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)
Completed · Phase 1 · Has a placebo group
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT01423825
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 27
- Starts
- 2011-08-01
- Expected to finish
- 2013-07-01
- Last updated by the study team
- 2021-10-14
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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:
- Negative urine glucose, and
- Negative or trace urine protein, and
- 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
You may not qualify if…
- 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)
Where it is running
- Brigham and Women's Hospital Vaccine CRS (BWH VCRS) — Boston, Massachusetts, United States
- Fenway Health (FH) CRS — Boston, Massachusetts, United States
- Soweto HVTN CRS — Johannesburg, Gauteng, South Africa
- Emavundleni CRS — Cape Town, Western Cape, South Africa
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.