xml: <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/NCT06026514</url>
    </required_header>
    <id_info>
      <org_study_id>CIR 355</org_study_id>
      <nct_id>NCT06026514</nct_id>
    </id_info>
    <brief_title>Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults</brief_title>
    <official_title>A Phase I Study of the Safety and Immunogenicity of the Recombinant, Live-Attenuated, Bovine/Human Parainfluenza Virus Vector Vaccine Expressing the 6P-Prefusion-Stabilized Version of the SARS-CoV-2 Spike Protein, Administered in Two Sequential Doses as Nasal Spray to Adults 18 to 50 Years of Age</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
        <agency_class>NIH</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Johns Hopkins Bloomberg School of Public Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institutes of Health (NIH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This Phase 1 clinical trial will evaluate the safety and immunogenicity of an intranasal&#xD;
        vaccine candidate, a recombinant, live-attenuated, bovine/human parainfluenza virus vector&#xD;
        vaccine expressing the 6-P prefusion-stabilized version of the SARS-CoV-2 spike protein.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The proposed study is a single center, open label study to be conducted at the Johns Hopkins&#xD;
        Bloomberg School of Public Health, Center for Immunization Research (CIR) in Baltimore, MD.&#xD;
        Participants will be followed for 12 months after the first immunization, so the duration of&#xD;
        study participation will be 12 months after receipt of initial vaccination.&#xD;
  &#xD;
        Approximately 30 subjects will be enrolled in a rolling fashion to receive 2 doses of the&#xD;
        B/HPIV3/S-6P vaccine intranasally 56 days apart. Participants who are enrolled and receive&#xD;
        the first vaccine dose will not be replaced, even in the event they are ineligible or unable&#xD;
        to take the second dose.&#xD;
  &#xD;
        Up to 60 subjects will be consented to ensure that 30 subjects are eligible for enrollment&#xD;
        and vaccination. Volunteers will be enrolled in a staggered fashion:&#xD;
  &#xD;
        Group 1: Up to 5 volunteers will be enrolled and vaccinated. Group 2: Up to 10 volunteers&#xD;
        will be enrolled and vaccinated. Group 3: The remaining volunteers (up to 15) will be&#xD;
        enrolled and vaccinated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">November 2024</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>Sequential Assignment</intervention_model>
      <intervention_model_description>Recombinant, Live-Attenuated, Bovine/Human Parainfluenza Virus Vector Vaccine Expressing the 6P-Prefusion-Stabilized Version of the SARS-CoV-2 Spike Protein, Administered in two Sequential Doses as Nasal Spray to Adults 18 to 50 Years of Age</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To determine the frequency of vaccine-related solicited adverse events (AEs)</measure>
      <time_frame>During study days 0 to 28 and 56 to 84 (28 days after each dose)</time_frame>
      <description>Summary and line listing of individual clinical solicited of the frequency of solicited AEs</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To determine the frequency of vaccine-related unsolicited AEs</measure>
      <time_frame>During study days 0 to 28 and 56 to 84 (28 days after each dose)</time_frame>
      <description>Summary and line listing of individual clinical solicited of the frequency of unsolicited AEs</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To determine the frequency of vaccine-related lower respiratory illness</measure>
      <time_frame>During study days 0 to 28 and 56 to 84 (28 days after each dose)</time_frame>
      <description>Summary and line listing of individual clinical solicited of the frequency of vaccine-related lower respiratory illness</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Vaccine virus shedding on 1 or more days</measure>
      <time_frame>On Days 4, 7, and 10, and 60, 63, and 66</time_frame>
      <description>As assessed by culture, or rRT-PCR</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evidence of a &gt;4-fold rise in HPIV3 antibody titers</measure>
      <time_frame>When comparing pre-vaccination titers day 29, 56 or 90</time_frame>
      <description>Using PRNT60 or ELISA</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rise in serum neutralizing antibody titer to SARS-CoV-2 S protein</measure>
      <time_frame>On days 63, 70, 84, 180, 360</time_frame>
      <description>Will be measured by ELISA and neutralization assay</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>SARS-CoV-2 Infection</condition>
