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A Phase 1 Clinical Trial 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 *Imatinib Mesylate Per Oral as a Clinical Therapeutic for TB
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.
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.
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
Yes
Start Date
March 1, 2022
Primary Completion Date
September 30, 2022
Completion Date
May 31, 2023
Last Updated
October 15, 2021
GEO-D02 DNA
BIOLOGICAL
MVA/HIV62B Vaccine
BIOLOGICAL
B63521^11 gp120
BIOLOGICAL
IHV01 Protein
BIOLOGICAL
Protein Placebo
BIOLOGICAL
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
NCT06694805
NCT04142047
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07428330