Immunogenicity nOPV2 With and Without bOPV

NCT ID: NCT04579510

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 795 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-08
• Study Completion Date: 2021-12-23

Brief Summary

This is an open-label randomized clinical trial that will compare immune responses among infants who receive either novel monovalent oral poliovirus vaccine type 2 (nOPV2) alone, bivalent oral poliovirus vaccine (bOPV) alone, or co-administered nOPV2 and bOPV.

Detailed Description

It is expected that nOPV2 would replace mOPV2 for responding to type 2 outbreaks. Outbreak response for cVDPV2 also offers the opportunity to close immunity gaps to polioviruses types 1 and 3. Furthermore, GPEI might have to respond to two poliovirus outbreaks in the same geography. For either scenario, it would be important to get data on the immunogenicity of co-administered nOPV2 and bOPV, compared to either vaccine given alone.

This clinical trial assesses and compares the immunogenicity of nOPV2 given with or without bOPV. Healthy infants 6 weeks of age will be enrolled in Dhaka, Bangladesh, and randomized to one of three study arms â " Arm A: nOPV2 only, Arm B: nOPV2 and bOPV, or Arm C: bOPV only. Infants will be followed-up until 18 weeks of age through clinic and household visits. Blood specimens will be collected to test for immunological response. Stool specimens will be collected from infant vaccine recipients and one sibling household contact each to assess viral recombinants and nOPV2 household transmission.

Conditions

Poliomyelitis

Study Design

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

Study Groups

nOPV2 only

Participants in this arm will receive nOPV2 at 6, 10, and 14 weeks of age

Group Type: ACTIVE_COMPARATOR

Novel monovalent oral poliovirus vaccine type 2 (nOPV2)

Intervention Type: BIOLOGICAL

nOPV2 candidate 1 (S2/cre5/S15domV/rec1/hifi3) is a live-attenuated serotype-2 poliovirus that was derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells. To improve genetic stability, nucleotide sequence modifications were made in the major determinant for attenuation in the Sabin 5'-untranslated region. Additionally, two modifications in the polymerase 3D were made to further improve stability of the attenuation, and a key replication element from the 2C coding region was relocated to the 5'-untranslated region to inhibit recombination.

nOPV2 and bOPV

Participants in this arm will receive both nOPV2 and bOPV at 6, 10, and 14 weeks of age

Group Type: ACTIVE_COMPARATOR

Novel monovalent oral poliovirus vaccine type 2 (nOPV2)

Intervention Type: BIOLOGICAL

nOPV2 candidate 1 (S2/cre5/S15domV/rec1/hifi3) is a live-attenuated serotype-2 poliovirus that was derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells. To improve genetic stability, nucleotide sequence modifications were made in the major determinant for attenuation in the Sabin 5'-untranslated region. Additionally, two modifications in the polymerase 3D were made to further improve stability of the attenuation, and a key replication element from the 2C coding region was relocated to the 5'-untranslated region to inhibit recombination.

Bivalent oral poliovirus vaccine (bOPV)

Intervention Type: BIOLOGICAL

The live types 1 \& 3 oral polio vaccine (bOPV) is a bivalent vaccine containing suspension of types 1 \& 3 attenuated Polio viruses (Sabin strains).

bOPV only

Participants in this arm will receive bOPV at 6, 10, and 14 weeks of age

Group Type: ACTIVE_COMPARATOR

Bivalent oral poliovirus vaccine (bOPV)

Intervention Type: BIOLOGICAL

The live types 1 \& 3 oral polio vaccine (bOPV) is a bivalent vaccine containing suspension of types 1 \& 3 attenuated Polio viruses (Sabin strains).

Interventions

Novel monovalent oral poliovirus vaccine type 2 (nOPV2)

nOPV2 candidate 1 (S2/cre5/S15domV/rec1/hifi3) is a live-attenuated serotype-2 poliovirus that was derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells. To improve genetic stability, nucleotide sequence modifications were made in the major determinant for attenuation in the Sabin 5'-untranslated region. Additionally, two modifications in the polymerase 3D were made to further improve stability of the attenuation, and a key replication element from the 2C coding region was relocated to the 5'-untranslated region to inhibit recombination.

Intervention Type: BIOLOGICAL

Bivalent oral poliovirus vaccine (bOPV)

The live types 1 \& 3 oral polio vaccine (bOPV) is a bivalent vaccine containing suspension of types 1 \& 3 attenuated Polio viruses (Sabin strains).

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy infants 6 weeks of age (range: 42-48 days).
• Parents that consent for participation in the full length of the study.
• Parents that can understand and comply with planned study procedures.
• Infant has at least one sibling aged <10 years living in the same household that is eligible for participation in the study.

Exclusion Criteria

• Parents and infants who are unable to participate in the full length of the study (e.g., plan to move away from the study area during the study period).
• A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
• A diagnosis or suspicion of bleeding disorder that would contraindicate administration of bOPV or nOPV2 or collection of blood by venipuncture.
• Acute diarrhoea, infection or illness at the time of enrolment (6 weeks of age) that would require infant's admission to a hospital.
• Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit (6 weeks of age).
• Evidence of a chronic medical condition identified by a study medical officer during physical exam.
• Receipt of any polio vaccine (OPV or IPV) before enrolment based upon documentation or parental recall.
• Known allergy/sensitivity or reaction to polio vaccine, or its contents.
• Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vaccine poliovirus to the enrolled infant. Even if all births from a multiple birth could be enrolled in the study, we will exclude multiple births as discontinuation of one may lead to discontinuation of multiple participants.
• Infants from premature births (<37 weeks of gestation).

• Minimum Eligible Age: 42 Days
• Maximum Eligible Age: 48 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda Wilkinson, PhD

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Khalequ Zaman, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

International Centre for Diarrhoeal Disease Research, Bangladesh

Locations

Icddr,B Study Clinics

Dhaka, , Bangladesh

Countries

Bangladesh

References

Wilkinson AL, Zaman K, Hoque M, Estivariz CF, Burns CC, Konopka-Anstadt JL, Mainou BA, Kovacs SD, An Q, Lickness JS, Yunus M, Snider CJ, Zhang Y, Coffee E, Abid T, Wassilak SGF, Pallansch MA, Oberste MS, Vertefeuille JF, Anand A. Immunogenicity of novel oral poliovirus vaccine type 2 administered concomitantly with bivalent oral poliovirus vaccine: an open-label, non-inferiority, randomised, controlled trial. Lancet Infect Dis. 2023 Sep;23(9):1062-1071. doi: 10.1016/S1473-3099(23)00139-1. Epub 2023 May 10.

Reference Type: DERIVED

PMID: 37178706 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

20060

Identifier Type: -

Identifier Source: org_study_id