Evaluating the Safety and Immune Response to an HIV Vaccine in Healthy, HIV-Uninfected Adults Who Have Participated in Previous HIV Vaccine Clinical Trials and in Adults Who Have Not Participated in Previous HIV Vaccine Clinical Trials
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      Previous clinical trials have shown that people who receive a second vaccine for certain
      conditions after having received a prior vaccine may have a better antibody response to the
      second vaccine than people who receive the vaccine for the first time. This is known as
      "priming" and it may occur in people receiving a second vaccine even if the first vaccine was
      received several years previously. This study will enroll healthy, HIV-uninfected adults who
      have participated in a previous HIV vaccine clinical trial and received HIV-1 subtype B
      envelope subunit vaccines with MF59 adjuvant, and healthy, HIV-uninfected adults who have not
      participated in a previous HIV vaccine clinical trial and therefore have not previously
      received any HIV vaccines. Participants in this study will receive a total of two injections,
      each 6 months apart, of the HIV-1 Sub Cgp140 vaccine with MF59 adjuvant. Researchers will
      evaluate the safety and immune response to the study vaccine and determine if people who
      participated in a previous HIV vaccine clinical trial demonstrate an improved antibody
      response to the study vaccine versus people who have never received an HIV vaccine.

      This study will enroll two groups of participants. Group 1 will include healthy,
      HIV-uninfected adults who have participated in a previous HIV vaccine clinical trial. Group 2
      will include healthy, HIV-uninfected adults who have not participated in an HIV vaccine
      clinical trial. All participants will receive the study vaccine injected into their upper arm
      at baseline and Month 6.

      At the baseline study visit, all participants will undergo a physical examination, a medical
      and medication history review, and blood collection. Female participants will also take a
      pregnancy test. Participants will complete questionnaires and receive counseling on HIV risk
      reduction and pregnancy prevention. Saliva samples will be obtained from all participants and
      rectal fluids, semen samples, and cervical secretions will be obtained from some
      participants. After receiving the vaccine, participants will remain in the clinic for at
      least 30 minutes for observation and monitoring of side effects. For 3 days after the
      vaccination, participants will record any side effects in a symptom log.

      Participants in Group 1 will attend study visits 1 and 2 weeks after the first vaccination
      study visit, at Month 6 for the second vaccination, 1 and 2 weeks after the Month 6 study
      visit, and at Months 9 and 12. Participants in Group 2 will attend study visits 1 and 3 days
      and 1 and 2 weeks after the first vaccination study visit, at Month 6 for the second
      vaccination, 1 and 3 days and 1 and 2 weeks after the Month 6 study visit, and at Months 9
      and 12. Follow-up study visits will include select study procedures. Blood collected during
      study visits may be saved for future testing. Study researchers will contact participants at
      Month 18 for follow-up health monitoring.

      In July 2013, an extension to the study was announced. Current study participants will be
      screened to see if they are eligible to participate in the study extension. Participants who
      are eligible will receive one additional injection of the study vaccine, at a visit
      approximately 14 to 20 months after their second (Month 6) vaccination. Additional study
      visits will occur 2 weeks, and 3 and 6 months after receiving the third vaccination. Select
      visits will include a physical examination, blood collection, saliva collection, pregnancy
      test for female participants, HIV testing and risk reduction counseling, and interviews and
      questionnaires. Study researchers will contact participants 1 year after the third
      vaccination for follow-up health monitoring.
    

Intervention name(s): Sub C gp140 Vaccine; MF59C.1 Adjuvant
Intervention type(s): Biological; Biological
Intervention description(s): Sub C gp140 100 mcg will be combined with MF59C.1 and administered as one injection (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.; Sub C gp140 100 mcg will be combined with MF59C.1 and administered as one injection (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.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention