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
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: DNA plasmid vaccine; Recombinant adenoviral serotype 5 (rAD5) vector vaccine; DNA vaccine placebo; HIV-1 recombinant adenovirus vaccine placebo
Intervention description: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid; 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid; 1 mL IM via Biojector® in either deltoid; 1 mL administered IM by needle and syringe in either deltoid
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 2504.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV Seronegativity; HIV Preventive Vaccine; HIV Treatment Vaccine; Adenovirus

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.

      NOTES:

      As of April 2013, all vaccinations in this study have been stopped.

      As of June 2017, this study has been closed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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:

               1. Unprotected anal intercourse with one or more male or MTF transgender partner(s)

               2. 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 Criteria:

          -  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