A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
- Conditions
- Respiratory Syncytial Virus Prevention
- Interventions
- Biological: Ad26.RSV.PreF-based Vaccine
- Registration Number
- NCT05101486
- Lead Sponsor
- Janssen Vaccines & Prevention B.V.
- Brief Summary
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 755
- Before randomization, a participant must be: a) postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b) not intending to conceive by any methods
- From the time of vaccination through 3 months after vaccination, agrees not to donate blood
- In the investigator's clinical judgment, a participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, Type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider. Participants will be included on the basis of medical history and vital signs performed between informed consent form (ICF) signature and vaccination
- Must be able to read, understand, and complete questionnaires in the electronic diary (eDiary)
- Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
- Must be able to work with smartphones/tablets/computers
- Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
- Abnormal function of the immune system resulting from clinical conditions or medication
- Per medical history, participant has chronic active hepatitis B or hepatitis C infection
- History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
- Has had major surgery (per the investigator's judgment) within 4 weeks before administration of the study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 3: Ad26.RSV.PreF-based Vaccine Ad26.RSV.PreF-based Vaccine Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 2). Group 1: Ad26.RSV.PreF-based Vaccine Ad26.RSV.PreF-based Vaccine Participants will receive a single intramuscular (IM) injection of Ad26.RSV.PreF-based vaccine on Day 1 (non-aged lot). Group 2: Ad26.RSV.PreF-based Vaccine Ad26.RSV.PreF-based Vaccine Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 1).
- Primary Outcome Measures
Name Time Method Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination 14 days post vaccination on Day 1 (Day 15) GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV vaccine were reported.
- Secondary Outcome Measures
Name Time Method Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183) Number of participants with SAEs until 6 months post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days Post Vaccination 14 days post vaccination on Day 1 (Day 15) RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay at 14 days post administration of Ad26/protein preF RSV-based vaccine were expressed as 50 percent (%) inhibitory concentration (IC50) units.
Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183) Number of participants with AESIs until 6 months post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI.
Number of Participants With Unsolicited AEs for 28 Days Post Vaccination Up to 28 days post vaccination on Day 1 (up to Day 29) Number of participants with unsolicited AEs 28 days post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination Up to Day 7 post vaccination on Day 1 (up to Day 8) Number of participants with solicited local AEs 7 days post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).
Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination Up to Day 7 post vaccination on Day 1 (up to Day 8) Number of participants with solicited systemic AEs 7 days post vaccination were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic events include events such as fatigue, headache, nausea, myalgia, and pyrexia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
Trial Locations
- Locations (13)
Clinical Research Consulting
🇺🇸Milford, Connecticut, United States
North Alabama Research Center, LLC
🇺🇸Athens, Alabama, United States
Achieve Clinical Research, LLC
🇺🇸Vestavia Hills, Alabama, United States
Hope Research Institute
🇺🇸Phoenix, Arizona, United States
Accel Research Sites
🇺🇸DeLand, Florida, United States
Pharmax Research Clinic Inc
🇺🇸Miami, Florida, United States
Suncoast Research Group
🇺🇸Miami, Florida, United States
Suncoast Research Associates, LLC
🇺🇸Miami, Florida, United States
Centennial Medical Group
🇺🇸Elkridge, Maryland, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Be Well Clinical Studies
🇺🇸Lincoln, Nebraska, United States
American Health Network, LLC
🇺🇸Charlotte, North Carolina, United States
CTI Clinical Trial and Consulting Services
🇺🇸Cincinnati, Ohio, United States