Prevention of Lower Respiratory Tract Disease Caused by The respiratory syncytial virus (RSV) MedDRA version: 20.0 Level: LLT Classification code 10039247 Term: RSV infection System Organ Class: 100000004862
Conditions
Sponsors
Janssen Vaccines & Prevention B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants above the age of 18 years in stable health at the time of vaccination, according to the investigator's judgement. - Female participants must be either a. not of childbearing potential or b. of childbearing potential and practicing an acceptable effective method of contraception and agrees to remain on such a method of contraception from signing the ICF until 3 months after study vaccination, and have a negative pregnancy test immediately prior to study vaccination. For Cohort 1 only: -participant is aged 18 to 59 years (inclusive) on the day of signing the ICF For Cohort 2 only (18-59 years): -participant is aged 18 to 59 years (inclusive) on the day of signing the ICF - has an existing chronic heart or lung condition, without hospitalizations or major medication class change (ie, new or stopped medications) within 30 days prior to screening, meeting the following criteria (based on Falsey et al. [2005]): a. Cardiac disease: at least Class II symptoms per New York Heart Association classification b. Pulmonary disease: activity-restricting symptoms or use of long-term medications. - participant may have other underlying illnesses 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. For Cohort 3 only: -participant is aged 65 years or older on the day of signing the ICF - participant may have underlying illnesses such as hypertension, congestive heart failure, COPD, 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: 1. history of malignancy within 5 years before screening which is not considered cured or with risk of recurrence, other than squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix 2. 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) 3. abnormal function of the immune system resulting from some clinical conditions, use of corticosteroids, immunomodulating agents or antineoplastic agents 4. per medical history, participant has chronic active hepatitis B or hepatitis C infection. 5. per medical history, participant has HIV type 1 or type 2 infection. 6. history of acute polyneuropathy (eg, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy. 7. received hematopoietic stem cell transplant in medical history, treatment with immunoglobulins (including monoclonal antibodies for chronic underlying conditions) in the 2 months, immunoglobulins specific to RSV, human metapneumovirus, or parainfluenza viruses in the 12 months, apheresis therapies in the 4 months, or blood products in the 4 months before the planned administration of the study vaccine or has any plans to receive such treatment during the study. 8. history of TTS or heparin-induced thrombocytopenia and thrombosis (HITT). 9. participant who is pregnant, breastfeeding or planning to become pregnant while enrolled in the study. 10. received or plans to receive: a. Licensed live attenuated vaccines within 28 days before or after planned administration of the study vaccine. b. Other licensed (not live) vaccines within 14 days before or after planned administration of the study vaccine. 11. received or plans to receive a SARS-COV-2 vaccine (licensed or used under EUA): a. Live attenuated SARS-COV-2 vaccine within 28 days before or after planned administration of the study vaccine. b. Non-live SARS-COV-2 vaccine within 14 days before or after planned administration of the study vaccine. c. A viral-vectored SARS-COV-2 vaccine within 28 days prior to randomization or during the study period until 28 days after the study vaccination. 12. received an RSV vaccine in a previous RSV vaccine study. 13. received or plans to receive an Ad26-vectored vaccine at any time prior to randomization until 28 days after the last study vaccination, other than a SARS-COV-2 vaccine. 14. received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of the study vaccine or is currently enrolled or plans to participate in another investigational study during this study. 15. has a serious chronic disorder, eg, 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 (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. 16. has had major surgery within 4 weeks before administration of the study vaccine or will not have recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study. 17.has had major psychiatric illness and/or drug or alcohol abuse which in the investigator’s opinion would compromise the participan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To assess the safety and reactogenicity of Ad26.RSV.preF-based RSV vaccine in healthy adults aged 18 to 59 years 2. To assess the safety and reactogenicity of Ad26.RSV.preF-based RSV vaccine in adults aged 18 to 59 years at high-risk of severe RSV disease 3. To demonstrate the non-inferiority of the humoral response to the administration of Ad26.RSV.preF-based vaccine in adults aged 18 to 59 years versus in adults aged 65 years and older 4. If non-inferiority is demonstrated in adults: To demonstrate the non-inferiority of the humoral response to the administration of Ad26.RSV.preF-based vaccine in high-risk adults aged 18 to 59 years versus in adults aged 65 years and older;Secondary Objective: 1. Investigate the vaccine-induced immune responses post-vaccination 2. To assess the seroresponse rate postvaccination in the Immuno Subset;Primary end point(s): 1. Solicited local (injection site) and systemic AEs for 7 days after vaccination 2. Unsolicited AEs for 28 days after vaccination 3. SAEs and AESIs until 6 months after vaccination 4. pre-F ELISA antibody titers at 14 days after vaccination in the Immuno Subset 5. pre-F ELISA antibody titers at 14 days after vaccination in the Immuno Subset;Timepoint(s) of evaluation of this end point: - 7, 14, 28 days after vaccination - SAEs and AESIs until 6 months after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. pre-F ELISA antibody titers at 6 months after vaccination 2. Pre-F ElISA seroresponse rate at Day 15;Timepoint(s) of evaluation of this end point: day 15 and 6 months after vaccination | — |
Countries
Belgium, Germany, Spain, Sweden, United States
Contacts
Public ContactGLOBAL CLÍNICAL OPERATIONS
JANSSEN CILAG, S.A.
Outcome results
None listed