  12. Comparison of geometric mean titer (GMT) (as measured by PRNT) to YF between Group 6 and Group 3

    Measured: Day 211

  13. Comparison of geometric mean titer (GMT) (as measured by PRNT) to YF between Group 6 and Group 4

    Measured: Day 211

  14. Comparison of peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 1 and Group 2

    Measured: Day 1 through Day 211

  15. Comparison of peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 1 and Group 3

    Measured: Day 1 through Day 211

  16. Comparison of peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 1 and Group 4

    Measured: Day 1 through Day 211

  17. Comparison of peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 2 and Group 3

    Measured: Day 1 through Day 211

  18. Comparison of peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 2 and Group 4

    Measured: Day 1 through Day 211

  19. Comparison of peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN between Group 3 and Group 4

    Measured: Day 1 through Day 211

  20. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 1 and Group 2

    Measured: Day 1 through Day 211

  21. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 1 and Group 3

    Measured: Day 1 through Day 211

  22. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 1 and Group 4

    Measured: Day 1 through Day 211

  23. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 2 and Group 3

    Measured: Day 1 through Day 211

  24. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 2 and Group 4

    Measured: Day 1 through Day 211

  25. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR between Group 3 and Group 4

    Measured: Day 1 through Day 211

  26. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 2 and Group 3

    Measured: Day 15 through Day 22

  27. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 2 and Group 3

    Measured: Day 36 through Day 211

  28. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 2 and Group 4

    Measured: Day 15 through Day 22

  29. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 2 and Group 4

    Measured: Day 36 through Day 211

  30. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 2 and Group 5

    Measured: Day 15 through Day 22

  31. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 2 and Group 5

    Measured: Day 36 through Day 211

  32. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 2 and Group 6

    Measured: Day 15 through Day 22

  33. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 2 and Group 6

    Measured: Day 36 through Day 211

  34. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 3 and Group 4

    Measured: Day 15 through Day 22

  35. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 3 and Group 4

    Measured: Day 36 through Day 211

  36. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 3 and Group 5

    Measured: Day 15 through Day 22

  37. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 3 and Group 5

    Measured: Day 36 through Day 211

  38. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 3 and Group 6

    Measured: Day 15 through Day 22

  39. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 3 and Group 6

    Measured: Day 36 through Day 211

  40. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 4 and Group 5

    Measured: Day 15 through Day 22

  41. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 4 and Group 5

    Measured: Day 36 through Day 211

  42. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 4 and Group 6

    Measured: Day 15 through Day 22

  43. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 4 and Group 6

    Measured: Day 36 through Day 211

  44. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 5 and Group 6

    Measured: Day 15 through Day 22

  45. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination between Group 5 and Group 6

    Measured: Day 36 through Day 211

  46. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination with MVA-BN-YF in Group 6 compared to Group 2

    Measured: Day 15 through Day 22

  47. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination with MVA-BN-YF in Group 6 compared to Group 2

    Measured: Day 36 through Day 211

  48. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination with MVA-BN-YF in Group 6 compared to Group 3

    Measured: Day 15 through Day 22

  49. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination with MVA-BN-YF in Group 6 compared to Group 3

    Measured: Day 36 through Day 211

  50. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination with MVA-BN-YF in Group 6 compared to Group 4

    Measured: Day 15 through Day 22

  51. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF after vaccination with MVA-BN-YF in Group 6 compared to Group 4

