Immunogenicity nOPV2 With and Without bOPV

NCT04579510 | Completed Phase 2 DMC

• 1 other identifier: 20060
• Study Type: interventional
• Target: 795
• Locations: 1 country
• Sites: 1

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.

Conditions

Poliomyelitis

Keywords

oral poliovirus vaccine; immunization; antibodies; poliovirus vaccines

Outcome Measures

Primary Outcomes (1)

• Vaccine response

  Dichotomous (yes/no) variable defined as participants who are either seronegative (\<1:8 titers) at baseline who become seropositive (≥1:8) after vaccination (seroconversion) or participants who demonstrate a four-fold rise in titers after vaccination between two specimens, e.g. a change from 1:8 to 1:32, after adjusting for expected decay in maternal antibodies. Antibody titers at 6 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days.

  Measured four weeks after administration of study vaccine(s).

Secondary Outcomes (3)

• Reciprocal antibody titers

  Measured four weeks after administration of study vaccine(s).

• Household transmission of nOPV2

  1, 2, and 4 weeks after first vaccination with nOPV2

• Viral recombinants

  2 and 4 weeks after first vaccination with study vaccine(s)

Study Arms (3)

nOPV2 only

ACTIVE COMPARATOR

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

Biological: Novel monovalent oral poliovirus vaccine type 2 (nOPV2)

nOPV2 and bOPV

ACTIVE COMPARATOR

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

Biological: Novel monovalent oral poliovirus vaccine type 2 (nOPV2); Biological: Bivalent oral poliovirus vaccine (bOPV)

bOPV only

ACTIVE COMPARATOR

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

Biological: Bivalent oral poliovirus vaccine (bOPV)

Interventions

Novel monovalent oral poliovirus vaccine type 2 (nOPV2) 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; nOPV2 only

Bivalent oral poliovirus vaccine (bOPV) 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; nOPV2 and bOPV

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 (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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Icddr,B Study Clinics

Dhaka, Bangladesh

Location

Related Publications (1)

• 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.

  PMID: 37178706 DERIVED

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 Officials

• Amanda Wilkinson, PhD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Khalequ Zaman, MBBS, PhD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 8, 2020
• Study Start: February 8, 2021
• Primary Completion: December 23, 2021
• Study Completion: December 23, 2021
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)