Clinical Trial of Novel OPV2 Vaccine
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ClinicalTrials.gov Identifier: NCT04693286 |
Recruitment Status :
Completed
First Posted : January 5, 2021
Last Update Posted : August 30, 2022
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Though OPV is safe and effective, it can mutate and reacquire neurovirulence in rare circumstances. This can result in vaccine-associated paralytic polio and circulating vaccine-derived polioviruses. Use of tOPV had risk of generating VAPP and seeding new type 2 circulating vaccine-derived polioviruses though wild type 2 virus was eradicated in September 2015. For this reason tOPV vaccine was withdrawn globally in April 2016 and switched to bOPV. cVDPV2 outbreaks have occurred in sixteen countries after cassation of OPV2. Using stockpiled mOPV2 to respond to this situation risks propagating new cVDPVs. IPV induces only limited intestinal mucosal immunity not effective to interrupt fecal-oral route transmission in settings of poor hygiene and sanitation. Therefore, development of novel oral polio vaccine with enhanced genetic stability and lower risk of reversion to neurovirulence compared to current Sabin 2 strains is major priority of global polio eradication Program
Current clinical development plan outlines studies through Phase II development with nOPV2 candidate strains being tested in adult toddler and infant populations who received prior dose of OPV or IPV. No study has been conducted in truly naive newborns with no prior receipt of any polio vaccines
Hypothesis: Vaccinating healthy newborns with novel type 2 polio virus candidate vaccines is safe and can induce putatively protective immune response
Objectives
Primary Objective
Safety
To evaluate the safety and tolerability after one and two doses of nOPV2 vaccine candidates 1 given 4 weeks apart in poliovirus vaccine-naïve newborn Immunogenicity To evaluate the immune response to vaccination after one and two doses of nOPV2 vaccine candidate 1 given 4 weeks apart in poliovirus vaccine-naïve newborns
Secondary objectives
Immunogenicity
To evaluate seroprotection rate geometric mean and median titers to vaccination after one dose of nOPV2 vaccine candidate 1 in poliovirus vaccine-naïve newborns To further evaluate seroprotection rate geometric mean and median titers to vaccination after two doses of nOPV2 candidate 1 in poliovirus vaccine-naïve newborns
Viral Shedding
To assess trate of fecal viral shedding at fixed time points following one and two doses of nOPV2 vaccine candidate 1 in newborns To assess duration of fecal viral shedding at fixed time points following one and two doses of nOPV2 vaccine candidate 1 in newborns To assess extent of fecal viral at fixed time points following one and two doses of nOPV2 vaccine candidate 1 in newborns
Exploratory objective
To assess genetic stability through genetic deep sequencing assay and neurovirulence test through transgenic mice NV assays from a subset of participants stools samples
Condition or disease | Intervention/treatment | Phase |
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Poliomyelitis | Biological: novel oral polio type 2 vaccine (nOPV2) Other: Placebo | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 330 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of Novel Oral Polio Type 2 Vaccine Candidate in Healthy Newborns in Bangladesh |
Actual Study Start Date : | September 21, 2020 |
Actual Primary Completion Date : | August 30, 2021 |
Actual Study Completion Date : | August 30, 2021 |

Arm | Intervention/treatment |
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Active Comparator: Vaccine candidate arm
In this arm, participants will get nOPV2 vaccine candidate 1
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Biological: novel oral polio type 2 vaccine (nOPV2)
• nOPV2 (C1) is a live-attenuated serotype-2 poliovirus that was derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells (S2/cre5/S15domV/rec1/hifi3). Placebo contain sucrose in buffer. |
Placebo Comparator: Placebo arm
In this arm, participants will get inactive substance like sucrose in BME media and buffer.
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Other: Placebo
Placebo contains no active ingradients, only sucrose in buffer |
- Safety of nOPV2 vaccine [ Time Frame: Upto 3 months ]
- Incidence rate of solicited systemic AEs within 7 days after each dose of vaccine
- Incidence rate of unsolicited AEs during entire study period
- Incidence rate of serious AEs and AESIs during entire study period
- Immunogenecity of nOPV2 vaccine , will be assessed as poliovirus type-2-specific serum neutralising antibodies [ Time Frame: 4 weeks ]Proportion of participants showing seroconversion and seroprotection will be calculated and reported
- Viral shedding in participants stool will be measured and reported by proportion of participants showing viral shedding in their stools, the time to cessation of viral shedding, the cell culture infective dose of shed virus in virus-positive stools [ Time Frame: 12 weeks ]Vaccine poliovirus shedding in the study participants stool will be assessed by real-time RT-PCR method.
- Genetic assay and Neurovirulance test to assess genetic stability by demonstrating the retention of key genetic regions engineered in the vaccine candidate [ Time Frame: 4 weeks ]WHO poliovirus receptor transgenic mouse (Tg-PVR21) neurovirulence test will be used. Deep sequencing will be performed on the cell culture-amplified virus and on viral RNA isolated from participants

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Ages Eligible for Study: | 1 Hour to 3 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Newborns at birth (range: 0-3 days of age).
- Mothers that consent for participation in the full length of the study.
- Mothers those are able to understand and comply with planned study procedures.
Exclusion Criteria:
- Mother and newborns who are unable to participate in the full length of the study.
- A diagnosis or suspicion of immunodeficiency disorder either in the newborn or in an immediate family member.
- A diagnosis or suspicion of bleeding disorder that would contraindicate collection of blood by venipuncture.
- Acute diarrhea, infection or illness at the time of enrollment that would require admission to a hospital.
- Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit.
- Receipt of any polio vaccine (OPV or IPV) and Rotavirus Vaccine (RVV) before enrollment based upon documentation or mothers recall.
- Newborns from multiple births. Newborns from multiple births will be excluded to reduce the potential for contact transmission of vaccine poliovirus to siblings. The newborn from a multiple birth who is /are not enrolled would be likely to receive routine immunization and transmit vaccine poliovirus to the enrolled infant.
- Newborns from premature births (<37 weeks of gestation).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693286
Bangladesh | |
: International Centre for Diarrhoeal Disease Research, Bangladesh | |
Dhaka, Bangladesh, 1212 |
Principal Investigator: | K Zaman, PhD FRCP | International Centre for Diarrhoeal Disease Research, Bangladesh |
Responsible Party: | International Centre for Diarrhoeal Disease Research, Bangladesh |
ClinicalTrials.gov Identifier: | NCT04693286 |
Other Study ID Numbers: |
PR-20001 |
First Posted: | January 5, 2021 Key Record Dates |
Last Update Posted: | August 30, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | IPD will be shared with BMGF, PATH, CDC, WHO |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | July 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Safety Immunogenecity nOPV2 Newborn Bangladesh |
Poliomyelitis Myelitis Central Nervous System Infections Infections Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Virus Diseases Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases |