A Phase 4 interventional study of Bivalent oral poliovirus vaccine (bOPV) at 6,10 and 14 weeks of age and Inactivated poliovirus vaccine (IPV) at 14 weeks and 18 months of age in Poliomyelitis, sponsored by Centers for Disease Control and Prevention. Completed at 2 sites in Bangladesh. Open to participants aged 6 Weeks to 7 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-25.
Sponsored by Centers for Disease Control and Prevention · Phase 4, Interventional, and Prevention
This is an open-label randomized phase IV clinical trial assessing immunogenicity of poliovirus vaccines.Participants will be enrolled at 6 weeks of age and followed to 18 months of age. The study will recruit 1645 participants in five arms.
Poliomyelitis is an acute infection caused by polioviruses. Oral poliovirus vaccines are live attenuated viral vaccines and the vaccine virus in OPV can mutate and acquire neurovirulence causing paralysis either due to vaccine-associated paralytic polio (VAPP) or due to circulating vaccine-derived polioviruses (cVDPV), in which the attenuated vaccine virus not only acquires the ability to cause paralysis but can also circulate similar to wild poliovirus (WPV). Therefore, polio eradication will require eventual cessation of all OPVs.
Wild poliovirus type 2 (WPV2) was declared eradicated in September 2015. Since then paralysis associated with type 2 poliovirus has continued mainly due to vaccine derived polio viruses (VDPVs) from type 2 OPV (OPV2). Due to the continued threat of paralysis from a mutated, neurovirulent and vaccine-derived type 2 poliovirus, the Strategic Advisory Group of Experts on Immunization (SAGE), a global advisory committee on immunization, recommended a phased cessation of OPV starting with OPV2. By May 2016, OPV2 was successfully withdrawn globally when trivalent OPV (tOPV) was replaced with bivalent OPV (bOPV), which was preceded by a phased introduction of inactivated poliovirus vaccine (IPV). SAGE has recommended at least one dose of IPV at age ≥14 weeks because IPV immunogenicity is expected to be highest after maternal antibodies have declined by age 14 weeks. However, studies have not assessed if priming after one IPV dose declines over time.
Types 1 and 3 OPV cessation is likely expected in 2020-2022, i.e. 1-2 years after certification of global interruption of wild poliovirus transmission. After cessation of bOPV, IPV will be used for routine polio vaccination for 5-10 years.Recently, SAGE recommended that IPV be used after global OPV withdrawal with an IPV schedule that achieves at least 90% seroconversion with two full or fractional doses. SAGE has recommended that the first dose be administered after 14 weeks of age and an interval of at least 4 months between two IPV doses. In the proposed clinical trial, immunogenicity of two IPV doses with schedules that are likely to achieve 90% immune response to all poliovirus types is being assessed to inform SAGE policy deliberations on potential IPV schedules after OPV cessation. A head-to-head comparison of different IPV schedules is important to determine the immunogenicity of the schedules under similar conditions and evaluate the differences in population immunity, a product of immunogenicity and vaccination coverage, with the different IPV schedules.
222 studies on the registry are indexed under Poliomyelitis; 11 are open to participants now.
This study's enrollment of 1,645 is above the median of 456 across 199 interventional studies indexed under Poliomyelitis.
Browse Poliomyelitis studies →Centers for Disease Control and Prevention is the lead sponsor of 273 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 bivalent oral poliovirus vaccine (bOPV) at 6, 10 and 14 weeks of age and inactivated poliovirus vaccine (IPV) at 14 weeks and 18 months of age
Biological: Bivalent oral poliovirus vaccine (bOPV) at 6,10 and 14 weeks of age · Biological: Inactivated poliovirus vaccine (IPV) at 14 weeks and 18 months of age
Participants in this arm will receive bivalent oral poliovirus vaccine (bOPV) at 6, 10 and 14 weeks of age and inactivated poliovirus vaccine (IPV) at 14 weeks, 18 weeks and 18 months of age
Biological: Bivalent oral poliovirus vaccine (bOPV) at 6,10 and 14 weeks of age · Biological: Inactivated poliovirus vaccine (IPV) at 14 weeks, 18 weeks and 18 months of age
Participants in this arm will inactivated poliovirus vaccine (IPV) at 14 weeks and 9 months of age
Biological: Inactivated poliovirus vaccine (IPV) at 14 weeks and 9 months of age
Participants in this arm will inactivated poliovirus vaccine (IPV) at 6 weeks and 9 months of age
Biological: Inactivated poliovirus vaccine (IPV) at 6 weeks and 9 months of age
Participants in this arm will inactivated poliovirus vaccine (IPV) at 6 and 14 weeks of age
Biological: Inactivated poliovirus vaccine (IPV) at 6 and 14 weeks of age
bOPV at 6, 10 and 14 weeks of age
IPV at 14 weeks and 18 months of age
IPV at 14 weeks, 18 weeks and 18 months of age
IPV at 14 weeks and 9 months of age
IPV at 6 weeks and 9 months of age
IPV at 6 and 14 weeks of age
Immunogenicity of IPV vaccination schedule
Immunogenicity will be assessed by measuring type-specific poliovirus antibody titers and assessing the change in antibody titers after receiving study vaccine compared to 6 weeks of age. The cumulative proportion of participants who demonstrate an immune response one month after receiving the last IPV dose of the experimental schedule. Immune response will be defined as either seronegative participants (\<1:8 titers) who become seropositive (≥1:8) \[seroconversion\] or participants who demonstrate a four-fold increase in titer (boosting).
Time frame: Change after receiving vaccine compared to that at 6 weeks of age
Poliovirus type 2 priming with IPV
The proportion of participants who demonstrate type 2 immune response one week after receiving an additional IPV dose (secondary vaccination) after the proposed primary IPV vaccination series will be determined. Priming is the proportion of participants that demonstrate type 2 immune response among those who have not previously responded to the primary IPV vaccination series.
Time frame: Proportion who demonstrate type 2 response at 18 months and 1 week among those who did not respond at 19 weeks
Plan to share: No — Summary tables to be shared December 2019
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