HIV-1 Vaccine Test in Uninfected Adult Volunteers

NCT00047931 | Completed Phase 1

• 2 other identifiers: 03002203-I-0022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the safety of an experimental vaccine against HIV and examine whether it induces an immune response to HIV. A vaccine is a substance given to try to create resistance or immunity to a disease or infection. The vaccine in this study is made from DNA (genetic material) of four HIV proteins called 'gag', 'pol', 'Nef', and 'Env'. Injected into a human, the viral DNA instructs the body to make small amounts of some HIV proteins. This study will see if the body then creates an immune response to these proteins. Study participants cannot catch HIV or AIDS from the DNA vaccine or any proteins made from it. Healthy normal volunteers between 18 and 40 years of age may be eligible for this study. Candidates will be screened with a medical history, physical examination and blood and urine tests. Women will also have a pregnancy test. Women enrolled in the study must either be infertile (e.g., due to menopause or hysterectomy) or must agree either to abstain from heterosexual sex or to practice birth control for at least 21 days before beginning the study and throughout its duration. Participants will be randomly assigned to receive either the experimental vaccine or a placebo (a salt solution that does not contain any active substance) and will be divided into three groups, based on their entry into the study. Of the first seven people enrolled (Group 1), five will receive a 2-mg dose of vaccine and two will receive placebo. If the vaccine is safe at this dose, then in Group 2, five people will receive a 4-mg dose of vaccine and two will receive placebo. If this dose is safe, then in Group 3, thirty people will receive an 8-mg dose of vaccine and six will receive placebo. All participants will receive three injections in an upper arm muscle-one injection a month for three months-with a needle-less device called a Biojector 2000® (Registered Trademark). At the time of each injection, participants will be observed for at least 1 hour after immunization. At home, they will record their temperature and any symptoms they may experience, including any effects at the injection site, for at least 7 days, or as long as the symptoms remain. If symptoms occur, participants will report them immediately to the clinic staff and, if necessary, come to the clinic for an examination. Participants will have about 10 clinic visits during the study. Most visits will last about 2 hours; those on vaccination days will last about 4 hours. ...

Conditions

HIV Seronegativity; AIDS Vaccines

Keywords

Healthy; HIV-Negative; Placebo-Controlled; Volunteer; Dose-Escalation; HIV Seronegativity; Healthy Volunteer; HV

Interventions

VRC-HIVDNA009-00-VP DRUG

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A participant must meet all of the following criteria:
• to 40 years old.
• Available for follow-up for the duration of the study (12 months).
• Able to provide proof of identity to the acceptance of the study clinician completing the enrollment process.
• Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly.
• Able and willing to sign the informed consent form.
• Willing to receive HIV test results and willing to abide by NIH guidelines for partner notification of positive HIV results.
• Willing to have blood samples used for future research.
• Willing to discuss HIV infection risks and amenable to risk reduction counseling.
• In good general health without clinically significant medical history.
• Physical examination and laboratory results without clinically significant findings within the 28 days prior to enrollment.
• Laboratory Criteria within 28 days prior to enrollment:
• Hematocrit greater than or equal to 34 percent for women; greater than or equal to 38 percent for men.
• WBC count: Non-African Americans equals 3,300-12,000 cells/mm(3); African-Americans equals 2,500-12,000 cells/mm(3) (in the absence of clinical or pathological etiology).
• Differential either within institutional normal range or accompanied by site physician approval.

You may not qualify if:

• A volunteer will be excluded if one or more of the following conditions apply:
• Woman who is breast-feeding.
• Volunteer has received any of the following substances:
• HIV vaccines in a prior clinical trial.
• Immunosuppressive or cytotoxic medications within the past six months with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis.
• Blood products within 120 days prior to HIV screening.
• Immunoglobulin within 60 days prior to HIV screening.
• Live attenuated vaccines within 30 days prior to initial study vaccine administration.
• Investigational research agents within 30 days prior to initial study vaccine administration.
• Medically indicated subunit or killed vaccines ( e.g., influenza, pneumococcal, or allergy treatment with antigen injections) within 14 days of study vaccine administration.
• Current anti-TB prophylaxis or therapy.
• Volunteer has a history of any of the following clinically significant conditions:
• Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty angioedema, or abdominal pain.
• Autoimmune disease or immunodeficiency.
• Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Graham BS. Clinical trials of HIV vaccines. Annu Rev Med. 2002;53:207-21. doi: 10.1146/annurev.med.53.082901.104035.

  PMID: 11818471 BACKGROUND

• Bagarazzi ML, Boyer JD, Ayyavoo V, Weiner DB. Nucleic acid-based vaccines as an approach to immunization against human immunodeficiency virus type-1. Curr Top Microbiol Immunol. 1998;226:107-43. doi: 10.1007/978-3-642-80475-5_8. No abstract available.

  PMID: 9479839 BACKGROUND

• Heilman CA, Baltimore D. HIV vaccines--where are we going? Nat Med. 1998 May;4(5 Suppl):532-4. doi: 10.1038/nm0598supp-532. No abstract available.

  PMID: 9585205 BACKGROUND

• Graham BS, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Martin JE, McCluskey MM, Chakrabarti BK, Lamoreaux L, Andrews CA, Gomez PL, Mascola JR, Nabel GJ; Vaccine Research Center 004 Study Team. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine. J Infect Dis. 2006 Dec 15;194(12):1650-60. doi: 10.1086/509259. Epub 2006 Nov 8.

  PMID: 17109336 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 22, 2002
• First Posted: October 23, 2002
• Study Start: October 17, 2002
• Study Completion: May 5, 2009
• Last Updated: July 2, 2017

Record last verified: 2009-05-05

Locations

US (1)