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

Condition(s) targeted: HIV Infections; Measles

Intervention: Measles Virus Vaccine (Live) (Biological); Measles-Mumps-Rubella Vaccine (Live) (Biological)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Chandwani S, Study Chair
Krasinski K, Study Chair

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.

Official title: 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

Study design: Treatment

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 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.

Patients, HIV infected and uninfected, are randomized to one of two attenuated measles vaccine schedules: at 6 and 12 months of age, or at 12 months of age only. Attenuvax is administered as the month 6 vaccine and M-M-R II as the month 12 vaccine. Patients are followed for 24 months after the last vaccination.

Minimum age: 6 Months. Maximum age: 7 Months. Gender(s): Both.

Criteria:

Inclusion Criteria

Patients must have:

- Positive or negative HIV blood 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.

San Juan City Hosp, San Juan 009367344, Puerto Rico

Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan 009365067, Puerto Rico

Ramon Ruiz Arnau Univ Hosp / Pediatrics, Bayamon 00956, Puerto Rico

Univ of Alabama at Birmingham - Pediatric, Birmingham, Alabama 35233, United States

UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla, California 920930672, United States

Harbor - UCLA Med Ctr / UCLA School of Medicine, Los Angeles, California 905022004, United States

UCLA Med Ctr / Pediatric, Los Angeles, California 900951752, United States

Long Beach Memorial (Pediatric), Long Beach, California 90801, United States

AIDS Clinical Research Ctr / UCLA Med Ctr, Los Angeles, California 900951793, United States

Harbor UCLA Med Ctr, Torrance, California 90502, United States

Los Angeles County - USC Med Ctr, Los Angeles, California 90033, United States

Children's Hosp of Denver, Denver, Colorado 802181088, United States

Yale Univ Med School, New Haven, Connecticut 06504, United States

Howard Univ Hosp, Washington, District of Columbia 20060, United States

Children's Hosp of Washington DC, Washington, District of Columbia 200102916, United States

Univ of Florida Health Science Ctr / Pediatrics, Jacksonville, Florida 32209, United States

Emory Univ Hosp / Pediatrics, Atlanta, Georgia 30306, United States

Chicago Children's Memorial Hosp, Chicago, Illinois 606143394, United States

Cook County Hosp, Chicago, Illinois 60612, United States

Univ of Illinois College of Medicine / Pediatrics, Chicago, Illinois 60612, United States

Univ of Chicago Children's Hosp, Chicago, Illinois 606371470, United States

Tulane Univ / Charity Hosp of New Orleans, New Orleans, Louisiana 701122699, United States

Univ of Maryland at Baltimore / Univ Med Ctr, Baltimore, Maryland 21201, United States

Johns Hopkins Hosp - Pediatric, Baltimore, Maryland 212874933, United States

Children's Hosp of Boston, Boston, Massachusetts 021155724, United States

Children's Hosp of Michigan, Detroit, Michigan 48201, United States

Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark, New Jersey 071032714, United States

UMDNJ - Robert Wood Johnson Med School / Pediatrics, New Brunswick, New Jersey 089030019, United States

Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl, Newark, New Jersey 071072198, United States

Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl, Newark, New Jersey 07103, United States

King's County Hosp Ctr / Pediatrics, Brooklyn, New York 11203, United States

Harlem Hosp Ctr, New York, New York 10037, United States

North Shore Univ Hosp, Great Neck, New York 11021, United States

Westchester Hosp, Valhalla, New York 10595, United States

Schneider Children's Hosp, New Hyde Park, New York 11040, United States

Bellevue Hosp / New York Univ Med Ctr, New York, New York 10016, United States

Columbia Presbyterian Med Ctr, New York, New York 10032, United States

Mount Sinai Med Ctr / Pediatrics, New York, New York 10029, United States

Metropolitan Hosp Ctr, New York, New York 10029, United States

Children's Hosp at Albany Med Ctr, Albany, New York 12208, United States

SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse, New York 13210, United States

Incarnation Children's Ctr / Columbia Presbyterian Med Ctr, New York, New York 10032, United States

State Univ of New York at Stony Brook, Stony Brook, New York 117948111, United States

Univ of Rochester Med Ctr, Rochester, New York 146420001, United States

Duke Univ Med Ctr, Durham, North Carolina 277103499, United States

Case Western Reserve Univ - Pediatric, Cleveland, Ohio 44106, United States

Children's Hosp of Philadelphia, Philadelphia, Pennsylvania 191044318, United States

Med Univ of South Carolina, Charleston, South Carolina 294253312, United States

Texas Children's Hosp / Baylor Univ, Houston, Texas 77030, United States

Children's Hosp of the King's Daughters, Norfolk, Virginia 23507, United States

Children's Hospital & Medical Center / Seattle ACTU, Seattle, Washington 981050371, United States

Last updated: June 23, 2005