Status:
TERMINATED
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
HIV Vaccine Trials Network
Conditions:
HIV Infections
Eligibility:
MALE
18-50 years
Phase:
PHASE2
Brief Summary
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. NOT...
Detailed Description
In 2007, the Joint United Nations Programme on HIV/AIDS estimated that 33.2 million people were living with HIV/AIDS globally. The U.S. HIV prevalence data reported in October 2008 by the Centers for ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2017
Estimated Enrollment :
2504 Patients enrolled
Trial Details
Trial ID
NCT00865566
Start Date
May 1 2009
End Date
October 6 2017
Last Update
October 15 2021
Active Locations (22)
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1
Alabama CRS
Birmingham, Alabama, United States, 35294
2
The AIDS Research Alliance of America CRS
Los Angeles, California, United States, 90015
3
UCLA CARE Center CRS
Los Angeles, California, United States, 90035
4
Bridge HIV CRS
San Francisco, California, United States, 94143