A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000633

Collaborator

Immuno-US (Industry)

Enrollment

Locations

27.5

Patients Per Site

Study Details

Study Description

Brief Summary

To determine the safety and immunogenicity of vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) in asymptomatic HIV-infected adult volunteers. To compare safety and immunogenicity of two different schedules of gp160 administration. To examine the effects of gp160 and hepatitis B vaccine (Engerix-B) on various markers of viral load and on selected immune parameters.

Potentiation of a patient's immune response to HIV might possibly prolong the period of clinical latency and protect the patient indefinitely. Preliminary results from a study of Immuno-AG recombinant gp160 vaccine in healthy volunteers not infected with HIV suggest that the vaccine is safe and produces antibodies against the virus. Because another previous study failed to demonstrate a specific anti-HIV response in patients injected with a recombinant vaccinia virus containing HIV-1 genes, this study is also testing the immunotherapeutic role of other immunizations (such as hepatitis B vaccination) that would be expected to induce a nonspecific immune response in HIV-infected persons.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Biological: gp160 Vaccine (Immuno-AG) Biological: Hepatitis B Vaccine (Recombinant)	Phase 1

Detailed Description

Fifty-five healthy HIV-positive volunteers are randomly assigned to one of the following treatment arms: six injections (arm I) or four injections (arm II) of HIV-1 gp160 vaccine, four injections of hepatitis B vaccine as a non-HIV viral vaccine control (arm III), or six placebo injections consisting of the adjuvant vehicle used for the gp160 vaccine (arm IV). Immunizations or placebo are given at 4-week intervals for 5 months. To maintain blinding, adjuvant vehicle placebo is administered on days 84 and 112 to those volunteers receiving four instead of six vaccine injections (arms II and III). Volunteers are followed at 4-month intervals for 2 years.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals

Actual Study Completion Date :

Oct 1, 1998

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Concurrent Medication: Recommended:

Prophylaxis with isoniazid in patients not previously treated.

Patients must have:

HIV seropositivity by Western blot.
Normal history and physical exam (generalized lymphadenopathy is acceptable).
Mean CD4 cell count = or > 600 cells/mm3 for all visits (minimum 2 counts) within 60 days prior to study entry, with no single count < 450 cells/mm3.
Negative PPD test or normal chest x-ray with positive PPD (induration = or > 5 mm).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Hepatitis B surface antigen positive.
Evidence of an AIDS- or ARC-defining opportunistic infection.
Evidence of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month.
Active syphilis.

Patients with the following prior conditions are excluded:

Evidence of psychiatric disorder within the past year that would impair adherence to the protocol.
History of an AIDS- or ARC-defining opportunistic infection.
History of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month.

Prior Medication:

Excluded:

Immunomodulating agents (e.g., isoprinosine, imuthiol, lithium) within 90 days of screening.
Immunosuppressive medications within the previous 3 months.
Zidovudine (AZT) or any antiviral agent (including interferon) within the previous 6 months.
Vaccination against other pathogens within 4 weeks of initial screening laboratory work.

Use of illicit drugs or significant amounts of alcohol that could significantly interfere with study compliance.