Comparison of Immune Response Using 2 Vaccination Schedules Using Inactivated Polio Vaccine

This study has been completed.
Sponsor:
Collaborator:
Ponce School of Medicine
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00137696
First received: August 27, 2005
Last updated: December 12, 2005
Last verified: August 2005
  Purpose

As poliovirus eradication progresses rapidly, strategies to discontinue oral poliovirus vaccination need to be established. One strategy would be to use inactivated poliovirus vaccine (IPV) transitionally, and this has already occurred in the United States. It is not clear, however, if 3 doses of IPV provide sufficient immunogenicity when administered according to World Health Organization (WHO)/Expanded Programme on Immunization (EPI) schedule in a tropical, developing area where no wild-poliovirus circulates.

Puerto Rico will be the study site for this randomized clinical trial. Healthy infants will be identified at birth in a hospital-system, enrolled within 4 weeks of birth, and randomized into one of two arms: United States of America (U.S.A.) schedule (8, 16, 24 weeks/2, 4, 6 months) or WHO schedule (6, 10, 14 weeks). Both groups will receive IPV at visits 1, 2 and 3. Infants will receive all age-appropriate EPI childhood vaccinations along with IPV, to decrease confusion and inconvenience to the parent. Serum will be collected twice, at visit 1 and visit 4 (30-45 days after IPV-3), to measure antibody titers. Sera will be measured for neutralizing antibodies at the Centers for Disease Control (CDC). Based on the lowest seroconversion rate estimate of 85%, and to have a probability of .80 that the estimate from this study is in error by no more than 10%, the investigators will need to enroll 220 infants in each arm. To compensate for attrition and retain statistical power, the investigators plan to enroll up to 250 infants in each arm. This study is expected to require at least 20 months to complete. Results will provide valuable and timely information applicable to global polio eradication efforts. Any participant found not to be protected after 3 doses of IPV will be given a booster at 9-12 months. Results will provide valuable and timely information applicable to global polio eradication efforts.


Condition Intervention
Poliomyelitis
Biological: Vaccination with inactivated polio vaccine
Procedure: Collection of serum

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Immunogenicity of Inactivated Polio Vaccine in Puerto Rico; A Comparative Cohort Study of Two Vaccination Schedules

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Serum will be collected twice, at visit 1 and visit 4 (30-45 days after IPV-3), to measure antibody titers.

Secondary Outcome Measures:
  • Reports on adverse events will be obtained after each vaccination.

Estimated Enrollment: 500
Study Start Date: September 2002
Estimated Study Completion Date: March 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants under 48 hours of age born at San Lucas Hospital during study enrollment period
  • Infants with gestational age of > 37 weeks as assessed by neonatologist
  • Mother/guardian gives informed consent
  • Infant is expected to reside in Puerto Rico for the following 8 months

Exclusion Criteria:

  • Mother/guardian does not speak English or Spanish
  • Mother/guardian has religious/philosophical objection to immunizations
  • Infant has serious chronic or acute health problems that require hospitalization immediately (within 1 day) after birth (assessed by infant not being placed in San Lucas Hospital well-baby clinic)
  • Mother expects to travel with infant during study period to a country known to have circulating poliovirus or that uses oral poliovirus vaccine (OPV)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137696

Locations
Puerto Rico
Ponce School of Medicine
Ponce, Puerto Rico
Sponsors and Collaborators
Ponce School of Medicine
Investigators
Principal Investigator: Gustavo H Dayan, MD Centers for Disease Control and Prevention
Study Chair: Margaret Thorley, MPH Centers for Disease Control and Prevention
Study Chair: Steve McLaughlin, DV Centers for Disease Control and Prevention
Study Chair: Mark Pallansch Centers for Disease Control and Prevention
Study Director: Yasuhiro Yamamura, PhD Ponce School of Medicine
Study Chair: Nayra Rodriguez Ponce School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00137696     History of Changes
Other Study ID Numbers: CDC-NIP-3436, 020918-YY
Study First Received: August 27, 2005
Last Updated: December 12, 2005
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
polio
vaccine
immunogenicity

Additional relevant MeSH terms:
Poliomyelitis
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on October 19, 2014