A Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2

NCT05677256 | Completed Phase 4

• 1 other identifier: IPV-005-ABMG
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The study will compare the poliovirus type-2 pharyngeal mucosal excretion in the first week, and at 2 and 4 weeks following the administration of a challenge novel OPV2 (nOPV2) dose at 18 weeks of age in 2 parallel groups of infants

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (1)

• Poliovirus type-2 viral shedding

  To compare the presence of poliovirus type-2 in pharyngeal samples detected by reverse-transcription polymerase chain reaction (RT PCR) in the first week, and at D14 and D28 in both groups.

  1 month

Secondary Outcomes (3)

• Pharyngeal neutralizing antibodies (NAbs) and IgA response to poliovirus type-2.

  1 month

• Seroconversion rate of poliovirus type-2 neutralizing antibodies (NAbs)

  2 months

• Incidence of Serious Adverse Events (SAEs) and Important Medical Events (IMEs)

  5 months

Study Arms (2)

IPV-primed Group

EXPERIMENTAL

Approximately 250 subjects to receive 3 doses of IPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.

Biological: nOPV2

bOPV-primed Group

ACTIVE COMPARATOR

Approximately 250 subjects to receive 3 doses of bOPV administered at approx. 6, 10, 14 weeks of age and an nOPV2-002 challenge at approx. 18 weeks of age.

Biological: nOPV2

Interventions

nOPV2 BIOLOGICAL

Vaccination

IPV-primed Group; bOPV-primed Group

Eligibility Criteria

• Age: 5 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged 6 to 8 weeks with birth weight \>2,500 g.
• Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject from participating in the study as established by the medical history and physical examination.
• Written informed consent obtained from both parents or legal guardian(s) as per country regulations.

You may not qualify if:

• Infants who have received previous vaccination against poliomyelitis.
• Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household.
• Family history of congenital or hereditary immunodeficiency.
• Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
• Known allergy to any component of the study vaccines or to any antibiotics that share molecular composition with a component of the study vaccines.
• Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections (of IPV)
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
• Infants from multiple births or born prematurely (\< 37 weeks of gestation).

Sponsors & Collaborators

• Fidec Corporation: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

International Centre for Diarrhoeal Diseases Research

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Conditions

Poliomyelitis

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: January 10, 2023
• Study Start: November 9, 2023
• Primary Completion: February 20, 2024
• Study Completion: August 25, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)