A Study to Evaluate the Different Doses of VAC52416 (ExPEC10V) in Japanese Adults

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: Placebo; Biological: ExPEC10V

Study type: Interventional

Funder types: Industry

Identifiers

NCT04306302

CR108778

VAC52416BAC1002 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and reactogenicity of different doses of extraintestinal pathogenic Escherichia coli 10 valent (ExPEC10V) in Japanese participants greater than or equal to (>=) 60 to less than or equal to (<=) 85 years of age.

Enrollment: 24 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant must be Japanese as determined by participant's verbal report
• Must be healthy or medically stable, in the investigator's clinical judgment, as confirmed by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at the screening visit
• Willing and able to adhere to the lifestyle restrictions
• Agrees not to donate blood until 12 weeks after receiving the study intervention
• Must be willing to provide verifiable identification, has means to be contacted, and to contact the investigator during the study

Exclusion criteria

• Clinically significant illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or 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 excipients
• Contraindication to Intramuscular (IM) injections and blood draws example, bleeding disorders

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Medium-dose ExPEC10V or Placebo: Group 1

Experimental group

Description:

Participants will be randomized to receive a single intramuscular (IM) injection of medium dose of ExPEC10V or Placebo on Day 1.

Treatment:

Biological: ExPEC10V

Biological: Placebo

High-dose ExPEC10V or Placebo: Group 2

Experimental group

Description:

Participants will be randomized to receive a single IM injection of high dose (based on safety assessment through Day 15 postvaccination of medium dose) of ExPEC10V or Placebo on Day 1.

Treatment:

Biological: ExPEC10V

Biological: Placebo