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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)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MTP-PE/MF59
Env 2-3
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Vaccines, Synthetic, Recombinant Proteins, Adjuvants, Immunologic, Acquired Immunodeficiency Syndrome, HIV Envelope Protein gp120, AIDS Vaccines, HIV Therapeutic Vaccine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univ. of Rochester AVEG

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Biocine
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1. Study Identification

Unique Protocol Identification Number
NCT00000958
Brief 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)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 1995 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Biocine

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Vaccines, Synthetic, Recombinant Proteins, Adjuvants, Immunologic, Acquired Immunodeficiency Syndrome, HIV Envelope Protein gp120, AIDS Vaccines, HIV Therapeutic Vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
8 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
MTP-PE/MF59
Intervention Type
Biological
Intervention Name(s)
Env 2-3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corey L
Official's Role
Study Chair
Facility Information:
Facility Name
Univ. of Rochester AVEG
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8744579
Citation
Keefer MC, Graham BS, McElrath MJ, Matthews TJ, Stablein DM, Corey L, Wright PF, Lawrence D, Fast PE, Weinhold K, Hsieh RH, Chernoff D, Dekker C, Dolin R. Safety and immunogenicity of Env 2-3, a human immunodeficiency virus type 1 candidate vaccine, in combination with a novel adjuvant, MTP-PE/MF59. NIAID AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 1996 May 20;12(8):683-93. doi: 10.1089/aid.1996.12.683.
Results Reference
background
PubMed Identifier
8133447
Citation
Mohamed OA, Ashley R, Goldstein A, McElrath J, Dalessio J, Corey L. Detection of rectal antibodies to HIV-1 by a sensitive chemiluminescent western blot immunodetection method. J Acquir Immune Defic Syndr (1988). 1994 Apr;7(4):375-80.
Results Reference
background

Learn more about this trial

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)

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