Clinical trial NCT04354480: 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
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Single Vaccination of an Ad26.RSV.preF-based Regimen in Japanese Adults Aged 60 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2020-04-21
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of Participants with Solicited Local Adverse Events (AEs) After Vaccination
timeFrame: 7 days after vaccination (Day 1 to Day 8)
measure: Number of Participants with Solicited Systemic Adverse Events (AEs) After Vaccination
timeFrame: 7 days after vaccination (Day 1 to Day 8)
measure: Number of Participants with Unsolicited AEs
timeFrame: 28 days after vaccination (Day 1 to Day 29)
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: First vaccination (Day 1) to the end of the study (up to Day 183)
Secondary outcomes:
measure: RSV Neutralization Assay
timeFrame: Day 1 (pre-vaccination), Days 14, 28, and 182 (post-vaccination)
measure: RSV Fusion Protein (F-Protein) Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA)
timeFrame: Day 1 (pre-vaccination), Days 14, 28, and 182 (post-vaccination)
measure: Interferon (IFN)-Gamma Enzyme-Linked Immunospot (ELISpot) Assay
timeFrame: Day 1 (pre-vaccination) and Day 29 (post-vaccination)
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Souseikai Hakata Clinic
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: