A Phase 2 interventional study of Novel monovalent oral poliovirus vaccine type 2 (nOPV2) and Bivalent oral poliovirus vaccine (bOPV) in Poliomyelitis, sponsored by Centers for Disease Control and Prevention. Completed at 1 site in Bangladesh. Open to participants aged 42 Days to 48 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-04.
Sponsored by Centers for Disease Control and Prevention · Phase 2, Interventional, and Other
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.
274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.
This study's enrollment of 795 is above the median of 476 across 249 interventional studies indexed under Poliomyelitis.
Browse Poliomyelitis studies →Centers for Disease Control and Prevention is the lead sponsor of 275 studies on the registry; 2 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
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Exclusion Criteria:
Participants in this arm will receive nOPV2 at 6, 10, and 14 weeks of age
Biological: Novel monovalent oral poliovirus vaccine type 2 (nOPV2)
Participants in this arm will receive both nOPV2 and bOPV at 6, 10, and 14 weeks of age
Biological: Novel monovalent oral poliovirus vaccine type 2 (nOPV2) · Biological: Bivalent oral poliovirus vaccine (bOPV)
Participants in this arm will receive bOPV at 6, 10, and 14 weeks of age
Biological: Bivalent oral poliovirus vaccine (bOPV)
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.
The live types 1 \& 3 oral polio vaccine (bOPV) is a bivalent vaccine containing suspension of types 1 \& 3 attenuated Polio viruses (Sabin strains).
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.
Time frame: Measured four weeks after administration of study vaccine(s).
Reciprocal antibody titers
Variable of the observed reciprocal antibody titer results.
Time frame: Measured four weeks after administration of study vaccine(s).
Household transmission of nOPV2
Detection of type 2 OPV in stool of household contact
Time frame: 1, 2, and 4 weeks after first vaccination with nOPV2
Viral recombinants
Detection and characterization of viral recombinants
Time frame: 2 and 4 weeks after first vaccination with study vaccine(s)
Plan to share: No — 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.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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