    Measured: Day 36 through Day 211

  52. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 2 and Group 3

    Measured: Day 1 through Day 211

  53. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 2 and Group 4

    Measured: Day 1 through Day 211

  54. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 2 and Group 5

    Measured: Day 1 through Day 211

  55. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 2 and Group 6

    Measured: Day 1 through Day 211

  56. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 3 and Group 4

    Measured: Day 1 through Day 211

  57. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 3 and Group 5

    Measured: Day 1 through Day 211

  58. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 3 and Group 6

    Measured: Day 1 through Day 211

  59. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 4 and Group 5

    Measured: Day 1 through Day 211

  60. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 4 and Group 6

    Measured: Day 1 through Day 211

  61. Comparison of peak geometric mean titer (GMT) (as measured by PRNT) to YF between Group 5 and Group 6

    Measured: Day 1 through Day 211

  62. Peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 1

    Measured: Day 1 through Day 211

  63. Peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 2

    Measured: Day 1 through Day 211

  64. Peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 3

    Measured: Day 1 through Day 211

  65. Peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 4

    Measured: Day 1 through Day 211

  66. Peak geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 6

    Measured: Day 1 through Day 211

  67. Peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 1

    Measured: Day 1 through Day 211

  68. Peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 2

    Measured: Day 1 through Day 211

  69. Peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 3

    Measured: Day 1 through Day 211

  70. Peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 4

    Measured: Day 1 through Day 211

  71. Peak geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 6

    Measured: Day 1 through Day 211

  72. Peak geometric mean titer (GMT) (as measured by PRNT) to YF in Group 2

    Measured: Day 1 through Day 211

  73. Peak geometric mean titer (GMT) (as measured by PRNT) to YF in Group 3

    Measured: Day 1 through Day 211

  74. Peak geometric mean titer (GMT) (as measured by PRNT) to YF in Group 4

    Measured: Day 1 through Day 211

  75. Peak geometric mean titer (GMT) (as measured by PRNT) to YF in Group 5

    Measured: Day 1 through Day 211

  76. Peak geometric mean titer (GMT) (as measured by PRNT) to YF in Group 6

    Measured: Day 1 through Day 211

  77. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 1

    Measured: Day 15

  78. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 1

    Measured: Day 211

  79. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 1

    Measured: Day 22

  80. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 1

    Measured: Day 36

  81. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 1

    Measured: Day 43

  82. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 1

    Measured: Day 50

  83. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 1

    Measured: Day 57

  84. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 2

    Measured: Day 15

  85. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 2

    Measured: Day 211

  86. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 2

    Measured: Day 22

  87. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 2

    Measured: Day 36

  88. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 2

    Measured: Day 43

  89. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 2

    Measured: Day 50

  90. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 2

    Measured: Day 57

  91. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 3

    Measured: Day 15

  92. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 3

    Measured: Day 211

  93. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 3

    Measured: Day 22

  94. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 3

    Measured: Day 36

  95. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 3

    Measured: Day 43

  96. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 3

    Measured: Day 50

  97. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 3

    Measured: Day 57

  98. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 4

    Measured: Day 15

  99. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 4

    Measured: Day 211

  100. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 4

    Measured: Day 22

  101. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 4

    Measured: Day 36

  102. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 4

    Measured: Day 43

  103. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 4

    Measured: Day 50

  104. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 4

    Measured: Day 57

  105. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 6

    Measured: Day 15

  106. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 6

    Measured: Day 211

  107. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 6

    Measured: Day 22

  108. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 6

    Measured: Day 36

  109. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 6

    Measured: Day 43

  110. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 6

    Measured: Day 50

  111. Per-visit geometric mean titer (GMT) (as measured by ELISA) to MVA-BN in Group 6

    Measured: Day 57

  112. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 1

    Measured: Day 15

  113. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 1

    Measured: Day 211

  114. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 1

    Measured: Day 22

  115. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 1

    Measured: Day 36

  116. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 1

    Measured: Day 43

  117. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 1

    Measured: Day 50

  118. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 1

    Measured: Day 57

  119. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 2

    Measured: Day 15

  120. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 2

    Measured: Day 211

  121. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 2

    Measured: Day 22

  122. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 2

    Measured: Day 36

  123. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 2

    Measured: Day 43

  124. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 2

    Measured: Day 50

  125. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 2

    Measured: Day 57

  126. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 3

    Measured: Day 15

  127. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 3

    Measured: Day 211

  128. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 3

    Measured: Day 22

  129. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 3

    Measured: Day 36

  130. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 3

    Measured: Day 43

  131. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 3

    Measured: Day 50

  132. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 3

    Measured: Day 57

  133. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 4

    Measured: Day 15

  134. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 4

    Measured: Day 211

  135. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 4

    Measured: Day 22

  136. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 4

    Measured: Day 36

  137. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 4

    Measured: Day 43

  138. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 4

    Measured: Day 50

  139. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 4

    Measured: Day 57

  140. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 6

    Measured: Day 15

  141. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 6

    Measured: Day 211

  142. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 6

    Measured: Day 22

  143. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 6

    Measured: Day 36

  144. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 6

    Measured: Day 43

  145. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 6

    Measured: Day 50

  146. Per-visit geometric mean titer (GMT) (as measured by PRNT) to VACV-WR in Group 6

    Measured: Day 57

  147. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 2

    Measured: Day 15

  148. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 2

    Measured: Day 211

  149. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 2

    Measured: Day 22

  150. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 2

    Measured: Day 36

  151. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 2

    Measured: Day 43

  152. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 2

    Measured: Day 50

  153. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 2

    Measured: Day 57

  154. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 3

    Measured: Day 15

  155. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 3

    Measured: Day 211

  156. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 3

    Measured: Day 22

  157. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 3

    Measured: Day 36

  158. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 3

    Measured: Day 43

  159. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 3

    Measured: Day 50

  160. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 3

