<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03795441</url>
  </required_header>
  <id_info>
    <org_study_id>CR108554</org_study_id>
    <secondary_id>2018-003261-34</secondary_id>
    <secondary_id>VAC18193RSV1005</secondary_id>
    <nct_id>NCT03795441</nct_id>
  </id_info>
  <brief_title>A Shedding Study of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF) Vaccine in Adults</brief_title>
  <official_title>Open Label, Single Arm Phase 1 Study to Evaluate the Shedding, Biodistribution, Safety and Immunogenicity of Ad26.RSV.preF Vaccine in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Vaccines &amp; Prevention B.V.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Vaccines &amp; Prevention B.V.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the shedding and kinetics of the Adenovirus Serotype&#xD;
      26 Based Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF) vaccine after one&#xD;
      intramuscular injection of Ad26.RSV.preF in adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">July 28, 2019</completion_date>
  <primary_completion_date type="Actual">July 28, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants with Presence of Ad26.RSV.preF (shedding) as Assessed by qPCR</measure>
    <time_frame>Up to Day 183</time_frame>
    <description>Percentage of Participants with presence of Ad26.RSV.preF in the adhesive bandage covering the injection site, the injection site area, nares (mid-turbinate), throat, rectum, urine, semen and blood, will be assessed by Quantitative Polymerase Chain Reaction (qPCR). Percentage of participants with presence of Ad26.RSV.preF (shedding) will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Serious Adverse Events (SAEs)</measure>
    <time_frame>First vaccination (Day 1) to the end of the study (Day 183)</time_frame>
    <description>Number of participants with SAEs will be evaluated. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Solicited Local and Systemic Adverse Events (AEs) After Vaccination</measure>
    <time_frame>7 days after vaccination (Day 1 up to Day 7)</time_frame>
    <description>Number of participants with solicited local and systemic AEs will be evaluated. Solicited local AEs (erythema, swelling/induration, and pain/tenderness at the injection site) and solicited systemic AEs (fatigue, headache, myalgia, arthralgia, chills, nausea, and fever) will be noted in the participant diary through the 7 days post-vaccination. Local and systemic AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Unsolicited AEs as a Measure of Safety</measure>
    <time_frame>Day 1 Up to Day 28</time_frame>
    <description>Number of participants with unsolicited AEs will be evaluated. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product, and it does not necessarily have a causal relationship with the intervention, therefore an AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product. Unsolicited AEs will include all AEs for which the participant is specifically not questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Ad26.RSV.preF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive one intramuscular injection of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ad26.RSV.preF</intervention_name>
    <description>Ad26.RSV.preF will be administered as intramuscular injection on Day 1.</description>
    <arm_group_label>Ad26.RSV.preF</arm_group_label>
    <other_name>JNJ-64400141</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In the investigator's clinical judgment, participant must be in good or stable health.&#xD;
             Participants may have underlying illnesses such as hypertension, Type 2 diabetes&#xD;
             mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs&#xD;
             are medically controlled. If they are on medication for a condition, the medication&#xD;
             dose must have been stable for at least 12 weeks preceding vaccination and expected to&#xD;
             remain stable for the duration of the study. Participants will be included on the&#xD;
             basis of physical examination, medical history, vital signs measurement and 12-lead&#xD;
             electrocardiogram (ECG; for participants greater than [&gt;] 65 years of age only)&#xD;
             performed at screening&#xD;
&#xD;
          -  Contraceptive use by women should be consistent with local regulations regarding the&#xD;
             use of contraceptive methods for participants in clinical studies&#xD;
&#xD;
          -  All women of childbearing potential must have a negative highly sensitive serum&#xD;
             beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a&#xD;
             negative urine beta-hCG pregnancy test immediately prior to study vaccine&#xD;
             administration&#xD;
&#xD;
          -  From the time of vaccination through 3 months after vaccination, participant agrees&#xD;
             not to donate blood&#xD;
&#xD;
          -  Participant must be willing to provide verifiable identification, have means to be&#xD;
             contacted and to contact the investigator during the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has a serious chronic disorder, including severe chronic obstructive&#xD;
             pulmonary disease or clinically significant congestive heart failure, requirement for&#xD;
             supplemental oxygen, end-stage renal disease with or without dialysis, clinically&#xD;
             unstable cardiac disease, Alzheimer's disease, or has any condition for which, in the&#xD;
             opinion of the investigator, participation would not be in the best interest of the&#xD;
             participant (eg, compromise well-being) or that could prevent, limit, or confound the&#xD;
             protocol-specified assessments&#xD;
&#xD;
          -  Per medical history, participant has chronic active hepatitis B or hepatitis C&#xD;
             infection&#xD;
&#xD;
          -  Participant has received an investigational drug or used an invasive investigational&#xD;
             medical device within 30 days or received an investigational vaccine within 6 months&#xD;
             before the planned administration of study vaccine or is currently enrolled or plans&#xD;
             to participate in another investigational study during the course of this study&#xD;
&#xD;
          -  Participant has received treatment with immunoglobulin in the 2 months, or blood&#xD;
             products in the 4 months before the planned administration of study vaccine or has any&#xD;
             plans to receive such treatment during the study&#xD;
&#xD;
          -  Participant has received any RSV vaccine in any previous RSV vaccine study at any time&#xD;
             prior to randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Vaccines &amp; Prevention B.V. Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Vaccines &amp; Prevention B.V.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Pharmacology Unit</name>
      <address>
        <city>Merksem</city>
        <zip>2170</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>August 29, 2019</last_update_submitted>
  <last_update_submitted_qc>August 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data sharing policy of the Janssen Pharmaceutical Companies of Johnson &amp; Johnson is available at www.janssen.com/clinical-trials/transparency.&#xD;
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</ipd_description>
    <ipd_url>https://www.janssen.com/clinical-trials/transparency</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03795441
org study id: CR108554
secondary id: 2018-003261-34
secondary id: VAC18193RSV1005
nct id: NCT03795441
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to assess the shedding and kinetics of the Adenovirus Serotype
      26 Based Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF) vaccine after one
      intramuscular injection of Ad26.RSV.preF in adults.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percentage of Participants with Presence of Ad26.RSV.preF (shedding) as Assessed by qPCR
time frame: Up to Day 183
description: Percentage of Participants with presence of Ad26.RSV.preF in the adhesive bandage covering the injection site, the injection site area, nares (mid-turbinate), throat, rectum, urine, semen and blood, will be assessed by Quantitative Polymerase Chain Reaction (qPCR). Percentage of participants with presence of Ad26.RSV.preF (shedding) will be assessed.
measure: Number of Participants with Serious Adverse Events (SAEs)
time frame: First vaccination (Day 1) to the end of the study (Day 183)
description: Number of participants with SAEs will be evaluated. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
measure: Number of Participants with Solicited Local and Systemic Adverse Events (AEs) After Vaccination
time frame: 7 days after vaccination (Day 1 up to Day 7)
description: Number of participants with solicited local and systemic AEs will be evaluated. Solicited local AEs (erythema, swelling/induration, and pain/tenderness at the injection site) and solicited systemic AEs (fatigue, headache, myalgia, arthralgia, chills, nausea, and fever) will be noted in the participant diary through the 7 days post-vaccination. Local and systemic AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).
measure: Number of Participants with Unsolicited AEs as a Measure of Safety
time frame: Day 1 Up to Day 28
description: Number of participants with unsolicited AEs will be evaluated. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product, and it does not necessarily have a causal relationship with the intervention, therefore an AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product. Unsolicited AEs will include all AEs for which the participant is specifically not questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).
arm group label: Ad26.RSV.preF
arm group type: Experimental
description: Participants will receive one intramuscular injection of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) on Day 1.
intervention type: Biological
intervention name: Ad26.RSV.preF
description: Ad26.RSV.preF will be administered as intramuscular injection on Day 1.
arm group label: Ad26.RSV.preF
other name: JNJ-64400141
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Vaccines & Prevention B.V. Clinical Trial
role: Study Director
affiliation: Janssen Vaccines & Prevention B.V.
facility: 
country: Belgium
responsible party type: Sponsor
sharing ipd: Yes
ipd 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
ipd url: https://www.janssen.com/clinical-trials/transparency