A Study to Evaluate the Single Vaccination of an Adenovirus Serotype 26 Pre-Fusion F (Ad26.preF) Based Respiratory Syncytial Virus (RSV) Vaccine in Japanese Adults Aged 60 Years and Older

NCT ID: NCT04354480

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-15
• Study Completion Date: 2021-01-20

Brief Summary

The main purpose of this study is to assess the safety and reactogenicity of the Ad26.preF based RSV vaccine administered intramuscularly as a single injection versus placebo in Japanese adults aged greater than equal to 60 years.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

RSV Vaccine

Participants will receive a single intramuscular (IM) injection of an adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV) vaccine at a single dose level on Day 1.

Group Type: EXPERIMENTAL

RSV Vaccine

Intervention Type: BIOLOGICAL

Participants will receive single IM injection of Ad26.preF RSV based vaccine on Day 1.

Placebo

Participants will receive single IM injection in the deltoid muscle of matching placebo on Day 1.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Participants will receive a single IM injection of matching placebo on Day 1.

Interventions

RSV Vaccine

Participants will receive single IM injection of Ad26.preF RSV based vaccine on Day 1.

Intervention Type: BIOLOGICAL

Placebo

Participants will receive a single IM injection of matching placebo on Day 1.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participant must be a Japanese participant whose parents and grandparents are Japanese as determined by the participant's verbal report
• Before randomization, a woman must be: postmenopausal (A postmenopausal state is defined as no menses for 12 months without an alternative medical cause); not intending to conceive by any methods
• A male participant must agree not to donate sperm for the purpose of reproduction for a minimum 28 days after receiving the dose of study vaccine
• In the investigator's clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs , and 12-lead electrocardiogram (ECG) performed at screening
• From the time of vaccination through 3 months, participant agrees not to donate blood
• Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study

Exclusion Criteria

• Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, end stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
• Participant has 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)
• Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
• Participant has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
• Participant has a history of chronic urticaria (recurrent hives), eczema and/or atopic dermatitis

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Souseikai Hakata Clinic

Fukuoka, , Japan

Countries

Japan

References

Eto T, Okubo Y, Momose A, Tamura H, Zheng R, Callendret B, Bastian AR, Comeaux CA. A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Single Vaccination of Ad26.RSV.preF-Based Regimen in Japanese Adults Aged 60 Years and Older. Influenza Other Respir Viruses. 2024 Jun;18(6):e13336. doi: 10.1111/irv.13336.

Reference Type: DERIVED

PMID: 38880785 (View on PubMed)

Other Identifiers

VAC18193RSV1006

Identifier Type: OTHER

Identifier Source: secondary_id

CR108768

Identifier Type: -

Identifier Source: org_study_id