Evaluating the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of GEO-D02 DNA and MVA/HIV62B With and Without B63521^11 gp120 and IHV01 gp120 Env Proteins in Healthy, HIV-uninfected Adult Participants

Phase 1

Withdrawn

• Conditions: HIV Infections

• Registration Number: NCT04041674
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of a prime-boost vaccine regimen of GEO-D02 DNA and MVA/HIV62B with and without B63521\^11 gp120 and IHV01 gp120 Env proteins in healthy, HIV-uninfected adult participants.

Detailed Description

This study will evaluate the safety and immunogenicity of a prime-boost vaccine regimen of GEO-D02 DNA and MVA/HIV62B with and without B63521\^11 gp120 and IHV01 gp120 Env proteins in healthy, HIV-uninfected adult participants.

Participants will be randomly assigned to one of five groups. Participants in all five groups will receive GEO-D02 DNA by intramuscular (IM) injection at Months 0 and 2. Then, at Months 4, 6, and 10, participants will receive three additional injections according to their assigned group:

* Group 1: MVA/HIV62B, placebo for B63521\^11 gp120, and placebo for IHV01, all by IM injection

* Group 2: MVA/HIV62B by IM injection and placebo for B63521\^11 gp120 and for IHV01, both by subcutaneous (SC) injection

* Group 3: MVA/HIV62B, B63521\^11 gp120, and IHV01, all by IM injection

* Group 4: MVA/HIV62B, placebo for B63521\^11 gp120, and IHV01, all by IM injection

* Group 5: MVA/HIV62B by IM injection and IHV01 and B63521\^11 gp120, both by SC injection

Participants will attend several study visits through Month 16. Visits may include physical examinations, blood and urine collection, electrocardiogram, HIV testing, risk reduction counseling, and questionnaires. Study staff will contact participants at Month 24 for follow-up health monitoring.

Study Timeline

• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-15
• Study Start: 2022-03-01
• Primary Completion: 2022-09-30
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Frequency of serious adverse events	Measured through Month 16	Summarized using MedDRA System Organ Class and preferred terms
HIV-specific IgG binding breadth to cross-clade panels of gp120 and V1V2, and gp41	Measured through Month 10.5	As assessed by BAMA
Frequency of systemic reactogenicity signs and symptoms	Measured through Month 10	Systemic symptoms include increased body temperature, malaise and/or fatigue, myalgia, headache, chills, arthralgia, and nausea.
HIV-specific IgG binding magnitude to cross-clade panels of gp120 and V1V2, and gp41	Measured through Month 10.5	As assessed by binding antibody multiplex assay (BAMA)
Response rate of CD4+ T-cell responses to Env	Measured through Month 10.5	As assessed by intracellular cytokine staining (ICS)
HIV-specific IgG binding response rate to cross-clade panels of gp120 and V1V2, and gp41	Measured through Month 10.5	As assessed by BAMA
Magnitude of CD4+ T-cell responses to Env	Measured through Month 10.5	As assessed by ICS
Frequency of local reactogenicity signs and symptoms	Measured through Month 10	Local symptoms include pain and/or tenderness at the injection site.
Frequency of adverse events	Measured through Month 16	Summarized using Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class and preferred terms

Secondary Outcome Measures

Name	Time	Method
IgA responses to gp120 and gp41	Measured through Month 16	As assessed by BAMA
IgG avidity to defined epitope specificities	Measured through Month 10.5	Determined from the immunogenicity data
HIV-specific IgG binding magnitude to gp120, V1V2, and gp41	Measured through Month 16	As assessed by BAMA
Response rate of antibody-dependent cellular cytotoxicity (ADCC)-mediating antibody responses	Measured through Month 16	Assessed using serum samples taken at a primary immunogenicity timepoint
HIV-specific IgG binding magnitude to V3, CD4i and gp41 IDR	Measured through Month 10.5	As assessed by BAMA
IgA responses to gp120, V1V2, and gp41	Measured through Month 10.5	As assessed by BAMA
IgG3 responses to gp120, V1V2, and gp41	Measured through Month 10.5	As assessed by BAMA
HIV-specific IgG binding response rate to V3, CD4i and gp41 IDR	Measured through Month 10.5	As assessed by BAMA
HIV-specific IgG binding response rate to gp120, V1V2, and gp41	Measured through Month 16	As assessed by BAMA
Magnitude of antibody-dependent cellular phagocytosis (ADCP)-mediating antibody responses	Measured through Month 16	Measured using serum samples taken at baseline and at a primary immunogenicity timepoint
IgG3 responses to gp120 and gp41	Measured through Month 16	As assessed by BAMA
Magnitude of ADCC-mediating antibody responses	Measured through Month 16	Assessed using serum samples taken at a primary immunogenicity timepoint
Response rate of vaccine-elicited antibody binding to FcƴR proteins	Measured through Month 16	Assessed on serum samples taken at the primary immunogenicity timepoints and baseline
Magnitude of vaccine-elicited antibody binding to FcƴR proteins	Measured through Month 16	Assessed on serum samples taken at the primary immunogenicity timepoints and baseline
Response rate of antibody-dependent cellular phagocytosis (ADCP)-mediating antibody responses	Measured through Month 16	Measured using serum samples taken at baseline and at a primary immunogenicity timepoint