A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older

• Register: ClinicalTrials.gov
• Last refreshed on: 21 June 2021
• Main ID: NCT04908683
• Date of registration: 27/05/2021
• Prospective Registration: Yes
• Primary sponsor: Janssen Vaccines & Prevention B.V.
• Public title: A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older EVERGREEN
• Scientific title: A Randomized, Double-blind, Placebo-controlled Phase 3 Efficacy Study of an Ad26.RSV.preF-based Vaccine in the Prevention of Lower Respiratory Tract Disease Caused by RSV in Adults Aged 60 Years and Older
• Date of first enrolment: July 26, 2021
• Target sample size: 23000
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT04908683
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Australia, Brazil, Canada, Chile, Estonia, Finland, Japan, New Zealand, Poland, South Africa, Taiwan, Thailand, United Kingdom, United States

Contacts

• Name: Study Contact

• Name: Janssen Vaccines & Prevention B.V. Clinical Trial
• Affiliation: Janssen Vaccines & Prevention B.V.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Must be able to work with smartphones/tablets/computers

- From the time of vaccination through 3 months after vaccination, participant agrees
not to donate blood

- Must be willing to provide verifiable identification, has means to be contacted and to
contact the investigator during the study

- 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

- Participants must sign an Inform Consent Form (ICF) indicating that the participant
understands the purpose, procedures and potential risks and benefits of the study, and
is willing to participate in the study

Exclusion Criteria:

- Has a serious clinically unstable condition, (example, end-stage renal disease with or
without dialysis, clinically unstable cardiac disease), Alzheimer's disease, or any
other 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, confound, or limit the protocol specified assessments

- History of malignancy within 5 years before screening or revaccination not in the
following categories: a. Participants with squamous and basal cell carcinomas of the
skin and carcinoma in situ of the cervix may be enrolled at the discretion of the
investigator; b. Participants with a history of malignancy within 5 years, which is
considered cured with minimal risk of recurrence per investigator's judgement, can be
enrolled

- Had major surgery (example, major cardiopulmonary or abdominal operations) as per the
investigator's judgment within 4 weeks before vaccination, or will not have fully
recovered from surgery, or has major surgery planned during the time the participant
is expected to participate in the study

- Employee of the investigator or study site, with direct involvement in the proposed
study or other studies under the direction of that investigator or study site, as well
as family members of the employees or the investigator, or an employee of the sponsor

- Contraindication to Intramuscular (IM) injections and blood draws (example, bleeding
disorders)

- Known or suspected allergy or history of anaphylaxis or other serious adverse
reactions to vaccines or vaccine components (including any of the constituents of the
study vaccine)



Age minimum: 60 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Lower Respiratory Tract Disease

Respiratory Syncytial Viruses

Intervention(s)

Biological: Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF

Biological: Placebo

Primary Outcome(s)

Percentage of Participants with Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV) mediated Lower Respiratory Tract Disease (LRTD) [Time Frame: Up to 19 months]

Secondary Outcome(s)

Area Under the Curve (AUC) of the Change from Baseline in Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Total Symptom Scale Score [Time Frame: Baseline up to 21 months]

Interferon Gamma (IFN-gamma) Enzyme-Linked Immunospot (ELISpot) Assay [Time Frame: Up to 21 months]

Percentage of Participants with Adverse Events of Special Interest (AESIs) [Time Frame: Up to 21 months]

Percentage of Participants with predefined clinically relevant disease associated with RT-PCR-confirmed RSV-mediated ARI Over the Whole Study [Time Frame: Up to 21 months]

Percentage of Participants with RT-PCR Confirmed RSV-mediated Acute Respiratory Infection (ARI) During the First RSV Season [Time Frame: Up to 9 months]

Percentage of Participants with RT-PCR Confirmed RSV-mediated Acute Respiratory Infection (ARI) Over the Whole Study [Time Frame: Up to 21 months]

Percentage of participants with RT-PCR Confirmed RSV-mediated ARI during the Second RSV Season [Time Frame: Up to 21 months]

Percentage of Participants with RT-PCR Confirmed RSV-mediated Lower Respiratory Tract Disease (LRTD) during the Second RSV Season [Time Frame: Up to 9 months after Day 365 vaccination (Up to 21 months)]

Percentage of Participants with RT-PCR Confirmed RSV-mediated LRTD Over the Whole Study [Time Frame: Up to 21 months]

Percentage of Participants with Serious Adverse Events (SAEs) [Time Frame: Up to 21 months]

Percentage of Participants with Solicited Local Adverse Events (AEs) [Time Frame: 7 days after each Vaccination (Day 8 and Day 373)]

Percentage of Participants with Solicited Systemic AEs [Time Frame: 7 days after each Vaccination (Day 8 and Day 373)]

Percentage of Participants with Unsolicited AEs [Time Frame: 28 days after each Vaccination (Day 29 and Day 393)]

RSV Neutralizing Antibody Levels [Time Frame: Up to 21 months]

RSV preF and postF Protein Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA) [Time Frame: Up to 21 months]

Secondary ID(s)

2020-005458-97

CR108959

VAC18193RSV3001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors