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Ebola VirusesPhase 1NCT02280408

Safety and Immunogenicity of Prime-Boost Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-002)

A Phase 1 study testing V920 in people with Ebola Viruses, run by Merck Sharp & Dohme LLC.

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

Ebola virus has infected and killed people, mostly in Africa. In 2014, the Zaire ebolavirus (ZEBOV) has affected several thousand people. There is no approved effective way to treat or prevent Ebola. Researchers are trying to develop a vaccine for it. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Ebola Viruses
What is being tested?
V920
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
No sites listed yet
Study dates
7 Oct 2014to 10 Dec 2015
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy male or females, ages 18 to 65 (inclusive) at the time of screening
  • Females of childbearing potential and all males, must be willing to use effective methods of contraception, from at least 14 days prior to vaccination through Day 56 which would include:
  • Oral contraceptives, either combined or progestogen alone
  • injectable progestogen
  • implants of etonogestrel or levonorgestrel
  • oestrogenic vaginal ring
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  • percutaneous contraceptive patches
  • intrauterine device or intrauterine system
  • male partner sterilization
  • male condom combined with a spermicide
  • Must be willing to minimize blood and body fluid exposure of others for at least 7 days after vaccination, which includes:
  • Use of effective barrier prophylaxis, such as latex condoms, during any sexual interaction (regardless of childbearing status or sexual orientation)
  • Avoiding the sharing of needles, razors, eating utensils, drinking from the same cup, or toothbrushes
  • Avoiding open-mouth kissing
  • Must be willing to forgo blood donation for one year
  • Must agree not to enroll in another study of an investigational agent prior to completion of Day 56 and not participate in an investigational vaccine study until the last required protocol visit on Day 365
  • Ability to provide informed consent

Who cannot join

  • FACTORS THAT INCREASE RISK TO THE SUBJECT:
  • Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
  • A process that would affect the immune response
  • A process that would require medication that affects the immune response
  • Any contraindication to repeated injections or blood draws
  • A condition that requires active medical intervention or monitoring to avert grave danger to the participant's health or well-being during the study period
Show all 46Show fewer
  • A condition or process for which signs or symptoms could be confused with reactions to vaccine
  • Any condition specifically listed among the exclusion criteria below
  • Active malignancy
  • Asplenia
  • History of Guillain-Barré Syndrome
  • History of neurological or neuropsychiatric disorder that may either increase risk (history of encephalitis, narcolepsy, stroke, depression, bipolar disorder, seizure, etc.) or could interfere with the assessment of safety (e.g., frequent headaches)
  • History of autoimmune disease
  • History of hemoglobinopathy or a coagulopathy
  • Women who are breast-feeding
  • Positive urine or serum pregnancy test
  • Abnormal chemistry panel; defined as:
  • Defined as any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table
  • Evaluating only creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, and estimated glomerular filtration rate
  • Abnormal complete blood count (CBC) defined as:
  • Defined as any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table
  • Evaluating only the white blood cell (WBC), hemoglobin, hematocrit, and platelets
  • Abnormal urinalysis defined as:
  • Defined as any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table
  • Evaluating red blood cells (RBC), protein, and glucose only
  • Positive serology for hepatitis B surface antigen
  • Positive serology for hepatitis C
  • Positive serology for human immunodeficiency virus (HIV)
  • Known allergy to the components of the VSVΔG-ZEBOV vaccine (V920) vaccine product (VSV, albumin, tris)
  • History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
  • FACTORS THAT MAY LIMIT VSV REPLICATION OR MAKE INTERPRETATION OF IMMUNOGENICITY DIFFICULT:
  • History of prior infection with a filovirus or prior participation in a filovirus vaccine trial
  • Veterinarian or ranchers exposed to livestock known to be infected with VSV
  • History of prior infection with VSV or receipt of a VSV vectored vaccine
  • FACTORS THAT WOULD INCREASE RISK TO OTHERS DUE TO VSV VIRAL SHEDDING:
  • Is a healthcare worker who will have direct contact with patients within 14 days of each vaccination
  • Is an animal care worker, who will have direct contact with animals (livestock or domestic, besides subjects family pet) within 14 days of each vaccination
  • Has a house-hold contact (HHC) who is immunodeficient (in the opinion of the investigator), pregnant, has an unstable medical condition, or is under the age of 5 years
  • Is a childcare worker who has direct contact with children 5 years of age or younger
  • FACTORS THAT COULD IMPAIR INTERPRETATION OR EXECUTION OF THE STUDY:
  • Receipt of any investigational drug within 5 half-lives or 30 days, whichever is longer, prior to study drug administration (i.e., Day 0)
  • Receipt of licensed vaccines 14 days before the planned study immunization
  • Receipt of immunoglobulins and/or any blood products within the 120 days preceding study entry or that are planned during the study period
  • Immunosuppressive medications received within 168 days before first vaccination. (Not including: [1] corticosteroid nasal spray for allergic rhinitis; [2] topical corticosteroids for mild, uncomplicated dermatitis; or [3] oral/parenteral corticosteroids given for non-chronic conditions not expected to recur [length of therapy 10 days or less with completion at least 30 days prior to vaccination(s)].)
  • Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled through Day 56
  • Participants who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol

