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A Placebo-Controlled, Phase I, Pilot Clinical Trial to Evaluate the Safety and Immunogenicity of ENV 2-3, a Yeast-Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59 in Individuals With HIV Infection (Placebo Patients Receive MF59 Emulsion Only)

This study has been completed.
Sponsor:
Collaborator:
Biocine
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000958
First received: November 2, 1999
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

To determine the safety and immunogenicity of Env 2-3 in combination with MTP-PE/MF59 adjuvant in adult volunteers with HIV infection.

By vaccinating those who have HIV infection, perhaps the replication (reproduction) of existing viral strains can be suppressed and the asymptomatic period early in the infectious process can be prolonged. One potential way to do this is to boost HIV antigen-specific CD4 responses, which may in turn increase the effectiveness of CD8 killing of HIV infected cells.


Condition Intervention Phase
HIV Infections
Biological: MTP-PE/MF59
Biological: Env 2-3
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Placebo-Controlled, Phase I, Pilot Clinical Trial to Evaluate the Safety and Immunogenicity of ENV 2-3, a Yeast-Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59 in Individuals With HIV Infection (Placebo Patients Receive MF59 Emulsion Only)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 8
Study Completion Date: September 1995
Detailed Description:

By vaccinating those who have HIV infection, perhaps the replication (reproduction) of existing viral strains can be suppressed and the asymptomatic period early in the infectious process can be prolonged. One potential way to do this is to boost HIV antigen-specific CD4 responses, which may in turn increase the effectiveness of CD8 killing of HIV infected cells.

Eight patients are entered in the pilot portion of the study, thirty patients are entered on Part A and fifteen patients are entered on Part B. In the pilot study, patients receive 30 mcg Env 2-3 vaccine plus 0 - 10 mcg MTP-PE/MF59 adjuvant. Patients on Part A receive one of the following: MF59 emulsion only; 100 mcg MTP-PE/MF59 only; 30 mcg Env 2-3 with MF59 emulsion only; or 30 mcg Env 2-3 vaccine with 100 mcg MTP-PE/MF59. Patients on Part B receive either 100 mcg MTP-PE/MF59 only or 30 mcg Env 2-3 vaccine plus 100 mcg MTP-PE/MF59. Treatment is administered on days 0, 28, and 112, and patients are followed for up to 10 months. Per amendment, patients may receive two additional doses of 30 mcg Env 2-3 or placebo in MTP-PE/MF59 at 7 and 10 months (Parts A and B) or 9 and 12 months (Pilot study) after their initial inoculation.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Patients must be:

  • Healthy HIV-seropositive adults (generalized lymphadenopathy, seborrheic dermatitis acceptable).
  • Negative for HIV plasma culture.
  • Available for 6 months follow-up (patients in Pilot study) or 10 months follow-up (patients in Parts A and B).

Prior Medication: Required:

  • Part B: Zidovudine (AZT), tolerating a dose of 500 - 600 mg/day for at least 4 months prior to entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Evidence of psychological disorder during the past year that would impair adherence to the protocol.
  • Evidence of an AIDS defining opportunistic infection.

Prior Medication:

Excluded:

  • Any potential immunomodulating agents (e.g., isoprinosine, imuthiol, lithium) within 90 days of screening.
  • Immunosuppressive medications during the past 3 months.
  • Part A: Use of zidovudine (AZT) for more than 30 days in the preceding 6 months, or any AZT within the last 30 days.
  • Parts A and B: Any non-AZT antiretroviral drug.
  • Any other investigational agent within the past 30 days.
  • Immunoglobulins within the past 60 days.

Patients may not have the following prior conditions:

  • Evidence of psychological disorder during the past year that would impair adherence to the protocol.
  • History of an AIDS-defining opportunistic infection.

Use of illicit drugs or significant amounts of alcohol that, in the opinion of the principal investigator, would interfere with compliance with the study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000958

Locations
United States, New York
Univ. of Rochester AVEG
Rochester, New York, United States, 14642
Sponsors and Collaborators
Biocine
Investigators
Study Chair: Corey L
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000958     History of Changes
Other Study ID Numbers: AVEG 103, 11546, AVEG 103A, AVEG 103B
Study First Received: November 2, 1999
Last Updated: May 17, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic
Recombinant Proteins
Adjuvants, Immunologic
Acquired Immunodeficiency Syndrome
HIV Envelope Protein gp120
AIDS Vaccines
HIV Therapeutic Vaccine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Immunologic Deficiency Syndromes
Infection
Immune System Diseases
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014