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A Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health

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: NCT02926430
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Tracking Information
First Submitted Date  ICMJE September 22, 2016
First Posted Date  ICMJE October 6, 2016
Last Update Posted Date February 19, 2019
Actual Study Start Date  ICMJE November 8, 2016
Actual Primary Completion Date March 14, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2016)
  • Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1) [ Time Frame: 7 days after each vaccination (Day 1) ]
  • Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365) [ Time Frame: 7 days after each vaccination (Day 365) ]
  • Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 1) [ Time Frame: 7 days after each vaccination (Day 1) ]
  • Number of Participants With Solicited Systemic Adverse Events (AEs) for 7 Days After Each Vaccination (Day 365) [ Time Frame: 7 days after each vaccination (Day 365) ]
  • Number of Participants With Unsolicited AEs for 28 Days After Each Vaccination [ Time Frame: 28 days after each vaccination (from signing the informed consent form [ICF] to Day 29 inclusive) ]
  • Number of Participants With Serious Adverse Events (SAEs) Throughout Study [ Time Frame: Up to 730 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2016)
  • Respiratory Syncytial Virus (RSV) Neutralization A2 [ Time Frame: Days 1, 29, 183, 365, 393, 547, 730 ]
    Analysis of RSV A2 neutralizing titers of the vaccine-induced immune response will be assessed.
  • RSV Fusion Protein (F-protein) Enzyme-linked Immunosorbent Assay [ Time Frame: Days 1, 29, 183, 365, 393, 547, 730 ]
    Analysis of antibodies binding to RSV F protein in post-fusion and pre-fusion form.
  • Intracellular Cytokine Staining [ Time Frame: Day 1, 29, 183, 365, 393, 547, 730 ]
    The activation of cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) T-cell subsets and their cytokine expression patterns will be determined by flow cytometry after RSV protein peptide stimulation (including, but not limited to CD4/CD8, interleukin [IL-2], interferon gamma [IFN gamma], tumor necrosis factor alpha [TNF-alpha] and/or activation markers, memory, T-helper [cells] Th1/Th2 subtyping).
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 the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health
Official Title  ICMJE A Randomized, Double-blind, First-in-Human Phase 1 Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Vaccinations of Ad26.RSV.preF One Year Apart in Adults Aged 60 Years and Older in Stable Health
Brief Summary The purpose of this study is to assess the safety and tolerability of 2 single doses of either 5*10^10 viral particles (vp) or 1*10^11 vp of Ad26.RSV.preF, administered intramuscularly to elderly adults given approximately 12 months apart.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: Ad26.RSV.preF 5*10^10 vp
    Ad26.RSV.preF will be given at a concentration of 5*10^10 vp/0.5 milliliter (mL).
    Other Name: JNJ-64400141
  • Biological: Ad26.RSV.preF 1*10^11 vp
    Ad26.RSV.preF will be given at a concentration of 1*10^11 vp/0.5 milliliter (mL).
    Other Name: JNJ-64400141
  • Drug: Placebo
    Participants will receive placebo as formulation buffer.
Study Arms  ICMJE
  • Experimental: Ad26.RSV.preF 5*10^10 vp (Day 1 and Day 365): Group 1
    Participants will receive 5*10^10 viral particles (vp) Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination).
    Intervention: Biological: Ad26.RSV.preF 5*10^10 vp
  • Experimental: Ad26.RSV.preF 5*10^10 vp (Day 1)- Placebo (Day 365): Group 2
    Participants will receive 5*10^10 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination).
    Interventions:
    • Biological: Ad26.RSV.preF 5*10^10 vp
    • Drug: Placebo
  • Experimental: Ad26.RSV.preF 1*10^11 vp (Day 1 and Day 365): Group 3
    Participants will receive 1*10^11 vp Ad26.RSV.preF at Day 1 and Day 365 (10 to 13 months after first vaccination).
    Intervention: Biological: Ad26.RSV.preF 1*10^11 vp
  • Experimental: Ad26.RSV.preF 1*10^11 vp (Day 1)- Placebo (Day 365): Group 4
    Participants will receive 1*10^11 vp Ad26.RSV.preF at Day 1 and placebo on Day 365 (10 to 13 months after first vaccination).
    Interventions:
    • Biological: Ad26.RSV.preF 1*10^11 vp
    • Drug: Placebo
  • Experimental: Placebo (Day 1 and Day 365): Group 5
    Participants will receive placebo at Day 1 and Day 365 (10 to 13 months after first vaccination).
    Intervention: Drug: 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: November 6, 2017)
73
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2016)
72
Actual Study Completion Date  ICMJE January 29, 2019
Actual Primary Completion Date March 14, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, is willing to participate in the study and attend all scheduled visits, and is willing and able to comply with all study procedures and adhere to the prohibitions and restrictions specified in this protocol
  • Before randomization, a woman must be: postmenopausal - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; and not intending to conceive by any methods
  • From the time of first vaccination until 3 months after the first dose of study vaccine, and from the second vaccination through 3 months after, a man who has not had a vasectomy (or if a vasectomy was performed less than 1 year ago and the absence of sperm cannot be verified)
  • In the investigator's clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms/signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
  • Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the central laboratory normal reference ranges and additionally within the limits of toxicity Grades 1 or 2 according to the US Food and Drug Administration (FDA) toxicity tables (for tests in the FDA table ), the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator

Exclusion Criteria:

  • Participant has acute illness (this does not include minor illnesses such as diarrhea) or temperature greater than or equal to (>=) 38.0 degree celsius within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted
  • Participant has a serious chronic disorder, including severe chronic obstructive pulmonary disease or clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
  • Participant has had major surgery within the 4 weeks prior to randomization or has planned major surgery through the course of the study
  • Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
  • Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
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 NCT02926430
Other Study ID Numbers  ICMJE CR108214
VAC18193RSV1003 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
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 February 2019

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