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Immunogenicity nOPV2 With and Without bOPV

NCT04579510 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 795

Last updated 2024-10-04

No results posted yet for this study

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

Interventions

BIOLOGICAL

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.

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).

Sponsors & Collaborators

Principal Investigators

  • Amanda Wilkinson, PhD · Centers for Disease Control and Prevention

  • Khalequ Zaman, MBBS, PhD · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
48 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-08
Primary Completion
2021-12-23
Completion
2021-12-23

Countries

  • Bangladesh

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04579510 on ClinicalTrials.gov