    <arm_group>
      <arm_group_label>Intranasal Vaccine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>B/HPIV3/S-6P vaccine intranasally given in 2 doses, 56 days apart.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>B/HPIV3/S-6P</intervention_name>
      <description>Intranasal vaccine.</description>
      <arm_group_label>Intranasal Vaccine</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Nonpregnant adults between 18 years and 50 years of age, inclusive.&#xD;
  &#xD;
            2. General good health, without significant medical illness, physical examination&#xD;
               findings, or significant laboratory abnormalities as determined by the investigator.&#xD;
  &#xD;
            3. Demonstrates comprehension of the protocol procedures and knowledge of the trial by&#xD;
               passing a written comprehension examination (passing grade &gt; 70%).&#xD;
  &#xD;
            4. Available for the duration of the trial.&#xD;
  &#xD;
            5. Willingness to participate in the study and cooperate with the study procedures as&#xD;
               evidenced by signing the informed consent document.&#xD;
  &#xD;
            6. Persons of childbearing potential must have used effective birth control methods for&#xD;
               at least one month prior to vaccination, and agree to continue with 'per label/fully&#xD;
               effective use' for the chosen method for the duration of the study (30 days prior to&#xD;
               first vaccination until 12 months after first vaccination), from amongst these:&#xD;
  &#xD;
                 -  pharmacologic/hormonal contraceptives, including oral, parenteral, subcutaneous,&#xD;
                    and transcutaneous delivery;&#xD;
  &#xD;
                 -  condoms or diaphragm with spermicide;&#xD;
  &#xD;
                 -  intrauterine device;&#xD;
  &#xD;
                 -  absolute abstinence from heterosexual intercourse as a matter of normal preferred&#xD;
                    lifestyle;&#xD;
  &#xD;
                 -  or must be surgically sterile or have documented menopause, having had no menses&#xD;
                    at all for at least one full year.&#xD;
  &#xD;
               All persons of childbearing potential must provide samples for urine and serum&#xD;
               pregnancy testing prior to enrollment and prior to vaccination. Pregnancy risk&#xD;
               assessment and pregnancy prevention counseling will occur at each point of contact.&#xD;
  &#xD;
            7. Willingness to refrain from blood donation during participation in the study and for&#xD;
               at least 1 year after receiving the second dose of vaccine.&#xD;
  &#xD;
            8. Willingness to refrain from receiving vaccines or other investigational products&#xD;
               during the first 90 days of the study after enrollment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnancy as determined by a positive human choriogonadotropin (ßHCG) test in a person&#xD;
               of reproductive capacity.&#xD;
  &#xD;
            2. Currently breastfeeding.&#xD;
  &#xD;
            3. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic,&#xD;
               rheumatologic, autoimmune, or renal disease by history, physical examination,&#xD;
               electrocardiogram (EKG), and/or laboratory studies.&#xD;
  &#xD;
            4. Behavioral or cognitive impairment or psychiatric disease that in the opinion of the&#xD;
               investigator affects the ability of the subject to understand and cooperate with the&#xD;
               study protocol.&#xD;
  &#xD;
            5. A history of asthma within the past 5 years, or a current diagnosis of asthma or&#xD;
               reactive airway disease associated with exercise, seasonal hay fever or allergic&#xD;
               rhinitis.&#xD;
  &#xD;
            6. Presence of any febrile illness or symptoms suggestive of a respiratory infection&#xD;
               within 2 weeks prior to inoculation.&#xD;
  &#xD;
            7. Use of systemic or nasal steroid preparations or immunosuppressive drugs within 30&#xD;
               days prior to vaccination. Topical steroid preparations are permitted.&#xD;
  &#xD;
            8. Inhaled bronchodilator or inhaled steroid use within the last year or use after upper&#xD;
               respiratory tract infections within the last 5 years.&#xD;
  &#xD;
            9. Current or past (in the last 4 weeks) use of intranasal medications (including&#xD;
               steroids, decongestants, or hormonal medications), or planning to use them within 28&#xD;
