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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: cIPV; Biological: sIPV

Study type: Interventional

Funder types: Industry

Identifiers

NCT03032588

GV000051POL1001 (Other Identifier)

2016-002775-99 (EudraCT Number)

CR108290

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Group 1: sIPV

Experimental group

Description:

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.

Treatment:

Biological: sIPV

Group 2: cIPV

Active Comparator group

Description:

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.

Treatment:

Biological: cIPV