Safety of and Immune Response to a New HIV Vaccine: HIV CTL MEP

NCT00076037 | Completed Phase 1

• 2 other identifiers: HVTN 05610122
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 7

Brief Summary

The effectiveness of a vaccine can be improved by using a "prime boost strategy" or by using an adjuvant. A prime boost strategy is the administration of one type of vaccine (the primer) followed by the administration of another type vaccine (the booster). An adjuvant is a substance that can enhance the immune response when given at the same time as a vaccine. This study will evaluate the safety of and immune response to a vaccine designed to be used as part of a prime boost strategy. The study will also evaluate the vaccine when given with an adjuvant. The vaccine in this study is not produced from live HIV or from infected cells. It does not contain HIV, and it cannot cause HIV infection.

Conditions

HIV Infections

Keywords

HIV Preventive Vaccine; Granulocyte-Macrophage Colony-Stimulating Factor; AIDS Vaccines; HIV-1; HIV Seronegativity; Injections, Intramuscular; RC529; Epitopes; T-Lymphocytes, Cytotoxic

Interventions

HIV CTL MEP administered with RC529-SE adjuvant BIOLOGICAL

GM-CSF DRUG

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• HIV uninfected
• Willing to receive HIV test results
• Good general health
• One of the following major histocompatibility (MHC) alleles: HLA A3, B7, or B8
• Acceptable methods of contraception for females of reproductive potential
• Hepatitis B surface antigen negative
• Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive
• Access to participating site and available for follow-up during the 15 month study

You may not qualify if:

• HIV vaccines or placebos in prior HIV vaccine trial
• Immunosuppressive medications within 168 days prior to first study vaccine administration
• Blood products within 120 days prior to first study vaccine administration
• Immunoglobulin within 60 days prior to first study vaccine administration
• Live attenuated vaccines within 30 days prior to first study vaccine administration
• Investigational research agents within 30 days prior to first study vaccine administration
• Subunit or killed vaccines within 14 days prior to first study vaccine administration
• Current tuberculosis prophylaxis or therapy
• Serious adverse reaction to a vaccine. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
• Hypersensitivity to egg products or yeast-derived products
• Autoimmune disease or immunodeficiency
• Active syphilis
• Unstable asthma
• Type 1 or Type 2 diabetes mellitus
• Thyroid disease requiring treatment in the past 12 months

Sponsors & Collaborators

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

Study Sites (7)

Alabama Vaccine CRS

Birmingham, Alabama, 35294-2041, United States

Location

San Francisco Vaccine and Prevention CRS

San Francisco, California, United States

Location

Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore

Baltimore, Maryland, United States

Location

Saint Louis Univ. School of Medicine, HVTU

St Louis, Missouri, 63110-2500, United States

Location

Univ. of Rochester HVTN CRS

Rochester, New York, 14642, United States

Location

Vanderbilt Vaccine CRS

Nashville, Tennessee, 37232, United States

Location

FHCRC/UW Vaccine CRS

Seattle, Washington, 98104, United States

Location

Related Publications (2)

• Somani J, Lonial S, Rosenthal H, Resnick S, Kakhniashvili I, Waller EK. A randomized, placebo-controlled trial of subcutaneous administration of GM-CSF as a vaccine adjuvant: effect on cellular and humoral immune responses. Vaccine. 2002 Dec 13;21(3-4):221-30. doi: 10.1016/s0264-410x(02)00463-2.

  PMID: 12450697 BACKGROUND

• Gilbert PB, Chiu YL, Allen M, Lawrence DN, Chapdu C, Israel H, Holman D, Keefer MC, Wolff M, Frey SE; NIAID HIV Vaccine Trials Network. Long-term safety analysis of preventive HIV-1 vaccines evaluated in AIDS vaccine evaluation group NIAID-sponsored Phase I and II clinical trials. Vaccine. 2003 Jun 20;21(21-22):2933-47. doi: 10.1016/s0264-410x(03)00158-0.

  PMID: 12798637 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor

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

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Paul Spearman, MD

  Vanderbilt University

  STUDY CHAIR

• Spyros Kalams, MD

  Vanderbilt University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 13, 2004
• First Posted: January 14, 2004
• Study Start: April 1, 2004
• Study Completion: June 1, 2006
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

US (7)