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

NCT00137696 | Completed

• 2 other identifiers: CDC-NIP-3436020918-YY
• Study Type: interventional
• Target: 473
• Locations: 1 country
• Sites: 1

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 global polio eradication efforts.

Conditions

Poliomyelitis

Keywords

polio; vaccine; immunogenicity

Outcome Measures

Primary Outcomes (1)

• Serum collection and antibody titers

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

  30-45 days after vaccination

Secondary Outcomes (1)

• Adverse Events

  7 days after vaccination

Study Arms (2)

Cohort A-WHO/EPI Schedule

EXPERIMENTAL

Received IPV at ages 6, 10, and 14 weeks (this schedule is also approved for use in the United States if an accelerated schedule is needed.

Biological: Vaccination with inactivated polio vaccine; Procedure: Collection of serum

Cohort A-US Schedule

ACTIVE COMPARATOR

Received IPV at ages 8, 16, and 24 weeks.

Biological: Vaccination with inactivated polio vaccine; Procedure: Collection of serum

Interventions

Vaccination with inactivated polio vaccine BIOLOGICAL

Cohort A-US Schedule; Cohort A-WHO/EPI Schedule

Collection of serum PROCEDURE

Cohort A-US Schedule; Cohort A-WHO/EPI Schedule

Eligibility Criteria

• Age: 1 Hour - 48 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• San Lucas Hospital, Ponce, Puerto Rico: collaborator

Study Sites (1)

Ponce School of Medicine

Ponce, Puerto Rico

Location

Related Publications (1)

• Dayan GH, Thorley M, Yamamura Y, Rodriguez N, McLaughlin S, Torres LM, Seda A, Carbia M, Alexander LN, Caceres V, Pallansch MA. Serologic response to inactivated poliovirus vaccine: a randomized clinical trial comparing 2 vaccination schedules in Puerto Rico. J Infect Dis. 2007 Jan 1;195(1):12-20. doi: 10.1086/508427. Epub 2006 Nov 28.

  PMID: 17152004 RESULT

MeSH Terms

Conditions

Poliomyelitis

Interventions

Vaccination; Poliovirus Vaccine, Inactivated

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health; Vaccines, Inactivated; Vaccines; Biological Products; Complex Mixtures; Poliovirus Vaccines; Viral Vaccines

Study Officials

• Gustavo H Dayan, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• Yasuhiro Yamamura, PhD

  Ponce School of Medicine

  STUDY DIRECTOR

• Nayra Rodriguez

  Ponce School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2005
• First Posted: August 30, 2005
• Study Start: July 1, 2003
• Primary Completion: July 1, 2004
• Study Completion: July 1, 2004
• Last Updated: May 31, 2024

Record last verified: 2024-05

Locations

PR (1)