Status:
COMPLETED
Early Immune Responses to Vaccination - A Substudy to HVTN 205
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-50 years
Brief Summary
HVTN 908 is a sub study of the HIV vaccine trial, HVTN 205. The purpose of this sub study is to better understand how a person's immune system responds to vaccines, particularly HIV vaccines. More spe...
Detailed Description
Some of the first HIV vaccines were designed to trigger neutralizing antibody responses as a way to prevent HIV infection. Unfortunately, the first versions of these vaccines were not able to achieve ...
Eligibility Criteria
Inclusion
- Scheduled receipt of a vaccine or placebo in HVTN 205
- For participants in Part B of HVTN 205, enrollment in HVTN 908 and HVTN 205 at the same time
- HVTN 908 assessment of understanding: completion of a questionnaire prior to enrollment; demonstration of understanding for all questionnaire items answered incorrectly.
- Body weight of 50 kg (110 lbs) or more
- Hemoglobin of 12.0 g/dL or more for female volunteers, and 13.0 g/dL or more for male volunteers
- Negative HIV-1 and -2 blood test
Exclusion
- Clinically significant medical condition, physical examination finding, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. More information on this criterion can be found in the study protocol.
- Any medical, psychiatric, or occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, or a participant's ability to give informed consent
- Pregnancy
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00908323
Start Date
July 1 2009
End Date
July 1 2012
Last Update
October 15 2021
Active Locations (3)
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1
Alabama Vaccine CRS
Birmingham, Alabama, United States, 35294
2
Bridge HIV CRS
San Francisco, California, United States, 94143
3
Seattle Vaccine and Prevention CRS
Seattle, Washington, United States, 98109-1024