Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Uninfected Adults

NCT00054860 | Completed Phase 1

• 2 other identifiers: HVTN 04810197
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 5

Brief Summary

The purpose of this study is to test the safety of an HIV DNA vaccine (EP HIV-1090) and to test whether or not the vaccine can stimulate immune system responses in HIV uninfected people. This vaccine uses only parts of the virus's DNA and cannot cause HIV infection.

Conditions

HIV Infections

Keywords

HIV Preventive Vaccine; HIV Seronegativity; HIV-1; AIDS Vaccines; Vaccines, DNA; Dose-Response Relationship, Immunologic; CD4-Positive T-Lymphocytes; CD8-Positive T-Lymphocytes; Epitopes

Interventions

EP HIV-1090 BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• HIV negative
• Positive for one or more of the following HLA supertypes: -A2, -A3, or -B7
• Willing to receive HIV test results
• Good general health
• 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

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
• Active syphilis
• Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
• Autoimmune disease or immunodeficiency
• Unstable asthma
• Type 1 or Type 2 Diabetes Mellitus
• Thyroid disease requiring treatment
• Serious angioedema within the past 3 years

Sponsors & Collaborators

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

Study Sites (5)

Brigham and Women's Hosp. CRS

Boston, Massachusetts, 02115, United States

Location

Fenway Community Health Clinical Research Site (FCHCRS)

Boston, Massachusetts, 02115, United States

Location

Saint Louis Univ. School of Medicine, HVTU

St Louis, Missouri, 63110, United States

Location

Miriam Hospital's HVTU

Providence, Rhode Island, 02906, United States

Location

Gaborone Prevention/Treatment Trials CRS

Gaborone, Botswana

Location

Related Publications (5)

• Sette A, Vitiello A, Reherman B, Fowler P, Nayersina R, Kast WM, Melief CJ, Oseroff C, Yuan L, Ruppert J, Sidney J, del Guercio MF, Southwood S, Kubo RT, Chesnut RW, Grey HM, Chisari FV. The relationship between class I binding affinity and immunogenicity of potential cytotoxic T cell epitopes. J Immunol. 1994 Dec 15;153(12):5586-92.

  PMID: 7527444 BACKGROUND

• Altfeld MA, Livingston B, Reshamwala N, Nguyen PT, Addo MM, Shea A, Newman M, Fikes J, Sidney J, Wentworth P, Chesnut R, Eldridge RL, Rosenberg ES, Robbins GK, Brander C, Sax PE, Boswell S, Flynn T, Buchbinder S, Goulder PJ, Walker BD, Sette A, Kalams SA. Identification of novel HLA-A2-restricted human immunodeficiency virus type 1-specific cytotoxic T-lymphocyte epitopes predicted by the HLA-A2 supertype peptide-binding motif. J Virol. 2001 Feb;75(3):1301-11. doi: 10.1128/JVI.75.3.1301-1311.2001.

  PMID: 11152503 BACKGROUND

• Woodberry T, Gardner J, Mateo L, Eisen D, Medveczky J, Ramshaw IA, Thomson SA, Ffrench RA, Elliott SL, Firat H, Lemonnier FA, Suhrbier A. Immunogenicity of a human immunodeficiency virus (HIV) polytope vaccine containing multiple HLA A2 HIV CD8(+) cytotoxic T-cell epitopes. J Virol. 1999 Jul;73(7):5320-5. doi: 10.1128/JVI.73.7.5320-5325.1999.

  PMID: 10364278 BACKGROUND

• Livingston BD, Newman M, Crimi C, McKinney D, Chesnut R, Sette A. Optimization of epitope processing enhances immunogenicity of multiepitope DNA vaccines. Vaccine. 2001 Sep 14;19(32):4652-60. doi: 10.1016/s0264-410x(01)00233-x.

  PMID: 11535313 BACKGROUND

• Hanke T, Samuel RV, Blanchard TJ, Neumann VC, Allen TM, Boyson JE, Sharpe SA, Cook N, Smith GL, Watkins DI, Cranage MP, McMichael AJ. Effective induction of simian immunodeficiency virus-specific cytotoxic T lymphocytes in macaques by using a multiepitope gene and DNA prime-modified vaccinia virus Ankara boost vaccination regimen. J Virol. 1999 Sep;73(9):7524-32. doi: 10.1128/JVI.73.9.7524-7532.1999.

  PMID: 10438842 BACKGROUND

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

• Geoffrey J. Gorse, MD

  St. Louis University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: February 11, 2003
• First Posted: February 13, 2003
• Study Completion: September 1, 2005
• Last Updated: October 14, 2021

Record last verified: 2021-10

Locations

US (4); BO (1)