Screening Protocol for HIV Vaccine Studies

NCT00031304 | Completed

• 2 other identifiers: 02012702-I-0127
• Study Type: observational
• Target: 1,324
• Locations: 1 country
• Sites: 1

Brief Summary

Healthy volunteers will be screened under this protocol for possible participation in a study testing a vaccine against HIV, the virus that causes AIDS. Healthy adults 18 to 60 years of age may be eligible for this study. Participants must be in good general health with no history of significant medical problems or abnormal laboratory test results. Pregnant or breast-feeding women and people infected with HIV will not be enrolled. Participants enrolled in this protocol will undergo the following tests and procedures within 8 weeks before the start of the experimental vaccine study:

• Medical history, including history of sexual activity and drug use
• Physical examination
• Pregnancy test for women of childbearing age
• Blood and urine tests to evaluate possible medical problems such as liver and kidney function; to evaluate immune function; and to test for HIV, hepatitis and syphilis Individuals who are identified through this screening protocol as possible candidates for an HIV vaccine trial will be provided additional information about study options.

Conditions

HIV Seronegativity; HIV Infections

Keywords

HIV; AIDS; Vaccine; Screening; Prevention; HV; Healthy Volunteer; Volunteer; HIV Seronegativity; HIV Preventive Vaccine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-60 years of age.
• Available to participate for the planned duration of the investigational vaccine study for which the screening is being done (vaccine studies may require 6 months to 18 months of clinic visits).
• Able and willing to complete the informed consent process.
• Agree to have blood stored for future studies of the vaccine, the immune system, and/or other medical conditions.

You may not qualify if:

• Known to be HIV infected.
• Women who are known to be pregnant and/or breast feeding.
• A condition in which repeated blood draws or injections pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access.
• A condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Officials

• Barney S Graham, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 28, 2002
• First Posted: March 1, 2002
• Study Start: February 27, 2002
• Study Completion: April 8, 2013
• Last Updated: December 5, 2019

Record last verified: 2013-04-08

Locations

US (1)