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

NCT00000774 | Completed Phase 1

• 2 other identifiers: ACTG 23011207
• Study Type: interventional
• Target: 156
• Locations: 2 countries
• Sites: 37

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.

Conditions

HIV Infections; HIV Seronegativity

Keywords

Vaccines, Synthetic; Virus Replication; HIV Envelope Protein gp120; AIDS Vaccines; HIV Preventive Vaccine; HIV Therapeutic Vaccine

Outcome Measures

Primary Outcomes (3)

• Development of adverse clinical, laboratory, or immunological responses to any of the recombinant vaccines

  Throughout study

• Changes in viral load in infants found to be HIV infected

  Throughout study

• Changes in the slope of absolute CD4 counts in all immunized children

  Throughout study

Secondary Outcomes (1)

• Changes in immune response to the vaccine candidates

  Throughout study

Study Arms (4)

1

EXPERIMENTAL

Patients who will receive rgp120/HIV-1MN

Biological: rgp120/HIV-1MN

2

EXPERIMENTAL

Patients who will receive rgp120/HIV-1SF2

Biological: rgp120/HIV-1 SF-2

3

PLACEBO COMPARATOR

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

Biological: Placebo version of rgp120/HIV-1MN

4

PLACEBO COMPARATOR

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

Biological: Placebo version of rgp120/HIV-1SF2

Interventions

rgp120/HIV-1MN BIOLOGICAL

Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

1

rgp120/HIV-1 SF-2 BIOLOGICAL

Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

2

Placebo version of rgp120/HIV-1MN BIOLOGICAL

Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

3

Placebo version of rgp120/HIV-1SF2 BIOLOGICAL

Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

4

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Genentech, Inc.: collaborator
• Biocine: collaborator

Study Sites (37)

Long Beach Memorial Med. Ctr., Miller Children's Hosp.

Long Beach, California, 90801, United States

Location

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS

Los Angeles, California, 900951752, United States

Location

UCSD Maternal, Child, and Adolescent HIV CRS

San Diego, California, 920930672, United States

Location

San Francisco Gen. Hosp.

San Francisco, California, 94110, United States

Location

UCSF Pediatric AIDS CRS

San Francisco, California, 941430105, United States

Location

Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases

Torrance, California, 905022004, United States

Location

Univ. of Colorado Denver NICHD CRS

Aurora, Colorado, 802181088, United States

Location

Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease

New Haven, Connecticut, 06504, United States

Location

Univ. of Florida Jacksonville NICHD CRS

Jacksonville, Florida, 32209, United States

Location

Univ. of Miami Ped. Perinatal HIV/AIDS CRS

Miami, Florida, 33161, United States

Location

Cook County Hosp.

Chicago, Illinois, 60612, United States

Location

Chicago Children's CRS

Chicago, Illinois, 606143394, United States

Location

Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease

Chicago, Illinois, 606371470, United States

Location

Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic

New Orleans, Louisiana, 701122699, United States

Location

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, United States

Location

Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases

Baltimore, Maryland, 212874933, United States

Location

Brigham and Women's Hosp., Div. of Infectious Disease

Boston, Massachusetts, 02115, United States

Location

BMC, Div. of Ped Infectious Diseases

Boston, Massachusetts, 02118, United States

Location

HMS - Children's Hosp. Boston, Div. of Infectious Diseases

Boston, Massachusetts, United States

Location

Baystate Health, Baystate Med. Ctr.

Springfield, Massachusetts, 01199, United States

Location

NJ Med. School CRS

Newark, New Jersey, 07103, United States

Location

St. Joseph's Hosp. & Med. Ctr. of New Jersey

Paterson, New Jersey, United States

Location

NYU Med. Ctr., Dept. of Medicine

New York, New York, 10016, United States

Location

Columbia IMPAACT CRS

New York, New York, 10032, United States

Location

Incarnation Children's Ctr.

New York, New York, 10032, United States

Location

Strong Memorial Hospital Rochester NY NICHD CRS

Rochester, New York, 14642, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, United States

Location

SUNY Stony Brook NICHD CRS

Stony Brook, New York, 117948111, United States

Location

SUNY Upstate Med. Univ., Dept. of Peds.

Syracuse, New York, 13210, United States

Location

Bronx-Lebanon Hosp. IMPAACT CRS

The Bronx, New York, 10457, United States

Location

WNE Maternal Pediatric Adolescent AIDS CRS

Worcester, New York, United States

Location

DUMC Ped. CRS

Durham, North Carolina, 277103499, United States

Location

The Children's Hosp. of Philadelphia IMPAACT CRS

Philadelphia, Pennsylvania, 191044318, United States

Location

Univ. of Pennsylvania Health System, Hosp. of the Univ. of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Children's Hosp. CRS

Houston, Texas, 77030, United States

Location

UW School of Medicine - CHRMC

Seattle, Washington, 981050371, United States

Location

San Juan City Hosp. PR NICHD CRS

San Juan, 009367344, Puerto Rico

Location

Related Publications (3)

• 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.

  PMID: 7657952 BACKGROUND

• 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.

  PMID: 11229849 BACKGROUND

• 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.

  PMID: 10720509 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Borkowsky W

  NYU MEDICAL CENTER

  STUDY CHAIR

• Wara DW

  UCSF Moffit Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: January 1, 1999
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

PR (1); US (36)