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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)

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ClinicalTrials.gov Identifier: NCT04908683
Recruitment Status : Recruiting
First Posted : June 1, 2021
Last Update Posted : November 23, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Brief Summary:
The study will enroll up to 27,200 participants in order to demonstrate the efficacy of the active Ad26.RSV.preF-based study vaccine in the prevention of Reverse Transcription Polymerase Chain Reaction (RT-PCR) confirmed Respiratory Syncytial Virus (RSV)-mediated Lower Respiratory Tract Disease (LRTD) when compared to placebo in adults aged 60 years and above.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Viruses Lower Respiratory Tract Disease Biological: Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : July 21, 2021
Estimated Primary Completion Date : October 23, 2024
Estimated Study Completion Date : November 18, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: Respiratory Syncytial Virus (RSV) vaccine
All participants in the active group will receive a single dose intramuscular (IM) injection of study vaccine on Day 1.
Biological: Adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV). preF
Participants will receive a single IM injection of an RSV vaccine.

Placebo Comparator: Group 2: Placebo
All participants in the placebo group will receive a single IM injection of matching placebo on Day 1.
Biological: Placebo
Participants will receive a single IM injection of matching placebo.




Primary Outcome Measures :
  1. 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 24 months ]
    Percentage of participants with protocol defined RT-PCR confirmed RSV mediated LRTD will be reported.


Secondary Outcome Measures :
  1. Percentage of Participants with RT-PCR Confirmed RSV-mediated Acute Respiratory Infection (ARI) [ Time Frame: Up to 24 months ]
    Percentage of participants with RT-PCR confirmed RSV-mediated ARI will be reported.

  2. Percentage of Participants with RT-PCR Confirmed RSV-mediated Lower Respiratory Tract Disease (LRTD) During the Second Year [ Time Frame: From Month 12 to Month 24 ]
    Percentage of participants with RT-PCR confirmed RSV-mediated LRTD during the second year will be reported.

  3. Percentage of participants with RT-PCR Confirmed RSV-mediated ARI During the Second Year [ Time Frame: From Month 12 to Month 24 ]
    Percentage of participants with RT-PCR confirmed RSV-mediated ARI during the second year will be reported.

  4. Percentage of Participants with Predefined Clinically Relevant Disease Associated with RT-PCR-confirmed RSV-mediated ARI Over the Whole Study [ Time Frame: Up to 24 months ]
    Percentage of participants with predefined clinically relevant disease associated with RT-PCR confirmed RSV mediated ARI over the whole study will be reported.

  5. Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 6 months ]
    An adverse event (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. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  6. Percentage of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Up to 6 months ]
    Percentage of participants with AESIs will be reported. Confirmed thrombosis with thrombocytopenia syndrome (TTS) is considered to be an AESI in this study.

  7. Percentage of Participants with Solicited Local Adverse Events (AEs) [ Time Frame: 7 days after Vaccination (Day 8) ]
    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 are pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their ediary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs are: injection site pain/tenderness, erythema and swelling at the vaccination site.

  8. Percentage of Participants with Solicited Systemic AEs [ Time Frame: 7 days after Vaccination (Day 8) ]
    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. Participants will be instructed on how to note signs and symptoms in the electronic diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events will include fatigue, headache, nausea, and myalgia.

  9. Percentage of Participants with Unsolicited AEs [ Time Frame: 28 days after Vaccination (Day 29) ]
    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 are all AEs for which the participant is not specifically questioned in the participant eDiary.

  10. RSV Neutralizing Antibody Levels [ Time Frame: Up to 24 months ]
    Analysis of neutralizing antibodies to the RSV A strain will be reported.

  11. RSV preF and/or postF Protein Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: Up to 24 months ]
    Antibodies binding to RSV F protein in pre-fusion and/or post-fusion form will be assessed by ELISA.

  12. Interferon Gamma (IFN-gamma) Enzyme-Linked Immunospot (ELISpot) Assay [ Time Frame: Up to 24 months ]
    RSV F-specific cellular immune responses elicited by the different vaccine regimens.

  13. 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 24 months ]

    RiiQ is a 4-point scale and it can be scored as a mean of all scores (total symptom scale score) or 2 subscales scores that is respiratory symptoms and systemic symptoms. Respiratory symptoms subscale score is the mean of 6 symptoms, that is, 2 upper respiratory tract infection (URTI) symptoms (nasal congestion and sore throat) and 4 lower respiratory tract infection (LRTI) symptoms (cough, wheezing, shortness of breath, and coughing up phlegm/sputum) whereas systemic symptom subscale score is the mean of 7 systemic symptoms (headache, feeling feverish, neck pain, body aches and pain, fatigue/tiredness, interrupted sleep, and loss of appetite). Each symptom is rated on the scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicating greater severity.

    The area under the curve during the ARI episode is determined.




Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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)

Information from the National Library of Medicine

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): NCT04908683


Contacts
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Contact: Study Contact 844-434-4210 Participate-In-This-Study@its.jnj.com

Locations
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Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
Investigators
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Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
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Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT04908683    
Other Study ID Numbers: CR108959
2020-005458-97 ( EudraCT Number )
VAC18193RSV3001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: June 1, 2021    Key Record Dates
Last Update Posted: November 23, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Vaccines & Prevention B.V.:
Acute Respiratory Infections
Vaccine
Ad26.RSV.preF-based Vaccine
Additional relevant MeSH terms:
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Respiratory Tract Diseases