SmallpoxPhase 2NCT02038881
Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine in Immunocompromised Subjects With HIV Infection
A Phase 2 study testing IMVAMUNE® in people with Smallpox, run by Bavarian Nordic at 12 sites in 2 countries.
Trial summary
The main purpose of this clinical trial is to generate additional safety data in a highly immunocompromised population. HIV-infected persons are considered excellent candidates to represent the highly immunocompromised population for enrolment in this trial. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Smallpox
- What is being tested?
- IMVAMUNE®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 28 Apr 2014to 10 May 2017
- Phase
- Phase 2
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female subjects aged between 18-45 years, vaccinia-naïve.
- HIV-1 infection documented by ELISA and confirmed by Western blot at any time prior to study entry. HIV-1 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR), HIV-1 culture, HIV-1 antigen, plasma HIV-1 ribonucleic acid (RNA), or a second antibody test other than ELISA is acceptable as an alternative test at any time prior to study entry.
- On stable antiretroviral therapy (ART) i.e. Combination ART for at least 6 months. Subject must be on the same ART regimen for at least 12 weeks with no change prior to enrollment in this clinical trial.
- Screening HIV-1 RNA < 200 copies/ml by US Food and Drug Administration (FDA) approved PCR assay within 45 days prior to study entry.
- Current CD4 counts ≥ 100 cells/µl ≤ 500 cells/µl.
- Documented nadir CD4 count < 200 cells/µl at any time prior to enrollment.
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- Hemoglobin ≥ 9.0 g/dl for female subjects, ≥ 10.0 g/dl or male subjects.
- Platelets ≥ 100,000/mm3.
- Ability and willingness of subject to provide written informed consent.
- Body Mass Index (BMI) ≥ 18.5 and < 35 kg/m2.
- Women of childbearing potential (WOCBP) must have used an acceptable method of contraception for 30 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 (defined as ≥ 12 months without a menstrual period) or surgically sterilized. Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products).
- WOCBP must have a negative serum pregnancy test at screening (SCR) and a negative urine pregnancy test within 24 hours prior to each vaccination.
- Absolute neutrophil count cells ≥ 750/mm3.
- Adequate renal function defined as a calculated Creatinine Clearance (CrCl) > 60 ml/min as estimated by the Cockcroft-Gault equation.
- For men: (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dl x 72) = CrCl (ml/min)
- For women: multiply the result by 0.85 = CrCl (ml/min).Adequate hepatic function defined as: Total bilirubin ≤ 2 x upper limit normal (ULN) in the absence of other evidence of significant liver disease
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤ 2.5 x ULN.
- Troponin I < 2 x ULN at entry in the clinical trial.
- 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, AV node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, two premature ventricular contractions (PVC) 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.
- History of vaccination with any poxvirus-based vaccine.
- Uncontrolled serious infection, i.e. not responding to antimicrobial therapy.
- History of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject or would limit the subject's ability to complete the trial including uncontrolled diabetes as according to the 'Division of Acquired Immune Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events' Version 1.0, December 2004, Clarification August 2009.
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- History of or active autoimmune disease, persons with vitiligo or thyroid disease taking thyroid replacement are not excluded.
- Known or suspected impairment of immunologic function except those defined in the inclusion criteria, including, but not limited to clinically significant liver disease, diabetes mellitus type I and moderate to severe kidney impairment.
- 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 history of skin cancer must not be vaccinated at the previous tumor site.
- History or clinical manifestation of clinically significant and severe hematological, pulmonary, central nervous, cardiovascular or gastrointestinal disorders (except HIV infection, chronic or active Hepatitis-B-Virus or Hepatitis-C-Virus infection).
- Clinically significant psychiatric disorder not adequately controlled by medical treatment.
- History of coronary heart disease, myocardial infarction, angina pectoris, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor.
- Known history of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before age 50 years.
- 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?usertype=prof). NOTE: This criterion applies only to subjects 20 years of age and older.
- Current alcohol abuse (40 g/day for at least 6 month) and/or intravenous and/or intranasal drug abuse (within the past 6 months).
- Known allergy to MVA-BN® vaccine or any of its constituents, e.g. tris (hydroxymethyl)-amino methane, including known allergy to egg or aminoglycosides.
- History of anaphylaxis or severe allergic reaction to any vaccine.
- Acute disease (illness with or without a fever) at the time of enrollment.
- Body temperature ≥ 100.4°F (≥ 38.0°C) at the time of enrollment.
- Having received any vaccinations or planned vaccinations with a live vaccine within 30 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.
- Use of immunosuppressant or immunomodulatory agents including systemic glucocorticoids (excluding nasal or inhaled steroids), tacrolimus, sirolimus, rapamycin, mycophenolate, cyclosporine, TNF-alpha blockers or antagonists, azathioprine, interferon, growth factors, or intravenous immunoglobulin in the 60 days prior to enrollment in this clinical trial.
- Post organ transplant subjects whether or not receiving chronic immunosuppressive therapy.
- 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 last physical trial visit.
- Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the first dose of the trial vaccine, or planned administration of such a drug during the trial period.
- Trial personnel.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States10 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Illinois - Chicago
Chicago, Illinois, 60612
University of Iowa Departments of Internal Medicine and Microbiology University of Iowa
Iowa City, Iowa, 52242
Health for Life Clinic Little Rock
Little Rock, Arkansas, 72207
Infectious Disease Associats of NW Florida Center for Prevention and Treatment of Infections Infectious Diseases Associates of NW FL
Pensacola, Florida, 32504
University of Pennsylvania Clinical Trials Unit
Philadelphia, Pennsylvania, 19104
Quest Clinical Research
San Francisco, California, 94115
Washington University School of Medicine
St Louis, Missouri, 63110
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 20009
Rowan Tree Medical
Wilton Manors, Florida, 33305
Puerto Rico2 sites
Clinical Research Puerto Rico, Inc.
San Juan, PR, 009091711
Fundacion de Investigacion
San Juan, PR, 00927
About this study
Official title: Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine When Increasing the Number of Injections Compared to the Standard Regimen in Immunocompromised Subjects With HIV Infection
The main purpose of this clinical trial is to generate additional safety data in a highly immunocompromised population. HIV-infected persons are considered excellent candidates to represent the highly immunocompromised population for enrolment in this trial. Additionally, the immune system's response (protection against smallpox as measured by the amount of antibodies produced) following injections of MVA-BN® smallpox vaccine will be evaluated. All participants in this trial will be randomly and evenly assigned to one of three groups to receive two, three or four injections. Group 1 will receive the standard regime consisting of one dose at each vaccination time point, Group 2 will receive two doses at each vaccination time point and Group 3 will receive a booster vaccination 12 weeks after the standard vaccination schedule with MVA-BN® smallpox vaccine. Participation in the trial is scheduled to last up to 75 weeks.
- Conditions
- Smallpox
- Being tested
- IMVAMUNE®
- Medical subject headings
- Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMVAMUNE®Biological
Also called IMVANEX®, MVA-BN® smallpox vaccine
0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (standard regimen) | Experimental | One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®) Receives: Biological: IMVAMUNE® |
| Group 2 (double dose regimen) | Experimental | Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®) Receives: Biological: IMVAMUNE® |
| Group 3 (booster regimen) | Experimental | One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®) Receives: Biological: IMVAMUNE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With SAEs
Occurrence, relationship and intensity of any serious AE (SAE)
Measured: within 75 weeks
Secondary outcomes (23)
Number of Participants With AESIs
Occurrence, relationship to the trial vaccine, and intensity of any adverse event of special interest (AESI)
Measured: within 75 weeks
Number of Participants With Related Grade >=3 Adverse Events
Number of Participants with any Grade >=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited and unsolicited AEs.
Measured: within 29 days after any vaccination
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
Measured: within 29 days after any vaccination
Number of Unsolicited Non-serious Adverse Events: Intensity
Occurrence of unsolicited non-serious AEs by Intensity
Measured: within 29 days after any vaccination
Number of Participants With Solicited Local Adverse Events
Number of participants with solicited local AEs (redness, swelling, induration, pruritus, and pain) by intensity. Percentages based on subjects with at least one completed diary card. [Injection site erythema, injection site swelling and injection site induration--all sizes measured in diameter with max severity of: 0=0, 1 = <30 mm, 2 = ≥30 - <100 mm, 3 = ≥100 mm. Injection site pruritus: 0=absent, 1=mild, 2=moderate, 3=severe. Injection site pain: 0=absent, 1=painful to touch, 2=painful when limb is moved, 3=spontaneously painful/prevents normal activity.]
Measured: within 8 days after any vaccination
Number of Participants With Solicited General AEs
Number of Participants with solicited systemic/general AEs (pyrexia, headache, myalgia, nausea, fatigue, and chills) by intensity. Percentages based on subjects with at least one completed diary card. [Body temperature: 0 = <99.5 F (<37.5 C), 1 = ≥99.5 - <100.4 F (≥37.5 - <38.0 C), 2= ≥100.4 - <102.2 F (≥38.0 - <39.0 C), 3= ≥102.2 - <104.0 F (≥39.0 - <40.0 C), 4= ≥ 104.0 F (≥40.0 C); pyrexia is defined as oral temperature ≥ 100.4 F (≥ 38.0 C).] [Headache, myalgia, nausea, chills and fatigue: 0 = none, 1 = mild: easily tolerated, minimal discomfort and no interference with daily activity, 2 = moderate: some interference with daily activity, 3 = severe: prevents daily activity.]
Measured: within 8 days after any vaccination
CD4+ T Cell Counts
Mean CD4+ T-cell counts over time
Measured: within 15 days after each vaccination
Geometric Mean Titers (GMT) Measured by Enzyme-linked Immunosorbent Assay (ELISA) at All Immunogenicity Sampling Points
GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.
Measured: within 64 weeks
ELISA GMT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.
Measured: Week 6
ELISA GMT 2 Weeks Following the Last Vaccination
GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.
Measured: Week 6 (Groups 1 and 2), Week 14 (Group 3)
ELISA GMT During Follow-up
GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'. Participants discontinued prior to the follow-up visits are excluded.
Measured: Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)
GMTs Measured by Plaque Reduction Neutralization Test (PRNT) at All Immunogenicity Sampling Points
GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.
Measured: within 64 weeks
PRNT GMT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.
Measured: Week 6
PRNT GMT 2 Weeks Following the Last Vaccination
GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.
Measured: Week 6 (Groups 1 and 2), Week 14 (Group 3)
PRNT GMT During Follow-up
GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'. Participants discontinued prior to the follow-up visits are excluded.
Measured: Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)
Percentage of Participants With Seroconversion by ELISA
SC rate based on ELISA. SC is defined as the appearance of antibody titers >= 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: within 64 weeks
Percentage of Participants With Seroconversion by ELISA 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
SC rate based on ELISA. SC is defined as the appearance of antibody titers >= 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: Week 6
Percentage of Participants With Seroconversion by ELISA 2 Weeks Following the Last Vaccination
SC rate based on ELISA. SC is defined as the appearance of antibody titers >= 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: Week 6 (Groups 1 and 2), Week 14 (Group 3)
Percentage of Participants With Seroconversion by ELISA During Follow-up
SC rate based on ELISA. SC is defined as the appearance of antibody titers >= 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: Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)
Percentage of Participants With Seroconversion by PRNT
SC rate based on PRNT. SC is defined as the appearance of antibody titers >= 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: within 64 weeks
Percentage of Participants With Seroconversion by PRNT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
SC rate based on PRNT. SC is defined as the appearance of antibody titers >= 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: Week 6
Percentage of Participants With Seroconversion by PRNT 2 Weeks Following the Last Vaccination
SC rate based on PRNT. SC is defined as the appearance of antibody titers >= 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: Week 6 (Groups 1 and 2), Week 14 (Group 3)
Percentage of Participants With Seroconversion by PRNT During Follow-up
SC rate based on PRNT. SC is defined as the appearance of antibody titers >= 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: Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study start28 Apr 2014
- Primary completion10 May 2017
- Study completion10 May 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 SmallpoxStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edgar T Overton, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038881
- Sponsor's protocol ID
- POX-MVA-037
- Status last verified
- Mar 2020
- First submitted
- 15 Jan 2014
- Last updated
- 2 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Overton ET, Lawrence SJ, Stapleton JT, Weidenthaler H, Schmidt D, Koenen B, Silbernagl G, Nopora K, Chaplin P. A randomized phase II trial to compare safety and immunogenicity of the MVA-BN smallpox vaccine at various doses in adults with a history of AIDS. Vaccine. 2020 Mar 4;38(11):2600-2607. doi: 10.1016/j.vaccine.2020.01.058. Epub 2020 Feb 11.
PubMed 32057574
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine When Increasing the Number of Injections Compared to the Standard Regimen in Immunocompromised Subjects With HIV Infection
- ClinicalTrials.gov ID
- NCT02038881
- Acronym / sponsor ID
- POX-MVA-037
- Conditions
- Smallpox
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2014 (actual)
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Posted 2 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this clinical trial is to generate additional safety data in a highly immunocompromised population. HIV-infected persons are considered excellent candidates to represent the highly immunocompromised population for enrolment in this trial. Additionally, the immune system's response (protection against smallpox as measured by the amount of antibodies produced) following injections of MVA-BN® smallpox vaccine will be evaluated. All participants in this trial will be randomly and evenly assigned to one of three groups to receive two, three or four injections. Group 1 will receive the standard regime consisting of one dose at each vaccination time point, Group 2 will receive two doses at each vaccination time point and Group 3 will receive a booster vaccination 12 weeks after the standard vaccination schedule with MVA-BN® smallpox vaccine. Participation in the trial is scheduled to last up to 75 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 (standard regimen) | Experimental | Biological: IMVAMUNE®One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®) |
| Group 2 (double dose regimen) | Experimental | Biological: IMVAMUNE®Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®) |
| Group 3 (booster regimen) | Experimental | Biological: IMVAMUNE®One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Male and female subjects aged between 18-45 years, vaccinia-naïve.