About this study

Official title: A Phase 1 Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of Prime-Boost VSV Ebola Vaccine in Healthy Adults

Ebola virus has infected and killed people, mostly in Africa. In 2014, the Zaire ebolavirus (ZEBOV) has affected several thousand people. There is no approved effective way to treat or prevent Ebola. Researchers are trying to develop a vaccine for it. This is a study of the anti-Ebola vaccine vesicular stomatitis virus (VSV) ZEBOV (V920; BPSC-1001) to see if it is safe and to see how it affects people's immune system.

Read the detailed description

Between 1994 and the present, there have been many Ebola virus (EBOV) outbreaks affecting mostly central Africa. However, the 2014 West African outbreak significantly exceeds all previous outbreaks in geographic range, number of individuals affected and in disruption of typical activities of civil society.

This is a Phase 1 safety and tolerability study to evaluate a novel vaccine to Ebola using a live VSV replacing the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Zaire strain of Ebola (VSVΔG-ZEBOV also known as V920 and BPSC-1001).

Conditions
Ebola Viruses
Being tested
Placebo, V920

What participants receive

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

  • PlaceboOther

    Normal saline placebo.

  • V920Biological

    Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^6, 2x10^7, or 1x10^8 pfu.

Study groups in NCT02280408
Study groupRoleWhat they receive
3x10^6 plaque-forming units (pfu) Vaccine CohortExperimentalParticipants will receive a 1-mL intramuscular injection of V920 3x10^6 pfu in the deltoid on Day 0 and Day 28.
Receives: Biological: V920
2x10^7 pfu Vaccine CohortExperimentalParticipants will receive a 1-mL intramuscular injection of V920 2x10^7 pfu in the deltoid on Day 0 and Day 28.
Receives: Biological: V920
1x10^8 pfu Vaccine CohortExperimentalParticipants will receive a 1-mL intramuscular injection of V920 1x10^8 pfu in the deltoid on Day 0 and Day 28.
Receives: Biological: V920
Placebo CohortPlacebo comparatorParticipants will receive a 1-mL intramuscular injection of placebo in the deltoid on Day 0 and Day 28.
Receives: Other: Placebo

What is being measured

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

  1. Percentage of Participants With 1 or More Unsolicited AE : Vaccination 1

    An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. An unsolicited AE was an AE other than those specifically designated local or systemic. The percentage of participants that experienced at least 1 unsolicited AE was summarized.

    Measured: Up to 28 days post vaccination 1 (From Day 1 up to Day 28)

  2. Percentage of Participants With 1 or More Unsolicited AE : Vaccination 2

    An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. An unsolicited AE was an AE other than those specifically designated local or systemic. The percentage of participants that experienced at least 1 unsolicited AE was summarized.

