A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
2 other identifiers
interventional
60
2 countries
33
Brief Summary
To assess whether HIV-infected infants who receive a heptavalent pneumococcal conjugate vaccine have more local reactions at the site of injection and systemic reactions than placebo subjects. To assess whether this vaccine is more immunogenic than placebo following the third vaccination. Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
October 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 28, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Comparison of adverse reactions between PCV and placebo patients that occur within 48 hours after each injection
Throughout study
Comparison of seroconversion rates and changes in (IgG) ELISA antibody levels between PCV and placebo patients after the primary series
Throughout study
Secondary Outcomes (4)
Comparison of booster rates in serum ELISA (IgG) antibody levels just before the 4th vaccination and one month after the 4th vaccination in children receiving PCV and placebo
Prior to 4th vaccination and at 1 month after 4th vaccination
Comparison of serum IgG1 and IgG2 subclass and IgA type specific seroconversion rates and changes in antibody levels in response to the primary immunization series and booster vaccination between PCV and placebo patients
Throughout study
To compare the decline of serum total IgG, IgG1, IgG2, and IgA pneumococcal type specific antibody after the 3rd and after the 4th vaccination in PCV versus placebo patients
At a time after the 3rd vaccination and at a time after the 4th vaccination
Modeling of the rates of seroconversion and changes in serum antibody levels in PCV patients, after the primary series and booster series, to clinical HIV staging and T-lymphocyte parameters, as well as B-lymphocyte parameters
Throughout study
Study Arms (2)
1
EXPERIMENTALPatients receiving intramuscular heptavalent pneumococcal conjugate vaccine
2
PLACEBO COMPARATORPatients receiving placebo vaccine
Interventions
Administered as an injection at 24 months of age
Administered as an injection at 0, 2, 4, and 15 months of age
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Antipyretics for rectal temperature \>= 100.4 F.
- Antiretroviral therapy.
- Patients must have:
- HIV positivity.
- Birth weight at least 1800 g (3.75 lb).
- Consent and compliance of parent or guardian.
- NOTE:
- Coenrollment in other therapeutic protocols (except ACTG 218, 230, and 279) is permitted.
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Enrollment in HIV vaccine trials.
- Major congenital anomalies that are incapacitating, result in immunologic abnormalities, or require major surgical procedures.
- Congenital immunoglobulin deficiency, SS or SC hemoglobinopathy, or asplenia.
- Hypogammaglobulinemia.
- Concurrent Medication:
- Excluded:
- Prophylactic antipyretics.
- Patients with the following prior conditions are excluded:
- Acute moderate to severe intercurrent illness or fever within 72 hours prior to study entry.
- Prior Medication:
- Excluded:
- Any prior pneumococcal vaccine.
- Measles vaccine within 1 month prior to study vaccination.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Usc La Nichd Crs
Los Angeles, California, 90033, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, 946091809, United States
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, 920930672, United States
San Francisco Gen. Hosp.
San Francisco, California, 94110, United States
UCSF Pediatric AIDS CRS
San Francisco, California, 941430105, United States
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 32209, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, 33161, United States
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Atlanta, Georgia, 30306, United States
Cook County Hosp.
Chicago, Illinois, 60612, United States
Chicago Children's CRS
Chicago, Illinois, 606143394, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, 606371470, United States
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, 701122699, United States
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, 21201, United States
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, 212874933, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, 021155724, United States
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, 48201, United States
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, 089030019, United States
NJ Med. School CRS
Newark, New Jersey, 071072198, United States
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, 11021, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, 10016, United States
Columbia IMPAACT CRS
New York, New York, 10032, United States
Incarnation Children's Ctr.
New York, New York, 10032, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, 10037, United States
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, 117948111, United States
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, 13210, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, 10457, United States
DUMC Ped. CRS
Durham, North Carolina, 277103499, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, 191044318, United States
Texas Children's Hosp. CRS
Houston, Texas, 77030, United States
UW School of Medicine - CHRMC
Seattle, Washington, 981050371, United States
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, 009365067, Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
James King, Jr, M.D.
University of Maryland, College Park
- STUDY CHAIR
Sharon Nachman, M.D.
SUNY at Stony Brook
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
October 1, 1999
Last Updated
October 28, 2021
Record last verified: 2021-10