MMR and Varicella Vaccine in Premature Infants

NCT ID: NCT00156559

Last Updated: 2015-09-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2005-05-31

Brief Summary

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

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

Conditions

Chickenpox; Rubella; Rubeola; Mumps

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Premature infant < 29 weeks' gestation at birth or term infant >/= 37 weeks' gestation at birth.

2. Postnatal age < 16 months, 0 days.

3. 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.)

4. Parental permission.

5. Agreement of primary care pediatrician/ health care provider.

6. Receives primary pediatric care within an approximate 25-mile radius of the University of Rochester.

7. Healthy status at enrollment.

Exclusion Criteria

1. Known immunodeficiency.

2. Systemic corticosteroid therapy at the time of MMR/varicella vaccination.

3. Requiring oxygen therapy.

4. Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion.

5. Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 16 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Carl D'Angio

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carl T. D'Angio, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

References

D'Angio CT, Boohene PA, Mowrer A, Audet S, Menegus MA, Schmid DS, Beeler JA. Measles-mumps-rubella and varicella vaccine responses in extremely preterm infants. Pediatrics. 2007 Mar;119(3):e574-9. doi: 10.1542/peds.2006-2241.

Reference Type: RESULT

PMID: 17332177 (View on PubMed)

Other Identifiers

N01-AI-25460

Identifier Type: -

Identifier Source: secondary_id

DMID 03-140

Identifier Type: -

Identifier Source: org_study_id