    Measured: Up to 28 days post vaccination 2 (From Day 29 to Day 56)

  3. Percentage of Participants With 1 or More Solicited Systemic Adverse Event (AE) by Severity: Vaccination 1

    A solicited AE was a predetermined specific event. The solicited systemic AEs for this study were the following: redness, swelling, or pain at site of injection, subjective and objective fever, chills, sweats, myalgia, arthralgia, fatigue, headache and gastrointestinal symptoms (nausea, vomiting, abdominal pain, and/or diarrhea). All AEs were assessed for severity by the investigator according to the Food and Drug Administration(FDA's) Guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" and were classified into 4 categories: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3) and Potentially Life-Threatening (Grade 4). The percentage of participants that experienced at least 1 solicited systemic AE were summarized by grade.

    Measured: Up to 14 days post vaccination 1 (From Day 1 up to Day 14)

  4. Percentage of Participants With 1 or More Solicited Systemic AE by Severity: Vaccination 2

    A solicited AE was a predetermined specific event. The solicited systemic AEs for this study were the following: redness, swelling, or pain at site of injection, subjective and objective fever, chills, sweats, myalgia, arthralgia, fatigue, headache and gastrointestinal symptoms (nausea, vomiting, abdominal pain, and/or diarrhea). All AEs were assessed for severity by the investigator according to the Food and Drug Administration(FDA's) Guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" and were classified into 4 categories: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3) and Potentially Life-Threatening (Grade 4). The percentage of participants that experienced at least 1 solicited systemic AE were summarized by grade.

    Measured: Up to 14 days post vaccination 2 (Day 29 up to Day 42)

  5. Percentage of Participants With One or More Serious Adverse Event

    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the study vaccine. An SAE is an AE that results in death, is life-threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. The percentage of participants that experienced 1 or more SAEs was summarized.

    Measured: Up to Day 56 (Day 1 up to Day 56)

  6. Percentage of Participants With 1 or More Solicited Local Injection-site AE by Severity: Vaccination 1

    A solicited AE was a predetermined specific event. The solicited local AEs for this study were the following: Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). All AEs were assessed for severity by the investigator according to the Food and Drug Administration(FDA's) Guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" and were classified into 4 categories: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3) and Potentially Life-Threatening (Grade 4). The percentage of participants that experienced at least 1 solicited local AE was summarized by grade.

    Measured: Up to 14 days post vaccination 1 (Day 1 to Day 14)

  7. Percentage of Participants With 1 or More Solicited Local Injection-site AE by Severity: Vaccination 2

    A solicited AE was a predetermined specific event. The solicited local AEs for this study were the following: Local reactogenicity signs and symptoms include pain, erythema (redness), and induration (swelling). All AEs were assessed for severity by the investigator according to the Food and Drug Administration(FDA's) Guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" and were classified into 4 categories: Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3) and Potentially Life-Threatening (Grade 4). The percentage of participants that experienced at least 1 solicited local AE was summarized by grade.

    Measured: Up to 14 days post vaccination 2 (Day 29 up to Day 42)

  8. Percentage of Participants With Early Discontinuation of Vaccination

    The percentage of participants that had vaccination discontinued for any reason was summarized.

    Measured: Up to Day 28

Secondary outcomes (8)

  1. Geometric Mean Titers of Zaire Ebolavirus-(ZEBOV)-Specific Immunoglobin G (IgG) Antibodies: Day 28

    Blood was drawn on Day 28 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by enzyme-linked immunosorbent assay (ELISA).

    Measured: Day 28

  2. Geometric Mean Titers of ZEBOV-specific IgG Antibodies: Day 56

    Blood was drawn on Day 56 to assess the GMTs of ZEBOV-specific IgG antibodies as determined by Enzyme-linked immunosorbent assay (ELISA).

    Measured: Day 56 (28 days post vaccination 2)

  3. Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies: Day 28

    Blood was drawn on Day 28 to assess the GMTs of Zaire ebolavirus neutralizing antibodies as determined by Pseudovirion neutralizing assay (PsVNA). Titers are reported for PsVNA50 values, which was derived from the reciprocal of the dilution that resulted in a 50% decrease in luciferase activity.

