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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000815
Other study ID # ACTG 225
Secondary ID 11202
Status Completed
Phase Phase 2
First received
Last updated
Est. completion date August 2001

Study information

Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 270
Est. completion date August 2001
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 7 Months
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Attenuvax
Measles virus vaccine (attenuate)administered subcutaneously at a single dose of 0.5 mL at 6 months of age
M-M-R-II
Measles-Mumps-Rubella vaccine (attenuated)administered subcutaneously as a single dose of 0.5 mL at 12 months of age

Locations

Country Name City State
Puerto Rico Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds. Bayamon
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
United States Children's Hospital at Albany Medical Center, Dept. of Peds. Albany New York
United States Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases Atlanta Georgia
United States Univ. of Colorado Denver NICHD CRS Aurora Colorado
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 UAB, Dept. of Ped., Div. of Infectious Diseases Birmingham Alabama
United States HMS - Children's Hosp. Boston, Div. of Infectious Diseases Boston Massachusetts
United States Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases Charleston South Carolina
United States Chicago Children's CRS Chicago Illinois
United States Cook County Hosp. 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 Children's Hospital of Michigan NICHD CRS Detroit Michigan
United States DUMC Ped. CRS Durham North Carolina
United States North Shore-Long Island Jewish Health System, Dept. of Peds. Great Neck New York
United States Texas Children's Hosp. CRS Houston Texas
United States Univ. of Florida Jacksonville NICHD CRS Jacksonville Florida
United States Long Beach Memorial Med. Ctr., Miller Children's Hosp. Long Beach California
United States UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS Los Angeles California
United States Usc La Nichd Crs Los Angeles California
United States UMDNJ - Robert Wood Johnson New Brunswick New Jersey
United States Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease New Haven Connecticut
United States Schneider Children's Hosp., Div. of Infectious Diseases New Hyde Park New York
United States Tulane/LSU Maternal/Child CRS New Orleans Louisiana
United States Columbia IMPAACT CRS New York New York
United States Harlem Hosp. Ctr. NY NICHD CRS New York New York
United States Incarnation Children's Ctr. New York New York
United States Metropolitan Hosp. Ctr. New York New York
United States Metropolitan Hosp. NICHD CRS New York New York
United States NYU Med. Ctr., Dept. of Medicine New York New York
United States NJ Med. School CRS Newark New Jersey
United States Childrens Hosp. of the Kings Daughters Norfolk Virginia
United States Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. Oakland California
United States St. Joseph's Hosp. & Med. Ctr. of New Jersey Paterson New Jersey
United States The Children's Hosp. of Philadelphia IMPAACT CRS Philadelphia Pennsylvania
United States Strong Memorial Hospital Rochester NY NICHD CRS Rochester New York
United States UCSD Maternal, Child, and Adolescent HIV CRS San Diego California
United States UW School of Medicine - CHRMC Seattle Washington
United States SUNY Stony Brook NICHD CRS Stony Brook New York
United States SUNY Upstate Med. Univ., Dept. of Peds. Syracuse New York
United States Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases Torrance California
United States Children's National Med. Ctr., ACTU Washington District of Columbia
United States Howard Univ. Washington DC NICHD CRS Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Merck Sharp & Dohme Corp.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & 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 Tri — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Comparison of seroconversion rates at 13 months of age (following second vaccination) of HIV-uninfected children with HIV-infected children. Throughout study
Primary 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 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
Secondary Assessment of measles antibody decay and persistence in HIV-infected and HIV-unifected vaccinees Throughout study
Secondary Evaluation of adverse effects and immune reactions to vaccine in HIV-infected children and HIV-uninfected vaccinees Throughout study
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