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A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04453202
Recruitment Status : Completed
First Posted : July 1, 2020
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Tracking Information
First Submitted Date  ICMJE June 29, 2020
First Posted Date  ICMJE July 1, 2020
Last Update Posted Date September 28, 2021
Actual Study Start Date  ICMJE July 16, 2020
Actual Primary Completion Date September 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
  • Cohort 1: RSV Fusion Protein (F Protein) Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: 14 days after vaccination (Day 15) ]
    Antibodies binding to RSV F protein in pre-fusion form will be assessed by ELISA.
  • Cohorts 2 and 3: Number of Participants with Solicited Local Adverse Events (AEs) After Vaccination [ Time Frame: 7 days after vaccination (Day 1 to Day 8) ]
    An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment. Solicited local AEs (including erythema, swelling, and pain/tenderness at the study vaccine injection site) will be noted in the participant diary after 7 days of vaccination.
  • Cohorts 2 and 3: Number of Participants with Solicited Systemic AEs After Vaccination [ Time Frame: 7 days after vaccination (Day 1 to Day 8) ]
    Solicited systemic AEs (fatigue, headache, myalgia, nausea and fever) will be noted in the participant diary after 7 days of vaccination.
  • Cohorts 2 and 3: Number of Participants with Unsolicited AEs After Vaccination [ Time Frame: 28 days after vaccination (Day 1 to Day 29) ]
    Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
  • Cohorts 1, 2 and 3: RSV preF Protein Binding Antibodies by Enzyme-linked Immunosorbent Assay (ELISA) [ Time Frame: Cohort 1: Day 85 and 183; Cohorts 2 and 3: Day 15, 85 and 183 ]
    Antibodies binding to RSV F protein in pre-fusion form will be assessed by ELISA.
  • Cohorts 1, 2 and 3: RSV A2 Neutralizing Antibody Levels [ Time Frame: Days 15, 85, and 183 ]
    Analysis of neutralizing antibodies to the A2 strain.
  • Cohorts 1, 2 and 3: Interferon Gamma (IFN-gamma) Enzyme-Linked Immunospot (ELISpot) Assay [ Time Frame: Days 15, 85, and 183 ]
    RSV F-specific cellular immune responses elicited by the different vaccine regimens.
  • Cohorts 1, 2 and 3: Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: First vaccination (Day 1) to the end of the study (up to Day 183) ]
    A SAE is any untoward medical occurrence that at any dose: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
  • Cohort 1: Number of Participants with Solicited Local AEs After Vaccination [ Time Frame: 7 days after vaccination (Day 1 to Day 8) ]
    Solicited local AEs (including erythema, swelling, and pain/tenderness at the study vaccine injection site) will be noted in the participant diary after 7 days of vaccination.
  • Cohort 1: Number of Participants with Solicited Systemic AEs After Vaccination [ Time Frame: 7 days after vaccination (Day 1 to Day 8) ]
    Solicited systemic AEs (fatigue, headache, myalgia, nausea and fever) will be noted in the participant diary after 7 days of vaccination.
  • Cohort 1: Number of Participants with Unsolicited AEs After Vaccination [ Time Frame: 28 days after vaccination (Day 1 to Day 29) ]
    Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels of an Ad26.RSV.preF-based Vaccine in Adults Aged 60 Years and Older
Brief Summary The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: RSV Vaccine
    Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
  • Other: Placebo
    Participants will receive a single IM injection of placebo on Day 1.
Study Arms  ICMJE
  • Experimental: Cohort 1 Group 1: RSV Vaccine
    Participants will receive a single intramuscular (IM) injection of an Ad26-based RSV vaccine on Day 1.
    Intervention: Biological: RSV Vaccine
  • Experimental: Cohort 1 Group 2: RSV Vaccine
    Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 1) on Day 1.
    Intervention: Biological: RSV Vaccine
  • Experimental: Cohort 1 Group 3: RSV Vaccine
    Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 2) on Day 1.
    Intervention: Biological: RSV Vaccine
  • Experimental: Cohort 1 Group 4: RSV Vaccine
    Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 3) on Day 1.
    Intervention: Biological: RSV Vaccine
  • Placebo Comparator: Cohort 1 Group 5: Placebo
    Participants will receive IM injection of placebo on Day 1.
    Intervention: Other: Placebo
  • Experimental: Cohort 2 Group 6: RSV Vaccine
    Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
    Intervention: Biological: RSV Vaccine
  • Experimental: Cohort 2 Group 7: RSV Vaccine
    Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 1) on Day 1.
    Intervention: Biological: RSV Vaccine
  • Placebo Comparator: Cohort 2 Group 8: Placebo
    Participants will receive IM injection of placebo on Day 1.
    Intervention: Other: Placebo
  • Experimental: Cohort 3 Group 9: RSV Vaccine
    Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
    Intervention: Biological: RSV Vaccine
  • Experimental: Cohort 3 Group 10: RSV Vaccine
    Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 2) on Day 1.
    Intervention: Biological: RSV Vaccine
  • Experimental: Cohort 3 Group 11: Placebo
    Participants will receive IM injection of placebo on Day 1.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2020)
459
Original Estimated Enrollment  ICMJE
 (submitted: June 29, 2020)
450
Actual Study Completion Date  ICMJE April 9, 2021
Actual Primary Completion Date September 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • In the investigator's clinical judgment, participants must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their signs and symptoms are stable and medically controlled in the judgment of the investigator. Participants will be included on the basis of medical history and of physical examination and vital signs performed at screening (all cohorts), and of physical examination and/or vital signs performed prevaccination on Day 1 (Cohorts 2 and 3)
  • A woman must be postmenopausal (defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods
  • Agree to not donate blood from the time of vaccination until 3 months after vaccination
  • Have a body mass index (BMI) less than (<) 40 kilogram per meter square (kg/m^2)
  • Be willing to provide verifiable identification and have means to be contacted and to contact the investigator during the study

Exclusion Criteria:

  • Has a contraindication to intramuscular injection (IM) injections and blood draws (example, bleeding disorders)
  • Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine components (including any of the constituents of the study vaccine)
  • History of chronic urticaria (recurrent hives), eczema, or atopic dermatitis
  • Has hepatitis B or C infection, including history of treated hepatitis C infection
  • Received an active RSV vaccine in a previous RSV vaccine study or an Ad26-vectored vaccine at any time prior to randomization
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04453202
Other Study ID Numbers  ICMJE CR108835
VAC18193RSV2005 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Janssen Vaccines & Prevention B.V.
Study Sponsor  ICMJE Janssen Vaccines & Prevention B.V.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
PRS Account Janssen Vaccines & Prevention B.V.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP