A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B)

NCT00000767 | Completed Phase 1

• 3 other identifiers: AVEG 014A10561AVEG 014A/B
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 5

Brief Summary

To evaluate, in healthy HIV-1 seronegative vaccinia-immune and vaccinia-naive volunteers, the safety and immunogenicity of an HIV-1 candidate vaccine (TBC-3B) consisting of a live recombinant vaccinia virus expressing the env, gag, and pol genes of HIV-1 IIIB strain. To evaluate the potential of boosting with one of a variety of HIV-1 recombinant subunit, peptide, or pseudovirion vaccines, if available, to augment the immune responses of the vaccinees. Antigenic drift, defined as the genetic variation of the HIV-1 envelope gene that results in antigenic variation during natural infection, may confound attempts to achieve protective immunity using a vaccine based solely on HIV-1 envelope proteins. Inclusion of conserved core and polymerase proteins along with envelope protein in a candidate vaccine may address some of the problems with antigenic variability. A prime-boost immunization approach using a novel priming immunogen expressing env, gag, and pol genes of the HIV-1 IIIB strain will be attempted in this study.

Conditions

HIV Infections

Keywords

Vaccines, Synthetic; Vaccinia Virus; Viral Vaccines; Smallpox Vaccine; HIV-1; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine

Interventions

TBC-3B Vaccine BIOLOGICAL

Smallpox Vaccine BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must have:
• Negative ELISA and Western blot for HIV-1 within 6 weeks prior to immunization.
• Normal history and physical exam.
• History of smallpox vaccination at least 5 years prior to study entry (Part I) OR no prior smallpox vaccination (Part II).
• Absolute CD4 count \>= 400 cells/mm3.
• Normal urinalysis.
• NOTE:
• No more than 10 percent of volunteers in both Parts I and II may be over 50 years of age.

You may not qualify if:

• Co-existing Condition:
• Subjects with the following symptoms or conditions are excluded:
• Positive hepatitis B surface antigen.
• Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
• Occupational responsibilities that preclude compliance.
• Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (\> 6 months) treated infection are eligible.
• Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
• Eczema.
• Household contact with persons meeting any of the following criteria:
• pregnancy, less than 12 months of age, eczema, immunodeficiency disease, or use of immunosuppressive medications.
• Subjects with the following prior conditions are excluded:
• History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
• History of anaphylaxis or other serious adverse reactions to vaccines.
• Eczema within the past year.
• History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Steven-Johnson syndrome, bronchospasm, or hypotension).

Sponsors & Collaborators

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

Study Sites (5)

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, 63104, United States

Location

Univ. of Rochester AVEG

Rochester, New York, 14642, United States

Location

JHU AVEG

Pittsburgh, Pennsylvania, United States

Location

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, 37232, United States

Location

UW - Seattle AVEG

Seattle, Washington, 98144, United States

Location

MeSH Terms

Conditions

HIV Infections; Vaccinia

Interventions

Smallpox Vaccine

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; Poxviridae Infections; DNA Virus Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Keefer M

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: July 1, 1996
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

US (5)