Safety Study of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) in Infants Early in Life

NCT02111135 | Completed Phase 2 DMC

• 1 other identifier: IPV005ABMG
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II, observer-blind, randomized study on the safety, reactogenicity, immunogenicity and impact on intestinal shedding of a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD) or a single dose of standard trivalent inactivated poliovirus vaccine (t-IPV) when given concomitantly with the third dose of bivalent oral poliovirus vaccine (b-OPV) to infants early in life

Conditions

Polio

Outcome Measures

Primary Outcomes (2)

• Safety

  To assess and compare descriptively the safety of a single dose of a m-IPV2 HD vaccine in healthy infants to that of a licensed t-IPV vaccine when given concomitantly with the third dose of b-OPV measured by the incidence of serious adverse events (SAEs) and important medical events (IMEs) from the day of vaccine administration until day of last visit at study week 15 (\~ week 21 of life).

  6 weeks

• Efficacy

  To determine whether 1 dose of a m-IPV2 HD vaccine given to infants is superior to 1 dose of t-IPV given at study week 8 (\~14 weeks of age) in inducing a humoral immune response to type 2 poliovirus when measured as seroconversion to type 2 poliovirus (type-specific titers ≥1:8 and \>4-fold over expected levels of maternally-derived antibody) and as median titers four weeks later at study week 12 (\~ 18 weeks of age).

  4 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

b-OPV, m-IPV HD and m-OPV2

Biological: b-OPV; Biological: m-OPV2; Biological: m-IPV HD

Group 2

ACTIVE COMPARATOR

b-OPV, t-IPV and m-OPV2

Biological: b-OPV; Biological: m-OPV2; Biological: t-IPV

Interventions

b-OPV BIOLOGICAL

Group 1; Group 2

m-OPV2 BIOLOGICAL

Group 1; Group 2

m-IPV HD BIOLOGICAL

Group 1

t-IPV BIOLOGICAL

Group 2

Eligibility Criteria

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

You may qualify if:

• Age: 6 weeks (-7 to +14 days).
• 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 parents or legal guardian as per Panama regulations.

You may not qualify if:

• Previous vaccination against poliovirus.
• Low birth weight (BW \<2,500 gm).
• Any confirmed or suspected immunosuppressive or 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.
• Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections.
• 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

• Vaxtrials S.A.: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Hospital del Niño

Panama City, Provincia de Panamá, Panama

Location

Related Publications (2)

• Brickley EB, Strauch CB, Wieland-Alter WF, Connor RI, Lin S, Weiner JA, Ackerman ME, Arita M, Oberste MS, Weldon WC, Saez-Llorens X, Bandyopadhyay AS, Wright PF. Intestinal Immune Responses to Type 2 Oral Polio Vaccine (OPV) Challenge in Infants Previously Immunized With Bivalent OPV and Either High-Dose or Standard Inactivated Polio Vaccine. J Infect Dis. 2018 Jan 17;217(3):371-380. doi: 10.1093/infdis/jix556.

  PMID: 29304199 DERIVED

• Saez-Llorens X, Clemens R, Leroux-Roels G, Jimeno J, Clemens SA, Weldon WC, Oberste MS, Molina N, Bandyopadhyay AS. Immunogenicity and safety of a novel monovalent high-dose inactivated poliovirus type 2 vaccine in infants: a comparative, observer-blind, randomised, controlled trial. Lancet Infect Dis. 2016 Mar;16(3):321-30. doi: 10.1016/S1473-3099(15)00488-0. Epub 2015 Dec 21.

  PMID: 26719058 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 Officials

• Xavier Sáez, MD

  Hospital Del Niño

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: March 1, 2015
• Last Updated: July 20, 2015

Record last verified: 2015-07

Locations

PA (1)