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 Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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HIV Infections, Measles

Intervention / Treatment
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* Biological: Attenuvax
* Biological: M-M-R-II


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 7 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants who receive vaccination at 6 and 12 months of age | Biological: Attenuvax<br>* Measles virus vaccine (attenuate)administered subcutaneously at a single dose of 0.5 mL at 6 months of age<br>Biological: M-M-R-II<br>* Measles-Mumps-Rubella vaccine (attenuated)administered subcutaneously as a single dose of 0.5 mL at 12 months of age<br>|
| Experimental: 2<br>Participants who receive vaccination only at 12 months of age | Biological: M-M-R-II<br>* Measles-Mumps-Rubella vaccine (attenuated)administered subcutaneously as a single dose of 0.5 mL at 12 months of age<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Comparison of seroconversion rates at 13 months of age (following second vaccination) of HIV-uninfected children with HIV-infected children. |  | Throughout study | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Assessment of measles antibody decay and persistence in HIV-infected and HIV-unifected vaccinees |  | Throughout study | 
| Evaluation of adverse effects and immune reactions to vaccine in HIV-infected children and HIV-uninfected vaccinees |  | Throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Measles-Mumps-Rubella Vaccine, Vaccines, Attenuated, Measles Vaccine, Immunization Schedule, Measles Virus, Measles