A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

To determine the safety and immunogenicity of gp160 (MicroGeneSys), rgp120/HIV-1MN (Genentech), and rgp120/HIV-1SF2 (BIOCINE) and their adjuvants in HIV-infected children 1 month to 18 years of age.

The initiation of this immunotherapy trial will provide multiple benefits by assessing in asymptomatic HIV-infected children a therapy currently being tested in their adult counterparts, in the hope of forestalling the progression of HIV immunosuppression and clinical disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The initiation of this immunotherapy trial will provide multiple benefits by assessing in asymptomatic HIV-infected children a therapy currently being tested in their adult counterparts, in the hope of forestalling the progression of HIV immunosuppression and clinical disease.

Patients are randomized to receive one of three vaccines (9 patients/vaccine) or the adjuvant placebos (3 patients/vaccine). The vaccines will be studied at both low and high doses. When three of four patients at the low dose of a vaccine have received two immunizations without evidence of dose-limiting toxicity, dose escalation to the higher dose of that vaccine is initiated in subsequent patient cohorts, provided all low dose arms are filled. A total of six immunizations are given, at 0, 4, 8, 12, 16, and 24 weeks. Patients are followed for 24 weeks after the last immunization.

Study Type

Interventional

Enrollment

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 009367344
        • San Juan City Hosp. PR NICHD CRS
  • United States
    • California
      • Long Beach, California, United States, 90801
        • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
      • Los Angeles, California, United States, 900951752
        • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
      • Los Angeles, California, United States, 900481804
        • Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
      • Oakland, California, United States, 946091809
        • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
      • San Francisco, California, United States, 941430105
        • UCSF Pediatric AIDS CRS
      • San Francisco, California, United States, 94110
        • San Francisco Gen. Hosp.
      • Torrance, California, United States, 905022004
        • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Univ. of Connecticut Health Ctr., Dept. of Ped.
      • New Haven, Connecticut, United States, 06504
        • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Cook County Hosp.
      • Chicago, Illinois, United States, 60612
        • Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
      • Chicago, Illinois, United States, 606143394
        • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
      • Chicago, Illinois, United States, 606371470
        • Chicago Children's CRS
    • Louisiana
      • New Orleans, Louisiana, United States, 701122699
        • Tulane/LSU Maternal/Child CRS
    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • BMC, Div. of Ped Infectious Diseases
      • Boston, Massachusetts, United States, 021155724
        • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
      • Springfield, Massachusetts, United States, 01199
        • Baystate Health, Baystate Med. Ctr.
      • Worcester, Massachusetts, United States, 016550001
        • WNE Maternal Pediatric Adolescent AIDS CRS
    • New Jersey
      • New Brunswick, New Jersey, United States
        • UMDNJ - Robert Wood Johnson
      • Newark, New Jersey, United States, 071072198
        • NJ Med. School CRS
      • Paterson, New Jersey, United States, 07103
        • St. Joseph's Hosp. & Med. Ctr. of New Jersey
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
      • Great Neck, New York, United States, 11021
        • North Shore-Long Island Jewish Health System, Dept. of Peds.
      • New York, New York, United States, 10032
        • Columbia IMPAACT CRS
      • New York, New York, United States, 10016
        • NYU Med. Ctr., Dept. of Medicine
      • New York, New York, United States, 10032
        • Incarnation Children's Ctr.
      • Rochester, New York, United States, 14642
        • Univ. of Rochester ACTG CRS
      • Syracuse, New York, United States
        • SUNY Upstate Med. Univ., Dept. of Peds.
    • North Carolina
      • Durham, North Carolina, United States, 277103499
        • DUMC Ped. CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 191341095
        • St. Christopher's Hosp. for Children
      • Philadelphia, Pennsylvania, United States, 191044318
        • The Children's Hosp. of Philadelphia IMPAACT CRS
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hosp. CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication: Recommended:

  • PCP prophylaxis.

Patients must have:

  • Documented asymptomatic HIV infection.
  • CD4+ count as follows:
  • 1-11 months of age must have > 2000 cells/mm3 and >= 30 percent of the total lymphocytes; 12-23 months must have > 1000 cells/mm3 and >= 20 percent of the total lymphocytes; 24 months-6 years must have > 750 cells/mm3 and >= 20 percent of the total lymphocytes; and 7 years and older must have > 500 cells/mm3 and >= 20 percent of the total lymphocytes.

NOTE:

  • Patients who received zidovudine for 3 consecutive months immediately prior to study entry may receive only high doses of vaccine.

Exclusion Criteria

Co-existing Condition:

Patients with the following condition are excluded:

  • Any serious acute infection.

Concurrent Medication:

Excluded:

  • Anticipated steroid therapy of > 6 weeks duration.

Excluded within the past 2 years:

  • More than one serious proven bacterial infection such as sepsis, pneumonia, meningitis, bone or joint infection, abscess of an internal organ or body cavity (other than otitis media or superficial skin or mucosal abscesses) caused by Haemophilus, Streptococcus, Pneumococcus, or other pyogenic bacteria.

Prior Medication:

Excluded:

  • Antiretroviral therapy or immunomodulators (e.g., IVIG) within 1 month prior to study entry (NOTE: AZT is allowed within 1 month prior to study entry if patient is entering a high-dose arm).
  • Uninterrupted steroid therapy of > 6 weeks duration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Genentech, Inc.
MicroGeneSys Inc (nka Protein Sciences Corporation)

Investigators

  • Study Chair: Lambert JS
  • Study Chair: Katz S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

February 1, 1996

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 218
  • 11195 (Registry Identifier: DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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