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

NCT00000633 | Completed Phase 1

• 3 other identifiers: ACTG 20511182AVEG 101
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections

Keywords

Vaccines, Synthetic; Vaccinia Virus; Viral Vaccines; HIV-1; HIV Envelope Protein gp160; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; AIDS Vaccines; HIV Therapeutic Vaccine

Interventions

gp160 Vaccine (Immuno-AG) BIOLOGICAL

Hepatitis B Vaccine (Recombinant) BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Immuno-US: collaborator

Study Sites (2)

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

Washington U CRS

St Louis, Missouri, 63104, United States

Location

Related Publications (2)

• Keefer MC, Graham BS, Belshe RB, Schwartz D, Corey L, Bolognesi DP, Stablein DM, Montefiori DC, McElrath MJ, Clements ML, et al. Studies of high doses of a human immunodeficiency virus type 1 recombinant glycoprotein 160 candidate vaccine in HIV type 1-seronegative humans. The AIDS Vaccine Clinical Trials Network. AIDS Res Hum Retroviruses. 1994 Dec;10(12):1713-23. doi: 10.1089/aid.1994.10.1713.

  PMID: 7888231 BACKGROUND

• Belshe RB, Clements ML, Dolin R, Graham BS, McElrath J, Gorse GJ, Schwartz D, Keefer MC, Wright P, Corey L, et al. Safety and immunogenicity of a fully glycosylated recombinant gp160 human immunodeficiency virus type 1 vaccine in subjects at low risk of infection. National Institute of Allergy and Infectious Diseases AIDS Vaccine Evaluation Group Network. J Infect Dis. 1993 Dec;168(6):1387-95. doi: 10.1093/infdis/168.6.1387.

  PMID: 8245523 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Vaccinia; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Hepatitis B Vaccines

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; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Schwartz D

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: October 1, 1998
• Last Updated: November 2, 2021

Record last verified: 2021-10

Locations

US (2)