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| Name | Class |
|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nOPV2 only | Active Comparator | Participants in this arm will receive nOPV2 at 6, 10, and 14 weeks of age |
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| nOPV2 and bOPV | Active Comparator | Participants in this arm will receive both nOPV2 and bOPV at 6, 10, and 14 weeks of age |
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| bOPV only | Active Comparator | Participants in this arm will receive bOPV at 6, 10, and 14 weeks of age |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Reciprocal antibody titers | Variable of the observed reciprocal antibody titer results. | Measured four weeks after administration of study vaccine(s). |
| Household transmission of nOPV2 | Detection of type 2 OPV in stool of household contact |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda Wilkinson, PhD | Centers for Disease Control and Prevention | Principal Investigator |
| Khalequ Zaman, MBBS, PhD | International Centre for Diarrhoeal Disease Research, Bangladesh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icddr,B Study Clinics | Dhaka | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37178706 | Derived | 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. |
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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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 3, 2020 | Apr 21, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| 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). |
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| 1, 2, and 4 weeks after first vaccination with nOPV2 |
| Viral recombinants | Detection and characterization of viral recombinants | 2 and 4 weeks after first vaccination with study vaccine(s) |
| D010850 |
| Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |