"Prime-Boost" Vaccine Schedule for Prevention of HIV Infection

NCT00109629 | Completed Phase 1

• 2 other identifiers: 05014805-I-0148
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the safety and side effects of two experimental HIV vaccines given in a "prime-boost" schedule. It will also monitor participants for the social impact of being in an HIV vaccine study (e.g., problems with insurance, health care, friends, family, employment, housing, and so forth). The vaccines are VRC-HIVDNA016-00-VP (called the DNA vaccine) and VRC-HIVADV014-00-VP (called the rAd vaccine). The DNA vaccine codes for four HIV proteins. The rAd vaccine is made using an adenovirus (a common virus that causes upper respiratory infections, such as the common cold) that has been modified to contain DNA that codes for three HIV proteins. These vaccines cannot cause HIV or adenoviral infections. The study will also see if the vaccines cause an immune response; if the injection of the DNA vaccine given using a needle and syringe is similar in safety and immune response to giving them with a needleless injection device called a Biojector 2000; if people who already have antibodies to adenovirus still have an immune response to rAd vaccine; and if there are social harms that result from participating in an HIV vaccine study. Healthy volunteers between 18 and 50 years of age may be eligible for this 42-week study. Candidates are screened with a medical history, physical examination, blood and urine tests (including pregnancy test for women), and questions regarding sexual behavior and other practices. Participants receive three injections (shots) of the DNA vaccine and one injection of the rAd vaccine. All injections are given into a muscle in the upper arm (alternating right and left arms with each injection), using a needle and syringe or the needleless Biojector 2000. The first vaccination is given the day of enrollment into the study, and the DNA vaccinations are given about 4 weeks apart from each other, with a minimum of 21 days between injections. The rAd "booster"vaccination is given at Week 24. Participants fill out a diary card at home for 5 days after each vaccination, recording their temperature and any symptoms. They come to the clinic for follow-up 3 days each DNA vaccine injection, and call or return again 7 days after each injection. They call a study nurse 1 or 2 days after the rAd injection. There are 15 to 18 clinic visits during the course of the study. At each visit, participants are checked for health changes or problems. Blood and urine samples are collected at some visits. Participants are periodically tested for HIV and asked questions about their sexual behavior and drug use and are counseled throughout the study on HIV risk reduction. They are also asked about any social effects they may have experienced as a result of their participation in this study.

Conditions

HIV Infections

Keywords

HIV-Negative; Healthy; Immunity; Preventive; Virus; Healthy Volunteer

Interventions

VRC-HIVDNA016-00-VP DRUG

VRC-HIVADV014-00 DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A participant must meet all of the following criteria:
• to 50 years old.
• Available for clinical follow-up through Week 42 of the study.
• Able to provide proof of identity to the satisfaction 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 complete the informed consent process.
• Willing to receive HIV test results and willing to abide by NIH guidelines for partner notification of positive HIV results.
• Willing to donate blood for sample storage to be 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 and a body mass index (BMI) less than 40 within the 28 days prior to enrollment.
• Laboratory Criteria within 28 days prior to enrollment:
• Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men.
• White blood cells (WBC) = 3,300-12,000 cells/mm(3).
• 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:
• Women:
• Woman who is breast-feeding or planning to become pregnant during the 42 weeks of study participation.
• Volunteer has received any of the following substances:
• HIV vaccine in a prior clinical trial.
• Immunosuppressive medications or cytotoxic medications or inhaled corticosteroids 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.
• Investigational research agents within 30 days prior to initial study vaccine administration.
• Live attenuated vaccines 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-tuberculosis 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.

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 (1)

• Graham BS, Enama ME, Nason MC, Gordon IJ, Peel SA, Ledgerwood JE, Plummer SA, Mascola JR, Bailer RT, Roederer M, Koup RA, Nabel GJ; VRC 008 Study Team. DNA vaccine delivered by a needle-free injection device improves potency of priming for antibody and CD8+ T-cell responses after rAd5 boost in a randomized clinical trial. PLoS One. 2013;8(4):e59340. doi: 10.1371/journal.pone.0059340. Epub 2013 Apr 8.

  PMID: 23577062 DERIVED

MeSH Terms

Conditions

HIV Infections; Virus Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: April 29, 2005
• First Posted: May 2, 2005
• Study Start: April 26, 2005
• Study Completion: January 22, 2008
• Last Updated: July 2, 2017

Record last verified: 2008-01-22

Locations

US (1)