    Measured: Day 28 (28 days post vaccination 1)

  4. Geometric Mean Titers of ZEBOV-specific Neutralizing Antibodies: Day 56

    Blood was drawn on Day 56 to assess the GMTs of Zaire ebolavirus neutralizing antibodies as determined by Pseudovirion neutralizing assay (PsVNA). Titers are reported for PsVNA50 values, which was derived from the reciprocal of the dilution that resulted in a 50% decrease in luciferase activity.

    Measured: Day 56 (28 days post vaccination 2)

  5. Percentage of Participants Who Seroconvert: Day 28

    GMTs for Zebov-specific antibodies were determined via ELISA. Seroconversion was defined as a post-vaccination titer ≥ 200 that is also at least a 4-fold increase in titer compared to baseline.

    Measured: Day 28 (28 days post vaccination 1)

  6. Percentage of Participants Who Seroconvert: Day 56

    GMTs for Zebov-specific antibodies were determined via ELISA. Seroconversion was defined as a post-vaccination titer ≥ 200 that is also at least a 4-fold increase in titer compared to baseline.

    Measured: Day 56 (28 days post vaccination 2)

  7. Percentage of Participants With Viremia on Day 3 and Day 7: Vaccination 1

    Blood was drawn on Days 3 and 7 to assess the presence of V920 via polymerase chain reaction (PCR) assay. The percentage of participants that were positive for V920 in serum was summarized.

    Measured: Day 3 and Day 7 post vaccination 1

  8. Percentage of Participants With Viremia on Day 3 and Day 7: Vaccination 2

    Blood was drawn on Days 3 and 7 to assess the presence of V920 via polymerase chain reaction (PCR) assay. The percentage of participants that were positive for V920 in serum was summarized.

    Measured: Day 3 and Day 7 post vaccination 2 (Day 31 and Day 35)

Timeline

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

  1. First posted31 Oct 2014 (estimated)
  2. Study start7 Oct 2014
  3. Primary completion10 Dec 2015
  4. Study completion10 Dec 2015

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
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02280408
Sponsor's protocol ID
V920-002
Other IDs
NLG0207 (Study 15-I-0001)
Status last verified
Jul 2019
First submitted
23 Oct 2014
Last updated
12 Jul 2019
Data monitoring committee
No
Individual data sharing
Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Coller BG, Blue J, Das R, Dubey S, Finelli L, Gupta S, Helmond F, Grant-Klein RJ, Liu K, Simon J, Troth S, VanRheenen S, Waterbury J, Wivel A, Wolf J, Heppner DG, Kemp T, Nichols R, Monath TP. Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic. Vaccine. 2017 Aug 16;35(35 Pt A):4465-4469. doi: 10.1016/j.vaccine.2017.05.097. Epub 2017 Jun 21.

    PubMed 28647166

  • Regules JA, Beigel JH, Paolino KM, Voell J, Castellano AR, Hu Z, Munoz P, Moon JE, Ruck RC, Bennett JW, Twomey PS, Gutierrez RL, Remich SA, Hack HR, Wisniewski ML, Josleyn MD, Kwilas SA, Van Deusen N, Mbaya OT, Zhou Y, Stanley DA, Jing W, Smith KS, Shi M, Ledgerwood JE, Graham BS, Sullivan NJ, Jagodzinski LL, Peel SA, Alimonti JB, Hooper JW, Silvera PM, Martin BK, Monath TP, Ramsey WJ, Link CJ, Lane HC, Michael NL, Davey RT Jr, Thomas SJ; rVSVDeltaG-ZEBOV-GP Study Group. A Recombinant Vesicular Stomatitis Virus Ebola Vaccine. N Engl J Med. 2017 Jan 26;376(4):330-341. doi: 10.1056/NEJMoa1414216. Epub 2015 Apr 1.

    PubMed 25830322

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing V920 in people with Ebola Viruses, run by Merck Sharp & Dohme LLC.

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 17 inclusion and 46 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 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 12 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With 1 or More Unsolicited AE : Vaccination 1 (time frame: Up to 28 days post vaccination 1 (From Day 1 up to Day 28)). The study lists 8 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 NCT02280408, which also lists 2 linked publications.

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 12 Jul 2019.

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