Status:

COMPLETED

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)

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18-60 years

Phase:

PHASE1

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...

Detailed Description

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 ...

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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).
  • Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
  • History of cancer unless there has been surgical excision that is considered to have achieved cure.

Prior Medication:

Excluded:

  • Prior HIV vaccines.
  • Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) do not exclude but should be administered at least 2 weeks prior to HIV immunizations.
  • Experimental agents within the past 30 days.

Prior Treatment:

Excluded:

  • Receipt of blood products or immunoglobulins within the past 6 months. It is STRONGLY RECOMMENDED that any activity that might expose subject to HIV (unprotected sex or needle sharing) be avoided.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

July 1 1996

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT00000767

End Date

July 1 1996

Last Update

October 28 2021

Active Locations (5)

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Page 1 of 2 (5 locations)

1

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, United States, 63104

2

Univ. of Rochester AVEG

Rochester, New York, United States, 14642

3

JHU AVEG

Pittsburgh, Pennsylvania, United States

4

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, United States, 37232