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A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05083585
Recruitment Status : Recruiting
First Posted : October 19, 2021
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Brief Summary:
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses induced by vaccination with one dose of the Phase 3 clinical trial material (CTM) compared with one dose of the Phase 2b CTM.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Prevention Biological: Ad26.RSV.preF-based vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Randomized, Double-blind Phase 3 Study to Compare the Immunogenicity of Clinical Trial Material of an Ad26.RSV.preF-based Vaccine for Phase 3 With Clinical Trial Material Representative of Phase 2b in Adults Aged 60 to 75 Years
Actual Study Start Date : October 8, 2021
Estimated Primary Completion Date : July 28, 2022
Estimated Study Completion Date : July 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: Phase 3 Clinical Trial Material (CTM)
Participants will receive a single intramuscular (IM) injection of adenovirus serotype 26 (Ad26). respiratory syncytial virus (RSV). prefusion conformation-stabilized F protein (preF)-based vaccine on Day 1, which is a Phase 3 CTM.
Biological: Ad26.RSV.preF-based vaccine
Ad26.RSV.preF-based vaccine will be administered as a single intramuscular injection.

Experimental: Group 2: Phase 2b CTM
Participants will receive a single IM injection of Ad26.RSV.preF-based vaccine on Day 1, which is a Phase 2b CTM.
Biological: Ad26.RSV.preF-based vaccine
Ad26.RSV.preF-based vaccine will be administered as a single intramuscular injection.




Primary Outcome Measures :
  1. Prefusion Conformation-stabilized F Protein (pre-F) Enzyme-linked Immunosorbent Assay (ELISA) Antibody Titers [ Time Frame: 14 days after vaccination (Day 15) ]
    pre-F ELISA antibody titers at 14 days after vaccination will be reported. To demonstrate non-inferiority in terms of humoral immune responses induced by vaccination with one dose of the Phase 3 clinical trial material (CTM) compared with one dose of the Phase 2b CTM.


Secondary Outcome Measures :
  1. Number of Participants with Solicited Local Adverse Events (AEs) (Injection Site) for 7 Days after Vaccination [ Time Frame: Up to 7 days after vaccination (Up to Day 8) ]
    Number of participants with solicited local AEs (injection site) for 7 days after vaccination will be reported. Solicited local AEs include injection site pain/tenderness, erythema and swelling (mild to severe).

  2. Number of Participants with Solicited Systemic AEs for 7 Days after Vaccination [ Time Frame: Up to 7 days after vaccination (Up to Day 8) ]
    Number of participants with solicited systemic AEs for 7 days after vaccination will be reported. Solicited systemic AEs include fatigue, headache, nausea, myalgia, and fever (mild to severe).

  3. Number of Participants with Unsolicited AEs for 28 Days after Vaccination [ Time Frame: Up to 28 days after vaccination (Up to Day 29) ]
    Number of participants with unsolicited AEs for 28 days after vaccination will be reported. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.

  4. Number of Participants with Serious Adverse Events (SAEs) until 6 Months after Vaccination [ Time Frame: Up to 6 months ]
    Number of participants with SAEs until 6 months after vaccination will be reported. 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.

  5. Number of Participants with Adverse Events of Special Interest (AESIs) until 6 Months after Vaccination [ Time Frame: Up to 6 months ]
    Number of participants with AESIs until 6 months after vaccination will be reported. Thrombosis with thrombocytopenia syndrome (TTS) is considered to be an AESI.

  6. Respiratory Syncytial Virus (RSV) Neutralization Antibody (VNA_A2) Titers [ Time Frame: 14 days post vaccination (Day 15) ]
    RSV VNA titers at 14 days post vaccination will be reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing and able to adhere to the prohibitions and restrictions specified in the protocol
  • Before randomization, a participant must be postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and not intending to conceive by any methods
  • In the investigator's clinical judgment, 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 willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
  • From the time of vaccination through 3 months after vaccination, agrees not to donate blood

Exclusion Criteria:

  • 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 condition or medication
  • History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
  • History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT)
  • 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

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): NCT05083585


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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United States, California
Artemis Institute for Clinical Research Recruiting
San Diego, California, United States, 92103
Optimal Research Not yet recruiting
San Diego, California, United States, 92108
United States, Florida
Accel Research Sites Not yet recruiting
Lakeland, Florida, United States, 33803
Optimal Research Not yet recruiting
Melbourne, Florida, United States, 32934
Pharmax Research Clinic Inc Recruiting
Miami, Florida, United States, 33126
Suncoast Clinical Research Not yet recruiting
Miami, Florida, United States, 33137
Progressive Medical Research Recruiting
Port Orange, Florida, United States, 32127
United States, Ohio
Meridian Clinical Research, LLC Recruiting
Cincinnati, Ohio, United States, 45219
Meridian Clinical Research, LLC Withdrawn
Cincinnati, Ohio, United States, 45246
United States, Texas
Tekton Research Inc. Recruiting
San Antonio, Texas, United States, 78229
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.
Additional Information:
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Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT05083585    
Other Study ID Numbers: CR109065
VAC18193RSV3004 ( Other Identifier: Janssen Vaccines & Prevention B.V )
First Posted: October 19, 2021    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: January 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 and 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