Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT03505060
Brief Summary:
The purpose of this study is to evaluate the safety and immunogenicity of the IHV01 protein vaccine primed and co-administered with HIV DNA CON-S env vaccine in healthy, HIV-1-uninfected adults.
Detailed Description:
This study will evaluate the safety and immunogenicity of the IHV01 protein vaccine primed and co-administered with HIV DNA CON-S env vaccine in healthy, HIV-1-uninfected adults.
Participants will be randomly assigned to two groups. Participants in Group 1 will receive 4 mg of DNA CON-S env at Months 0 and 1. They will receive 4 mg of DNA CON-S env and 150 mcg of IHV01 at Months 3 and 6. Participants in Group 2 will receive placebo at Months 0, 1, 3, and 6.
Study visits will occur at Day 0 (study entry), Week 2, and Months 1, 1.5, 3, 3.5, 6, 6 + 1 week, 6.5, and 12. Visits may include physical examinations, medical history, injection of study product, blood and urine collection, pregnancy testing, HIV testing, risk reduction counseling, and questionnaires.
Study:
NCT03505060
Study Brief:
Protocol Section:
NCT03505060