Assessment of Poliovirus Type 2 Immunogenicity of One and Two Dose Schedule With IPV and fIPV When Administered at 9-13 Months of Age in Bangladesh

Assessment of Poliovirus Type 2 Immunogenicity of One and Two Dose Schedule With IPV and fIPV

Following a recommendation on October 2017 meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization; low- risk bOPV-using countries may adopt 2 dose fIPV schedule prior to global OPV cessation as it provides better seroconversion than 1 full dose IPV and in the post-cessation era, the 2 fIPV doses will provide sufficient (above 90%) seroconversion. Countries, which delayed the introduction of IPV or had a vaccine stock-out, should provide 1 full dose or 2 fIPV doses to all children who were missed as soon as supply becomes available. The IPV supply situation is expected to improve in 2018; all countries are expected to have access to IPV for their routine immunization programmes from the end of the first quarter of 2018.

While immunogenicity after one and two doses of IPV and fIPV has been estimated when administered to younger children ; the immunogenicity of IPV (or fIPV) when administered at 9 months of age or later is not known. We propose to conduct a study to assess the immunogenicity of one and two doses of fIPV and IPV when administered between 9-13 months of age.

Study Overview

• Status: Recruiting
• Conditions: Poliomyelitis
• Intervention / Treatment: Biological: IPV

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Asma Aziz, MBBS, MPH; Phone Number: 3812 +8801719326323; Email: asma.aziz@icddrb.org

Study Locations

• Bangladesh
  • Chandpur, Bangladesh
    • Recruiting
    • Matlab Health Research Centre
    • Contact: Asma Aziz, MBBS, MPH; Phone Number: 3812 +8801719326323; Email: asma.aziz@icddrb.org
  • Dhaka, Bangladesh
    • Recruiting
    • Mirpur Study clinic
    • Contact: Asma Aziz, MBBS,MPH; Phone Number: 3812 +8801719326323; Email: asma.aziz@icddrb.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 1 year (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Apparently healthy children with no obvious clinical symptom of illness
2. Parents/legal guardians of participants willing to give written informed consent and willing to comply with study protocol.
3. Free of obvious health problems (congenital abnormalities, severe malnutrition, acute or chronic diarrhea, bleeding disorder etc) as established by medical history and screening evaluation including clinical examination.
4. Resident of study area.

Exclusion Criteria:

1. Participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination or planned participation in another clinical trial during the present trial period.
2. A diagnosis or suspicion of congenital or acquired immunodeficiency disorder, malignancy,
3. A diagnosis or suspicion of bleeding disorder
4. Acute or persistent diarrhoea
5. History of allergy or systemic hypersensitivity to any of the vaccine components
6. Chronic illness at a stage that could interfere with trial conduct or completion.
7. Presence of significant malnutrition
8. History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode.

09. Febrile illness or acute illness on the day of inclusion

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Full dose of IPV; IPV first dose between 9 -13 months with second dose administered 2 months later.	Biological: IPV; The inactivated poliovirus vaccine (IPV) developed by Salk was the first available polio vaccine licensed in 1955 in the United States. The current formulation of IPV got licensed in 1987 and has a higher potency than the original Salk IPV. Almost 100% of children two months of age or older who receive 2-3 doses of intramuscular (IM) IPV achieve high antibody levels against the all three serotypes. IPV (.5mL) can be administered subcutaneously (SC) or IM and fractional (0.1 ml) doses of IPV are generally administered intradermally; Other Names: fIPV
ACTIVE_COMPARATOR: Fractional Dose of IPV; fIPV first dose between 9 -13 months with second dose administered 2 months later	Biological: IPV; The inactivated poliovirus vaccine (IPV) developed by Salk was the first available polio vaccine licensed in 1955 in the United States. The current formulation of IPV got licensed in 1987 and has a higher potency than the original Salk IPV. Almost 100% of children two months of age or older who receive 2-3 doses of intramuscular (IM) IPV achieve high antibody levels against the all three serotypes. IPV (.5mL) can be administered subcutaneously (SC) or IM and fractional (0.1 ml) doses of IPV are generally administered intradermally; Other Names: fIPV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Seroconversion to PV2 two months after the first fIPV or IPV dose	2 months

Collaborators and Investigators

• Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
• Collaborators: World Health Organization

Publications and helpful links

General Publications

• Aziz AB, Verma H, Jeyaseelan V, Yunus M, Nowrin S, Moore DD, Mainou BA, Mach O, Sutter RW, Zaman K. One Full or Two Fractional Doses of Inactivated Poliovirus Vaccine for Catch-up Vaccination in Older Infants: A Randomized Clinical Trial in Bangladesh. J Infect Dis. 2022 Oct 17;226(8):1319-1326. doi: 10.1093/infdis/jiac205.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 27, 2018
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: March 19, 2019
• First Submitted That Met QC Criteria: March 24, 2019
• First Posted (ACTUAL): March 26, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Neuromuscular Diseases; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Myelitis; Poliomyelitis
• Other Study ID Numbers: PR-18016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No