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A Phase 1 Double-Blind, Randomized Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Oligomeric gp145 Clade C Env Protein (gp145 C.6980) in Healthy, HIV-1-Uninfected Adult Participants in the US
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an HIV vaccine (gp145 C.6980) with aluminum hydroxide adjuvant in healthy, HIV-1-uninfected adults in the United States.
This study will evaluate the safety, tolerability, and immunogenicity of an HIV vaccine (gp145 C.6980) with aluminum hydroxide adjuvant in healthy, HIV-1-uninfected adults in the United States. Participants will be randomly assigned to one of three groups. Participants in Group 1 will receive 300 mcg of gp145 C.6980 and aluminum hydroxide adjuvant on Day 0 and Months 2 and 6. Participants in Group 2 will receive 100 mcg of gp145 C.6980 and aluminum hydroxide adjuvant on Day 0 and Months 2 and 6. Participants in Group 3 will receive placebo on Day 0 and Months 2 and 6. Study visits will occur at Day 0 (study entry), Weeks 1 and 2, and Months 2, 2.5, 6, 6.25, 6.5, 9, and 12. Visits may include physical examinations, blood and urine collection, HIV testing, risk reduction counseling, and questionnaires.
Age
18 - 50 years
Sex
ALL
Healthy Volunteers
Yes
Columbia P&S CRS
New York, New York, United States
New York Blood Center CRS
New York, New York, United States
Penn Prevention CRS
Philadelphia, Pennsylvania, United States
Start Date
December 27, 2017
Primary Completion Date
September 25, 2019
Completion Date
September 25, 2019
Last Updated
October 8, 2021
45
ACTUAL participants
gp145 C.6980 Vaccine
BIOLOGICAL
Placebo
BIOLOGICAL
Aluminum Hydroxide Adjuvant
BIOLOGICAL
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NCT04142047
NCT06694805
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