Safety of and Immune Response to a Combination HIV Vaccine Regimen in HIV Uninfected Adults

NCT00073216 | Completed Phase 1

• 2 other identifiers: HVTN 04910054
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 4

Brief Summary

To prevent HIV infection, a vaccine that produces strong HIV-specific humoral (B-cell) and cellular (T-cell) immune system responses is desirable. The purpose of this study is to test the safety of and immune response to a novel combination HIV vaccine in HIV uninfected adults. This study will also test the safety of and immune response to a protein vaccine given alone.

Conditions

HIV Infections

Keywords

HIV Seronegativity; HIV Preventive Vaccine

Outcome Measures

Primary Outcomes (3)

• Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse and serious experiences)

• immunogenicity (presence of HIV-specific immune response as measured by the interferon-gamma ELISpot, FACS Intracellular Cytokine Staining [ICS], neutralizing antibody, or HIV antigen-binding ELISA assays)

• social impacts (negative experiences or problems reported by the participants)

Interventions

Clade B gag DNA/PLG and env DNA/PLG Microparticles BIOLOGICAL

Clade B Recombinant, Oligomeric gp140/MF59 Adjuvant BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• Understanding of vaccination procedure
• Willing to receive HIV test results and provide informed consent
• Good general health
• HIV negative
• Hepatitis B surface antigen negative
• Anti-hepatitis C virus (HCV) antibody negative, or negative for HCV PCR if the anti-HCV is positive
• Not pregnant and agrees to use acceptable forms of contraception

You may not qualify if:

• Received HIV vaccines or placebo in a prior HIV vaccine trial
• Immunosuppressive medications within 168 days prior to study
• Blood products within 120 days prior to study
• Immunoglobulin within 60 days prior to study
• Live attenuated vaccines within 30 days prior to study
• Investigational research agents within 30 days prior to study
• Medically indicated subunit or killed vaccines within 14 days prior to study
• Current anti-tuberculosis prophylaxis or therapy
• Anaphylaxis or other serious adverse reactions to vaccines; a person who had an adverse reaction to pertussis vaccine as a child is not excluded
• Autoimmune disease or immunodeficiency
• Active syphilis infection
• Unstable asthma (e.g., use of oral, orally inhaled, or intravenous corticosteroids, emergent care, urgent care, hospitalization or intubation during the past 2 years)
• Diabetes mellitus; a participant with past gestational diabetes is not excluded
• Thyroid disease, including removal of thyroid and diagnoses requiring medication
• Serious angioedema

Sponsors & Collaborators

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

Study Sites (4)

Saint Louis Univ. School of Medicine, HVTU

St Louis, Missouri, United States

Location

Miriam Hospital's HVTU

Providence, Rhode Island, 02906, United States

Location

Vanderbilt Vaccine CRS

Nashville, Tennessee, 37232, United States

Location

FHCRC/UW Vaccine CRS

Seattle, Washington, 98104, United States

Location

Related Publications (6)

• Malkevitch NV, Robert-Guroff M. A call for replicating vector prime-protein boost strategies in HIV vaccine design. Expert Rev Vaccines. 2004 Aug;3(4 Suppl):S105-17. doi: 10.1586/14760584.3.4.s105.

  PMID: 15285710 BACKGROUND

• O'Hagan D, Singh M, Ugozzoli M, Wild C, Barnett S, Chen M, Schaefer M, Doe B, Otten GR, Ulmer JB. Induction of potent immune responses by cationic microparticles with adsorbed human immunodeficiency virus DNA vaccines. J Virol. 2001 Oct;75(19):9037-43. doi: 10.1128/JVI.75.19.9037-9043.2001.

  PMID: 11533167 BACKGROUND

• O'Hagan DT, Ugozzoli M, Barackman J, Singh M, Kazzaz J, Higgins K, Vancott TC, Ott G. Microparticles in MF59, a potent adjuvant combination for a recombinant protein vaccine against HIV-1. Vaccine. 2000 Mar 6;18(17):1793-801. doi: 10.1016/s0264-410x(99)00522-8.

  PMID: 10699327 BACKGROUND

• Slobod KS, Bonsignori M, Brown SA, Zhan X, Stambas J, Hurwitz JL. HIV vaccines: brief review and discussion of future directions. Expert Rev Vaccines. 2005 Jun;4(3):305-13. doi: 10.1586/14760584.4.3.305.

  PMID: 16026246 BACKGROUND

• Stratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. doi: 10.2174/1389450043490686.

  PMID: 14738219 BACKGROUND

• Spearman P, Lally MA, Elizaga M, Montefiori D, Tomaras GD, McElrath MJ, Hural J, De Rosa SC, Sato A, Huang Y, Frey SE, Sato P, Donnelly J, Barnett S, Corey LJ; HIV Vaccine Trials Network of NIAID. A trimeric, V2-deleted HIV-1 envelope glycoprotein vaccine elicits potent neutralizing antibodies but limited breadth of neutralization in human volunteers. J Infect Dis. 2011 Apr 15;203(8):1165-73. doi: 10.1093/infdis/jiq175.

  PMID: 21451004 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Paul Spearman

  Vanderbilt University

  STUDY CHAIR

• Michelle Lally

  Brown University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2003
• First Posted: November 19, 2003
• Study Completion: September 1, 2007
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

US (4)