18-42 Year Old Healthy Vaccinia-naïve SubjectsPhase 3NCT01913353
A Non-inferiority Trial to Compare MVA-BN® Smallpox Vaccine to ACAM2000®
A Phase 3 study testing MVA BN® and ACAM2000® in people with 18-42 Year Old Healthy Vaccinia-naïve Subjects, run by Bavarian Nordic at 1 site in South Korea.
Trial summary
To demonstrate the efficacy of MVA-BN® in terms of vaccinia-specific Plaque Reduction Neutralization Test (PRNT) antibody response and by showing that vaccination prior to administration of ACAM2000® results in an attenuated take. Read more about this study
- Who is it for?
- Ages 18 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- 18-42 Year Old Healthy Vaccinia-naïve Subjects
- What is being tested?
- MVA BN® and ACAM2000®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Aug 2017
- Phase
- Phase 3
- 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 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects, 18-42 years of age
- The subject has read, signed and dated the Informed Consent, having been advised of the risks and benefits of the trial in a language understood by the subject and prior to performance of any trial specific procedure
- Acceptable medical history by screening evaluation and physical examination
- BMI greater or eaqual than 18.5 and smaller than 35
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening and a negative urine or serum pregnancy test within 24 hours prior to each vaccination
- WOCBP must have used an acceptable method of contraception for 28 days prior to the first vaccination, must agree to use an acceptable method of contraception during the trial, and must avoid becoming pregnant for at least 28 days after the last vaccination. A woman is considered of childbearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products)
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- Human Immunodeficiency Virus (HIV) antibody negative, hepatitis B surface antigen negative and negative antibody test to hepatitis C virus
- White blood cells greater or eaqual than 2500/mm3 and smaller than 11,000/mm3
- Hemoglobin within normal limits
- Platelets greater or eaqual than lower normal limits
- Adequate renal function defined as a calculated Creatinine Clearance (CrCl) greater than 60 ml/min as estimated by the Cockcroft-Gault equation
- Adequate hepatic function in the absence of other evidence of significant liver disease defined as:
- Total bilirubin greater than 1.5 x Upper Limit Normal (ULN)
- Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) greater than 1.5 x ULN
- Alkaline Phosphatase (Alk Phos) greater than 1.5 x ULN
- Troponin I smaller than 2 x ULN
- Electrocardiogram (ECG) without clinically significant findings, e.g. any kind of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, atrioventricular node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, two premature ventricular contractions in a row, ST elevation consistent with ischemia
Who cannot join
- Pregnant or breast-feeding women
- Typical vaccinia scar
- Known or suspected history of smallpox vaccination defined as visible vaccination scar or documentation of smallpox vaccination or as reported by the subject
- History of vaccination with any poxvirus-based vaccine
- History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject
- History of or active immunodeficiency or immunosuppression caused by acquired or congenital diseases or caused by ongoing treatments such as chronic (greater than 14 days) high-dose corticosteroids (smaller than 5 mg prednisone [or equivalent] per day applied systemically, i.e. parenterally or orally), chronic or planned treatment with steroid eye drops or ointment at time of enrollment or radiation, or immunosuppressive drugs; low-dose corticosteroid topical products and nasal sprays used sporadically, i.e. pro re nata (according to circumstances) are permissible
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- Having had radiation or X-ray treatment (not routine X-rays) within the last 3 months
- Post organ and bone-marrow transplant subjects whether or not receiving chronic immunosuppressive therapy
- Eye surgery within 4 weeks prior to trial vaccination
- History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded
- Uncontrolled serious infection, i.e. not responding to antimicrobial therapy
- History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision considered to have achieved cure. Subjects with history of skin cancer must not be vaccinated at the previous site of cancer
- History of keloid formation
- History or clinical manifestation of severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders
- History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor
- Chest pain (that is diagnosed as cardiac related) or trouble breathing on exertion
- Ten percent or greater risk of developing a myocardial infarction or coronary death within the next 10 years using the National Cholesterol Education Program's Risk Assessment Tool: http://hin.nhlbi.nih.gov/atpiii/calculator.asp NOTE: This criterion applies only to subjects 20 years of age and older
- History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before the age of 50 years
- Clinically significant psychological disorder not adequately controlled by medical treatment
- Active or history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse (within the past 6 months)
- History of anaphylaxis or any severe allergic reaction or serious adverse reaction to a vaccine
- Eczema of any degree or history of eczema
- People with active atopic dermatitis (AD) [characterized by pruritus, eczematous lesions, xerosis (dry skin), and lichenification (thickening of the skin and an increase in skin markings] or with a history of AD
- People with chronic exfoliative skin disorders/conditions
- People with active current Varicella zoster, Herpes zoster, impetigo, uncontrolled acne, Darier's disease or any acute skin disorders of large magnitude, e.g., laceration requiring sutures
- People with a tattoo that covers the vaccination injection area (preventing assessment of the area and interfering with a vaccination site photograph)
- Having received any vaccinations or planned vaccinations with a live vaccine within 28 days prior to or after trial vaccination
- Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior to or after trial vaccination
- Administration or planned administration of immunoglobulins and/or any blood products during a period starting from three months prior to administration of the vaccine and ending at trial conclusion
- Use of any investigational or non-registered drug or vaccine other than the trial vaccines within 28 days preceding the first dose of the trial vaccine or planned administration of such a drug /vaccine during the trial period
- Blood donation for the duration of the trial
- Acute disease (illness with or without a fever) at the time of enrollment
- Temperature ≥ 100.4°F (38.0°C) at the time of enrollment
- Known household contacts with, or occupational exposure (other than minimal contact) to any of the following:
- Pregnant women
- Children <12 months of age
- People with eczema or a history of eczema
- People with active AD or history of AD
- People with chronic exfoliative skin disorders/conditions
- People with active Varicella zoster, Herpes zoster, impetigo, uncontrolled acne, Darier's disease or any acute skin disorders of large magnitude, e.g., laceration requiring sutures, burn with areas greater than 2×2 cm
- People with active or recent immunodeficiency disease or use of immunosuppressive medications, for example: have or take medication for HIV, AIDS, leukemia, lymphoma, or chronic liver problem, have or take medication for Crohn's disease, lupus, arthritis, or other immune disease; have had radiation or X-ray treatment (not routine X-rays) within the last 3 months; have ever had a bone-marrow or organ transplant (or take medication for that ); or have another problem that requires steroids, prednisone or a cancer drug for treatment
- People having had eye surgery within the last 4 weeks
- Known allergy to MVA-BN® vaccine or any of its constituents, e.g. tris(hydroxymethyl)-amino methane, including known allergy to egg or aminoglycoside (gentamycin)
- Known allergies to ACAM2000® and its diluents including polymyxin B sulfate, neomycin sulfate, and phenol
- Known allergies to vaccinia immunoglobulin (VIG) including thimerosal or previous allergic reaction to immunoglobulins
- Known allergies to cidofovir, sulfa drugs, or probenecid
- Trial personnel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label Phase III Non-inferiority Trial to Compare Indicators of Efficacy for MVA-BN® Smallpox Vaccine to ACAM2000® in 18-42 Year Old Healthy Vaccinia-naïve Subjects
To demonstrate the efficacy of MVA-BN® in terms of vaccinia-specific Plaque Reduction Neutralization Test (PRNT) antibody response and by showing that vaccination prior to administration of ACAM2000® results in an attenuated take.
Read the detailed description
To demonstrate the efficacy of MVA-BN® by assessing non-inferiority of MVA-BN® compared to ACAM2000® in terms of vaccinia-specific Plaque Reduction Neutralization Test (PRNT) antibody response at the Peak Visits (Day 42 for Group 1 and Day 28 for Group 2) and by showing that vaccination with MVA-BN® prior to administration of ACAM2000® results in an attenuation of take.
- Being tested
- MVA BN®, ACAM2000®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA BN®Biological
Also called IMVAMUNE, IMVANEX
0.5 ml MVA BN® with a nominal titer of 1x10E8 TCID50, administered as a subcutaneous injection
ACAM2000®Biological
0.0025 ml ACAM2000®, consisting of 2.5-12.5x10E5 plaque forming units of live vaccinia virus (VACV). Picked up with a bifurcated needle and administered by the percutaneous route (scarification) using 15 jabs of that bifurcated needle.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Two vaccinations; MVA BN ®; administered 4 weeks apart (Day 0 and Day 28) followed by a single vaccination of ACAM2000® vaccine 4 weeks after the second MVA BN® vaccination (Day 56). Receives: Biological: MVA BN®; Biological: ACAM2000® |
| Group 2 | Active comparator | A single vaccination of ACAM2000® will be administered at Day 0. Receives: Biological: ACAM2000® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Reduction Neutralization Test (PRNT) Geometric Mean Titer (GMT) at the Peak Visits
GMT based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of 1.
Measured: Day 42 for Group 1 and Day 28 for Group 2
Maximum Lesion Area (MLA) in mm2 After Scarification With ACAM2000®
The MLA was defined as the maximum of two measurements: the lesion area measured on Day 6-8 (after scarification) or the lesion area measured on Day 13-15 (after scarification). This was measured using the SilhouetteConnect camera system, and confirmed by the Independent Take Review Committee (ITRC).
Measured: Day 6-8, 13-15 after 3rd Vaccination for Group 1 and Day 6-8, 13-15 after 1st vaccination for Group 2
Secondary outcomes (22)
Investigator-measured Maximum Lesion Diameter (MLD) in mm After Scarification With ACAM2000
The MLD was defined as the largest major diameter measured across the lesion on Day 6-8 (after scarification) or Day 13-15 (after scarification)
Measured: Day 6-8 and Day 13-15 after ACAM2000 scarification
Investigator-measured Lesion Diameter in mm at Day 6-8 After Scarification With ACAM2000
The lesion diameter at Day 6-8 was defined as the major lesion diameter measured on Day 6-8 (after scarification)
Measured: Day 6-8 after ACAM2000 scarification
Investigator-measured Lesion Diameter in mm at Day 13-15 After Scarification With ACAM2000
The lesion diameter at Day 13-15 was defined as the major lesion diameter measured on Day 13-15 (after scarification)
Measured: Day 13-15 after ACAM2000 scarification
Individual Take as Classified by a Blinded Independent Take Review Committee (ITRC)
Take was assessed as either full, partial, or absent take by the ITRC based on Day 6-8 evaluations following ACAM2000 vaccination using subject profiles that contained supportive data up to Day 14 following ACAM2000 vaccination (in accordance with the ITRC Charter).
Measured: Day 6-8 visit following ACAM2000 vaccination
Lesion Area in mm2 at Day 6-8 After Scarification With ACAM2000
Lesion area was measured by the Investigator using the SilhouetteConnect camera system and confirmed by the blinded ITRC.
Measured: Day 6-8 after ACAM2000 scarification
Lesion Area in mm2 at Day 13-15 After Scarification With ACAM2000
Lesion area was measured by the Investigator using the SilhouetteConnect camera system and confirmed by the blinded ITRC.
Measured: Day 13-15 after ACAM2000 scarification
Relationship to Vaccine of Any Serious Adverse Event (SAE)
Presentation of SAEs by relationship to study vaccine
Measured: Within 38 weeks for Group 1 and 30 weeks for Group 2
Intensity of Any Serious Adverse Event (SAE)
Presentation of SAEs by intensity
Measured: Within 38 weeks for Group 1 and 30 weeks for Group 2
Incidence of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis, i.e. Adverse Events of Special Interest (AESIs)
In this clinical trial, an AESI was defined as any cardiac sign or symptom developed since the first vaccination, any ECG changes determined to be clinically significant, or any cardiac enzyme results of Troponin I ≥ 2 x ULN.
Measured: Within 38 weeks for Group 1 and 30 weeks for Group 2
Related Grade >=3 Adverse Events
Incidence of any Grade 3 or 4 adverse events (AEs) possibly, probably, or definitely related to the vaccine. Pooled solicited (general only) and unsolicited AEs.
Measured: within 29 days after vaccination
Relationship to Vaccine of Any Non-serious AEs
Presentation of non-serious AEs by relationship to study vaccine
Measured: within 29 days after vaccination
Intensity of Any Non-serious AEs
Presentation of non-serious AEs by intensity
Measured: within 29 days after vaccination
Solicited General AEs
Occurrence, intensity and relationship of solicited general AEs (body temperature [fever], headache, myalgia [muscle pain], chills, nausea, fatigue, malaise)
Measured: within 15 days after vaccination
Incidence of Lymphadenopathy
Incidence of events of Lymphadenopathy. Pooled solicited and unsolicited events.
Measured: within 29 days after vaccination
Solicited Local AEs: Intensity
Incidence of solicited local AEs (pain, redness [erythema], swelling, induration, itching [pruritus])
Measured: within 15 days after vaccination
Major Lesion Size, Major Erythema, and Major Induration Diameter
Daily measurement of major lesion size, major erythema, and major induration diameter (mm) based on physical appearance of vaccination site as documented in the memory aid. If the shape of the lesion, erythema [excludes lymphangitis], and induration observed was not round but rather asymmetrical, then the largest [or major] cross-sectional measurement was recorded.
Measured: Within 15 days after scarification with ACAM2000
GMTs at the Peak Visits and Individual Peak Measured by Vaccinia-specific ELISA
Peak Visit was defined as Day 42 for Group 1 and Day 28 for Group 2. Individual Peak was the maximum titer per subject from Visit 1 to Visit 7 (Week 8) in Group 1 and maximum titer from Visit 1 to Visit 6 (Week 8) in Group 2.
Titers below the detection limit are included with a value of 1.
Measured: within 8 weeks (for both groups)
GMTs at the Individual Peak Measured by Vaccinia-specific PRNT
Individual Peak was the maximum titer per subject from Visit 1 to Visit 7 (Week 8) in Group 1 and maximum titer from Visit 1 to Visit 6 (Week 8) in Group 2.
Titers below the detection limit are included with a value of 1.
Measured: within 8 weeks (for both groups)
GMTs as Measured by Vaccinia-specific ELISA
GMT based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.
Measured: within 12 weeks
GMTs as Measured by Vaccinia-specific PRNT
GMT based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.
Measured: within 12 weeks
PRNT Seroconversion Rates at Peak Visits
Seroconversion rate based on PRNT. Seroconversion is defined as the appearance of antibody titers "greater than or equal" detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Measured: Group 1 at Week 6; Group 2 at Week 4
ELISA Seroconversion Rates at Peak Visits
Seroconversion rate based on ELISA. Seroconversion is defined as the appearance of antibody titers "greater than or equal" detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Measured: Group 1 at Week 6; Group 2 at Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startMar 2015
- Primary completionMar 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 18-42 Year Old Healthy Vaccinia-naïve SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- US Army Medical Research Institute of Infectious Diseases
- Responsible party
- Sponsor
- Investigators
- Phillip R Pittman, MD, MPH, Principal investigator, US Army Medical Research Institute of Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913353
- Sponsor's protocol ID
- POX-MVA-006
- Status last verified
- Nov 2019
- First submitted
- 26 Jul 2013
- Last updated
- 5 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Pittman PR, Hahn M, Lee HS, Koca C, Samy N, Schmidt D, Hornung J, Weidenthaler H, Heery CR, Meyer TPH, Silbernagl G, Maclennan J, Chaplin P. Phase 3 Efficacy Trial of Modified Vaccinia Ankara as a Vaccine against Smallpox. N Engl J Med. 2019 Nov 14;381(20):1897-1908. doi: 10.1056/NEJMoa1817307.
PubMed 31722150
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Phase III Non-inferiority Trial to Compare Indicators of Efficacy for MVA-BN® Smallpox Vaccine to ACAM2000® in 18-42 Year Old Healthy Vaccinia-naïve Subjects
- ClinicalTrials.gov ID
- NCT01913353
- Acronym / sponsor ID
- POX-MVA-006
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Collaborators
- US Army Medical Research Institute of Infectious Diseases
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Posted 5 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the efficacy of MVA-BN® in terms of vaccinia-specific Plaque Reduction Neutralization Test (PRNT) antibody response and by showing that vaccination prior to administration of ACAM2000® results in an attenuated take.
Detailed description
To demonstrate the efficacy of MVA-BN® by assessing non-inferiority of MVA-BN® compared to ACAM2000® in terms of vaccinia-specific Plaque Reduction Neutralization Test (PRNT) antibody response at the Peak Visits (Day 42 for Group 1 and Day 28 for Group 2) and by showing that vaccination with MVA-BN® prior to administration of ACAM2000® results in an attenuation of take.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: MVA BN®, Biological: ACAM2000®Two vaccinations; MVA BN ®; administered 4 weeks apart (Day 0 and Day 28) followed by a single vaccination of ACAM2000® vaccine 4 weeks after the second MVA BN® vaccination (Day 56). |
| Group 2 | Active comparator | Biological: ACAM2000®A single vaccination of ACAM2000® will be administered at Day 0. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Healthy male and female subjects, 18-42 years of age
- The subject has read, signed and dated the Informed Consent, having been advised of the risks and benefits of the trial in a language understood by the subject and prior to performance of any trial specific procedure
- Acceptable medical history by screening evaluation and physical examination
- BMI greater or eaqual than 18.5 and smaller than 35
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening and a negative urine or serum pregnancy test within 24 hours prior to each vaccination
Key exclusion criteria (47 listed)
- Pregnant or breast-feeding women
- Typical vaccinia scar
- Known or suspected history of smallpox vaccination defined as visible vaccination scar or documentation of smallpox vaccination or as reported by the subject
- History of vaccination with any poxvirus-based vaccine
- History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVA BN®Also: IMVAMUNE, IMVANEX0.5 ml MVA BN® with a nominal titer of 1x10E8 TCID50, administered as a subcutaneous injection | Biological | Group 1 |
| ACAM2000®0.0025 ml ACAM2000®, consisting of 2.5-12.5x10E5 plaque forming units of live vaccinia virus (VACV). Picked up with a bifurcated needle and administered by the percutaneous route (scarification) using 15 jabs of that bifurcated needle. | Biological | Group 1, Group 2 |
Primary outcome
Plaque Reduction Neutralization Test (PRNT) Geometric Mean Titer (GMT) at the Peak Visits
Time frame: Day 42 for Group 1 and Day 28 for Group 2
GMT based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of 1.
Maximum Lesion Area (MLA) in mm2 After Scarification With ACAM2000®
Time frame: Day 6-8, 13-15 after 3rd Vaccination for Group 1 and Day 6-8, 13-15 after 1st vaccination for Group 2
The MLA was defined as the maximum of two measurements: the lesion area measured on Day 6-8 (after scarification) or the lesion area measured on Day 13-15 (after scarification). This was measured using the SilhouetteConnect camera system, and confirmed by the Independent Take Review Committee (ITRC).
22 secondary outcomes
Investigator-measured Maximum Lesion Diameter (MLD) in mm After Scarification With ACAM2000
Time frame: Day 6-8 and Day 13-15 after ACAM2000 scarification
Investigator-measured Lesion Diameter in mm at Day 6-8 After Scarification With ACAM2000
Time frame: Day 6-8 after ACAM2000 scarification
Investigator-measured Lesion Diameter in mm at Day 13-15 After Scarification With ACAM2000
Time frame: Day 13-15 after ACAM2000 scarification
Individual Take as Classified by a Blinded Independent Take Review Committee (ITRC)
Time frame: Day 6-8 visit following ACAM2000 vaccination
Lesion Area in mm2 at Day 6-8 After Scarification With ACAM2000
Time frame: Day 6-8 after ACAM2000 scarification
Lesion Area in mm2 at Day 13-15 After Scarification With ACAM2000
Time frame: Day 13-15 after ACAM2000 scarification
Relationship to Vaccine of Any Serious Adverse Event (SAE)
Time frame: Within 38 weeks for Group 1 and 30 weeks for Group 2
Intensity of Any Serious Adverse Event (SAE)
Time frame: Within 38 weeks for Group 1 and 30 weeks for Group 2
Incidence of Any Cardiac Sign or Symptom Indicating a Case of Myo-/Pericarditis, i.e. Adverse Events of Special Interest (AESIs)
Time frame: Within 38 weeks for Group 1 and 30 weeks for Group 2
Related Grade >=3 Adverse Events
Time frame: within 29 days after vaccination
Relationship to Vaccine of Any Non-serious AEs
Time frame: within 29 days after vaccination
Intensity of Any Non-serious AEs
Time frame: within 29 days after vaccination
Solicited General AEs
Time frame: within 15 days after vaccination
Incidence of Lymphadenopathy
Time frame: within 29 days after vaccination
Solicited Local AEs: Intensity
Time frame: within 15 days after vaccination
Major Lesion Size, Major Erythema, and Major Induration Diameter
Time frame: Within 15 days after scarification with ACAM2000
GMTs at the Peak Visits and Individual Peak Measured by Vaccinia-specific ELISA
Time frame: within 8 weeks (for both groups)
GMTs at the Individual Peak Measured by Vaccinia-specific PRNT
Time frame: within 8 weeks (for both groups)
GMTs as Measured by Vaccinia-specific ELISA
Time frame: within 12 weeks
GMTs as Measured by Vaccinia-specific PRNT
Time frame: within 12 weeks
PRNT Seroconversion Rates at Peak Visits
Time frame: Group 1 at Week 6; Group 2 at Week 4
ELISA Seroconversion Rates at Peak Visits
Time frame: Group 1 at Week 6; Group 2 at Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31722150Pittman PR, Hahn M, Lee HS, Koca C, Samy N, Schmidt D, Hornung J, Weidenthaler H, Heery CR, Meyer TPH, Silbernagl G, Maclennan J, Chaplin P. Phase 3 Efficacy Trial of Modified Vaccinia Ankara as a Vaccine against Smallpox. N Engl J Med. 2019 Nov 14;381(20):1897-1908. doi: 10.1056/NEJMoa1817307.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillip R Pittman, MD, MPH principal investigator
US Army Medical Research Institute of Infectious Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MVA BN® and ACAM2000® in people with 18-42 Year Old Healthy Vaccinia-naïve Subjects, run by Bavarian Nordic at 1 site in South Korea.
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 47 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 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 5 Dec 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?
Plaque Reduction Neutralization Test (PRNT) Geometric Mean Titer (GMT) at the Peak Visits (time frame: Day 42 for Group 1 and Day 28 for Group 2). The study lists 2 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 NCT01913353, which also lists 1 linked publication.
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 5 Dec 2019.