A First in Human Study to Assess the Safety, Tolerability... | NCT03032588

ID	Type	Description	Link
2016-002775-99	EudraCT Number
GV000051POL1001	Other Identifier	Janssen Vaccines & Prevention B.V.

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: sIPV	Experimental	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.	Biological: sIPV
Group 2: cIPV	Active Comparator	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.	Biological: cIPV

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sIPV	Biological	Participants will receive single dose (0.5 milliliter [mL]) of sIPV as a suspension for intramuscular injection on Day 1.	Group 1: sIPV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Solicited Local Adverse Events (AEs)	Participants will be requested to record any occurrences of solicited AEs on a daily basis in a diary on the day of dosing and during the 7 days thereafter (up to Day 8). Solicited local AEs include erythema, swelling/induration and pain/tenderness. If erythema or swelling/induration is present, the diameters will be measured using the ruler supplied and the largest diameter recorded.	Up to Day 8
Number of Participants With Solicited Systemic Adverse Events (AEs)	Participants will be requested to record any occurrences of solicited AEs on a daily basis in a diary on the day of dosing and during the 7 days thereafter (up to Day 8). Solicited systemic AEs include fatigue, headache, nausea, myalgia and fever.	Up to Day 8
Number of Participants With Unsolicited AEs	Unsolicited adverse events will include all adverse events for which the participant is not specifically questioned in the participant diary.	Up to Week 4
Number of Participants With Serious Adverse Events (SAEs)	An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.	Up to Week 26

Secondary Outcomes

Measure	Description	Time Frame
Poliovirus Type- and Strain-specific Neutralizing Antibody (NAb) Responses	Polio NAb titers will be determined against the attenuated Sabin strains (Types 1, 2 and 3) as well as against the wild-type Salk strains (Type 1 [Mahoney], Type 2 [MEF-1] and Type 3 [Saukett]), in accordance with the World Health Organization (WHO) recommendations for immunogenicity assessment of inactivated poliovirus vaccine (IPV).

Eligibility Module

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

Name	Affiliation	Role
Janssen Vaccines & Prevention B.V. Clinical Trial	Janssen Vaccines & Prevention B.V.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Center for Vaccinology (CEVAC)		Ghent		9000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33175637	Derived	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.