MMR and Varicella Vaccine in Premature Infants

Study Overview
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Brief Summary
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This research is designed to address the question, Does the relative deficit in vaccine immunogenicity in extremely premature infants persist beyond the first 6 months of life? We propose to measure the immunogenicity of varicella and mumps-measles-rubella vaccines in relatively healthy, 12-to-15 month-old children born at <29 weeks gestation, when compared to full-term infants, as measured by the relevant viral serologies.

Detailed Description
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Title: MMR and Varicella Vaccine Responses in Extremely Premature Infants Phase: IV Population: 16 generally healthy premature infants born at < 29 weeks' gestation, < 16 months old from the Rochester area 16 generally healthy full-term infants born at >/= 37 weeks' gestation, < 16 months old from the Rochester area Number of Sites: University of Rochester Study Duration: 1.5 - 8.5 months Description of Agent or Intervention: Subjects will make 2 study visits. The first, at 15 months of age, will coincide with a routine well child visit. Subjects will have 2 mL of blood drawn at the time of their routine, 15-month MMR, varicella, and pneumococcal conjugate immunizations. At a second study visit 4-6 weeks later, another 2 mL of blood will be drawn. Objectives: Primary: We propose to measure the immunogenicity of routinely administered varicella and mumps-measles-rubella vaccines in relatively healthy, 12-to-15 month-old children born at <29 weeks gestation (premature), when compared to that in full-term infants. Measles titers will be measured by neutralization assay. Mumps and rubella titers will be measured by enzyme-linked florescent immunoassay. Varicella titers will be measured by enzyme linked immunosorbent assay. Safety will be assessed by parental recall of vaccine-related adverse events and by active, prospective collection of blood-draw-associated adverse events. Schematic of Study Design: Subjects will be approached at 9-12 months of age for inclusion, and will consent at this time or at Visit 1 Visit 1 (15 mos): Preterm N = 16, Full term N = 16, 2 ml blood draw Routine MMR, varicella vaccines administered by primary pediatrician per standard of care (at Visit 1) Visit 2 (16 mos): Preterm N = 16, Full term N = 16, 2 ml blood draw Varicella, mumps, measles and rubella vaccine titers measured by ELISA

Official Title
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MMR and Varicella Vaccine Responses in Extremely Premature Infants

Conditions
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Chickenpox, Rubella, Rubeola, Mumps

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all of the inclusion criteria to participate in this study. Premature infant < 29 weeks' gestation at birth or term infant >/= 37 weeks' gestation at birth. Postnatal age < 16 months, 0 days. Has not yet received MMR or varicella vaccines. (There are no restrictions on the administration of other vaccines at the time of MMR/varicella vaccination.) Parental permission. Agreement of primary care pediatrician/ health care provider. Receives primary pediatric care within an approximate 25-mile radius of the University of Rochester. Healthy status at enrollment. Exclusion Criteria: Known immunodeficiency. Systemic corticosteroid therapy at the time of MMR/varicella vaccination. Requiring oxygen therapy. Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion. Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 16 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunization, vaccine, low birth weight infant, premature infant