Study to Evaluate Safety and Immunogenicity of nOPV2 at Different Intervals in Infants

NCT05033561 | Completed Phase 3 Results DMC

• 1 other identifier: nOPV2-002-ABMG
• Study Type: interventional
• Target: 905
• Locations: 1 country
• Sites: 2

Brief Summary

Study to determine immunogenicity and safety following administration of 2 doses of novel oral poliovirus vaccine type 2 (nOPV2) given at different intervals of 1 week or 2 weeks or the standard 4-week interval in infants

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (1)

• Seroconversion Rate at 1, 2 & 4 Weeks Interval

  Cumulative seroconversion rate of type 2 polio neutralizing antibodies 28 days following administration of 2 doses of nOPV2 in 1-week, 2-week and 4-weeks interval to infants 6 to 8 weeks of age

  Up to max 8 weeks

Secondary Outcomes (4)

• Neutralizing Antibodies at 1, 2 & 4 Week Interval

  Up to max 8 weeks

• Serious Adverse Events (SAEs) and Important Medical Events (IMEs)

  6 months

• Solicited Adverse Events (AEs)

  Up to max 5 weeks

• Unsolicited Adverse Events (AEs)

  Up to max 8 weeks

Study Arms (3)

2 doses, 1 week apart

EXPERIMENTAL

Administration of 2 doses of nOPV2, 1 week apart

Biological: nOPV2

2 doses, 2 week apart

EXPERIMENTAL

Administration of 2 doses of nOPV2, 2 weeks apart

Biological: nOPV2

2 doses, 4 week apart

ACTIVE COMPARATOR

Administration of 2 doses of nOPV2, 4 weeks apart

Biological: nOPV2

Interventions

nOPV2 BIOLOGICAL

Novel Oral Poliomyelitis Type 2 Vaccine

2 doses, 1 week apart; 2 doses, 2 week apart; 2 doses, 4 week apart

Eligibility Criteria

• Age: 6 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged 6 to 8 weeks with birth weight \> 2,500 g.
• Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject from participating 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:

• Infants who have received previous vaccination against poliomyelitis.
• Infants with anyone under 5 years of age in their household (living in the same house or apartment unit) who does not have the complete "age appropriate" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration according to the Dominican Republic National Immunization Program (NIP).
• Infants having a member of their household (living in the same house or apartment unit) who is under 6 months of age at the moment of study vaccine administration.
• Infants having a member of their household (living in the same house or apartment unit) who has received oral poliomyelitis vaccine (OPV) in the previous 3 months before study vaccine administration.
• Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household.
• 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 vaccine or to any antibiotics that share molecular composition with the nOPV2 vaccine.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• 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.
• Infants from multiple births or born prematurely (\< 37 weeks of gestation)

Sponsors & Collaborators

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

Study Sites (2)

Clinica Cruz Jiminián

Santo Domingo, Dominican Republic

Location

Hospital Universitario Maternidad Nuestra Señora de la Altagracia

Santo Domingo, Dominican Republic

Location

Related Publications (1)

• Rivera Mejia L, Pena Mendez L, Bandyopadhyay AS, Gast C, Mazara S, Rodriguez K, Rosario N, Zhang Y, Mainou BA, Jimeno J, Aguirre G, Ruttimann R. Safety and immunogenicity of shorter interval schedules of the novel oral poliovirus vaccine type 2 in infants: a phase 3, randomised, controlled, non-inferiority study in the Dominican Republic. Lancet Infect Dis. 2024 Mar;24(3):275-284. doi: 10.1016/S1473-3099(23)00519-4. Epub 2023 Dec 15.

  PMID: 38109921 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

Results Point of Contact

• Title: Ricardo Rüttimann
• Organization: FIDEC Corporation

rruttimann@fidec-online.org

+5491161188536

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: September 5, 2021
• Study Start: December 16, 2021
• Primary Completion: May 24, 2022
• Study Completion: October 25, 2022
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DO (2)