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
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|ClinicalTrials.gov Identifier: NCT04354480|
Recruitment Status : Completed
First Posted : April 21, 2020
Last Update Posted : February 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Biological: RSV Vaccine Other: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Actual Study Start Date :||May 15, 2020|
|Actual Primary Completion Date :||January 20, 2021|
|Actual Study Completion Date :||January 20, 2021|
Experimental: 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.
Biological: RSV Vaccine
Participants will receive single IM injection of Ad26.preF RSV based vaccine on Day 1.
Placebo Comparator: Placebo
Participants will receive single IM injection in the deltoid muscle of matching placebo on Day 1.
Participants will receive a single IM injection of matching placebo on Day 1.
- Number of Participants with Solicited Local Adverse Events (AEs) After Vaccination [ Time Frame: 7 days after vaccination (Day 1 to Day 8) ]Number of participants with solicited local AE's will be evaluated. Solicited local AEs (including erythema, swelling, and pain/tenderness at the study vaccine injection site) will be noted in the participant diary after 7 days of vaccination.
- Number of Participants with Solicited Systemic Adverse Events (AEs) After Vaccination [ Time Frame: 7 days after vaccination (Day 1 to Day 8) ]Number of participants with solicited systemic AEs will be evaluated. Solicited systemic AEs (fatigue, headache, myalgia, nausea and fever) will be noted in the participant diary after 7 days of vaccination.
- Number of Participants with Unsolicited AEs [ Time Frame: 28 days after vaccination (Day 1 to Day 29) ]Number of participants with unsolicited AEs will be evaluated. 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 AEs will include all AEs for which the participant is not specifically questioned in the participant diary.
- Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: First vaccination (Day 1) to the end of the study (up to Day 183) ]Number of participants with SAEs will be evaluated. A 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.
- RSV Neutralization Assay [ Time Frame: Day 1 (pre-vaccination), Days 14, 28, and 182 (post-vaccination) ]Analysis of neutralizing antibodies to RSV A strain will be performed.
- RSV Fusion Protein (F-Protein) Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: Day 1 (pre-vaccination), Days 14, 28, and 182 (post-vaccination) ]Antibodies binding to RSV F-protein in pre-fusion and post-fusion forms will be assessed by ELISA.
- Interferon (IFN)-Gamma Enzyme-Linked Immunospot (ELISpot) Assay [ Time Frame: Day 1 (pre-vaccination) and Day 29 (post-vaccination) ]RSV F-specific cellular immune responses elicited by the different vaccine regimens.
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): NCT04354480
|Souseikai Hakata Clinic|
|Fukuoka, Japan, 812-0025|
|Study Director:||Janssen Pharmaceutical K.K., Japan Clinical Trial||Janssen Pharmaceutical K.K.|