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A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers

Primary Purpose

HIV Infections, HIV Seronegativity

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
rgp120/HIV-1MN
rgp120/HIV-1 SF-2
Placebo version of rgp120/HIV-1MN
Placebo version of rgp120/HIV-1SF2
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Vaccines, Synthetic, Virus Replication, HIV Envelope Protein gp120, AIDS Vaccines, HIV Preventive Vaccine, HIV Therapeutic Vaccine

Eligibility Criteria

1 Day - 3 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria Concurrent Medication: Allowed: Antiretroviral therapy. Coenrollment in a therapeutic protocol if begun at least 30 days following the week 20 immunization. Routine immunizations if given more than 1 week before or after study vaccine. Patients must be: > 37 weeks gestation and < 72 hours of age born to HIV-infected women. NOT born to women who received either passive or active immunotherapy during pregnancy. NOT breast-fed. NOT born to women who are hepatitis B surface antigen positive. Receiving AZT at study entry (except infants enrolled in ACTG 076). NOTE: Parent or guardian must provide informed consent and be willing to comply with study requirements. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Documented or suspected serious bacterial infection, metabolic illness, or other immediate life-threatening conditions. Concurrent Medication: Excluded: Passive or active HIV-specific immunotherapy other than the study candidate vaccines. Investigational medications.

Sites / Locations

  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
  • UCSD Maternal, Child, and Adolescent HIV CRS
  • San Francisco Gen. Hosp.
  • UCSF Pediatric AIDS CRS
  • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
  • Univ. of Colorado Denver NICHD CRS
  • Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
  • Univ. of Florida Jacksonville NICHD CRS
  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS
  • Cook County Hosp.
  • Chicago Children's CRS
  • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
  • Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic
  • Tulane/LSU Maternal/Child CRS
  • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
  • Brigham and Women's Hosp., Div. of Infectious Disease
  • BMC, Div. of Ped Infectious Diseases
  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
  • Baystate Health, Baystate Med. Ctr.
  • NJ Med. School CRS
  • St. Joseph's Hosp. & Med. Ctr. of New Jersey
  • Bronx-Lebanon Hosp. IMPAACT CRS
  • NYU Med. Ctr., Dept. of Medicine
  • Columbia IMPAACT CRS
  • Incarnation Children's Ctr.
  • Strong Memorial Hospital Rochester NY NICHD CRS
  • Univ. of Rochester ACTG CRS
  • SUNY Stony Brook NICHD CRS
  • SUNY Upstate Med. Univ., Dept. of Peds.
  • WNE Maternal Pediatric Adolescent AIDS CRS
  • DUMC Ped. CRS
  • The Children's Hosp. of Philadelphia IMPAACT CRS
  • Univ. of Pennsylvania Health System, Hosp. of the Univ. of Pennsylvania
  • Texas Children's Hosp. CRS
  • UW School of Medicine - CHRMC
  • San Juan City Hosp. PR NICHD CRS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Patients who will receive rgp120/HIV-1MN

Patients who will receive rgp120/HIV-1SF2

Patients who will receive the placebo counterpart of 120/HIV-1MN

Patients who will receive the placebo counterpart of rgp120/HIV-1SF2

Outcomes

Primary Outcome Measures

Development of adverse clinical, laboratory, or immunological responses to any of the recombinant vaccines
Changes in viral load in infants found to be HIV infected
Changes in the slope of absolute CD4 counts in all immunized children

Secondary Outcome Measures

Changes in immune response to the vaccine candidates

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Genentech, Inc., Biocine
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1. Study Identification

Unique Protocol Identification Number
NCT00000774
Brief Title
A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers
Official Title
A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers
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
January 1999 (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., Biocine

