Clinical Trial: Comparison of Immune Response Using 2 Vaccination Schedules Using Inactivated Polio Vaccine
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Immunogenicity of Inactivated Polio Vaccine in Puerto Rico; A Comparative Cohort Study of Two Vaccination Schedules
Brief Summary:
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
Detailed Summary:
The proposed study will be a prospective, randomized clinical trial of the immunogenicity of IPV among two groups of infants using different immunization schedules (WHO/EPI and US).
Study will begin with an enrollment period up to 10 months. All infants born at San Lucas Hospital will be eligible unless otherwise excluded. The study will continue until 10 months after the last infant is enrolled. There will be four or five study visits, depending on the cohort.
Study Population:
Infants will be identified at birth at San Lucas Hospital; all babies born during the enrollment period at the selected hospital will be considered eligible. Mothers will be approached in the hospital by the study -nurse after infant’s birth and be informed about the study. Inclusion and exclusion criteria will be assessed at this time and if the mother agrees to the study, informed consent will be obtained.
Randomization will be based on what day the baby was born. Even days will be assigned to the WHO schedule and odd days to the US schedule. The mother will be told which cohort the infant is in and given an immunization card with dates that the infant is to return to receive vaccinations. The card will also include study contact phone numbers.
The study will be implemented through the Ponce School of Medicine at San Lucas Hospital in Ponce Puerto Rico. This teaching hospital has a 24 bed well-baby nursery where approximately 150 babies are born per month.
Interventions:
To avoid confusion, inconvenience and error, and to limit differences among participants, DTaP, Hib, PCV, and HepB (if appropr
Sponsor: Centers for Disease Control and Prevention
Current Primary Outcome: Serum will be collected twice, at visit 1 and visit 4 (30-45 days after IPV-3), to measure antibody titers.
Original Primary Outcome: Same as current
Current Secondary Outcome: Reports on adverse events will be obtained after each vaccination.
Original Secondary Outcome: Reports on adverse events will be obtained after each vaccination
Information By: Centers for Disease Control and Prevention
Dates:
Date Received: August 27, 2005
Date Started: September 2002
Date Completion: March 2005
Last Updated: December 12, 2005
Last Verified: August 2005
