NCT03202719

Duration of IPV Priming and Antibody Decay

Duration of Priming and Antibody Decay With Full-dose Inactivated Poliovirus Vaccine (IPV) Administered With or Without Bivalent Oral Poliovirus Vaccine (bOPV)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,645 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 6 Weeks – 7 Weeks
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 By May 2016, OPV2 was successfully withdrawn globally when trivalent OPV (tOPV) was replaced with bivalent OPV (bOPV), which was preceded by a phased introduction of inactivated poliovirus vaccine (IPV).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.

Conditions

• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Bivalent oral poliovirus vaccine (bOPV) at 6,10 and 14 weeks of age	bOPV at 6, 10 and 14 weeks of age
BIOLOGICAL	Inactivated poliovirus vaccine (IPV) at 14 weeks and 18 months of age	IPV at 14 weeks and 18 months of age
BIOLOGICAL	Inactivated poliovirus vaccine (IPV) at 14 weeks, 18 weeks and 18 months of age	IPV at 14 weeks, 18 weeks and 18 months of age
BIOLOGICAL	Inactivated poliovirus vaccine (IPV) at 14 weeks and 9 months of age	IPV at 14 weeks and 9 months of age
BIOLOGICAL	Inactivated poliovirus vaccine (IPV) at 6 weeks and 9 months of age	IPV at 6 weeks and 9 months of age
BIOLOGICAL	Inactivated poliovirus vaccine (IPV) at 6 and 14 weeks of age	IPV at 6 and 14 weeks of age

Timeline

• Start date: 2017-11-05
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2017-06-29
• Last updated: 2020-11-25

Locations

2 sites across 1 country: Bangladesh