    Measured: Day 57

  161. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 4

    Measured: Day 15

  162. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 4

    Measured: Day 211

  163. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 4

    Measured: Day 22

  164. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 4

    Measured: Day 36

  165. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 4

    Measured: Day 43

  166. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 4

    Measured: Day 50

  167. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 4

    Measured: Day 57

  168. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 5

    Measured: Day 15

  169. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 5

    Measured: Day 211

  170. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 5

    Measured: Day 22

  171. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 5

    Measured: Day 36

  172. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 5

    Measured: Day 43

  173. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 5

    Measured: Day 50

  174. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 5

    Measured: Day 57

  175. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 6

    Measured: Day 15

  176. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 6

    Measured: Day 211

  177. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 6

    Measured: Day 22

  178. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 6

    Measured: Day 36

  179. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 6

    Measured: Day 43

  180. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 6

    Measured: Day 50

  181. Per-visit geometric mean titer (GMT) (as measured by PRNT) to YF in Group 6

    Measured: Day 57

  182. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1

    Measured: Day 1

  183. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1

    Measured: Day 15

  184. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1

    Measured: Day 211

  185. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1

    Measured: Day 22

  186. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1

    Measured: Day 29

  187. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1

    Measured: Day 36

  188. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1

    Measured: Day 43

  189. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1

    Measured: Day 50

  190. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 1

    Measured: Day 57

  191. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2

    Measured: Day 1

  192. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2

    Measured: Day 15

  193. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2

    Measured: Day 211

  194. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2

    Measured: Day 22

  195. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2

    Measured: Day 29

  196. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2

    Measured: Day 36

  197. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2

    Measured: Day 43

  198. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2

    Measured: Day 50

  199. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 2

    Measured: Day 57

  200. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3

    Measured: Day 1

  201. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3

    Measured: Day 15

  202. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3

    Measured: Day 211

  203. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3

    Measured: Day 22

  204. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3

    Measured: Day 29

  205. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3

    Measured: Day 36

  206. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3

    Measured: Day 43

  207. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3

    Measured: Day 50

  208. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 3

    Measured: Day 57

  209. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4

    Measured: Day 1

  210. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4

    Measured: Day 15

  211. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4

    Measured: Day 211

  212. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4

    Measured: Day 22

  213. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4

    Measured: Day 29

  214. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4

    Measured: Day 36

  215. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4

    Measured: Day 43

  216. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4

    Measured: Day 50

  217. Proportion of subjects seroconverting to MVA-BN (VACV-WR PRNT defined as PRNT50 = / > 2 and MVA-BN ELISA defined as titer = / > 50 or = / > 2-fold rise in ELISA antibody responses compared with baseline if baseline ELISA titer = / > 50) in Group 4

    Measured: Day 57

  218. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2

    Measured: Day 1

  219. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2

    Measured: Day 15

  220. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2

    Measured: Day 211

  221. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2

    Measured: Day 22

  222. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2

    Measured: Day 29

  223. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2

    Measured: Day 36

  224. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2

    Measured: Day 43

  225. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2

    Measured: Day 50

  226. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 2

    Measured: Day 57

  227. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3

    Measured: Day 1

  228. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3

    Measured: Day 15

  229. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3

    Measured: Day 211

  230. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3

    Measured: Day 22

  231. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3

    Measured: Day 29

  232. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3

    Measured: Day 36

  233. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3

    Measured: Day 43

  234. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3

    Measured: Day 50

  235. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 3

    Measured: Day 57

  236. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4

    Measured: Day 1

  237. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4

    Measured: Day 15

  238. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4

    Measured: Day 211

  239. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4

    Measured: Day 22

  240. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4

    Measured: Day 29

  241. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4

    Measured: Day 36

  242. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4

    Measured: Day 43

  243. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4

    Measured: Day 50

  244. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 4

    Measured: Day 57

  245. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5

    Measured: Day 1

  246. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5

    Measured: Day 15

  247. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5

    Measured: Day 211

  248. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5

    Measured: Day 22

  249. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5

    Measured: Day 29

  250. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5

    Measured: Day 36

  251. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5

    Measured: Day 43

  252. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5

    Measured: Day 50

  253. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 5

    Measured: Day 57

  254. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6

    Measured: Day 1

  255. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6

    Measured: Day 15

  256. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6

    Measured: Day 211

  257. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6

    Measured: Day 22

  258. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6

    Measured: Day 29

  259. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6

    Measured: Day 36

  260. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6

    Measured: Day 43

  261. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6

    Measured: Day 50

  262. Proportion of subjects seroconverting to YF (defined as PRNT50 titer = / > 20 or = / > 4-fold increase in neutralizing antibody responses to YF compared with baseline if baseline PRNT50 titer = / > 20) in Group 6

    Measured: Day 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2016 (estimated)
  2. Study start5 Jul 2016
  3. Primary completion22 Mar 2018
  4. Study completion22 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02743455
Sponsor's protocol ID
14-0107
Other IDs
HHSN272201300020I
Status last verified
1 Feb 2019
First submitted
14 Apr 2016
Last updated
9 Feb 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ISA-720, MVA Smallpox Vaccine and MVA-BN Yellow Fever Vaccine in people with Yellow Fever and Yellow Fever Immunisation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 58 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Grade 3 local, systemic or laboratory toxicities, continuous Grade 2 or greater local reactogenicity (time frame: Day 1 through Day 8). The study lists 67 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02743455.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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