A First in Human Study to Assess the Safety, Tolerability and Immunogenicity of a Single Dose of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains (sIPV) Given Intramuscularly in Healthy Adults

NCT ID: NCT03032588

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-09
• Study Completion Date: 2018-05-18

Brief Summary

The main purpose of this study is to assess the safety and tolerability of a single dose of JNJ-64152348, inactivated poliovirus vaccine produced from Sabin poliovirus strains on PER.C6 cells (sIPV) in healthy adults, using conventional inactivated poliovirus vaccine produced from Salk poliovirus strains (cIPV) as reference.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1: sIPV

Participants will receive single intramuscular injection of the trivalent inactivated poliovirus vaccine based on Sabin strains produced on PER.C6 cells (sIPV) on Day 1.

Group Type: EXPERIMENTAL

sIPV

Intervention Type: BIOLOGICAL

Participants will receive single dose (0.5 milliliter \[mL\]) of sIPV as a suspension for intramuscular injection on Day 1.

Group 2: cIPV

Participants will receive single intramuscular injection of the currently used trivalent inactivated poliovirus vaccine IMOVAX POLIO, based on the conventional Salk poliovirus strains produced on Vero cells (cIPV) on Day 1.

Group Type: ACTIVE_COMPARATOR

cIPV

Intervention Type: BIOLOGICAL

Participants will receive single dose (0.5 mL) of cIPV as a suspension for intramuscular injection on Day 1.

Interventions

sIPV

Participants will receive single dose (0.5 milliliter \[mL\]) of sIPV as a suspension for intramuscular injection on Day 1.

Intervention Type: BIOLOGICAL

cIPV

Participants will receive single dose (0.5 mL) of cIPV as a suspension for intramuscular injection on Day 1.

Intervention Type: BIOLOGICAL

Other Intervention Names

JNJ-64152348; IMOVAX POLIO

Eligibility Criteria

Inclusion Criteria

• Declared healthy by the investigator on the basis of physical examination, medical history, vital signs and clinical laboratory tests performed at screening. If the results of the serum chemistry panel or hematology are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
• Heterosexual male participants must not engage in intercourse with a female partner of childbearing potential who is not using a highly effective contraceptive method
• All female participants of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and immediately prior to study vaccine administration
• Willing and able to adhere to the prohibitions and restrictions specified in this protocol
• Agrees not to donate blood until the Week 4 visit

Exclusion Criteria

• Clinically significant neuro-psychiatric, cardiovascular, pulmonary, liver or renal insufficiency (estimated creatinine clearance below 60 milliliter per minute (mL/min) using the Cockcroft-Gault Equation); metabolic, gastrointestinal, urologic, or endocrine disease that is - in the opinion of the investigator - uncontrolled
• Any history of malignancy (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
• Previous severe allergic reaction after vaccination with polio vaccine
• Known allergies, hypersensitivity, or intolerance to one of the excipients of JNJ-64152348, inactivated poliovirus vaccine produced from Sabin poliovirus strains on PER.C6 cells (sIPV) or conventional inactivated poliovirus vaccine produced from Salk poliovirus strains (cIPV)
• Received any polio vaccine within 6 months before study inclusion

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Vaccines & Prevention B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Vaccines & Prevention B.V. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Vaccines & Prevention B.V.

Locations

Center for Vaccinology (CEVAC)

Ghent, , Belgium

Countries

Belgium

References

Leroux-Roels I, Leroux-Roels G, Shukarev G, Schuitemaker H, Cahill C, de Rooij R, Struijs M, van Zeeburg H, Jacquet JM. Safety and immunogenicity of a new Sabin inactivated poliovirus vaccine candidate produced on the PER.C6(R) cell-line: a phase 1 randomized controlled trial in adults. Hum Vaccin Immunother. 2021 May 4;17(5):1366-1373. doi: 10.1080/21645515.2020.1812315. Epub 2020 Nov 11.

Reference Type: DERIVED

PMID: 33175637 (View on PubMed)

Other Identifiers

2016-002775-99

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GV000051POL1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108290

Identifier Type: -

Identifier Source: org_study_id