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HIV Candidate Vaccine, ALVAC-HIV-1, Administration in HIV-Negative Adults

NCT ID: NCT00013572

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to determine the best way to administer the candidate HIV vaccine, ALVAC HIV-1 (vCP205).

Detailed Description

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Healthy adult volunteers are assigned randomly to either a vaccine or placebo group. Injections are received either intramuscularly, intradermally, or by delivery under the skin of the volunteer's own white blood cells which have had dendritic cell reinfusion. Volunteers are vaccinated at 0, 1, 3, and 6 month time points. Volunteers are closely monitored for 1 hour after vaccination and keep a diary of symptoms for 1 week post-immunization. Volunteers undergo leukopheresis at the start of the study and after the last vaccination at Walter Reed Army Medical Center. Volunteers receive compensation benefits.

Conditions

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HIV Infections HIV Seronegativity

Keywords

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Injections, Intramuscular Injections, Intradermal Injections, Subcutaneous HIV-1 AIDS Vaccines Dendritic Cells HIV Seronegativity Genes, env Genes, pol Genes, gag Transfection HIV Preventive Vaccine

Study Design

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Primary Study Purpose

PREVENTION

Interventions

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ALVAC-HIV MN120TMG (vCP205)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Volunteers may be eligible for this study if they:

* Are legal US residents.
* Are healthy adults from 18 to 55 years of age.

Exclusion Criteria

Volunteers will not be eligible for this study if they:

* Are HIV-positive.
* Are at highest risk for HIV infection.
* Are pregnant or breast-feeding.
* Are allergic to eggs or neomycin.
* Use certain prescription medications.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Walter Reed Army Institute of Research (WRAIR)

FED

Sponsor Role lead

Principal Investigators

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Mary Marovich

Role: PRINCIPAL_INVESTIGATOR

Locations

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Walter Reed Army Institute of Research (WRAIR)

Rockville, Maryland, United States

Site Status

Countries

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United States

References

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Eller MA, Slike BM, Cox JH, Lesho E, Wang Z, Currier JR, Darden JM, Polonis VR, Vahey MT, Peel S, Robb ML, Michael NL, Marovich MA. A double-blind randomized phase I clinical trial targeting ALVAC-HIV vaccine to human dendritic cells. PLoS One. 2011;6(9):e24254. doi: 10.1371/journal.pone.0024254. Epub 2011 Sep 16.

Reference Type DERIVED
PMID: 21949699 (View on PubMed)

Other Identifiers

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RV 138

Identifier Type: -

Identifier Source: secondary_id

B011

Identifier Type: -

Identifier Source: org_study_id