Status:
COMPLETED
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)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01423825
Start Date
August 1 2011
End Date
July 1 2013
Last Update
October 14 2021
Active Locations (4)
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1
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States, 02115-6110
2
Fenway Health (FH) CRS
Boston, Massachusetts, United States, 02215-4302
3
Soweto HVTN CRS
Johannesburg, Gauteng, South Africa, 1864
4
Emavundleni CRS
Cape Town, Western Cape, South Africa, 7750