Healthy
Conditions
Keywords
Healthy, Human immunodeficiency virus type 1 (HIV-1) infection, Acquired immunodeficiency syndrome (AIDS), recombinant adenovirus (rAd) vector-based vaccines, Vaccination, Ad26.ENVA.01, Recombinant, Modified Vaccinia Ankara (MVA) vector-based vaccines
Brief summary
The purpose of this study is to assess the safety and tolerability of Modified Vaccinia Ankara (MVA) Mosaic vaccine in healthy adult participants.
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.
Interventions
BIOLOGICALMVA Mosaic
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.
BIOLOGICALPlacebo
0.5 mL Sodium Chloride Injection USP, 0.9%will be administered by intramuscular (IM) injection.
Sponsors
US Military HIV Research Program
National Institute of Allergy and Infectious Diseases (NIAID)
Beth Israel Deaconess Medical Center
Crucell Holland BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants who Experience Adverse Events Within 28 days After Vaccination | 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. |
| The Number of Participants who Experience Reactogenicity Symptoms Following Vaccination | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Humoral Immune Responses | 4 weeks after the second vaccination | Humoral immune responses will be evaluated by the detection of env-specific binding antibody. |
| Durability of Immune Response | 6, 9, and 12 months after the first vaccination | Determined by humoral immune response assays. |
| The Number of Participants With T-cell Responses Following Vaccination | 4 weeks after the second vaccination | T-cell responses to be determined by epitope mapping. |
Countries
United States
Outcome results
None listed