Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031304
Status:
COMPLETED
Last Update Posted:
2019-12-05
First Post:
2002-02-28
Brief Title:
Screening Protocol for HIV Vaccine Studies
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Screening Subjects for HIV Vaccine Research Studies
Status:
COMPLETED
Status Verified Date:
2013-04-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Study Design The purpose of this study is to screen subjects to determine if they are suitable candidates for HIV vaccine trials
Healthy HIV-negative subjects will be recruited and screened The results of this study will be used to determine if the subject meets eligibility requirements for participation in H1V vaccine trials Educational materials on vaccines will be reviewed with and provided to subjects before enrollment into the study
Subjects Healthy adults
Number of Subjects Approximately 3000
Outline of Protocol There are one or more visits to evaluate the subject for their eligibility for an HIV vaccine trial The evaluation will usually include laboratory studies physical assessment and counseling on avoidance of HIV infection pregnancy and other HIV-related issues Only those evaluations needed to determine eligibility for a particular study will be done Evaluations of blood and urine samples other than those described in this protocol may be done if necessary for eligibility for a study
If it is determined that the subject might be eligible for an HIV vaccine trial the subject will receive additional information about trial options by telephone mail andor visit with study coordinator Several visits may occur if needed to confirm eligibility for participation in a vaccine clinical trial
Study Duration Varies from about 2 weeks to six months for each subject
Monitoring of Trial Principal Investigator and designated staff of the Vaccine Research Center Regulatory Affairs and Clinical Trials Core
Sponsoring Agency Vaccine Research Center VRC National Institute of Allergy and Infectious Diseases NIAID NIH
Clinical Sites NIH Clinical Center including satellite locations such as the VRC Mobile Clinical Trials Unit MCTU or the VRC Clinic at Cedar Lane and IRB-approved extramural sites
Principal Investigator Barney S Graham MD PhD VRCNIAIDNIH
Healthy HIV-negative subjects will be recruited and screened The results of this study will be used to determine if the subject meets eligibility requirements for participation in H1V vaccine trials Educational materials on vaccines will be reviewed with and provided to subjects before enrollment into the study
Subjects Healthy adults
Number of Subjects Approximately 3000
Outline of Protocol There are one or more visits to evaluate the subject for their eligibility for an HIV vaccine trial The evaluation will usually include laboratory studies physical assessment and counseling on avoidance of HIV infection pregnancy and other HIV-related issues Only those evaluations needed to determine eligibility for a particular study will be done Evaluations of blood and urine samples other than those described in this protocol may be done if necessary for eligibility for a study
If it is determined that the subject might be eligible for an HIV vaccine trial the subject will receive additional information about trial options by telephone mail andor visit with study coordinator Several visits may occur if needed to confirm eligibility for participation in a vaccine clinical trial
Study Duration Varies from about 2 weeks to six months for each subject
Monitoring of Trial Principal Investigator and designated staff of the Vaccine Research Center Regulatory Affairs and Clinical Trials Core
Sponsoring Agency Vaccine Research Center VRC National Institute of Allergy and Infectious Diseases NIAID NIH
Clinical Sites NIH Clinical Center including satellite locations such as the VRC Mobile Clinical Trials Unit MCTU or the VRC Clinic at Cedar Lane and IRB-approved extramural sites
Principal Investigator Barney S Graham MD PhD VRCNIAIDNIH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-I-0127 | None | None | None |