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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000774
Other study ID # ACTG 230
Secondary ID 11207
Status Completed
Phase Phase 1
First received
Last updated
Est. completion date January 1999

Study information

Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 156
Est. completion date January 1999
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 3 Days
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
rgp120/HIV-1MN
Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
rgp120/HIV-1 SF-2
Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
Placebo version of rgp120/HIV-1MN
Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.
Placebo version of rgp120/HIV-1SF2
Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

Locations

Country Name City State
Puerto Rico San Juan City Hosp. PR NICHD CRS San Juan
United States Univ. of Colorado Denver NICHD CRS Aurora Colorado
United States Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases Baltimore Maryland
United States BMC, Div. of Ped Infectious Diseases Boston Massachusetts
United States Brigham and Women's Hosp., Div. of Infectious Disease Boston Massachusetts
United States HMS - Children's Hosp. Boston, Div. of Infectious Diseases Boston Massachusetts
United States Bronx-Lebanon Hosp. IMPAACT CRS Bronx New York
United States Chicago Children's CRS Chicago Illinois
United States Cook County Hosp. Chicago Illinois
United States Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease Chicago Illinois
United States DUMC Ped. CRS Durham North Carolina
United States Texas Children's Hosp. CRS Houston Texas
United States Univ. of Florida Jacksonville NICHD CRS Jacksonville Florida
United States Long Beach Memorial Med. Ctr., Miller Children's Hosp. Long Beach California
United States UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS Los Angeles California
United States Univ. of Miami Ped. Perinatal HIV/AIDS CRS Miami Florida
United States Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease New Haven Connecticut
United States Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic New Orleans Louisiana
United States Tulane/LSU Maternal/Child CRS New Orleans Louisiana
United States Columbia IMPAACT CRS New York New York
United States Incarnation Children's Ctr. New York New York
United States NYU Med. Ctr., Dept. of Medicine New York New York
United States NJ Med. School CRS Newark New Jersey
United States St. Joseph's Hosp. & Med. Ctr. of New Jersey Paterson New Jersey
United States The Children's Hosp. of Philadelphia IMPAACT CRS Philadelphia Pennsylvania
United States Univ. of Pennsylvania Health System, Hosp. of the Univ. of Pennsylvania Philadelphia Pennsylvania
United States Strong Memorial Hospital Rochester NY NICHD CRS Rochester New York
United States Univ. of Rochester ACTG CRS Rochester New York
United States UCSD Maternal, Child, and Adolescent HIV CRS San Diego California
United States San Francisco Gen. Hosp. San Francisco California
United States UCSF Pediatric AIDS CRS San Francisco California
United States UW School of Medicine - CHRMC Seattle Washington
United States Baystate Health, Baystate Med. Ctr. Springfield Massachusetts
United States SUNY Stony Brook NICHD CRS Stony Brook New York
United States SUNY Upstate Med. Univ., Dept. of Peds. Syracuse New York
United States Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases Torrance California
United States WNE Maternal Pediatric Adolescent AIDS CRS Worcester New York

Sponsors (3)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Biocine, Genentech, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (3)

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. — View 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. Epub 2001 Feb 28. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Development of adverse clinical, laboratory, or immunological responses to any of the recombinant vaccines Throughout study
Primary Changes in viral load in infants found to be HIV infected Throughout study
Primary Changes in the slope of absolute CD4 counts in all immunized children Throughout study
Secondary Changes in immune response to the vaccine candidates Throughout study
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