HIV Seronegativity Clinical Trial
Official title:
A Phase 1 Placebo-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of SAAVI DNA-C2, SAAVI MVA-C and Novartis Subtype C gp140 With MF59 Adjuvant in Various Vaccination Schedules in HIV-uninfected Healthy Vaccinia-naïve Adult Participants in South Africa
Sub-Saharan Africa is the region most affected by the global Human Immunodeficiency Virus (HIV) epidemic. A vaccine is the most promising preventive approach against new HIV infections. The purpose of this study is to evaluate the safety and immunogenicity of 4 experimental preventive HIV vaccine regimens in HIV-uninfected adults in South Africa.
The worldwide Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome (HIV/AIDS)
epidemic may only be controlled through development and utilization of a safe and effective
vaccine that will prevent HIV infection. Due to the high prevalence of HIV-1 subtype C in
southern Africa, the South African AIDS Vaccine Initiative (SAAVI), the HIV Vaccine Trials
Network (HVTN), Novartis, and the National Institute of Allergy and Infectious Diseases
(NIAID) are evaluating three subtype C HIV vaccines, SAAVI DNA-C2, SAAVI MVA-C, and Novartis
Subtype C gp140 through this study. These vaccines will be used together in four prime-boost
regimens. The SAAVI DNA-C2 vaccine is a multigene deoxyribonucleic acid (DNA) vaccine
consisting of two DNA plasmids in equal amounts that express an HIV-1 subtype C polyprotein
comprising of Gag-Reverse Transcriptase-Tat-Nef and an HIV-1 subtype C truncated Env. SAAVI
MVA-C is a recombinant modified vaccinia Ankara (MVA) vaccine expressing the same immunogens
as the SAAVI DNA-C2 vaccine. MVA is a highly attenuated vaccinia virus. The Novartis protein
subunit vaccine is a Subtype C oligomeric V2 loop deleted glycoprotein 140 (gp140) vaccine
(gp140[delta]V2.TV1), given with MF59 adjuvant.
This trial is designed to build upon the Thai RV144 HIV vaccine trial, which demonstrated an
efficacy of 31.2% among participants who received a different vaccine regimen of a pox prime
followed by a concurrently-administered protein boost. This primary purpose of HVTN 086 is to
evaluate the safety and immunogenicity of SAAVI DNA-C2, SAAVI MVA-C and Novartis Clade C
gp140TV1ΔV2 with MF59 adjuvant in various vaccination regimens. The primary analysis will
focus on a ranking strategy of the vaccine regimens that is guided by measurements of the
immune responses elicited by these vaccines and their respective modes of delivery in various
combinations, both sequential and concurrent.
Participants will actively participate in this study for 12 months. Participants will be
randomly assigned to receive either a prime-boost preventive vaccine regimen or placebo. Four
prime-boost preventive vaccine regimens will be compared; each participant will be randomized
to one of 4 groups. Participants in Group 1 will receive MVA-C at months 0 and 1, and
gp140/MF59 at months 3 and 6. Group 2 will receive MVA-C and gp140/MF59 at months 1 and 3.
Group 3 will receive DNA-C at months 0 and 1, and MVA-C at months 3 and 6. Group 4 will
receive DNA-C at months 0 and 1, and both MVA-C and gp140/MF59 at months 3 and 6. Additional
study visits will occur at Weeks 2, 6, 13, 14, 26, 28, 36, and 48. All participants will be
contacted once annually for 3 years and asked questions about their health. Study procedures
include physical exams, blood and urine collection, HIV testing, an electrocardiogram, and
questionnaire. Some blood collected from participants will be stored and used in future
research. Risk-reduction counseling will be conducted at all study visits.
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