HVTN 088

Status:Completed
Phase:I
Principal Investigator(s):Paul Spearman, Emory University
Objective:The purpose of this study is to evaluate the safety and immune response to an HIV vaccine in healthy, HIV-uninfected adults who have participated in a previous HIV vaccine clinical trial and in healthy, HIV-uninfected adults who have not participated in a previous HIV vaccine clinical trial.
Prevention Option(s):HIV Vaccine
Study Design:Non-randomized, Open label
Arms and Assigned Interventions
DescriptionPrevious HIV Vaccine Trial Participants (Group 1): Participants will receive the study vaccine administered as one 0.5 mL intramuscular injection (IM) in either deltoid at baseline and Month 6. Participants in the study extension will receive an additional injection of the study vaccine approximately 14 to 20 months after their second (Month 6) vaccination.
Mode of Delivery
ARMsExperimental
DescriptionNo Previous HIV Vaccine Trial (Group 2): Participants will receive the study vaccine administered as one 0.5 mL IM in either deltoid at baseline and Month 6. Participants in the study extension will receive an additional injection of the study vaccine approximately 14 to 20 months after their second (Month 6) vaccination.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code: NCT01376726
Related Publications:
Broad diversity of neutralizing antibodies isolated from memory B cells in HIV-infected individuals
Durable HIV-1 antibody and T-cell responses elicited by an adjuvanted multi-protein recombinant vaccine in uninfected human volunteers
Trial Sponsors: NIAID
Start Date
End Date
July 1, 2011
December 31, 2014
Enrollment:36
Age range: 18 Years ↔ 55 Years
Population:Cisgender Men, Cisgender Women