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NCT00102089 · ClinicalTrials.gov registry record · Phase 1

HIV-1 Vaccine Booster in Previously Immunized Uninfected Adult Volunteers

A Phase 1 study of Healthy and HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
32
Enrollment target
1
Study location

NCT00102089 is a Phase 1 study of Healthy and HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 32 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00102089, a Phase 1 study of Healthy and HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target
1
Study location

Study Summary

This study will test the safety and side effects of an experimental vaccine booster against HIV. A vaccine is a substance given to try to create immunity or resistance to a disease or infection. The vaccine used in this study is called VRC-HIVADV014-00-VP. It is made from an adenovirus (a common virus that causes upper respiratory infections) that contains DNA (genetic material) of three HIV proteins. Injected into a human, the viral DNA instructs the body to make small amounts of some HIV proteins. VRC-HIVADV014-00-VP will be given to people who previously received a vaccine called VRC-HIVDNA009-00-VP under NIH protocol 03-I-0022. Important: Study participants cannot catch an adenovirus infection or HIV or AIDS from the vaccine or any proteins made from it. Healthy normal volunteers who participated in NIH protocol 03-I-0022 may be eligible for this study. They must have completed three injections of 4 mg or 8 mg of VRC-HIVDNA009-00-VP without experiencing a serious side effect that was possibly related to the vaccine. Candidates are screened with a medical history, clinical evaluation, blood and urine tests, and HIV and pregnancy counseling. Participants receive one injection of VRC-HIVADV014-00-VP the day they enroll in the study (study day 0). They are observed for at least 30 minutes after immunization. At home, they record their temperature and any symptoms they may experience, including any effects at the injection site, for 5 days and call a study nurse 1 or 2 days after the injection. They immediately report any symptoms to the clinic staff and, if necessary, come to the clinic for an examination. Participants have five additional clinic visits during the study, at weeks 2, 4, 6, 12 and 24, each lasting about 2 hours. At each visit, they are checked for health changes or problems and are asked about medications they are taking. Blood is drawn for immune function testing, HLA typing (a genetic test of immune system markers), and other genetic factors. A u

Conditions Studied

Healthy HIV Infections

Interventions

  • DRUG VRC-HIVADV014-00-VP
  • BIOLOGICAL VRC-HIVADV014-00-VP booster

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2005-01-18
Est. Completion 2007-10-10
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT00102089

The ClinicalTrials.gov registry entry for NCT00102089 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which VRC-HIVADV014-00-VP is the first listed.

NCT00102089 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00102089 about?

NCT00102089 is a clinical study titled "HIV-1 Vaccine Booster in Previously Immunized Uninfected Adult Volunteers". This study will test the safety and side effects of an experimental vaccine booster against HIV. A vaccine is a substance given to try to create immunity or resistance to a disease or infection. The vaccine used in this study is called VRC-HIVADV014-00-VP. It is made from an adenovirus (a common vir...

What is the current status of trial NCT00102089?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2005-01-18. Estimated completion is 2007-10-10.

What conditions does trial NCT00102089 study?

This clinical trial studies the following conditions: Healthy, HIV Infections.

What interventions are being tested in trial NCT00102089?

The interventions under investigation include: VRC-HIVADV014-00-VP (DRUG), VRC-HIVADV014-00-VP booster (BIOLOGICAL).

Who is sponsoring clinical trial NCT00102089?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00102089 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.