A Study to Evaluate Pharyngeal Immunity to Poliovirus Type-2

NCT ID: NCT05677256

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-09
• Study Completion Date: 2024-08-25

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

Detailed Description

In the light of the switch from OPV to IPV and the continued presence of cVDPV2 in many countries, it is important to understand and quantify the impact of IPV on pharyngeal mucosal immunity, to inform whether and to what extent the mucosal and humoral immune response following IPV could reduce transmission and spread.

This study will assess the effect of vaccination with IPV in parallel with poliovirus type-2 naïve infants (infants having received bOPV) on the pharyngeal and fecal shedding and the induction of immunity following type-2 poliovirus challenge. This understanding would provide critical information on the potential use of IPV in specific settings to interrupt transmission / reduce spread. The results from this study may potentially have important consequences on public health policy in countries which use IPV for infant priming, as they will help to show the extent to which a type-2 mucosal immunity gap remains following a primary series of IPV.

Conditions

Poliomyelitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

IPV-primed Group

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.

Group Type: EXPERIMENTAL

nOPV2

Intervention Type: BIOLOGICAL

Vaccination

bOPV-primed Group

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.

Group Type: ACTIVE_COMPARATOR

nOPV2

Intervention Type: BIOLOGICAL

Vaccination

Interventions

nOPV2

Vaccination

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Infants aged 6 to 8 weeks with birth weight >2,500 g.

2. 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.

3. Written informed consent obtained from both parents or legal guardian(s) as per country regulations.

9. 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.

10. Infants from multiple births or born prematurely (< 37 weeks of gestation).

Exclusion Criteria

1. Infants who have received previous vaccination against poliomyelitis.

2. 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.

3. Family history of congenital or hereditary immunodeficiency.

4. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).

5. Known allergy to any component of the study vaccines or to any antibiotics that share molecular composition with a component of the study vaccines.

6. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections (of IPV)

7. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

• Minimum Eligible Age: 5 Weeks
• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

Fidec Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

International Centre for Diarrhoeal Diseases Research

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

IPV-005-ABMG

Identifier Type: -

Identifier Source: org_study_id