NCT00000782

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

October 1, 1996

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 4, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 27, 2021

Conditions

HIV Infections

Keywords

Vaccines, SyntheticInjections, IntradermalHIV AntigensHIV-1HIV Envelope Protein gp160Acquired Immunodeficiency SyndromeAIDS-Related ComplexHypersensitivity, DelayedAIDS VaccinesHIV Therapeutic Vaccine

Interventions

gp160 Vaccine (Immuno-AG)BIOLOGICAL
gp160 Vaccine (MicroGeneSys)BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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:
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Stanford CRS

Palo Alto, California, 943055107, United States

Location

Santa Clara Valley Med. Ctr.

San Jose, California, 951282699, United States

Location

San Mateo County AIDS Program

San Mateo, California, 943055107, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Related Publications (1)

  • 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.

    PMID: 10634195BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHypersensitivity, Delayed

Interventions

VaxSyn HIV-1 (gp160) vaccine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus DiseasesHypersensitivity

Study Officials

  • Katzenstein D

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
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, 1996

Last Updated

November 4, 2021

Record last verified: 2021-10

Locations

US(4)