Completed

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

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What is being tested

gp160 Vaccine (Immuno-AG)

+ Hepatitis B Vaccine (Recombinant)
Biological
Who is being recruted

HIV Infections

From 18 to 60 Years
How is the trial designed

Treatment Study

Phase 1
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 2, 2021
Sourced from a government-validated database.Claim as a partner

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. 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. 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.

Official TitleA Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 2, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
55 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Criteria

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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
Johns Hopkins Adult AIDS CRSBaltimore, United StatesSee the location
Suspended
Washington U CRSSaint Louis, United States

Completed2 Study Centers