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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
rgp120/HIV-1MN
rgp120/HIV-1 SF-2
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, HIV Envelope Protein gp160, HIV Envelope Protein gp120, AIDS Vaccines, HIV Therapeutic Vaccine

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
  • Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
  • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
  • San Francisco Gen. Hosp.
  • UCSF Pediatric AIDS CRS
  • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
  • Univ. of Connecticut Health Ctr., Dept. of Ped.
  • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
  • Cook County Hosp.
  • Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
  • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
  • Chicago Children's CRS
  • Tulane/LSU Maternal/Child CRS
  • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
  • BMC, Div. of Ped Infectious Diseases
  • Baystate Health, Baystate Med. Ctr.
  • WNE Maternal Pediatric Adolescent AIDS CRS
  • UMDNJ - Robert Wood Johnson
  • NJ Med. School CRS
  • St. Joseph's Hosp. & Med. Ctr. of New Jersey
  • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
  • North Shore-Long Island Jewish Health System, Dept. of Peds.
  • NYU Med. Ctr., Dept. of Medicine
  • Columbia IMPAACT CRS
  • Incarnation Children's Ctr.
  • Univ. of Rochester ACTG CRS
  • SUNY Upstate Med. Univ., Dept. of Peds.
  • DUMC Ped. CRS
  • The Children's Hosp. of Philadelphia IMPAACT CRS
  • St. Christopher's Hosp. for Children
  • Texas Children's Hosp. CRS
  • San Juan City Hosp. PR NICHD 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)
Collaborators
Genentech, Inc., MicroGeneSys Inc (nka Protein Sciences Corporation)
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1. Study Identification

Unique Protocol Identification Number
NCT00000762
Brief Title
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
Official Title
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
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
February 1996 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Genentech, Inc., MicroGeneSys Inc (nka Protein Sciences Corporation)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Vaccines, Synthetic, HIV Envelope Protein gp160, HIV Envelope Protein gp120, AIDS Vaccines, HIV Therapeutic Vaccine

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
rgp120/HIV-1MN
Intervention Type
Biological
Intervention Name(s)
rgp120/HIV-1 SF-2
Intervention Type
Biological
Intervention Name(s)
gp160 Vaccine (MicroGeneSys)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lambert JS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Katz S
Official's Role
Study Chair
Facility Information:
Facility Name
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
City
Los Angeles
State/Province
California
ZIP/Postal Code
900481804
Country
United States
Facility Name
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
900951752
Country
United States
Facility Name
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
City
Oakland
State/Province
California
ZIP/Postal Code
946091809
Country
United States
Facility Name
San Francisco Gen. Hosp.
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
UCSF Pediatric AIDS CRS
City
San Francisco
State/Province
California
ZIP/Postal Code
941430105
Country
United States
Facility Name
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
City
Torrance
State/Province
California
ZIP/Postal Code
905022004
Country
United States
Facility Name
Univ. of Connecticut Health Ctr., Dept. of Ped.
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06504
Country
United States
Facility Name
Cook County Hosp.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606143394
Country
United States
Facility Name
Chicago Children's CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606371470
Country
United States
Facility Name
Tulane/LSU Maternal/Child CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021155724
Country
United States
Facility Name
BMC, Div. of Ped Infectious Diseases
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Baystate Health, Baystate Med. Ctr.
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
WNE Maternal Pediatric Adolescent AIDS CRS
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
016550001
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson
City
New Brunswick
State/Province
New Jersey
Country
United States
Facility Name
NJ Med. School CRS
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071072198
Country
United States
Facility Name
St. Joseph's Hosp. & Med. Ctr. of New Jersey
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
North Shore-Long Island Jewish Health System, Dept. of Peds.
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
NYU Med. Ctr., Dept. of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia IMPAACT CRS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Incarnation Children's Ctr.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Univ. of Rochester ACTG CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Upstate Med. Univ., Dept. of Peds.
City
Syracuse
State/Province
New York
Country
United States
Facility Name
DUMC Ped. CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
277103499
Country
United States
Facility Name
The Children's Hosp. of Philadelphia IMPAACT CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191044318
Country
United States
Facility Name
St. Christopher's Hosp. for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191341095
Country
United States
Facility Name
Texas Children's Hosp. CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
San Juan City Hosp. PR NICHD CRS
City
San Juan
ZIP/Postal Code
009367344
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
Citation
Lambert JS, McNamara J, Katz S, Fenton T, Nichols J, Roberts NJ. Safety and immunogenicity of recombinant envelope HIV vaccines in asymptomatic HIV-infected children. Natl Conf Hum Retroviruses Relat Infect (1st). 1993 Dec 12-16:72
Results Reference
background
Citation
Lambert JS, et al. Safety and immunogenicity of recombinant envelope HIV vaccines in asymptomatic HIV infected children. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:151
Results Reference
background
PubMed Identifier
9859958
Citation
Lambert JS, McNamara J, Katz SL, Fenton T, Kang M, VanCott TC, Livingston R, Hawkins E, Moye J Jr, Borkowsky W, Johnson D, Yogev R, Duliege AM, Francis D, Gershon A, Wara D, Martin N, Levin M, McSherry G, Smith G. Safety and immunogenicity of HIV recombinant envelope vaccines in HIV-infected infants and children. National Institutes of Health-sponsored Pediatric AIDS Clinical Trials Group (ACTG-218). J Acquir Immune Defic Syndr Hum Retrovirol. 1998 Dec 15;19(5):451-61. doi: 10.1097/00042560-199812150-00003.
Results Reference
background
Citation
Lambert JS, McNamara J, Katz S, Livingston R, Moye J. Safety and immunogenicity of HIV recombinant envelope vaccines in HIV-infected infants and children. Pediatric AIDS Clinical Trials Group Study ACTG 218. American Pediatric Association and Society for Pediatric Research annual meeting; 1996 May 6-10; Washington, D.C. Pediatr AIDS HIV Infect. 1996 Aug;7(4):279 (unnumbered abstract)
Results Reference
background
PubMed Identifier
16220994
Citation
Lambert JS. HIV vaccines in infants and children. Paediatr Drugs. 2005;7(5):267-76. doi: 10.2165/00148581-200507050-00001.
Results Reference
result

Learn more about this trial

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

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