A Phase 4 interventional study of polio vaccines: nOPV2, bOPV, IPV in Polio, sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. Not yet recruiting. Open to participants aged 42 Days to 48 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh · Phase 4, Interventional, and Prevention
The goal of this clinical trial is to explore two strategies to enhance nOPV2 immunogenicity in the field and overcome potential interference of bOPV:
Participants at 6 weeks of age will be enrolled and randomized to one of four arms receiving the different polio vaccines; nOPV2, bOPV and IPV, in different combination schedule. The target enrolment is 220 infants per arm for a total of 880. Blood will be collected from all participants to measure Poliovirus antibody titers to types 1, 2 and 3.
The study will assess whether adding IPV at the end of a 3-dose series of co-administered nOPV2+bOPV achieves at least a 95% seroconversion to all serotypes and whether adding IPV following two doses of co-administered nOPV2+bOPV achieves at least a 90% seroconversion to all poliovirus types.
Study findings will inform vaccination strategies in areas with co-circulation of poliovirus types and provide information about immunogenicity of potential routine immunization schedule with nOPV2 and bOPV in countries with persistent transmission or emergences of cVDPV2.
This is an open-label, controlled, inequality, four arm randomized clinical trial, will be conducted in two study sites in Dhaka, Bangladesh. Participants will be enrolled at 6 weeks of age following inclusion and exclusion criteria's, randomly assigned to one of the four study arms and followed to 18 weeks of age. Three polio vaccines will be used in the study: bOPV, nOPV2 and IPV in different sequential or combination schedules.
Entry evaluations will be completed at 6 weeks of age. Blood collection and study vaccine administration are planned during the study entry evaluation. Post-entry evaluations and follow-up will be done at 10 weeks, 14 weeks and 18 weeks of age. Blood will be collected before any study or EPI vaccines are administered. Presence of poliovirus neutralizing antibodies to all three poliovirus types will be assessed using a microneutralization assay.
International Centre for Diarrhoeal Disease Research, Bangladesh is the lead sponsor of 197 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in arm A will receive the following polio vaccines: nOPV2 +bOPV (2 drops = 0.1 ml) @ 6, 10, 14 weeks and IPV (0.5 mL) @ 14 weeks
Biological: polio vaccines: nOPV2, bOPV, IPV
Participants in arm B will receive the following polio vaccines: nOPV2+bOPV , (2 drops = 0.1 ml) @ 6, 10 weeks and IPV (0.5 mL) @ 14 weeks
Biological: polio vaccines: nOPV2, bOPV, IPV
Participants in arm C will receive the following polio vaccines: bOPV ( 2 drops) @ 6 week , nOPV2 (2 drops) at 10 weeks and IPV ( 0.5mL) @ 14 weeks
Biological: polio vaccines: nOPV2, bOPV, IPV
Participants in arm D will receive the following polio vaccines: nOPV2 (2 drops = 0.1 ml) at 6 and 10 weeks and IPV ( 0.5mL) @ 14 weeks
Biological: polio vaccines: nOPV2, bOPV, IPV
Co-administration of nOPV2 with bOPV along with IPV with different sequential or combination schedules.
Cumulative seroconversion to all serotypes at the end of a vaccination series including two or three doses of co-administered nOPV2 and bOPV plus one dose of IPV.
Poliovirus antibody titers to types 1, 2 and 3 will be measured in sera extracted from blood collected at 6, 10, 14, and 18 weeks of age
Time frame: Serology: 6 &18 weeks
Seroconversion for type 2 after one dose of nOPV2 alone, co-administered with bOPV, or administered 4-weeks after bOPV;
Compare type 2 seroconversion after one dose of nOPV2 administered alone or 4 weeks after bOPV
Time frame: Serology: 6 & 14 weeks for C, 6 & 10 weeks for D,
Cumulative seroconversion for type 2 after two doses of nOPV2 administered alone or co-administered with bOPV;
Compare seroconversion to all three serotypes after one dose of nOPV2 administered 4 weeks after bOPV or concomitantly with bOPV
Time frame: Serology: 6 & 14 weeks for C, 6 & 10 weeks for A
Cumulative seroconversion to all serotypes after 1 dose each of bOPV, nOPV2 and IPV administered sequentially one month apart.
Determine seroconversion to all serotypes reached with one dose of nOPV2, bOPV and IPV each administered sequentially at 4-week intervals (6, 10 and 14 weeks).
Time frame: Serology: 6 & 18 weeks
Antibody titers for all 3 serotypes reached at the end of each vaccination schedule
Determine seroconversion to all serotypes
Time frame: Serology: 6 & 18 weeks
No study locations are listed for this record.
Plan to share: Yes — Study data will be jointly owned by icddr,b and CDC. After completion of study activities, summary tables of study results will be available on www.clinicaltrials.gov. After study registration, clinicaltrials.gov provides unrestricted public access on study details including summary tables. Study investigators will have access to all participants' data without identifiers, including laboratory data. Co-investigators and technical advisors will have access to relevant data as defined in protocol
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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International Centre for Diarrhoeal Disease Research, Bangladesh