Status:
COMPLETED
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
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Measles
Eligibility:
All Genders
6-7 years
Phase:
PHASE2
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 v...
Detailed Description
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 int...
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2001
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00000815
End Date
August 1 2001
Last Update
October 28 2021
Active Locations (46)
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1
UAB, Dept. of Ped., Div. of Infectious Diseases
Birmingham, Alabama, United States, 35233
2
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
3
Usc La Nichd Crs
Los Angeles, California, United States, 90033
4
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States