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)

• Register: ClinicalTrials.gov
• Last refreshed on: 13 May 2013
• Main ID: NCT01423825
• Date of registration: 24/08/2011
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: 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)
• Scientific 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
• Date of first enrolment: August 2011
• Target sample size: 36
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01423825
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Countries of recruitment

South Africa, United States

Contacts

• Name: Glenda Gray
• Affiliation: University of the Witswatersrand

Key inclusion & exclusion criteria

Inclusion Criteria:

- Hemoglobin greater than or equal to 11.0 g/dL

- White blood cell (WBC) count greater than 2,500 cells/mm^3

- Platelets greater than or equal to 125,000/mm^3

- Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST),
and alkaline phosphatase less than 1.25 times the institutional upper limit of
normal; creatinine less than or equal to the institutional upper limit of normal

- Normal urine:

1. Negative urine glucose, and

2. Negative or trace urine protein, and

3. Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick,
a microscopic urinalysis within institutional normal range)

- Able and willing to provide informed consent

- Negative HIV-1 and -2 blood test: Participants must have a negative HIV test result
as specified by the HVTN Laboratory Program's in-study HIV diagnostic algorithm

- Participants who were born female: negative serum or urine beta human chorionic
gonadotropin (beta-HCG) pregnancy test performed on the day of initial study
extension vaccination prior to vaccination

- Reproductive status: A participant who was born female must agree to consistently use
effective contraception from at least 21 days prior to enrollment through 90 days
after the participant's final vaccination, for sexual activity that could lead to
pregnancy. More information on this criterion can be found in the protocol.

- Participants who were born female must also agree not to seek pregnancy through
alternative methods such as artificial insemination or in vitro fertilization until
after the last scheduled protocol visit

- Receipt of scheduled injection at visit 11 in the HVTN 073/SAAVI 102 study

Exclusion Criteria:

- Participant meets criteria for delay or discontinuation of vaccination or termination
from the study. More information on this criterion can be found in the protocol.

- Participant has an unresolved AE that is possibly, probably, or definitely related to
the study product

- Any medical, psychiatric, or social condition, or occupational or other
responsibility that, in the judgment of the investigator, would interfere with, or
serve as a contraindication to, protocol adherence, assessment of safety or
reactogenicity, or a participant's ability to give informed consent (e.g., a skin
condition overlying a potential injection site, which could interfere with
reactogenicity assessment)



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

HIV Infections

Intervention(s)

Biological: MF59C.1 Adjuvant

Biological: Sub C gp140 Vaccine

Other: Sodium chloride

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

11824

HVTN 073E/SAAVI 102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors