A Randomized, Double-blind Phase 3 Study to Assess the Immunogenicity and Safety of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years

ClinicalTrials.gov processed this data on October 11, 2023. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED - HAS RESULTS
 (See Contacts and Locations)
Verified October 2023 by Janssen Vaccines & Prevention B.V.

Sponsor

Janssen Vaccines & Prevention B.V.

Information Provided by (Responsible Party)

Janssen Vaccines & Prevention B.V.

Clinicaltrials.gov Identifier

NCT05101486
Other Study ID Numbers: CR109069
First Submitted: October 29, 2021
First Posted: November 1, 2021
Results First Posted: September 6, 2023
Last Update Posted: October 13, 2023
Last Verified: October 2023
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Respiratory Syncytial Virus Prevention
  • Biological: Ad26.RSV.PreF-based Vaccine

Study Design

Study TypeInterventional
Actual Enrollment755 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposePrevention
Official TitleA Randomized, Double-blind Phase 3 Study to Assess the Immunogenicity and Safety of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
Study Start DateNovember 1, 2021
Actual Primary Completion DateMarch 28, 2022
Actual Study Completion DateSeptember 20, 2022

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • Group 1: 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).
  • Biological: Ad26.RSV.PreF-based Vaccine
    • Ad26.RSV.PreF-based Vaccine will be administered as single IM injection.
  • Group 2: Ad26.RSV.PreF-based Vaccine
    • Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 1).
  • Biological: Ad26.RSV.PreF-based Vaccine
    • Ad26.RSV.PreF-based Vaccine will be administered as single IM injection.
  • Group 3: Ad26.RSV.PreF-based Vaccine
    • Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 2).
  • Biological: Ad26.RSV.PreF-based Vaccine
    • Ad26.RSV.PreF-based Vaccine will be administered as single IM injection.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.
  2. 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).
  3. 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).
  4. 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.
  5. 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.
  6. 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.

Eligibility Criteria

Ages Eligible for Study 60 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study All
Accepts Healthy Volunteers No
Inclusion Criteria
  • 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
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 conditions or medication
  • Per medical history, participant has chronic active hepatitis B or hepatitis C infection
  • History of acute polyneuropathy (example, Guillain-BarrĂ© 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

Contacts and Locations

Sponsors and Collaborators Janssen Vaccines & Prevention B.V.
Locations
  • North Alabama Research Center, LLC | Athens, Alabama, United States, 35611
  • Achieve Clinical Research, LLC | Vestavia Hills, Alabama, United States, 35216
  • Hope Research Institute | Phoenix, Arizona, United States, 85023
  • Clinical Research Consulting | Milford, Connecticut, United States, 06460
  • Accel Research Sites | DeLand, Florida, United States, 32720
  • Pharmax Research Clinic Inc | Miami, Florida, United States, 33126
  • Suncoast Research Group | Miami, Florida, United States, 33135
  • Suncoast Research Associates, LLC | Miami, Florida, United States, 33173
  • Atlanta Center for Medical Research | Atlanta, Georgia, United States, 30331
  • Centennial Medical Group | Elkridge, Maryland, United States, 21075
  • Be Well Clinical Studies | Lincoln, Nebraska, United States, 68516
  • American Health Network, LLC | Charlotte, North Carolina, United States, 28277
  • CTI Clinical Trial and Consulting Services | Cincinnati, Ohio, United States, 45212
Investigators

    Study Documents (Full Text)

    More Information

    Additional Relevant MeSH Terms