HIV SeronegativityNCT00031304
Screening Protocol for HIV Vaccine Studies
An observational study of HIV Seronegativity and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Seronegativity, HIV Infections
- How many people
- 1,324 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2002to 8 Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Screening Subjects for HIV Vaccine Research Studies
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.
Read more
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.
Read the 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 3,000
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 and/or 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, M.D., Ph.D., VRC/NIAID/NIH
- Conditions
- HIV Seronegativity, HIV Infections
- Keywords
- HIV, AIDS, Vaccine, Screening, Prevention, HV, Healthy Volunteer, Volunteer, HIV Seronegativity, HIV Preventive Vaccine
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2002 (estimated)
- Study start27 Feb 2002
- Study completion8 Apr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV SeronegativityStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 1,324 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Barney S Graham, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031304
- Sponsor's protocol ID
- 020127
- Other IDs
- 02-I-0127
- Status last verified
- 8 Apr 2013
- First submitted
- 28 Feb 2002
- Last updated
- 5 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Subjects for HIV Vaccine Research Studies
- ClinicalTrials.gov ID
- NCT00031304
- Acronym / sponsor ID
- 020127
- Conditions
- HIV Seronegativity, HIV Infections
- Keywords
- HIV, AIDS, Vaccine, Screening, Prevention, HV, Healthy Volunteer, Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,324 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 27 Feb 2002
- Study completion
- 8 Apr 2013
- First posted
- 1 Mar 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 3,000
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 and/or 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, M.D., Ph.D., VRC/NIAID/NIH
Study design
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barney S Graham, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Seronegativity and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.