Monovalent Oral Poliovirus Vaccine Type 1 Intestinal and Humoral Immunity Study

NCT03722004 | Completed Phase 4 DMC

• 1 other identifier: PR-18045
• Study Type: interventional
• Target: 1,256
• Locations: 1 country
• Sites: 1

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.

Conditions

Poliomyelitis

Keywords

monovalent oral poliovirus vaccine type 1; bivalent oral poliovirus vaccine; inactivated poliovirus vaccine; fractional inactivated poliovirus vaccine; humoral immunity; intestinal immunity; Bangladesh

Outcome Measures

Primary Outcomes (2)

• Vaccine response

  Dichotomous (yes/no) variable defined as participants who are either seronegative (\<1:8 titers) at baseline who become seropositive (≥1:8) after vaccination (seroconversion) or participants who demonstrate a four-fold rise in titers after vaccination between two specimens, e.g. a change from 1:8 to 1:32, after adjusting for expected decay in maternal antibodies. Antibody titers at 6 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days.

  Measured four weeks after administration of study vaccine(s). Vaccine response will be measured at 10 weeks, 14 weeks, and 18 weeks of age after 1, 2, and 3 doses of OPV, respectively.

• Vaccine virus particles

  Presence or absence of vaccine virus particles in stool specimens.

  Measured 7 and 14 days after administration of the study vaccine. For Arms B, C, and D, this will be after administration of the first mOPV1 or bOPV dose. For Arms A, B, and C, this will be after the mOPV1 challenge dose at 14 weeks of age.

Secondary Outcomes (1)

• Reciprocal antibody titers

  Measured four weeks after administration of study vaccine(s). Vaccine response will be measured at 10 weeks, 14 weeks, and 18 weeks of age after 1, 2, and 3 doses of OPV, respectively.

Study Arms (4)

mOPV1 + fIPV 6 weeks

ACTIVE COMPARATOR

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

Biological: mOPV1; Biological: fIPV

mOPV1 + fIPV 10 weeks

ACTIVE COMPARATOR

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

Biological: mOPV1; Biological: fIPV

mOPV1 only

ACTIVE COMPARATOR

mOPV1 administered at 6, 10, and 14 weeks.

Biological: mOPV1

bOPV only

ACTIVE COMPARATOR

bOPV administered at 6, 10, and 14 weeks.

Biological: bOPV

Interventions

mOPV1 BIOLOGICAL

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

mOPV1 + fIPV 10 weeks; mOPV1 + fIPV 6 weeks; mOPV1 only

bOPV BIOLOGICAL

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

bOPV only

fIPV 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 + fIPV 6 weeks

Eligibility Criteria

• Age: 35 Days - 41 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator

Study Sites (1)

icddr,b study clinics (Mirpur and CTU Dhaka)

Dhaka, Bangladesh

Location

Related Publications (1)

• 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.

  PMID: 37652822 DERIVED

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

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; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: October 26, 2018
• Study Start: December 18, 2018
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: February 21, 2021

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)