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)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an extension of the HVTN 073/SAAVI 102 study. This study will evaluate the safety and
      immune response to an HIV envelope protein vaccine boost in people who have previously
      received the SAAVI DNA-C2 and SAAVI MVA-C vaccines or placebo in the HVTN 073/SAAVI 102
      study.
    

Detailed description: 
      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.
    

Intervention name(s): Sub C gp140 Vaccine; MF59C.1 Adjuvant; Sodium chloride
Intervention type(s): Biological; Biological; Other
Intervention description(s): 100 mcg of Sub C gp140 vaccine admixed with MF59C.1 adjuvant administered as one 0.5 mL injection intramuscularly (IM) in either deltoid; 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.; Sodium chloride as 0.5 mL IM injection in either deltoid to act as placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention