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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

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.

Condition or disease Intervention/treatment Phase
Healthy Biological: sIPV Biological: cIPV Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 9, 2017
Actual Primary Completion Date : May 18, 2018
Actual Study Completion Date : May 18, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032588


Locations
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Belgium
Center for Vaccinology (CEVAC)
Gent, Belgium, 9000
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
Investigators
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Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
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Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT03032588    
Other Study ID Numbers: CR108290
2016-002775-99 ( EudraCT Number )
GV000051POL1001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No