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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Merck |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000815 |
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.
Condition | Intervention | Phase |
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HIV Infections Measles |
Biological: Attenuvax Biological: M-M-R-II |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
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 |
Estimated Enrollment: | 270 |
Study Start Date: | November 1999 |
Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants who receive vaccination at 6 and 12 months of age
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Biological: Attenuvax
Measles virus vaccine (attenuate)administered subcutaneously at a single dose of 0.5 mL at 6 months of age
Biological: M-M-R-II
Measles-Mumps-Rubella vaccine (attenuated)administered subcutaneously as a single dose of 0.5 mL at 12 months of age
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2: Experimental
Participants who receive vaccination only at 12 months of age
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Biological: M-M-R-II
Measles-Mumps-Rubella vaccine (attenuated)administered subcutaneously as a single dose of 0.5 mL at 12 months of age
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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.
Ages Eligible for Study: | 6 Months to 7 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Patients must have:
NOTE:
NOTE:
Recommended:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the prior condition are excluded:
Prior Medication:
Excluded:
Study Chair: | Chandwani S | |
Study Chair: | Krasinski K |
Responsible Party: | DAIDS ( Rona Siskind ) |
Study ID Numbers: | ACTG 225 |
Study First Received: | November 2, 1999 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000815 |
Health Authority: | United States: Food and Drug Administration |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Measles-Mumps-Rubella Vaccine Vaccines, Attenuated |
Measles Vaccine Immunization Schedule Measles Virus Measles |
Virus Diseases Sexually Transmitted Diseases, Viral Paramyxoviridae Infections Measles HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome AIDS-Related Complex Retroviridae Infections Rubella Immunologic Deficiency Syndromes Mumps |
RNA Virus Infections Morbillivirus Infections Slow Virus Diseases Immune System Diseases |
Lentivirus Infections Infection Mononegavirales Infections |