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)
Sponsored by
About this trial
This is an interventional other trial for Poliomyelitis focused on measuring oral poliovirus vaccine, immunization, antibodies, poliovirus vaccines
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).
Sites / Locations
- Icddr,B Study Clinics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
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
No
Studies a U.S. FDA-regulated Device Product
No
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
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.
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
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
No
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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