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A Study to Evaluate the Safety and Immunogenicity of Monovalent OPV2 in Children Aged 1 to 5 Years in Lithuania (M3-ABMG)

Primary Purpose

Poliomyelitis

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Sabin mOPV2

About this trial

This is an interventional prevention trial for Poliomyelitis

Eligibility Criteria

1 Year - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1 to 5 years of age, previously vaccinated with three or four doses of IPV.
Healthy without obvious medical conditions that preclude entry of the subject into the study as established by the medical history and physical examination.
Written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations.

Exclusion Criteria:

Previous vaccination against poliovirus outside the national immunization schedule.
Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus (HIV) infection.
Family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
Known allergy to any component of the study vaccines or to any antibiotics.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all in/exclusion criteria are met.).
Member of the subject's household (living in the same house or apartment unit) has received OPV in the last 3 months.
Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Sabin mOPV2 1 dose

SABIN mOPV2 2 doses

Arm Description

IPV-vaccinated children to receive 1 dose of SABIN mOPV2 (Group 1)

IPV-vaccinated children to receive 2 doses of SABIN mOPV2 (Group 2)

Outcomes

Primary Outcome Measures

SAEs and Severe AEs

Incidence of SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine throughout the study period in children 1 to 5 years.

Seroprotection Rate of Type 2 Polio Neutralizing Antibodies.

Seroprotection rate at type 2 polio neutralizing antibodies measured at D28 after the first dose of mOPV2.

Secondary Outcome Measures

Seroprotection Rate for Type 2 Polio Neutralizing Antibodies.

Seroprotection rate for type 2 polio neutralizing antibodies measured at D 28 after the secon dose of mOPV2.

Incidence of Any Serious Adverse Events (SAEs), Any Solicited AEs, Any Unsolicited AEs, and Any Important Medical Events (IMEs).

Incidence, severity and relationship) of any serious adverse events (SAEs), any solicited AEs, any unsolicited AEs, and any Important Medical Events (IMEs) with the exception of severe related AEs. (primary objective), as well as any laboratory deviations of one or two doses of SABIN mOPV2 in healthy IPV-vaccinated children aged 1 to 5 years.

Full Information

NCT ID

NCT02582255

First Posted

August 4, 2015

Last Updated

January 6, 2020

Sponsor

Fidec Corporation

Collaborators

Bill and Melinda Gates Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02582255

Brief Title

A Study to Evaluate the Safety and Immunogenicity of Monovalent OPV2 in Children Aged 1 to 5 Years in Lithuania

Acronym

M3-ABMG

Official Title

A Phase 4 Study to Evaluate the Safety and Immunogenicity of Monovalent Oral Polio Vaccine Type 2 in Healthy IPV-vaccinated Children Aged 1 to 5 Years in Lithuania

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

December 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fidec Corporation

Collaborators

Bill and Melinda Gates Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine type 2 in healthy IPV-vaccinated children aged 1 to 5 years in Lithuania.

Detailed Description

Sabin 2 will be withdrawn from routine use globally from April 2016 as per the SAGE recommendations at the time of writing this protocol. After this cessation of OPV2, stockpiles of mOPV2 will be maintained for potential use if necessary in response to a future outbreak. However, there is a risk of cVDPV2 from Sabin 2 in settings of low population immunity. Research is ongoing to develop vaccines that are genetically more stable than the currently available Sabin 2-containing OPVs. To generate data on immunogenicity, safety, and genetic stability on the Sabin 2 vaccine (mOPV2) and as a future comparator for new polio vaccine research after the global switch from tOPV to bOPV, this study with mOPV2 is performed to evaluate safety, immunogenicity (humoral and intestinal) and genetic stability endpoints of mOPV2 in children aged 1 to 5 years for better understanding of the stockpile use of this vaccine, and any potential new polio vaccine with a type 2 component in the future.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Poliomyelitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sabin mOPV2 1 dose

Arm Type

Experimental

Arm Description

IPV-vaccinated children to receive 1 dose of SABIN mOPV2 (Group 1)

Arm Title

SABIN mOPV2 2 doses

Arm Type

Experimental

Arm Description

IPV-vaccinated children to receive 2 doses of SABIN mOPV2 (Group 2)

Intervention Type

Biological

Intervention Name(s)

Sabin mOPV2

Other Intervention Name(s)

mOPV2

Intervention Description

Polio Sabin™ Mono Two (oral) is a licensed, monovalent, live attenuated poliomyelitis virus vaccine of the Sabin strain Type 2 (P 712, Ch, 2ab), propagated in MRC5 human diploid cells. Each two-drop dose (0.1 mL) contains not less than 105.0 CCID50 of Type 2. Magnesium chloride is used as a stabilizer. Polio Sabin™ Mono Two (Oral) contains trace amounts of neomycin sulphate and polymyxin B sulphate. One dose of vaccine (0.1 mL) is contained in two drops which are delivered from the polyethylene dropper supplied with vaccine.

Primary Outcome Measure Information:

Title

SAEs and Severe AEs

Description

Incidence of SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine throughout the study period in children 1 to 5 years.

Time Frame

3 months

Title

Seroprotection Rate of Type 2 Polio Neutralizing Antibodies.

Description

Seroprotection rate at type 2 polio neutralizing antibodies measured at D28 after the first dose of mOPV2.

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Seroprotection Rate for Type 2 Polio Neutralizing Antibodies.

Description

Seroprotection rate for type 2 polio neutralizing antibodies measured at D 28 after the secon dose of mOPV2.

Time Frame

3 months

Title

Incidence of Any Serious Adverse Events (SAEs), Any Solicited AEs, Any Unsolicited AEs, and Any Important Medical Events (IMEs).

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1 to 5 years of age, previously vaccinated with three or four doses of IPV. Healthy without obvious medical conditions that preclude entry of the subject into the study as established by the medical history and physical examination. Written informed consent obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations. Exclusion Criteria: Previous vaccination against poliovirus outside the national immunization schedule. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus (HIV) infection. Family history of congenital or hereditary immunodeficiency. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine). Known allergy to any component of the study vaccines or to any antibiotics. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Acute severe febrile illness at day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all in/exclusion criteria are met.). Member of the subject's household (living in the same house or apartment unit) has received OPV in the last 3 months. Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vytautas Usonis, Prof

Organizational Affiliation

Vilnius University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

32621741

Citation

Bandyopadhyay AS, Gast C, Brickley EB, Ruttimann R, Clemens R, Oberste MS, Weldon WC, Ackerman ME, Connor RI, Wieland-Alter WF, Wright P, Usonis V. A Randomized Phase 4 Study of Immunogenicity and Safety After Monovalent Oral Type 2 Sabin Poliovirus Vaccine Challenge in Children Vaccinated with Inactivated Poliovirus Vaccine in Lithuania. J Infect Dis. 2021 Jan 4;223(1):119-127. doi: 10.1093/infdis/jiaa390.

Results Reference

derived

Learn more about this trial

A Study to Evaluate the Safety and Immunogenicity of Monovalent OPV2 in Children Aged 1 to 5 Years in Lithuania

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