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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Page 1 of 1 (3 locations)

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