Phase I Study of HIV Adenoviral Vector Vaccine in Healthy Subjects Using Needle or Biojector Injection

NCT00709605 | Completed Phase 1

• 2 other identifiers: 08017108-I-0171
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the immune response and side effects of an experimental HIV vaccine given by two different methods of administration by needle injection or by use of a needle-free device called the Biojector 2000 (Registered Trademark). The vaccine, called VRC-HIVADV014-00-VP, or rAd5, is made using an adenovirus that has been modified to contain DNA that codes for three HIV proteins. It cannot cause HIV or adenoviral infections. Healthy volunteers who are not infected with the HIV virus may be eligible for this study. Subjects are recruited for two study groups: Group 1 comprises volunteers who are 18 to 50 years old and have never received an HIV vaccine and Group 2 comprises volunteers who are 18 to 55 years old and participated in a prior study in which they received at least one injection of the study rAd5 vaccine. Subjects in both groups are randomly assigned to receive the vaccine by needle or Biojector 2000 (Registered Trademark) into a muscle in the upper arm. They call a study nurse 2 days after the injection, record their temperature and symptoms on a diary card at home for 5 days after the injection for later review, and visit the clinic two weeks after the injection for a checkup. The injection is given on the day of enrollment. Additional visits are scheduled at weeks 2, 4, 12 and 24, when subjects are checked for health changes or problems, their use of medications and how they are feeling. Blood samples are collected at all clinic visits. Subjects are tested for HIV at the beginning and end of the study, are asked about their sexual behavior and drug use, and are counseled about HIV risk reduction. Women are tested for pregnancy at the beginning and end of the study. Participants in Group 2 may undergo apheresis at the 4-week visit. This procedure is done to collect white blood cells for tests to examine the immune response to the vaccine. Blood is collected through a needle in the vein of one arm and directed through a machine that separates the cell components. The white cells are removed and the rest of the blood is returned through the same needle. Subjects are asked about any social effects they may have experienced from participating in the study. These effects are monitored to make sure participants receive any needed assistance and to learn ways to prevent these problems in the future.

Conditions

HIV Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety (local and systemic reactogenicity, lab tests, AEs)

Secondary Outcomes (1)

• Immunogenicity (cellular and humoral immune function assays)

Interventions

VRC-HIVADV014-00-VP DRUG

Eligibility Criteria

• Age: 18 Years - 55 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 50 years old if enrolling into Group 1 or 18 to 55 years old if enrolling into Group 2.
• HIV vaccine naive if enrolling into Group 1, or receipt of the VRC HIV rAd5 vaccine in a previous study without experiencing a serious adverse event attributed (i.e., definitely, probably, possibly, or probably not related) to the vaccine if enrolling into Group 2.
• Available for clinical follow-up through Week 24 of the study and committed to four years of annual follow-up contact after Week 24.
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
• Complete an Assessment of Understanding that includes understanding of the STEP Study results 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, amenable to risk reduction counseling, committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit, and assessed by the clinic staff as being at low risk of HIV infection on the basis of behaviors in the 12 months before enrollment as follows:
• Sexually abstinent OR
• Had two or fewer mutually monogamous relationships with partners believed to be HIV-uninfected and who did not use injection drugs, crack cocaine or methamphetamine OR
• Had two or fewer partners believed to be HIV-uninfected and who did not use injection drugs, crack cocaine or methamphetamine and with whom he/she regularly used condoms for vaginal or anal intercourse.
• 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 or equal to 40 within the 56 days prior to enrollment.

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 24 weeks of study participation.
• Volunteer has received any of the following substances:
• Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past three months.
• \[Note: The following will NOT exclude study participation:
• use of corticosteroid nasal spray for rhinitis;
• topical corticosteroids for an acute uncomplicated dermatitis;
• short-acting beta-agonists in controlled asthmatics; a short course (10 days or less) of corticosteroids for a non-chronic condition completed at least 2 weeks prior to enrollment in this study\]
• Blood products within 112 days (16 weeks) prior to HIV screening.
• Immunoglobulin within 56 days (8 weeks) prior to HIV screening.
• Investigational research agents within 28 days (4 weeks) prior to initial study vaccine administration.
• Live attenuated vaccines within 28 days (4 weeks) 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 (2 weeks) prior to study vaccine administration.
• Current anti-tuberculosis prophylaxis or therapy.

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)

• Osmanov S, Pattou C, Walker N, Schwardlander B, Esparza J; WHO-UNAIDS Network for HIV Isolation and Characterization. Estimated global distribution and regional spread of HIV-1 genetic subtypes in the year 2000. J Acquir Immune Defic Syndr. 2002 Feb 1;29(2):184-90. doi: 10.1097/00042560-200202010-00013.

  PMID: 11832690 BACKGROUND

• Hemelaar J, Gouws E, Ghys PD, Osmanov S. Global and regional distribution of HIV-1 genetic subtypes and recombinants in 2004. AIDS. 2006 Oct 24;20(16):W13-23. doi: 10.1097/01.aids.0000247564.73009.bc.

  PMID: 17053344 BACKGROUND

• Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Gu L, Martin JE, Novik L, Chakrabarti BK, Butman BT, Gall JG, King CR, Andrews CA, Sheets R, Gomez PL, Mascola JR, Nabel GJ, Graham BS; Vaccine Research Center 006 Study Team. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector. J Infect Dis. 2006 Dec 15;194(12):1638-49. doi: 10.1086/509258. Epub 2006 Nov 8.

  PMID: 17109335 BACKGROUND

• Sarwar UN, Novik L, Enama ME, Plummer SA, Koup RA, Nason MC, Bailer RT, McDermott AB, Roederer M, Mascola JR, Ledgerwood JE, Graham BS; VRC 015 study team. Homologous boosting with adenoviral serotype 5 HIV vaccine (rAd5) vector can boost antibody responses despite preexisting vector-specific immunity in a randomized phase I clinical trial. PLoS One. 2014 Sep 29;9(9):e106240. doi: 10.1371/journal.pone.0106240. eCollection 2014.

  PMID: 25264782 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 Officials

• Barney S Graham, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 28, 2008
• First Posted: July 3, 2008
• Study Start: June 25, 2008
• Primary Completion: May 20, 2014
• Study Completion: May 20, 2014
• Last Updated: December 17, 2019

Record last verified: 2014-05-20

Locations

US (1)