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
NCT ID: NCT00000762
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
1996-02-29
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
DOUBLE
Interventions
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rgp120/HIV-1MN
rgp120/HIV-1 SF-2
gp160 Vaccine (MicroGeneSys)
Eligibility Criteria
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Inclusion Criteria
* 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
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.
1 Month
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
MicroGeneSys Inc (nka Protein Sciences Corporation)
UNKNOWN
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Lambert JS
Role: STUDY_CHAIR
Katz S
Role: STUDY_CHAIR
Locations
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Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States
Childrens Hosp. LA - Dept. of Ped., Div. of Clinical Immunology & Allergy
Los Angeles, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States
San Francisco Gen. Hosp.
San Francisco, California, United States
UCSF Pediatric AIDS CRS
San Francisco, California, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, United States
Univ. of Connecticut Health Ctr., Dept. of Ped.
Farmington, Connecticut, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, United States
Cook County Hosp.
Chicago, Illinois, United States
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
Chicago, Illinois, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States
Chicago Children's CRS
Chicago, Illinois, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, 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
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States
Columbia IMPAACT CRS
New York, New York, United States
Incarnation Children's Ctr.
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States
DUMC Ped. CRS
Durham, North Carolina, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States
Texas Children's Hosp. CRS
Houston, Texas, United States
San Juan City Hosp. PR NICHD CRS
San Juan, , Puerto Rico
Countries
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References
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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
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
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.
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)
Lambert JS. HIV vaccines in infants and children. Paediatr Drugs. 2005;7(5):267-76. doi: 10.2165/00148581-200507050-00001.
Other Identifiers
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11195
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 218
Identifier Type: -
Identifier Source: org_study_id