The purpose of this study is to assess the safety and tolerability of Modified Vaccinia Ankara (MVA) Mosaic vaccine in healthy adult participants.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
25
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.
0.5 mL Sodium Chloride Injection USP, 0.9%will be administered by intramuscular (IM) injection.
Unnamed facility
Boston, Massachusetts, United States
The Number of Participants who Experience Adverse Events Within 28 days After Vaccination
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.
Time frame: For 28 days following vaccination on Day 1 and Day 84
The Number of Participants who Experience Reactogenicity Symptoms Following Vaccination
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)
Time frame: 1 week following vaccination on Day 1 and Day 84
The Number of Participants With Humoral Immune Responses
Humoral immune responses will be evaluated by the detection of env-specific binding antibody.
Time frame: 4 weeks after the second vaccination
Durability of Immune Response
Determined by humoral immune response assays.
Time frame: 6, 9, and 12 months after the first vaccination
The Number of Participants With T-cell Responses Following Vaccination
T-cell responses to be determined by epitope mapping.
Time frame: 4 weeks after the second vaccination
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