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A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
gp160 Vaccine (Immuno-AG)
gp160 Vaccine (MicroGeneSys)
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, Injections, Intradermal, HIV Antigens, HIV-1, HIV Envelope Protein gp160, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Hypersensitivity, Delayed, AIDS Vaccines, HIV Therapeutic Vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed in Step 2 (PER 4/5/95 AMENDMENT): Approved antiretroviral drugs. Patients must have: Documented HIV infection. CD4 count >= 400 cells/mm3. NO current active opportunistic infection or neoplasm (other than stable cutaneous Kaposi's sarcoma). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known hypersensitivity to insect proteins. Concurrent Medication: Excluded: Antihistamine or anti-inflammatory medications for the 48-hour period between injection and skin test reading. Topical steroids. Prior Medication: PER 4/5/95 AMENDMENT - Excluded: Prior immunization with experimental HIV vaccines (strata 2 and 3 only). Systemic corticosteroids, topical corticosteroids on the arms, or other systemic immunosuppressant agents or antineoplastic agents within 30 days prior to study entry. Antihistamine or anti-inflammatory medications within 72 hours prior to intradermal injections. PREVIOUS VERSION - Excluded within 30 days prior to study entry: Any antiretroviral drugs (other than AZT, ddI, ddC, or d4T for patients in stratum 3). Systemic corticosteroids, topical corticosteroids on the arms, or other systemic immunosuppressant agents or antineoplastic agents. Excluded within 72 hours prior to intradermal injections: Antihistamine or anti-inflammatory medications.

Sites / Locations

  • Stanford CRS
  • Santa Clara Valley Med. Ctr.
  • San Mateo County AIDS Program
  • NY Univ. HIV/AIDS CRS

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)
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1. Study Identification

Unique Protocol Identification Number
NCT00000782
Brief Title
A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen
Official Title
A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen
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
October 1996 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
To determine the frequency of delayed-type hypersensitivity (DTH) reactions in HIV-positive patients to two doses of two envelope glycoprotein antigens prepared differently. To determine whether patients who have previously demonstrated a DTH response to intradermal MGStage HIV-1 gp160 IIIB baculovirus (MicroGeneSys) have a reproducible response to a repeat injection of gp160 and whether there is cross-reactivity to intradermal HIV-1 rgp160 IIIB vero cell expressed (Immuno-AG). PER 4/5/95 AMENDMENT: To also determine whether patients who respond to HIV-1 rgp160 IIIB baculovirus (MicroGeneSys) have cross-reactivity to intradermal skin tests of HIV-1 rgp160 MN (Immuno-AG). Previous studies in individuals immunized with gp160 suggest that a skin test response in immunized patients can be used as a surrogate marker for new proliferative and cytotoxic responses induced by vaccination.
Detailed Description
Previous studies in individuals immunized with gp160 suggest that a skin test response in immunized patients can be used as a surrogate marker for new proliferative and cytotoxic responses induced by vaccination. Patients are stratified into three groups. Fifteen patients previously immunized with MicroGeneSys rgp160 antigen in ACTG 137 and not on antiretroviral therapy will receive intradermal injections of Immuno-AG rgp160 IIIB (vero cell expressed) in one arm, followed 1 week later by intradermal injections of MicroGeneSys rgp160 IIIB (baculovirus expressed) in the opposite arm (stratum 1). Forty patients who are not previously immunized with rgp160 will receive intradermal injections of Immuno-AG gp160 IIIB in one arm simultaneously with MicroGeneSys gp160 IIIB in the opposite arm; these patients are either not on antiretroviral therapy (stratum 2) or currently on antiretroviral therapy (stratum 3). All patients return 48 hours after each injection for skin test reading. PER 4/5/95 AMENDMENT: Patients on all strata will re-enroll to receive Immuno-AG rgp160 MN in one arm simultaneously with MicroGeneSys rgp160 IIIB in the opposite arm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Vaccines, Synthetic, Injections, Intradermal, HIV Antigens, HIV-1, HIV Envelope Protein gp160, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Hypersensitivity, Delayed, AIDS Vaccines, HIV Therapeutic Vaccine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
Double
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
gp160 Vaccine (Immuno-AG)
Intervention Type
Biological
Intervention Name(s)
gp160 Vaccine (MicroGeneSys)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed in Step 2 (PER 4/5/95 AMENDMENT): Approved antiretroviral drugs. Patients must have: Documented HIV infection. CD4 count >= 400 cells/mm3. NO current active opportunistic infection or neoplasm (other than stable cutaneous Kaposi's sarcoma). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Known hypersensitivity to insect proteins. Concurrent Medication: Excluded: Antihistamine or anti-inflammatory medications for the 48-hour period between injection and skin test reading. Topical steroids. Prior Medication: PER 4/5/95 AMENDMENT - Excluded: Prior immunization with experimental HIV vaccines (strata 2 and 3 only). Systemic corticosteroids, topical corticosteroids on the arms, or other systemic immunosuppressant agents or antineoplastic agents within 30 days prior to study entry. Antihistamine or anti-inflammatory medications within 72 hours prior to intradermal injections. PREVIOUS VERSION - Excluded within 30 days prior to study entry: Any antiretroviral drugs (other than AZT, ddI, ddC, or d4T for patients in stratum 3). Systemic corticosteroids, topical corticosteroids on the arms, or other systemic immunosuppressant agents or antineoplastic agents. Excluded within 72 hours prior to intradermal injections: Antihistamine or anti-inflammatory medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katzenstein D
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford CRS
City
Palo Alto
State/Province
California
ZIP/Postal Code
943055107
Country
United States
Facility Name
Santa Clara Valley Med. Ctr.
City
San Jose
State/Province
California
ZIP/Postal Code
951282699
Country
United States
Facility Name
San Mateo County AIDS Program
City
San Mateo
State/Province
California
ZIP/Postal Code
943055107
Country
United States
Facility Name
NY Univ. HIV/AIDS CRS
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10634195
Citation
Katzenstein DA, Kundu S, Spritzler J, Smoller BR, Haszlett P, Valentine F, Merigan TC. Delayed-type hypersensitivity to recombinant HIV envelope glycoprotein (rgp160) after immunization with homologous antigen. J Acquir Immune Defic Syndr. 1999 Dec 1;22(4):341-7. doi: 10.1097/00126334-199912010-00004.
Results Reference
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A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen

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