Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men and Male-to-Female (MTF) Transgender Persons Who Have Sex With Men

Stopped early · Phase 2 · Has a placebo group

Conditions studied: HIV Infections

In brief

The purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, circumcised men and male-to-female (MTF) transgender persons who have sex with men. NOTES: As of April 2013, all vaccinations in this study have been stopped. As of June 2017, this study has been closed.

Key facts

Study ID

NCT00865566

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

2504

Starts

2009-05-01

Expected to finish

2017-10-06

Last updated by the study team

2021-10-15

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• HIV-1 and -2 negative
• Good general health
• Fully circumcised
• Experienced one or both of the following HIV risk criteria in the 6 months before study entry:
• Unprotected anal intercourse with one or more male or MTF transgender partner(s)
• Anal intercourse with two or more male or MTF transgender partners
• Alanine aminotransferase (ALT) 2.5 or less times the upper limit of normal (ULN)
• Ad5 neutralizing antibody (nAb) titer less than 1:18
• Have access to a participating study site and are willing to be followed during the study
• Demonstrate understanding of the study
• Willing to receive HIV test results
• Willing to discuss HIV infection risks and amenable to risk-reduction counseling
• Agrees not to enroll in another study of an investigational research agent before unblinding of this study
• NOTE: MTF transgender volunteers who have undergone gender reassignment surgery (GRS) are eligible to participate if they provide documentation from a health care provider confirming that they were fully circumcised prior to GRS. MTF transgender volunteers who have not undergone GRS are eligible to participate if they meet all enrollment criteria. Receipt of hormonal therapy does not make a transgender volunteer ineligible.

You may not qualify if…

• HIV vaccines in prior HIV vaccine trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
• Used antiretroviral (ARV) drugs for the purpose of HIV-1 prophylaxis for greater than or equal to 50% of days during the 3 months prior to first vaccination or for 30 consecutive days within the 60 days prior to first vaccination
• Circumcised within 90 days prior to first vaccination or displays evidence that surgical site is not fully healed
• Immunosuppressive medications within 168 days prior to first study vaccination. Participants who have used corticosteroid nasal sprays for allergic rhinitis; topical corticosteroids for mild, uncomplicated dermatitis; or oral/parenteral corticosteroids for nonchronic conditions are not excluded.
• Blood products within 90 days prior to first study vaccination
• Immunoglobulin within 90 days prior to first study vaccination
• Live attenuated vaccines other than influenza vaccine within 30 days prior to first study vaccination
• Investigational research agents within 90 days prior to first study vaccination
• Influenza vaccine or any vaccines that are not live attenuated within 14 days prior to first study vaccination
• Allergy treatment with antigen injections within 30 days prior to first study vaccination or that are scheduled within 14 days after first vaccination
• Clinically significant medical condition, physical examination findings, abnormal laboratory results, or past medical history that, in the judgment of the investigator, has significant implications for current health
• Any medical, psychiatric, or job-related responsibility that would interfere with the study. More information about this criterion can be found in the protocol.
• Any concern that, in the opinion of the investigator, may interfere with a participant's completion of the post-vaccination symptom log
• History of serious adverse reactions to vaccinations, including anaphylaxis or allergy to any of the vaccine's components
• Current anti-tuberculosis prophylaxis or therapy
• Autoimmune disease. People with mild, stable, and uncomplicated autoimmune disease that does not require immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate reactogenicity and adverse event assessments are not excluded.
• Immunodeficiency
• Bleeding disorder
• History of malignancy
• Seizure disorder. People with a history of seizures who have had no seizures within the 3 years prior to study entry are not excluded.
• Asthma other than mild, well-controlled asthma
• Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic angioedema

Where it is running

• Alabama CRS — Birmingham, Alabama, United States
• The AIDS Research Alliance of America CRS — Los Angeles, California, United States
• UCLA CARE Center CRS — Los Angeles, California, United States
• Bridge HIV CRS — San Francisco, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Orlando Immunology Center CRS — Orlando, Florida, United States
• The Hope Clinic of the Emory Vaccine Center CRS — Decatur, Georgia, United States
• UIC Project WISH CRS — Chicago, Illinois, United States
• VRC Clinical Trials Core CRS — Bethesda, Maryland, United States
• Brigham and Women's Hospital Vaccine CRS (BWH VCRS) — Boston, Massachusetts, United States
• Fenway Health (FH) CRS — Boston, Massachusetts, United States
• NY Univ. HIV/AIDS CRS — New York, New York, United States
• Columbia P&S CRS — New York, New York, United States
• New York Blood Center CRS — New York, New York, United States
• University of Rochester Vaccines to Prevent HIV Infection CRS — Rochester, New York, United States
• Case Clinical Research Site — Cleveland, Ohio, United States
• Penn Prevention CRS — Philadelphia, Pennsylvania, United States
• Vanderbilt Vaccine (VV) CRS — Nashville, Tennessee, United States
• University of Texas Southwestern CRS — Dallas, Texas, United States
• Baylor Vaccine Research Center CRS — Houston, Texas, United States
• Care-Id Crs — Annandale, Virginia, United States
• Seattle Vaccine and Prevention CRS — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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