Immunogenicity of Novel Oral Poliovirus Vaccine Type 2 (nOPV2), bOPV and IPV

NCT06114810 | Unknown Phase 4 DMC

• 1 other identifier: PR-23036
• Study Type: interventional
• Target: 880
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to explore two strategies to enhance nOPV2 immunogenicity in the field and overcome potential interference of bOPV:

1. 1.Addition of IPV after one or several doses of nOPV2 and bOPV to close remaining immunity gaps;
2. 2.Separation of bOPV and nOPV2 with an interval of 4 weeks.

Conditions

Polio

Keywords

nOPV2 bOPV IPV immunogenicity

Outcome Measures

Primary Outcomes (1)

• Cumulative seroconversion to all serotypes at the end of a vaccination series including two or three doses of co-administered nOPV2 and bOPV plus one dose of IPV.

  Poliovirus antibody titers to types 1, 2 and 3 will be measured in sera extracted from blood collected at 6, 10, 14, and 18 weeks of age

  Serology: 6 &18 weeks

Secondary Outcomes (4)

• Seroconversion for type 2 after one dose of nOPV2 alone, co-administered with bOPV, or administered 4-weeks after bOPV;

  Serology: 6 & 14 weeks for C, 6 & 10 weeks for D,

• Cumulative seroconversion for type 2 after two doses of nOPV2 administered alone or co-administered with bOPV;

  Serology: 6 & 14 weeks for C, 6 & 10 weeks for A

• Cumulative seroconversion to all serotypes after 1 dose each of bOPV, nOPV2 and IPV administered sequentially one month apart.

  Serology: 6 & 18 weeks

• Antibody titers for all 3 serotypes reached at the end of each vaccination schedule

  Serology: 6 & 18 weeks

Study Arms (4)

Arm A : 3 doses of nOPV2 and bOPV with IPV

ACTIVE COMPARATOR

Participants in arm A will receive the following polio vaccines: nOPV2 +bOPV (2 drops = 0.1 ml) @ 6, 10, 14 weeks and IPV (0.5 mL) @ 14 weeks

Biological: polio vaccines: nOPV2, bOPV, IPV

Arm B : 2 doses of nOPV2 and bOPV with IPV

ACTIVE COMPARATOR

Participants in arm B will receive the following polio vaccines: nOPV2+bOPV , (2 drops = 0.1 ml) @ 6, 10 weeks and IPV (0.5 mL) @ 14 weeks

Biological: polio vaccines: nOPV2, bOPV, IPV

Arm C: Single dose of bOPV, nOPV2, IPV

ACTIVE COMPARATOR

Participants in arm C will receive the following polio vaccines: bOPV ( 2 drops) @ 6 week , nOPV2 (2 drops) at 10 weeks and IPV ( 0.5mL) @ 14 weeks

Biological: polio vaccines: nOPV2, bOPV, IPV

Arm D: Single dose nOPV2, IPV

ACTIVE COMPARATOR

Participants in arm D will receive the following polio vaccines: nOPV2 (2 drops = 0.1 ml) at 6 and 10 weeks and IPV ( 0.5mL) @ 14 weeks

Biological: polio vaccines: nOPV2, bOPV, IPV

Interventions

polio vaccines: nOPV2, bOPV, IPV BIOLOGICAL

Co-administration of nOPV2 with bOPV along with IPV with different sequential or combination schedules.

Arm A : 3 doses of nOPV2 and bOPV with IPV; Arm B : 2 doses of nOPV2 and bOPV with IPV; Arm C: Single dose of bOPV, nOPV2, IPV; Arm D: Single dose nOPV2, IPV

Eligibility Criteria

• Age: 42 Days - 48 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants 6 weeks of age
• Parents that consent for participation in the full length of the study.
• Parents that can understand and comply with planned study procedures.

You may not qualify if:

• Parents and infants are unable to participate in the full length of the study
• A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
• A diagnosis or suspicion of bleeding disorder
• Acute diarrhoea, infection, or illness at the time of enrolment
• Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit
• Evidence of a chronic medical condition
• Receipt of any polio vaccine (OPV or IPV) before enrolment
• Known allergy/sensitivity or reaction to polio vaccine, or its contents.
• Infants from multiple births.
• Infants from premature births (\<37 weeks of gestation).

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Centers for Disease Control and Prevention: collaborator
• Government of Bangladesh: collaborator

MeSH Terms

Conditions

Poliomyelitis

Interventions

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)

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

Study Officials

• Dr. K Zaman, PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. K Zaman, PhD

CONTACT

+880 (0)2-2222-77001; kzaman@icddrb.org

Concepcion F. Estivariz,, MD

CONTACT

(470) 312-5677; cge3@cdc.gov

Study Design

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

Model Details: This is an open-label, controlled, inequality, 4 arm randomized clinical trial assessing immunogenicity of several poliovirus vaccines and doses

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: November 2, 2023
• Study Start: November 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After study registration, clinicaltrials.gov. provides unrestricted public access on study details including summary tables. After completion of study activities, summary tables of study results will be available on www.clinicaltrials.gov. Study investigators will have access to all participants' data without identifiers, including laboratory data.
• Access Criteria: Log in www.clinicaltrials.gov