NCT04579510

Immunogenicity nOPV2 With and Without bOPV

Immunogenicity of Novel Monovalent Oral Poliovirus Vaccine Type 2 (nOPV2) With and Without Bivalent OPV

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 795 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 42 Days – 48 Days
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-02-08
• Primary completion: 2021-12-23
• Completion: 2021-12-23
• First posted: 2020-10-08
• Last updated: 2024-10-04

Locations

1 site across 1 country: Bangladesh