Monovalent Oral Poliovirus Vaccine Type 1 Intestinal and Humoral Immunity Study

NCT ID: NCT03722004

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-18
• Study Completion Date: 2019-12-19

Brief Summary

This is an open-label phase IV randomized clinical trial that will assess intestinal and humoral immunity among infants who receive a combination of monovalent oral poliovirus vaccine type 1 and fractional dose of inactivated poliovirus vaccine, monovalent oral poliovirus vaccine type 1 only, and bivalent oral poliovirus vaccine only.

Detailed Description

The risk for circulating vaccine-derived poliovirus (cVDPV) will increase in the years immediately after the cessation of oral poliovirus vaccine (OPV) use in routine immunization programs. Judicious use of type-specific monovalent OPV (mOPV) will be necessary for outbreak response to prevent further paralytic infections and transmission; however, data on the intestinal and humoral immunity induced by mOPV1 are very limited. Furthermore, the additional benefit of fractional dose inactivated poliovirus vaccine (fIPV) on type 1 immunity when given with mOPV1 is unclear. Data on intestinal and humoral immunity of mOPV type 1 (mOPV1) and combination use of mOPV1 and fractional dose of IPV (fIPV) are urgently needed and would be used to inform guidelines for type 1 outbreak response in a post-OPV world. In the immediate future, a strategy of shifting from bivalent OPV (bOPV) to mOPV1 as part of supplemental immunization activities in endemic countries is under consideration but data on intestinal and humoral immunity to support this change does not exist. This trial is designed to address both areas in which data are lacking.

Healthy infants 5 weeks of age will be enrolled at two study clinics in Dhaka, Bangladesh, and randomized to one of four study arms: mOPV1 + fIPV at 6 weeks, mOPV1 + fIPV at 14 weeks, mOPV1 only, and bOPV only. Infants will be followed-up until 18 weeks of age by clinic and household visits. Blood and stool specimens will be collected to test for vaccine response (humoral immunity) and vaccine virus shedding (intestinal immunity).

Conditions

Poliomyelitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

mOPV1 + fIPV 6 weeks

mOPV1 administered at 6, 10, and 14 weeks and fIPV at 6 weeks.

Group Type: ACTIVE_COMPARATOR

mOPV1

Intervention Type: BIOLOGICAL

Monovalent oral poliovirus vaccine type 1 is a type-specific, live, attenuated oral poliovirus vaccine that protects against poliovirus type 1.

fIPV

Intervention Type: BIOLOGICAL

Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal injection in lieu of the full 0.5mL dose that is given intramuscularly.

mOPV1 + fIPV 10 weeks

mOPV1 administered at 6, 10, and 14 weeks and fIPV at10 weeks.

Group Type: ACTIVE_COMPARATOR

mOPV1

Intervention Type: BIOLOGICAL

Monovalent oral poliovirus vaccine type 1 is a type-specific, live, attenuated oral poliovirus vaccine that protects against poliovirus type 1.

fIPV

Intervention Type: BIOLOGICAL

Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal injection in lieu of the full 0.5mL dose that is given intramuscularly.

mOPV1 only

mOPV1 administered at 6, 10, and 14 weeks.

Group Type: ACTIVE_COMPARATOR

mOPV1

Intervention Type: BIOLOGICAL

Monovalent oral poliovirus vaccine type 1 is a type-specific, live, attenuated oral poliovirus vaccine that protects against poliovirus type 1.

bOPV only

bOPV administered at 6, 10, and 14 weeks.

Group Type: ACTIVE_COMPARATOR

bOPV

Intervention Type: BIOLOGICAL

Bivalent oral poliovirus vaccine is a live, attenuated oral poliovirus vaccine that protects against poliovirus types 1 and 3.

Interventions

mOPV1

Monovalent oral poliovirus vaccine type 1 is a type-specific, live, attenuated oral poliovirus vaccine that protects against poliovirus type 1.

Intervention Type: BIOLOGICAL

bOPV

Bivalent oral poliovirus vaccine is a live, attenuated oral poliovirus vaccine that protects against poliovirus types 1 and 3.

Intervention Type: BIOLOGICAL

fIPV

Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal injection in lieu of the full 0.5mL dose that is given intramuscularly.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy infants 5 weeks of age (range: 35-41 days).
• Parents that consent for participation in the full length of the study.
• Parents that are able to understand and comply with planned study procedures.

Exclusion Criteria

• Parents and infants who are unable to participate in the full length of the study.
• A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
• A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of fIPV or collection of blood by venipuncture.
• Evidence of a chronic medical condition identified by a study medical officer during physical exam.
• Infection or illness at the enrolment visit (i.e., 5 weeks of age) that a study medical officer judges would prevent the start of study activities at 6 weeks of age (i.e., blood collection and vaccination).
• Receipt of any polio vaccine (OPV or IPV/fIPV) before enrolment based upon documentation or parental recall.
• Known allergy/sensitivity or reaction to polio vaccine, or its contents.
• Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vaccine poliovirus to the enrolled infant.
• Infants from premature births (<37 weeks of gestation).

• Minimum Eligible Age: 35 Days
• Maximum Eligible Age: 41 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

icddr,b study clinics (Mirpur and CTU Dhaka)

Dhaka, , Bangladesh

Countries

Bangladesh

References

Snider CJ, Zaman K, Wilkinson AL, Binte Aziz A, Yunus M, Haque W, Jones KAV, Wei L, Estivariz CF, Konopka-Anstadt JL, Mainou BA, Patel JC, Lickness JS, Pallansch MA, Wassilak SGF, Steven Oberste M, Anand A. Poliovirus type 1 systemic humoral and intestinal mucosal immunity induced by monovalent oral poliovirus vaccine, fractional inactivated poliovirus vaccine, and bivalent oral poliovirus vaccine: A randomized controlled trial. Vaccine. 2023 Sep 22;41(41):6083-6092. doi: 10.1016/j.vaccine.2023.08.055. Epub 2023 Aug 29.

Reference Type: DERIVED

PMID: 37652822 (View on PubMed)

Other Identifiers

PR-18045

Identifier Type: -

Identifier Source: org_study_id