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Immunogenicity nOPV2 With and Without bOPV

Primary Purpose

Poliomyelitis

Status

Completed

Phase

Phase 2

Locations

Bangladesh

Study Type

Interventional

Intervention

Novel monovalent oral poliovirus vaccine type 2 (nOPV2)

Bivalent oral poliovirus vaccine (bOPV)

About this trial

This is an interventional other trial for Poliomyelitis focused on measuring oral poliovirus vaccine, immunization, antibodies, poliovirus vaccines

Eligibility Criteria

42 Days - 48 Days (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Icddr,B Study Clinics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

nOPV2 only

nOPV2 and bOPV

bOPV only

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Reciprocal antibody titers

Variable of the observed reciprocal antibody titer results.

Household transmission of nOPV2

Detection of type 2 OPV in stool of household contact

Viral recombinants

Detection and characterization of viral recombinants

Full Information

NCT ID

NCT04579510

First Posted

September 22, 2020

Last Updated

May 2, 2023

Sponsor

Centers for Disease Control and Prevention

Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh

1. Study Identification

Unique Protocol Identification Number

NCT04579510

Brief Title

Immunogenicity nOPV2 With and Without bOPV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

February 8, 2021 (Actual)

Primary Completion Date

December 23, 2021 (Actual)

Study Completion Date

December 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centers for Disease Control and Prevention

Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Poliomyelitis

Keywords

oral poliovirus vaccine, immunization, antibodies, poliovirus vaccines

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

795 (Actual)

8. Arms, Groups, and Interventions

Arm Title

nOPV2 only

Arm Type

Active Comparator

Arm Description

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

Arm Title

nOPV2 and bOPV

Arm Type

Active Comparator

Arm Description

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

Arm Title

bOPV only

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Novel monovalent oral poliovirus vaccine type 2 (nOPV2)

Intervention Description

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

Intervention Name(s)

Bivalent oral poliovirus vaccine (bOPV)

Intervention Description

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

Primary Outcome Measure Information:

Title

Vaccine response

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Reciprocal antibody titers

Description

Variable of the observed reciprocal antibody titer results.

Time Frame

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

Title

Household transmission of nOPV2

Description

Detection of type 2 OPV in stool of household contact

Time Frame

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

Title

Viral recombinants

Description

Detection and characterization of viral recombinants

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

42 Days

Maximum Age & Unit of Time

48 Days

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amanda Wilkinson, PhD

Organizational Affiliation

Centers for Disease Control and Prevention

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Khalequ Zaman, MBBS, PhD

Organizational Affiliation

International Centre for Diarrhoeal Disease Research, Bangladesh

Official's Role

Principal Investigator

Facility Information:

Facility Name

Icddr,B Study Clinics

City

Dhaka

Country

Bangladesh

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Aggregated data will be added to the registration with publication. In accordance with the protocol, icddr,b investigators will have access to participant data with identifiers. External investigators will have access to deidentified participant data. Deidentified data may be shared with national and international vaccine manufacturers and regulatory authorities upon request.

Learn more about this trial

Immunogenicity nOPV2 With and Without bOPV

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