Evaluating the Safety and Immune Response to an HIV Vaccine Boost Following the Administration of Two HIV Vaccines, in HIV-Uninfected, Healthy Adults (Study Extension to HVTN 073/SAAVI 102)
|HIV Infections||Biological: Sub C gp140 Vaccine Biological: MF59C.1 Adjuvant Other: Sodium chloride||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Phase 1 Placebo-Controlled Study Extension to HVTN 073 / SAAVI 102, to Evaluate the Safety and Immunogenicity of Novartis Sub C gp140 Vaccine With MF59 Adjuvant, as a Boost Following SAAVI DNA-C2 Vaccine and SAAVI MVA-C Vaccine, in HIV Uninfected Healthy Adult Participants in South Africa and the United States|
- Safety data, including signs and symptoms of local and systemic reactogenicity, laboratory measures of safety, adverse events (AEs), and AEs requiring expedited adverse event (EAE) reporting to DAIDS [ Time Frame: Measured through Month 15 ]
- HIV-1-specific neutralizing and binding antibody assays at 2 weeks following vaccination with Novartis Sub C gp140 with MF59 [ Time Frame: Measured at Months 0.5, 3.5 and 9 ]
- Neutralizing antibody breadth against heterologous primary isolates [ Time Frame: Measured at Months 0.5, 3.5 and 9 ]
|Study Start Date:||August 2011|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Sub C gp140/MF59C.1 Vaccine
Participants will receive Sub C gp140 vaccine (100 mcg) admixed with MF59C.1 adjuvant administered as one 0.5 mL injection intramuscularly (IM) in either deltoid at baseline and Month 3.
Biological: Sub C gp140 Vaccine
100 mcg of Sub C gp140 vaccine admixed with MF59C.1 adjuvant administered as one 0.5 mL injection intramuscularly (IM) in either deltoidBiological: MF59C.1 Adjuvant
MF59C.1 adjuvant admixed with 100 mcg of Sub C gp140 vaccine administered as one 0.5 mL injection intramuscularly (IM) in either deltoid. MF59C.1 adjuvant contains no biologicals.
Placebo Comparator: Sodium chloride for injection
Participants will receive placebo injection administered as 0.5 mL IM in either deltoid at baseline and Month 3.
Other: Sodium chloride
Sodium chloride as 0.5 mL IM injection in either deltoid to act as placebo
The HVTN 073/SAAVI 102 study is evaluating the safety of two experimental HIV vaccines—SAAVI DNA-C2 and SAAVI MVA-C—given sequentially as a prime-boost regimen in healthy, HIV-uninfected adults. This is an extension of that study and will enroll people who participated in the HVTN 073/SAAVI 102 study. Previous studies have shown that a protein vaccine boost to an HIV vaccine may improve antibody responses. This study will evaluate the safety and immune response to an HIV envelope protein vaccine—the Sub C gp140 vaccine with MF59 adjuvant—in healthy, HIV-uninfected adults who have previously participated in the HVTN 073/SAAVI 102 study. Study researchers will explore whether the addition of a protein boost vaccine to the SAAVI DNA-C2 and SAAVI MVA-C vaccine regimen improves antibody response.
This study will enroll people who participated in the HVTN 073/SAAVI 102 study,regardless of whether they received vaccine or placebo. Participants will be randomly assigned to receive either the Sub C gp140 vaccine with MF59 adjuvant or a placebo injection during study visits at baseline and Month 3. At the baseline and Month 3 visits, participants will undergo a physical examination, HIV testing and counseling, pregnancy testing for female participants, interviews and questionnaires, risk reduction counseling, and blood collection (at the baseline visit only). They will then receive their assigned vaccine or placebo as one injection in their upper arm. Participants will remain in the clinic for 30 minutes after receiving the vaccination for observation and monitoring. For 3 days after the vaccination, participants will record any side effects in a symptom log and make contact daily with the study site staff.
Additional study visits will occur at Weeks 1 and 2, 1 and 2 weeks after the Month 3 visit, and Months 6 and 9. At these visits, select baseline study procedures will occur. At Month 15, study staff will contact participants for follow-up health monitoring. Participants will then complete any annual health contacts for the original HVTN 073/SAAVI 102 study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423825
|United States, Massachusetts|
|Brigham and Women's Hospital Vaccine CRS (BWH VCRS)|
|Boston, Massachusetts, United States, 02115-6110|
|Fenway Health (FH) CRS|
|Boston, Massachusetts, United States, 02215-4302|
|Soweto HVTN CRS|
|Johannesburg, Gauteng, South Africa, 1864|
|Cape Town, Western Cape Province, South Africa, 7750|
|Study Chair:||Glenda Gray||University of the Witswatersrand|