A Phase II, Comparative Study of Seroconversion of Single-Dose and Two-Dose Measles Vaccination in HIV-Infected and HIV-Uninfected Children: A Multicenter Trial of the Pediatric AIDS Clinical Trials Group
2 other identifiers
interventional
270
2 countries
46
Brief Summary
To compare measles seroconversion rates (development of antibodies) at 13 months of age in HIV-infected and uninfected children on one of two immunization schedules: attenuated measles/mumps/rubella virus (M-M-R II) vaccine at 12 months versus attenuated measles vaccine (Attenuvax) at 6 months plus M-M-R II vaccine at 12 months. Recommendations for the age at vaccination should balance the need to minimize the risk of morbidity and mortality with the benefit of achieving the highest seroconversion rates. Immunizing a more intact immune system at an earlier stage of HIV infection may in turn achieve better and long-lasting measles protection. This study will help define a more effective measles vaccine regimen for children diagnosed with HIV infection and will provide greater insight into the functional status of the HIV-infected children's humoral immune system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
46 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
First Submitted
Initial submission to the registry
November 2, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2001
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 (3)
Comparison of measles seroconversion rates at 13 months of age between HIV-infected children vaccinated at 12 months of age and HIV-infected children vaccinated at 6 and 12 months of age
Throughout study
Comparison of seroconversion rates at 13 months of age (following second vaccination) of HIV-uninfected children with HIV-infected children.
Throughout study
Comparison of seroconversion rates at 13 months of age (following single vaccination) of HIV-uninfected children with HIV-infected children following vaccination at 12 months of age
Throughout study
Secondary Outcomes (3)
Comparison of measles seroconversion rates in HIV-infected children vaccinated at 6 months of age with HIV-infected children vaccinated at 12 months of age
Throughout study
Assessment of measles antibody decay and persistence in HIV-infected and HIV-unifected vaccinees
Throughout study
Evaluation of adverse effects and immune reactions to vaccine in HIV-infected children and HIV-uninfected vaccinees
Throughout study
Study Arms (2)
1
EXPERIMENTALParticipants who receive vaccination at 6 and 12 months of age
2
EXPERIMENTALParticipants who receive vaccination only at 12 months of age
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- Willing to have and receive results of HIV test
- Been born to mothers with HIV infection or history of AIDS-defining condition by CDC criteria.
- No history of opportunistic infection.
- No known exposure to measles within 14 days prior to study entry.
- CD4+ lymphocyte count \>= 750 cells/mm3 or more than 15% at 6 months of age.
- Parent or legal guardian available to give written informed consent and be willing to comply with all study requirements.
- Childhood immunizations (other than measles) according to current recommendations of the Immunization Practice Advisory Committee and American Academy of Pediatrics.
- NOTE:
- Coenrollment on other therapeutic protocols (except for ACTG 185) is permitted.
- NOTE:
- Patients must be located in a geographical area where measles immunization at 12 months is standard of care.
- Recommended:
- Childhood immunizations other than measles according to current guidelines.
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Intercurrent illness and/or fever for 7 days.
- Known sensitivity or allergy to neomycin or eggs.
- Concurrent Medication:
- Excluded:
- IVIG.
- Uninterrupted or anticipated steroid therapy (\>= 2 mg/kg/day) for more than 2 weeks duration.
- Patients with the prior condition are excluded:
- Platelet count \< 50,000/mm3 at any time prior to study entry.
- Prior Medication:
- Excluded:
- Any IgG preparation within the past 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, 35233, United States
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, 90801, United States
Usc La Nichd Crs
Los Angeles, California, 90033, 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, 94609, United States
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, United States
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States
Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
New Haven, Connecticut, 06504, United States
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, 20010, United States
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, 20060, United States
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, 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, 60614, United States
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
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
Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
Baltimore, Maryland, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, 48201, 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, 07503, United States
Children's Hospital at Albany Medical Center, Dept. of Peds.
Albany, New York, 12208, United States
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, 11021, United States
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, 11040, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, 10016, United States
Metropolitan Hosp. Ctr.
New York, New York, 10029, United States
Metropolitan Hosp. NICHD CRS
New York, New York, 10029, 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, United States
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, 13210, United States
DUMC Ped. CRS
Durham, North Carolina, 27710, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
Charleston, South Carolina, United States
Texas Children's Hosp. CRS
Houston, Texas, United States
Childrens Hosp. of the Kings Daughters
Norfolk, Virginia, 23507, United States
UW School of Medicine - CHRMC
Seattle, Washington, United States
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
Bayamón, Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, Puerto Rico
Related Publications (1)
Chandwani S, Beeler J, Li H, Audet S, Smith B, Moye J, Nalin D, Krasinski K; PACTG 225 Study Team. Safety and immunogenicity of early measles vaccination in children born to HIV-infected mothers in the United States: results of Pediatric AIDS Clinical Trials Group (PACTG) protocol 225. J Infect Dis. 2011 Jul;204 Suppl 1(Suppl 1):S179-89. doi: 10.1093/infdis/jir089.
PMID: 21666159RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Chandwani S
- STUDY CHAIR
Krasinski K
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- 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
August 1, 2001
Last Updated
October 28, 2021
Record last verified: 2021-10