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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

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ClinicalTrials.gov Identifier: NCT03032588
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Tracking Information
First Submitted Date  ICMJE January 24, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE October 9, 2017
Actual Primary Completion Date May 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
  • Number of Participants With Solicited Local Adverse Events (AEs) [ Time Frame: Up to Day 8 ]
    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.
  • Number of Participants With Solicited Systemic Adverse Events (AEs) [ Time Frame: Up to Day 8 ]
    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.
  • Number of Participants With Unsolicited AEs [ Time Frame: Up to Week 4 ]
    Unsolicited adverse events will include all adverse events for which the participant is not specifically questioned in the participant diary.
  • Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to Week 26 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • Number of Participants With Solicited Local Adverse Events (AEs) [ Time Frame: Up to Day 8 ]
  • Number of Participants With Solicited Systemic Adverse Events (AEs) [ Time Frame: Up to Day 8 ]
  • Number of Participants With Unsolicited AEs [ Time Frame: Up to Week 4 ]
  • Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to Week 26 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
Poliovirus Type- and Strain-specific Neutralizing Antibody (NAb) Responses [ Time Frame: Up to Week 4 ]
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A First in Human Double-blind, Randomized 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: sIPV
    Participants will receive single dose (0.5 milliliter [mL]) of sIPV as a suspension for intramuscular injection on Day 1.
    Other Name: JNJ-64152348
  • Biological: cIPV
    Participants will receive single dose (0.5 mL) of cIPV as a suspension for intramuscular injection on Day 1.
    Other Name: IMOVAX POLIO
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Biological: sIPV
  • Active Comparator: 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.
    Intervention: Biological: cIPV
Publications * 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® 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2017)
32
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 18, 2018
Actual Primary Completion Date May 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032588
Other Study ID Numbers  ICMJE CR108290
2016-002775-99 ( EudraCT Number )
GV000051POL1001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Vaccines & Prevention B.V.
Study Sponsor  ICMJE Janssen Vaccines & Prevention B.V.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
PRS Account Janssen Vaccines & Prevention B.V.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP