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

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 global polio eradication efforts.

Conditions

• Poliomyelitis

Interventions

BIOLOGICAL

Vaccination with inactivated polio vaccine

PROCEDURE

Collection of serum

Sponsors & Collaborators

• San Lucas Hospital, Ponce, Puerto Rico

  collaborator UNKNOWN

• Centers for Disease Control and Prevention

  lead FED

Principal Investigators

• Gustavo H Dayan, MD · Centers for Disease Control and Prevention

• Margaret Thorley, MPH · Centers for Disease Control and Prevention

• Steve McLaughlin, DV · Centers for Disease Control and Prevention

• Mark Pallansch · Centers for Disease Control and Prevention

• Yasuhiro Yamamura, PhD · Ponce School of Medicine

• Nayra Rodriguez · Ponce School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Hour

Max Age

48 Hours

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2003-07-31

Primary Completion

2004-07-31

Completion

2004-07-31

Countries

• Puerto Rico

Study Locations