4. Oversight

5. Study Description

Brief Summary
PRIMARY: To determine the safety of envelope recombinant proteins rgp120/HIV-1MN (Genentech) and rgp120/HIV-1SF2 (Chiron/Biocine) in infants who are of indeterminate HIV status born to HIV-infected women. To evaluate changes in viral load in infants proven to be infected and absolute CD4 counts in all immunized infants. SECONDARY: To evaluate the immunogenicity of these envelope recombinant proteins in infants of indeterminate HIV status born to HIV-infected women. Only 30-50 percent of HIV-infected infants have detectable virus at birth. Successful early sensitization to HIV envelope epitopes may help prevent infection or, alternatively, may enhance HIV-specific immune function to alter HIV replication and disease progression.
Detailed Description
Only 30-50 percent of HIV-infected infants have detectable virus at birth. Successful early sensitization to HIV envelope epitopes may help prevent infection or, alternatively, may enhance HIV-specific immune function to alter HIV replication and disease progression. Newborns are randomized to one of three different doses of either rgp120/HIV-1MN or rgp120/HIV-1SF2 or their matching placebos. At each dose level, 12 patients receive vaccine and three patients receive placebo. Immunizations are performed at 0, 4, 12, and 20 weeks, and patients are followed until 2 years of age. Three of four patients treated at a given dose level must have received two immunizations without evidence of grade 3 or 4 clinical or laboratory toxicity before dose escalation occurs. Twelve additional patients are treated with the optimal dose of each vaccine at weeks 0, 2, 8, and 20 (An accelerated schedule PER AMENDMENT 3/20/96. Changed from - 0, 4, 8, and 20) accompanied by three additional placebo patients per vaccine. PER AMENDMENT 3/20/96: The optimal dose of rgp120/HIV-1MN is 100 mcg and will be given to the 12 patients and the placebo will be given to 3. The optimal dose of rgp120/HIV-1SF2 is 5 mcg and will be given to the 12 patients and the placebo will be given to 3. PER 2/3/95 AMENDMENT: After the initial patients are enrolled, 18 additional newborns will be randomized to one of the three dose levels of rgp120/HIV-1MN (with no placebos). PER AMENDMENT 6/5/95: Another group of 18 newborns will be randomized to one of three treatments representing 3 different doses of the Chiron/Biocine vaccine (with no placebos).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients who will receive rgp120/HIV-1MN
Arm Title
2
Arm Type
Experimental
Arm Description
Patients who will receive rgp120/HIV-1SF2
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Patients who will receive the placebo counterpart of 120/HIV-1MN
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Patients who will receive the placebo counterpart of rgp120/HIV-1SF2
Intervention Type
Biological
Intervention Name(s)
rgp120/HIV-1MN
Intervention Description
Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
Intervention Type
Biological
Intervention Name(s)
rgp120/HIV-1 SF-2
Intervention Description
Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
Intervention Type
Biological
Intervention Name(s)
Placebo version of rgp120/HIV-1MN
Intervention Description
Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
Intervention Type
Biological
Intervention Name(s)
Placebo version of rgp120/HIV-1SF2
Intervention Description
Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
Primary Outcome Measure Information:
Title
Development of adverse clinical, laboratory, or immunological responses to any of the recombinant vaccines
Time Frame
Throughout study
Title
Changes in viral load in infants found to be HIV infected
Time Frame
Throughout study
Title
Changes in the slope of absolute CD4 counts in all immunized children
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Changes in immune response to the vaccine candidates
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Antiretroviral therapy. Coenrollment in a therapeutic protocol if begun at least 30 days following the week 20 immunization. Routine immunizations if given more than 1 week before or after study vaccine. Patients must be: > 37 weeks gestation and < 72 hours of age born to HIV-infected women. NOT born to women who received either passive or active immunotherapy during pregnancy. NOT breast-fed. NOT born to women who are hepatitis B surface antigen positive. Receiving AZT at study entry (except infants enrolled in ACTG 076). NOTE: Parent or guardian must provide informed consent and be willing to comply with study requirements. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Documented or suspected serious bacterial infection, metabolic illness, or other immediate life-threatening conditions. Concurrent Medication: Excluded: Passive or active HIV-specific immunotherapy other than the study candidate vaccines. Investigational medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Borkowsky W
Organizational Affiliation
NYU MEDICAL CENTER
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wara DW
Organizational Affiliation
UCSF Moffit Hospital
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
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
900951752
Country
United States
Facility Name
UCSD Maternal, Child, and Adolescent HIV CRS
City
San Diego
State/Province
California
ZIP/Postal Code
920930672
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 Colorado Denver NICHD CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
802181088
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
Univ. of Florida Jacksonville NICHD CRS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Cook County Hosp.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chicago Children's CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606143394
Country
United States
Facility Name
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606371470
Country
United States
Facility Name
Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
Tulane/LSU Maternal/Child CRS
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212874933
Country
United States
Facility Name
Brigham and Women's Hosp., Div. of Infectious Disease
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
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
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Baystate Health, Baystate Med. Ctr.
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
NJ Med. School CRS
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
St. Joseph's Hosp. & Med. Ctr. of New Jersey
City
Paterson
State/Province
New Jersey
Country
United States
Facility Name
Bronx-Lebanon Hosp. IMPAACT CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
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
Strong Memorial Hospital Rochester NY NICHD CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Univ. of Rochester ACTG CRS
City
Rochester
State/Province
New York
Country
United States
Facility Name
SUNY Stony Brook NICHD CRS
City
Stony Brook
State/Province
New York
ZIP/Postal Code
117948111
Country
United States
Facility Name
SUNY Upstate Med. Univ., Dept. of Peds.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
WNE Maternal Pediatric Adolescent AIDS CRS
City
Worcester
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
Univ. of Pennsylvania Health System, Hosp. of the Univ. of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Texas Children's Hosp. CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
UW School of Medicine - CHRMC
City
Seattle
State/Province
Washington
ZIP/Postal Code
981050371
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:
PubMed Identifier
7657952
Citation
Rogers MF, Mofenson LM, Moseley RR. Reducing the risk of perinatal HIV transmission through zidovudine therapy: treatment recommendations and implications. J Am Med Womens Assoc (1972). 1995 May-Aug;50(3-4):78-82, 93.
Results Reference
background
PubMed Identifier
11229849
Citation
Cunningham CK, Wara DW, Kang M, Fenton T, Hawkins E, McNamara J, Mofenson L, Duliege AM, Francis D, McFarland EJ, Borkowsky W; Pediatric AIDS Clinical Trials Group 230 Collaborators. Safety of 2 recombinant human immunodeficiency virus type 1 (HIV-1) envelope vaccines in neonates born to HIV-1-infected women. Clin Infect Dis. 2001 Mar 1;32(5):801-7. doi: 10.1086/319215. Epub 2001 Feb 28.
Results Reference
background
PubMed Identifier
10720509
Citation
Borkowsky W, Wara D, Fenton T, McNamara J, Kang M, Mofenson L, McFarland E, Cunningham C, Duliege AM, Francis D, Bryson Y, Burchett S, Spector SA, Frenkel LM, Starr S, Van Dyke R, Jimenez E. Lymphoproliferative responses to recombinant HIV-1 envelope antigens in neonates and infants receiving gp120 vaccines. AIDS Clinical Trial Group 230 Collaborators. J Infect Dis. 2000 Mar;181(3):890-6. doi: 10.1086/315298.
Results Reference
background

Learn more about this trial

A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers

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