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:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2025-12-26 @ 12:18 PM
NCT ID:
NCT01966900
Brief Summary:
The potential HIV vaccine has two components: a protein immunogen based on the coat protein of HIV; and an adjuvant which enhances the vaccinee's response to the immunogen. The immunogen is CN54gp140, and the adjuvant is glucopyranosyl lipid adjuvant - aqueous formulation (GLA-AF).
We wish to assess the vaccine's safety and immunogenicity (the nature of the immune response stimulated by the vaccine) when it is given in two different dose regimens:
Group A: vaccinations at Months 0, 1, 2 and 6Íž and Group B: vaccinations at Months 0, 1, 2 and 12.
Each dose will be an intramuscular injection of 100 micrograms of CN54gp140 mixed with 5 micrograms of GLA-AF.
We will recruit only healthy, HIV-uninfected men and women. We will assess the safety of the vaccine by monitoring the occurrence of adverse events in the participants. We will assess the immunogenicity of the vaccine by monitoring the immune response to the vaccine in blood and in genital mucosal secretion samples.
Study:
NCT01966900
Study Brief:
Protocol Section:
NCT01966900