A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of the Therion Recombinant Vaccinia-HIV-1 IIIB ENV/GAG/POL Vaccine (TCB-3B) and MN RGP 120/HIV-1 In Alum.

Completed · Not applicable

Conditions studied: HIV Infections

In brief

To evaluate the safety of administering Therion Recombinant Vaccinia-HIV-1 IIIB env/gag/pol Vaccine (TBC-3B) vaccinations to vaccinia-naive individuals. To evaluate the immunogenicity of priming with TBC-3B by the scarification, intradermal, and subcutaneous routes, followed by booster immunization of MN rgp120 HIV-1. To compare the immunogenicity of priming with TBC-3B in vaccinia-naive individuals to vaccinia-immune individuals. In prior trials evaluating alternative methods of vaccine administration, scarification has been found to be an imprecise method of administration and allows only 1.0 - 2.5 microliters of immunogen to be given. Since it is not feasible to produce vaccine at concentrations higher than 10 to the 10th pfu/ml, this method limits the maximum deliverable dose. Intradermal and subcutaneous injection routes allow larger volumes of vaccinia to be given, i.e.: up to 200 microliters intradermally and up to 100 ml subcutaneously. In the present study, the initial priming dose will be the same administered by all 3 methods; however, the second priming dose administered at 2 months intradermally and subcutaneously will be 2 logs higher in order to achieve boosting of immune responses, particularly to gag and pol components of TBC-3B.

Key facts

Study ID

NCT00000866

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

36

Expected to finish

1999-07-01

Last updated by the study team

2021-10-28

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients must have:
• Negative FDA-approved ELISA for HIV within 8 weeks of immunization.
• Normal history and physical examination.
• Negativity for Hepatitis B surface antigen.
• Availability for follow-up for planned duration of the study (18 months).

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol. Specifically excluded are people with a history of suicide attempts, recent suicidal ideation or who have past or present psychosis.
• Active syphilis. NOTE: If the serology is documented to be a false positive or due to a remote (> 6 months) treated infection, the volunteer is eligible.
• Active tuberculosis. NOTE: Patients with a positive PPD and a normal chest X-ray showing no evidence of TB and not requiring INH therapy are eligible.
• Household contacts with, or occupational exposure to, people with any of the following:
• Pregnancy. <12 months of age. Eczema or Immunodeficiency disease. Use of immunosuppressive medications.
• Patients with the following prior conditions are excluded:
• History of immunodeficiency, chronic illness, malignancy or autoimmune disease.
• History of cancer, unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure.
• Any history of anaphylaxis or history of other serious adverse reactions to vaccines.
• History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
• Eczema within the past year.
• History of smallpox vaccination.
• Envelope bands on HIV-1 Western blot within 8 weeks of immunization.
• Prior Medication: Excluded:
• Use of immunosuppressive.
• Live attenuated vaccines within 60 days of study.
• NOTE: Medically indicated subunit or killed vaccines (e.g. influenza, pneumococcal) do not exclude, but should be given at least 2 weeks prior to HIV immunizations.
• Experimental agents within 30 days prior to study.
• Prior receipt of HIV-1 vaccines or placebo recipient in a previous HIV vaccine trial.
• Receipt of blood products or immunoglobulin within past 6 months.
• Risk Behavior: Excluded:
• History of injection drug use within the last 12 months prior to enrollment.
• Higher or intermediate risk sexual behavior as defined by the AVEG.

Where it is running

• JHU AVEG — Baltimore, Maryland, United States
• St. Louis Univ. School of Medicine AVEG — St Louis, Missouri, United States
• Vanderbilt Univ. Hosp. AVEG — Nashville, Tennessee, United States
• UW - Seattle AVEG — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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