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A Study of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health

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ClinicalTrials.gov Identifier: NCT03819049
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to evaluate the safety and reactogenicity of three doses of VAC52416 (ExPEC10V) and to evaluate the dose‑dependent immunogenicity of ExPEC10V as measured by enzyme-linked immunosorbent assay (ELISA) and opsonophagocytic killing assay (OPA) on Day 15 in participants greater than equal to 60 to less than equal to 85 years of age.

Condition or disease Intervention/treatment Phase
Healthy Biological: ExPEC10V Biological: ExPEC4V Biological: Prevnar 13 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : May 13, 2020
Estimated Study Completion Date : October 9, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ExPEC10V: Low Dose
Participants will be randomized to receive a single intramuscular (IM) injection of low dose ExPEC10V on Day 1.
Biological: ExPEC10V
Participants will receive a single IM injection of ExPEC10V (1 of 3 doses [low or medium or high]) on Day 1.
Other Name: VAC52416

Experimental: ExPEC10V: Medium dose
Participants will be randomized to receive a single IM injection of medium dose ExPEC10V on Day 1.
Biological: ExPEC10V
Participants will receive a single IM injection of ExPEC10V (1 of 3 doses [low or medium or high]) on Day 1.
Other Name: VAC52416

Experimental: ExPEC10V: High dose
Participants will be randomized to receive a single IM injection of high dose ExPEC10V on Day 1.
Biological: ExPEC10V
Participants will receive a single IM injection of ExPEC10V (1 of 3 doses [low or medium or high]) on Day 1.
Other Name: VAC52416

Experimental: ExPEC4V
Participants will be randomized to receive a single IM injection of ExPEC4V on Day 1.
Biological: ExPEC4V
Participants will receive a single IM injection of ExPEC4V on Day 1.
Other Name: JNJ-63871860

Experimental: Prevnar 13
Participants will be randomized to receive a single IM injection of Prevnar 13 on Day 1.
Biological: Prevnar 13
Participants will receive a single IM injection of Prevnar 13 on Day 1.




Primary Outcome Measures :
  1. Number of Participants with Solicited Local and Systemic Adverse Events (AEs) Collected for 14 days post-Vaccination [ Time Frame: From Day 1 to Day 15 ]
    Number of participants with solicited local and systemic adverse events (AEs) will be reported. Solicited local AEs (pain/tenderness, erythema, and swelling at the injection site) and solicited systemic AEs (oral body temperature, headache, fatigue, nausea, and myalgia) will be noted in the participant diary for 14 days post-vaccination.

  2. Number of Participants with Unsolicited Adverse Events From the Administration of Study Intervention Until 29 Days post-Vaccination [ Time Frame: From Day 1 to Day 30 ]
    Number of participants with unsolicited AEs will be reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Unsolicited adverse events are all adverse events for which the participant is not specifically questioned in the participant ediary.

  3. Number of Participants with Serious Adverse Events (SAE's) from the Administration of the Study Intervention until Day 181 [ Time Frame: Up to Day 181 ]
    Number of participants with SAEs will be reported. 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, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.

  4. Antibody Titers for ExPEC10V as Determined by Enzyme-Linked Immunosorbent Assay (ELISA) on Day 15 [ Time Frame: On Day 15 ]
    Antibody titers for ExPEC10V will be determined by ELISA.

  5. Antibody Titers for ExPEC10V as Determined by Opsonophagocytic Killing Assay (OPA) on Day 15 [ Time Frame: On Day 15 ]
    Antibody titers for ExPEC10V will be determined by OPA.


Secondary Outcome Measures :
  1. Antibody Titers for ExPEC10V as Determined by ELISA and OPA to find Correlation Between ELISA and OPA [ Time Frame: Day 15 ]
    Antibody titers for ExPEC10V as determined by ELISA and OPA to find correlation between ELISA and OPA.

  2. Antibody Titers for ExPEC10V as Determined by Enzyme-Linked Immunosorbent Assay (ELISA) on Days 30, 181, 366, 731 and 1096 [ Time Frame: On Days 30, 181, 366, 731 and 1096 ]
    Antibody titers for ExPEC10V will be determined by ELISA.

  3. Antibody Titers for ExPEC10V as Determined by Opsonophagocytic Killing Assay (OPA) on Days 30, 181, 366, 731 and 1096 [ Time Frame: On Days 30, 181, 366, 731 and 1096 ]
    Antibody titers for ExPEC10V will be determined by OPA.

  4. Number of Participants with Serious Adverse Events Related to the Study Intervention or Study Procedures From Day 182 Until the end of the Study [ Time Frame: From Day 182 until end of study (Day 1096) ]
    Number of participants with SAEs related to the study intervention or study procedures will be reported. 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, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must have a body mass index (BMI) of greater than (>) 18.5 or less than equal to (<=) 35 kilogram per meter square (kg/m^2)
  • Before randomization, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; or not intending to conceive by any methods
  • Must be healthy or medically stable
  • Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
  • Willing and able to adhere to the lifestyle restrictions specified in this protocol
  • Agrees not to donate blood until 12 weeks after receiving the study intervention

Exclusion Criteria:

  • Acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than equal to >=38.0 degree Celsius (100.4 degree Fahrenheit) within 24 hours prior to the administration of study intervention; enrollment at a later date is permitted (provided the screening window of 28 days is respected)
  • History of malignancy within 5 years before screening (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)
  • Known allergies, hypersensitivity, or intolerance to ExPEC10V or its excipients
  • Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products (including any of the constituents of the active control vaccines)
  • Contraindication to intramuscular (IM) injections and blood draws example, bleeding disorders
  • Abnormal function of the immune system
  • Has had major psychiatric illness and/or drug substance or alcohol abuse in the past 12 months

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): NCT03819049


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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United States, Florida
Qps-Mra, Llc Not yet recruiting
Miami, Florida, United States, 33143
United States, Kansas
Johnson County Clin-Trials Recruiting
Lenexa, Kansas, United States, 66219
United States, New York
Rochester Clinical Research, Inc Not yet recruiting
Rochester, New York, United States, 14609
United States, South Carolina
Coastal Carolina Research Center Recruiting
Mount Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03819049     History of Changes
Other Study ID Numbers: CR108580
VAC52416BAC1001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

URL: https://www.janssen.com/clinical-trials/transparency

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

Additional relevant MeSH terms:
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Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs