- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02218125
A Phase I Study of an HIV Vaccine in Healthy, HIV Uninfected Adults (MENSCH)
November 23, 2018 updated by: Crucell Holland BV
A Phase I Study of Modified Vaccinia Ankara With Mosaic HIV Inserts in Healthy, HIV-Uninfected Adults, Some of Whom Have Previously Received an Adenovirus Type 26 ENVA.01 Vaccine
The purpose of this study is to assess the safety and tolerability of Modified Vaccinia Ankara (MVA) Mosaic vaccine in healthy adult participants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a Phase I, placebo-controlled (the use of an inactive substance identical in appearance to the active vaccine), double-blind (neither the participant or study personnel will know the identity of the treatment administered) study where participants will be randomized (treatment type assigned by chance) to receive a Modified Vaccinia Ankara (MVA) Mosaic vaccine (at 1x10E8 pfu) or placebo.
This design is intended to reduce the likelihood of observer and selection bias, provide control for confounding variables, and aid an unbiased analysis of the study results.
The study will include 4 groups of participants, 2 groups having previously been vaccinated with Ad26.ENVA.01
(A recombinant adenovirus [rAd] vaccine for HIV-1) and 2 groups not previously vaccinated with Ad26.ENVA.01.
Participants will be randomized in a 4:1 ratio to receive either a MVA Mosaic vaccine or placebo.
The trial comprises a 4-week screening period, a 12-week vaccination period during which participants will be vaccinated at baseline (Day 1) and Week 12 (Day 84), and a 40-week follow-up period to the final visit at Week 52.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adults (determined by medical history, physical examination, and clinical judgment)
- HIV uninfected
- Female participants of child bearing potential must have a negative serum β-human chorionic gonadotrophin pregnancy test at the screening visit and immediately prior to each vaccine/placebo administration, practice adequate birth control measures from 28 days prior to the first vaccine/placebo administration through to at least 3 months after the final vaccine/placebo administration
- Male participants who are sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a double barrier method of birth control, e.g. either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
Exclusion Criteria:
- Confirmed HIV-1/-2 infection
- Chronic active hepatitis B or hepatitis C or active syphilis infection. Active syphilis documented by exam or serology unless positive serology is due to past treated infection
- Within the 12 months prior to enrollment: a history of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), Chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B
- A woman who is breastfeeding
- Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation
- Major surgery within the 4 weeks prior to study entry or planned major surgery through the course of the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1- MVA Mosaic
Healthy volunteers not previously vaccinated with Ad26.ENVA.01 will be administered Modified Vaccinia Ankara (MVA) Mosaic at Week 0 and at Week 12.
|
0.5 mL (1x10E8 pfu) MVA Mosaic (comprised of MVA Mosaic 1 and MVA Mosaic 2 mixed in a 1:1 ratio before administration) will be administered by intramuscular (IM) injection.
|
Placebo Comparator: Group 2 - Placebo
Healthy volunteers not previously vaccinated with Ad26.ENVA.01 will be administered placebo at Week 0 and at Week 12.
|
0.5 mL Sodium Chloride Injection USP, 0.9%will be administered by intramuscular (IM) injection.
|
Experimental: Group 3 - MVA Mosaic
Healthy volunteers previously vaccinated with Ad26.ENVA.01 will be administered MVA Mosaic at Week 0 and at Week 12.
|
0.5 mL (1x10E8 pfu) MVA Mosaic (comprised of MVA Mosaic 1 and MVA Mosaic 2 mixed in a 1:1 ratio before administration) will be administered by intramuscular (IM) injection.
|
Placebo Comparator: Group 4- Placebo
Participants previously vaccinated with Ad26.ENVA.01 will be administered placebo at Week 0 and at Week 12.
|
0.5 mL Sodium Chloride Injection USP, 0.9%will be administered by intramuscular (IM) injection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number of Participants who Experience Adverse Events Within 28 days After Vaccination
Time Frame: For 28 days following vaccination on Day 1 and Day 84
|
In addition to the number of participants who experience adverse events within the time frame of 28 days after each vaccination, all adverse events that occur from the signing of the informed consent through to the last study visit (Visit 10 [Day 365]) will be reported.
|
For 28 days following vaccination on Day 1 and Day 84
|
The Number of Participants who Experience Reactogenicity Symptoms Following Vaccination
Time Frame: 1 week following vaccination on Day 1 and Day 84
|
Reactogenicity symptoms monitored following vaccination will include erythema (redness), induration (hardening), and local pain/tenderness, itching, swelling, or warmth at the site of injection, temperature (fever >37.7 degree Celsius); fatigue (extreme tiredness), headache, myalgia (muscle pain), arthralgia (joint pain), chills, nausea, vomiting, rashes, and itching (general and local)
|
1 week following vaccination on Day 1 and Day 84
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number of Participants With Humoral Immune Responses
Time Frame: 4 weeks after the second vaccination
|
Humoral immune responses will be evaluated by the detection of env-specific binding antibody.
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4 weeks after the second vaccination
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Durability of Immune Response
Time Frame: 6, 9, and 12 months after the first vaccination
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Determined by humoral immune response assays.
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6, 9, and 12 months after the first vaccination
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The Number of Participants With T-cell Responses Following Vaccination
Time Frame: 4 weeks after the second vaccination
|
T-cell responses to be determined by epitope mapping.
|
4 weeks after the second vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 23, 2014
Primary Completion (Actual)
November 30, 2015
Study Completion (Actual)
November 30, 2015
Study Registration Dates
First Submitted
August 14, 2014
First Submitted That Met QC Criteria
August 14, 2014
First Posted (Estimate)
August 15, 2014
Study Record Updates
Last Update Posted (Actual)
November 27, 2018
Last Update Submitted That Met QC Criteria
November 23, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR100965
- IPCAVD006 (Other Identifier: Ragon Institute, Division of AIDS)
- HIV-V-A002 (Other Identifier: Crucell Holland BV)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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