Search / Trial NCT00000815

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 14, 2024

Completed

Keywords

Acquired Immunodeficiency Syndrome Aids Related Complex Measles Mumps Rubella Vaccine Vaccines, Attenuated Measles Vaccine Immunization Schedule Measles Virus Measles

ClinConnect Summary

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 randomize...

Gender

ALL

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.

Trial Officials

Chandwani S

Study Chair

Krasinski K

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Oakland, California, United States

San Diego, California, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

Newark, New Jersey, United States

New York, New York, United States

Los Angeles, California, United States

Washington, District Of Columbia, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

New Brunswick, New Jersey, United States

Great Neck, New York, United States

New Hyde Park, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Durham, North Carolina, United States

Houston, Texas, United States

Bayamon, , Puerto Rico

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Long Beach, California, United States

Los Angeles, California, United States

Torrance, California, United States

Aurora, Colorado, United States

Washington, District Of Columbia, United States

Jacksonville, Florida, United States

Chicago, Illinois, United States

Detroit, Michigan, United States

Paterson, New Jersey, United States

New York, New York, United States

Rochester, New York, United States

Stony Brook, New York, United States

Syracuse, New York, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Norfolk, Virginia, United States

Seattle, Washington, United States

New Haven, Connecticut, United States

Albany, New York, United States

Birmingham, Alabama, United States

New York, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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