A Study to Evaluate the Safety and Immunogenicity of Oral Polio Vaccine Type 2 in Infants and Children

NCT02521974 | Completed Phase 4 Results DMC

• 1 other identifier: M2-ABMG
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sabin 2 will be withdrawn from routine use globally from April 2016 as per the SAGE recommendations at the time of writing this protocol.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 will be 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 and in infants approximately 18 weeks of aged vaccinated with bOPV-/IPV for better understanding of the stockpile use of this vaccine, and for comparison with any potential new polio vaccine with a type 2 component in the future.

Conditions

Adverse Event Following Immunisation

Outcome Measures

Primary Outcomes (2)

• Number of Subjects Experiencing SAEs, Severe AEs (Grade 3), and/or IMEs

  Number of subjects experiencing SAEs, severe AEs (grade 3), and IMEs considered consistent with a causal association to study vaccine throughout the study period in all groups.

  6 months

• Seroprotection Rate of Type 2 Polio Neutralizing Antibodies.

  Measured at Day 28 following a single dose of Sabin mOPV2 in both infant groups (Groups 2+3). Seroprotection is defined as type 2-specific antibody titers ≥1:8 and seroprotection rate as the percentage of seroprotected subjects per group.

  28 days

Study Arms (1)

SABIN monovalent OPV2 vaccine

EXPERIMENTAL

SABIN monovalent OPV2 is a licensed, monovalent, live attenuated poliomyelitis virus vaccine of the Sabin strain Type 2 (P 712, Ch, 2ab), propagated in MRC5 human diploid

Biological: SABIN monovalent OPV2

Interventions

SABIN monovalent OPV2 BIOLOGICAL

SABIN monovalent OPV2 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

Also known as: Polio Sabin™ Mono Two (oral)

SABIN monovalent OPV2 vaccine

Eligibility Criteria

• Age: 6 Weeks - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1 to 5 years previously vaccinated with three or four doses of IPV (Group 1) or unvaccinated infants aged 6 weeks (-7 to +14 days) (Groups 2 and 3).
• For Groups 2 and 3 (enrolled at 6 weeks of age) infants must have been vaccinated with 3 doses of bOPV and one dose of IPV prior to administration of the study vaccine, and the last Polio vaccine must have been administered at least 4 weeks prior to the study vaccine.
• Healthy without obvious medical conditions that preclude the subject to be in 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.

You may not qualify if:

• For Group 1: polio vaccines within the 3 months prior to the administration of the study vaccine (number of previous polio vaccine doses to be documented). For Groups 2 and 3: polio vaccines prior to administration of the study vaccine other than 3 doses of bOPV and 1 dose of IPV .
• 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.
• Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections (of IPV).
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• 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.

Sponsors & Collaborators

• Fidec Corporation: lead
• Bill and Melinda Gates Foundation: collaborator

Related Publications (2)

• Wahid R, Mercer LD, De Leon T, DeAntonio R, Saez-Llorens X, Macadam A, Chumakov K, Strating J, Koel B, Konopka-Anstadt JL, Oberste MS, Burns CC, Andino R, Tritama E, Bandyopadhyay AS, Aguirre G, Ruttimann R, Gast C, Konz JO. Genetic and phenotypic stability of poliovirus shed from infants who received novel type 2 or Sabin type 2 oral poliovirus vaccines in Panama: an analysis of two clinical trials. Lancet Microbe. 2022 Dec;3(12):e912-e921. doi: 10.1016/S2666-5247(22)00254-3. Epub 2022 Nov 1.

  PMID: 36332645 DERIVED

• Saez-Llorens X, Bandyopadhyay AS, Gast C, Leon T, DeAntonio R, Jimeno J, Caballero MI, Aguirre G, Oberste MS, Weldon WC, Konopka-Anstadt JL, Modlin J, Bachtiar NS, Fix A, Konz J, Clemens R, Costa Clemens SA, Ruttimann R. Safety and immunogenicity of two novel type 2 oral poliovirus vaccine candidates compared with a monovalent type 2 oral poliovirus vaccine in children and infants: two clinical trials. Lancet. 2021 Jan 2;397(10268):27-38. doi: 10.1016/S0140-6736(20)32540-X. Epub 2020 Dec 9.

  PMID: 33308427 DERIVED

Results Point of Contact

• Title: Ricardo Rüttimann
• Organization: FIDEC Corporationa

rruttimann@fidec-online.org

+17863546335

Study Officials

• Xavier M Saez-Llorens, MD

  Hospital del Niño de Panama

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 13, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 29, 2016
• Last Updated: August 14, 2020
• Results First Posted: August 14, 2020

Record last verified: 2017-07