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

Completed · Phase 2

Conditions studied: HIV Infections, Measles

In brief

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.

Key facts

Study ID

NCT00000815

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

270

Expected to finish

2001-08-01

Last updated by the study team

2021-10-28

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• UAB, Dept. of Ped., Div. of Infectious Diseases — Birmingham, Alabama, United States
• Long Beach Memorial Med. Ctr., Miller Children's Hosp. — Long Beach, California, United States
• Usc La Nichd Crs — 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
• 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, United States
• Children's National Med. Ctr., ACTU — Washington D.C., District of Columbia, United States
• Howard Univ. Washington DC NICHD CRS — Washington D.C., District of Columbia, 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, United States
• Cook County Hosp. — Chicago, Illinois, United States
• Chicago Children's CRS — Chicago, Illinois, 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, 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

Full record on ClinicalTrials.gov

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