- HIV-1 infection documented by ELISA and confirmed by Western blot at any time prior to study entry. HIV-1 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR), HIV-1 culture, HIV-1 antigen, plasma HIV-1 ribonucleic acid (RNA), or a second antibody test other than ELISA is acceptable as an alternative test at any time prior to study entry.
- On stable antiretroviral therapy (ART) i.e. Combination ART for at least 6 months. Subject must be on the same ART regimen for at least 12 weeks with no change prior to enrollment in this clinical trial.
- Screening HIV-1 RNA < 200 copies/ml by US Food and Drug Administration (FDA) approved PCR assay within 45 days prior to study entry.
- Current CD4 counts ≥ 100 cells/µl ≤ 500 cells/µl.
Key exclusion criteria (26 listed)
- Pregnant or breast-feeding women.
- Typical vaccinia scar.
- Known or suspected history of smallpox vaccination.
- History of vaccination with any poxvirus-based vaccine.
- Uncontrolled serious infection, i.e. not responding to antimicrobial therapy.
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 |
|---|---|---|
| IMVAMUNE®Also: IMVANEX®, MVA-BN® smallpox vaccine0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml | Biological | Group 1 (standard regimen), Group 2 (double dose regimen), Group 3 (booster regimen) |
Primary outcome
Number of Participants With SAEs
Time frame: within 75 weeks
Occurrence, relationship and intensity of any serious AE (SAE)
23 secondary outcomes
Number of Participants With AESIs
Time frame: within 75 weeks
Number of Participants With Related Grade >=3 Adverse Events
Time frame: within 29 days after any vaccination
Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Time frame: within 29 days after any vaccination
Number of Unsolicited Non-serious Adverse Events: Intensity
Time frame: within 29 days after any vaccination
Number of Participants With Solicited Local Adverse Events
Time frame: within 8 days after any vaccination
Number of Participants With Solicited General AEs
Time frame: within 8 days after any vaccination
CD4+ T Cell Counts
Time frame: within 15 days after each vaccination
Geometric Mean Titers (GMT) Measured by Enzyme-linked Immunosorbent Assay (ELISA) at All Immunogenicity Sampling Points
Time frame: within 64 weeks
ELISA GMT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
Time frame: Week 6
ELISA GMT 2 Weeks Following the Last Vaccination
Time frame: Week 6 (Groups 1 and 2), Week 14 (Group 3)
ELISA GMT During Follow-up
Time frame: Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)
GMTs Measured by Plaque Reduction Neutralization Test (PRNT) at All Immunogenicity Sampling Points
Time frame: within 64 weeks
PRNT GMT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
Time frame: Week 6
PRNT GMT 2 Weeks Following the Last Vaccination
Time frame: Week 6 (Groups 1 and 2), Week 14 (Group 3)
PRNT GMT During Follow-up
Time frame: Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)
Percentage of Participants With Seroconversion by ELISA
Time frame: within 64 weeks
Percentage of Participants With Seroconversion by ELISA 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
Time frame: Week 6
Percentage of Participants With Seroconversion by ELISA 2 Weeks Following the Last Vaccination
Time frame: Week 6 (Groups 1 and 2), Week 14 (Group 3)
Percentage of Participants With Seroconversion by ELISA During Follow-up
Time frame: Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)
Percentage of Participants With Seroconversion by PRNT
Time frame: within 64 weeks
Percentage of Participants With Seroconversion by PRNT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
Time frame: Week 6
Percentage of Participants With Seroconversion by PRNT 2 Weeks Following the Last Vaccination
Time frame: Week 6 (Groups 1 and 2), Week 14 (Group 3)
Percentage of Participants With Seroconversion by PRNT During Follow-up
Time frame: Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32057574Overton ET, Lawrence SJ, Stapleton JT, Weidenthaler H, Schmidt D, Koenen B, Silbernagl G, Nopora K, Chaplin P. A randomized phase II trial to compare safety and immunogenicity of the MVA-BN smallpox vaccine at various doses in adults with a history of AIDS. Vaccine. 2020 Mar 4;38(11):2600-2607. doi: 10.1016/j.vaccine.2020.01.058. Epub 2020 Feb 11.
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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.
Edgar T Overton, MD principal investigator
University of Alabama at Birmingham
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMVAMUNE® in people with Smallpox, run by Bavarian Nordic at 12 sites in 2 countries.
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 19 inclusion and 26 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 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 2 Apr 2020). 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?
Number of Participants With SAEs (time frame: within 75 weeks). 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 NCT02038881, 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 2 Apr 2020.