Comparison of Immunity Following IPV Versus fIPV: a Community Based Randomized Controlled Trial in Pakistan

NCT03286803 | Unknown Phase 4 DMC

• 1 other identifier: 4624-Ped-ERC-17
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted in four low-income areas of Bin Qasim Town Karachi. This will be a community based randomized control trial of 21 months duration. The trial will include four arms; arm A and B will enroll children age 14-18 weeks and randomize them to either full dose IPV (0.5ml) or fractional IPV (0.1ml). Arms C and D will enroll children at 9 months of age and randomize them to either fractional or full dose IPV. Children aged 14 weeks for arms A and B and 9 months for arms C and D living in the selected communities of Bin qasim Town Karachi who have not received IPV vaccine during routine immunization for arms A and B and who have documentary evidence of receiving IPV vaccine at 14 weeks of age for arms C and D will be eligible for enrollment. The investigators will exclude children who are found acutely ill or those requiring emergent medical care/hospitalization at the time of enrollment. The investigators will use the Demographic Surveillance System (DSS) in the four study areas to identify the households with eligible children. The children of the parents who agree to participate in the study will be screened for eligibility by the trained research associates. After randomization into four different arms, the study trained research vaccinators will administer the IPV or fIPV as per randomization. Children will be observed in the center for 30 minutes after vaccination before leaving for home. Parents/guardians of all the participants will also be requested to immediately report any adverse effect occurring later. This study will be conducted in compliance with this protocol, GCP guidelines and all applicable international and local regulatory requirements. The study has approval by the Ethical Review Committee of the Aga Khan University (AKU), the National Bioethics Committee of Pakistan, and ethical approval at WHO/Headquarters in Geneva. All study procedures will be conducted in AKU's field research sites from where subjects will be recruited. The Clinical Trials Unit (CTU) of AKU will be engaged in providing support for specific study procedures conducted at CTU such as randomization, management of vaccines (storage, dispensing and incineration), and other responsibilities agreed in writing. Adverse events following vaccine administration will be monitored and all serius adverse events will be reported within 24 hours to WHO, DSMB and AKU IRB. All the vaccines used are licensed in Pakistan and in routine use.

Conditions

Poliovirus Vaccine, Inactivated; Poliomyelitis; Immunization; Infection

Outcome Measures

Primary Outcomes (1)

• sero-conversion defined as the change from seronegative to seropositive (from reciprocal titer of <8 to >8)

  The difference in seroconversion at 10 months of age between two full dose IPV versus two fractional dose IPV administered at 14 weeks and 9 months of age.

  14 weeks to 10 months of age and 9 months to 10 months

Secondary Outcomes (1)

• Immune response defined as the combination of both seroconversion and boosting (defined as >4-fold increase in titers)

  14 weeks to 18 weeks, 9 months, 10 months and 21 months

Study Arms (4)

Arm A

EXPERIMENTAL

Inactivated Poliovirus vaccine

Biological: Inactivated Poliovirus vaccine

Arm B

ACTIVE COMPARATOR

fractional dose inactivated poliovirus vaccine

Biological: Inactivated Poliovirus vaccine

Arm C

EXPERIMENTAL

inactivated poliovirus vaccine

Biological: Inactivated Poliovirus vaccine

Arm D

ACTIVE COMPARATOR

fractional dose inactivated poliovirus vaccine

Biological: Inactivated Poliovirus vaccine

Interventions

Inactivated Poliovirus vaccine BIOLOGICAL

we will administer either full dose (0.5ml) or fractional dose (0.1ml) of inactivated poliovirus vaccine

Also known as: fractional dose Inactivated Poliovirus vaccine

Arm A; Arm B; Arm C; Arm D

Eligibility Criteria

• Age: 14 Weeks - 10 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 14 weeks for arms A and B and 9 months for arms C and D living in four peri-urban slums of Bin Qasim Town, Karachi (Rehri Goth, Bhains Colony, Ali Akber Shah, Ibrahim Hydri) who have not received IPV vaccine during routine immunization for arms A and B and who have documentary evidence of receiving IPV vaccine at 14 weeks of age for arms C and D.

You may not qualify if:

• Child found acutely ill at the time of enrolment and requiring emergent medical care/hospitalization
• Parents planning to shift out of the four communities during the study time (at least 18 months for arms A and B, and 1 year for arms C and D)
• Refusal of blood testing
• Already enrolled in any other clinical trial

Sponsors & Collaborators

• Aga Khan University: lead
• World Health Organization: collaborator

Study Sites (1)

Rehri goth, Ibrahim Hyderi, Ali Akbar Shah, and Bhens Colony

Karachi, Sindh, Pakistan

Location

Related Publications (2)

• Saleem AF, Parkar S, Zehra SM, Kazi Z, Pethani A, Zhang Y, Mainou BA, Cavestany RL, Macklin G, Jeyaseelan V, Mach O. Two-Year Duration of Immunity of Inactivated Poliovirus Vaccine: A Follow-up Study in Pakistan in 2020. J Infect Dis. 2024 Jan 12;229(1):39-42. doi: 10.1093/infdis/jiad237.

  PMID: 37368349 DERIVED

• Saleem AF, Mach O, Yousafzai MT, Kazi Z, Baig A, Sajid M, Jeyaseelan V, Sutter RW, Zaidi AKM. One-Year Decline of Poliovirus Antibodies Following Fractional-Dose Inactivated Poliovirus Vaccine. J Infect Dis. 2021 Apr 8;223(7):1214-1221. doi: 10.1093/infdis/jiaa504.

  PMID: 32798224 DERIVED

MeSH Terms

Conditions

Poliomyelitis; Infections

Interventions

Poliovirus Vaccine, Inactivated

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System 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)

Vaccines, Inactivated; Vaccines; Biological Products; Complex Mixtures; Poliovirus Vaccines; Viral Vaccines

Study Officials

• Ali Saleem

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This will be a four arms randomized controlled trial. Arms 1 and 2 will randomize children aged 14 weeks old into either full dose or fractional dose IPV and arms 3 and 4 will randomize children aged 9 months old into either full dose or fractional dose IPV

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 18, 2017
• Study Start: August 1, 2017
• Primary Completion: April 30, 2019
• Study Completion: June 30, 2019
• Last Updated: January 9, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)