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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000782
First received: November 2, 1999
Last updated: May 23, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: gp160 Vaccine (Immuno-AG)
Biological: gp160 Vaccine (MicroGeneSys)
Phase 1

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Delayed-Type Hypersensitivity (DTH) Reactions to Intradermal HIV Envelope Antigen

Resource links provided by NLM:


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

Estimated Enrollment: 50
Study Completion Date: October 1996
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000782

Locations
United States, California
Stanford CRS
Palo Alto, California, United States, 943055107
Santa Clara Valley Med. Ctr.
San Jose, California, United States, 951282699
San Mateo County AIDS Program
San Mateo, California, United States, 943055107
United States, New York
NY Univ. HIV/AIDS CRS
New York, New York, United States, 10016
Sponsors and Collaborators
Investigators
Study Chair: Katzenstein D
  More Information

Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000782     History of Changes
Other Study ID Numbers: ACTG 221, 11198
Study First Received: November 2, 1999
Last Updated: May 23, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
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

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

ClinicalTrials.gov processed this record on April 22, 2014