The primary purpose of this study is to assess safety/tolerability of 2 different prime/boost regimens containing adenovirus serotype 26 (Ad26).Mos4.HIV, Modified Vaccinia Ankara (MVA) -Mosaic or adjuvanted Mosaic and Clade C gp140 in Human immunodeficiency virus type 1 (HIV-1)-infected participants on suppressive antiretroviral treatment (ART).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
25
Participants will receive Ad26.Mos4.HIV 5\*10\^10 vp as 0.5 mL IM injection at Weeks 0, 12 in Group 1 and at Weeks 0, 12, 24, 36 in Group 2.
Participants will receive MVA-Mosaic 10\^8 pfu as IM injection at Weeks 24 and 36.
Participants will receive both Clade C gp140 125 mcg plus Mosaic gp140 125 mcg (250 mcg coformulated with Aluminum phosphate adjuvant) OR an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36.
Participants will receive matching placebo as IM injection at Weeks 24, 36 in Group 1 and at Weeks 0, 12, 24, 36 in Group 3.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Percentage of Participants With Solicited Local Adverse Events (AEs) as a Measure of Safety and Tolerability
Solicited local AEs: erythema, swelling/induration, and pain/tenderness will be assessed.
Time frame: 7 days post-vaccination (approximately up to 37 weeks)
Percentage of Participants With Solicited Systemic AEs as a Measure of Safety and Tolerability
Solicited systemic AEs: fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills will be assessed.
Time frame: 7 days post-vaccination (approximately up to 37 weeks)
Percentage of Participants With AEs as a Measure of Safety and Tolerability
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: Approximately up to 96 weeks
Total IgG and Subclass Specific Antibody Titer
Total immunoglobulin G (IgG) and subclass (IgG1-4) specific antibody titers (binding antibody) to envelope (Env) proteins representing Clades A, B, and C, as well as Mosaic antigens.
Time frame: Up to post-vaccination follow-up period until Week 96
Antibody Functionality Assessment by Antibody-dependent Cell-mediated Phagocytosis (ADCP)
Antibody functionality assessment will be assessed by antibody-dependent cell-mediated phagocytosis (ADCP) assay.
Time frame: Up to post-vaccination follow-up period until Week 96
Magnitude of T-cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay
Intracellular cytokine staining (ICS) assays with Env, group-specific antigen (Gag), and/or polymerase (Pol)-peptide pools will be used to determine the magnitude of T-cell responses elicited.
Time frame: Up to post-vaccination follow-up period until Week 96
Functionality of T-cell Responses as Measured by ICS Assay
ICS assays with Env, Gag, and/or Pol-peptide pools will be used to determine the functionality of T-cell responses elicited.
Time frame: Up to post-vaccination follow-up period until Week 96
Phenotype of T-cell Responses as Measured by ICS Assay
ICS assays with Env, Gag, and/or Pol-peptide pools will be used to determine the phenotype of T-cell responses elicited.
Time frame: Up to post-vaccination follow-up period until Week 96
Frequency of Epitope Recognition by Enzyme-Linked Immunospot (ELISPOT)
Assays of peptide pool sets covering the Gag, Env or Pol will be evaluated by standard enzyme linked immunospot assay (ELISPOT).
Time frame: Up to post-vaccination follow-up period until Week 96
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