               days of study vaccination.&#xD;
  &#xD;
           10. Evidence of current alcohol or illicit drug abuse or addiction.&#xD;
  &#xD;
           11. Other condition that in the opinion of the investigator would jeopardize the safety or&#xD;
               rights of a subject participating in the trial or would render the subject unable to&#xD;
               comply with the protocol.&#xD;
  &#xD;
           12. Positive ELISA and confirmatory tests for human immunodeficiency virus (HIV).&#xD;
  &#xD;
           13. Positive ELISA and confirmatory test (e.g., recombinant immunoblot assay) for&#xD;
               hepatitis C virus (HCV).&#xD;
  &#xD;
           14. Positive hepatitis B virus surface antigen (HBsAg) by ELISA.&#xD;
  &#xD;
           15. Known immunodeficiency syndrome.&#xD;
  &#xD;
           16. Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to&#xD;
               receipt of the study vaccine or planned receipt within 90 days after vaccination.&#xD;
               (Exception, influenza vaccine may be obtained more than 2 weeks after or prior to the&#xD;
               study vaccine).&#xD;
  &#xD;
           17. History of a surgical splenectomy.&#xD;
  &#xD;
           18. Receipt of blood or blood-derived products (including immunoglobulin [Ig]) within 6&#xD;
               months prior to study inoculation.&#xD;
  &#xD;
           19. Has participated in another investigational study involving any investigational&#xD;
               product within 30 days, or 5 half-lives, whichever is longer, before the first vaccine&#xD;
               administration.&#xD;
  &#xD;
           20. Body mass index (BMI) &lt; 18.5 or &gt;40.&#xD;
  &#xD;
           21. Any significant abnormality of the nose or nasopharynx, including recurrent epistaxis&#xD;
               and including nasal or sinus surgery.&#xD;
  &#xD;
           22. History of Bell's palsy.&#xD;
  &#xD;
           23. Has a confirmed SARS-CoV-2 infection or COVID-19 vaccine/booster within 16 weeks prior&#xD;
               to enrollment.&#xD;
  &#xD;
           24. Unwillingness to have nasopharyngeal (NP) or blood samples saved for future&#xD;
               respiratory virus research.&#xD;
  &#xD;
           25. Pulmonary function test (PFT) testing for FVC, FEV1, FEV1% and PEF of &lt;80 or incentive&#xD;
               spirometer value &lt; normal parameters based on gender, age, and height.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kawsar Talaat, MD</last_name>
      <phone>410-336-9164</phone>
      <email>ktalaat@jhu.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Johns Hopkins Bloomberg School of Public Health</name>
        <address>
          <city>Baltimore</city>
          <state>Maryland</state>
          <zip>20215</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kawsar Talaat, MD</last_name>
        <phone>410-336-9164</phone>
        <email>ktalaat@jhu.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026514
  org study id: CIR 355
  nct id: NCT06026514
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This Phase 1 clinical trial will evaluate the safety and immunogenicity of an intranasal
        vaccine candidate, a recombinant, live-attenuated, bovine/human parainfluenza virus vector
        vaccine expressing the 6-P prefusion-stabilized version of the SARS-CoV-2 spike protein.
  The proposed study is a single center, open label study to be conducted at the Johns Hopkins
        Bloomberg School of Public Health, Center for Immunization Research (CIR) in Baltimore, MD.
        Participants will be followed for 12 months after the first immunization, so the duration of
        study participation will be 12 months after receipt of initial vaccination.
  
        Approximately 30 subjects will be enrolled in a rolling fashion to receive 2 doses of the
        B/HPIV3/S-6P vaccine intranasally 56 days apart. Participants who are enrolled and receive
        the first vaccine dose will not be replaced, even in the event they are ineligible or unable
        to take the second dose.
  
        Up to 60 subjects will be consented to ensure that 30 subjects are eligible for enrollment
        and vaccination. Volunteers will be enrolled in a staggered fashion:
  
        Group 1: Up to 5 volunteers will be enrolled and vaccinated. Group 2: Up to 10 volunteers
        will be enrolled and vaccinated. Group 3: The remaining volunteers (up to 15) will be
        enrolled and vaccinated.
  allocation: N/A
  intervention model: Sequential Assignment
  intervention model description: Recombinant, Live-Attenuated, Bovine/Human Parainfluenza Virus Vector Vaccine Expressing the 6P-Prefusion-Stabilized Version of the SARS-CoV-2 Spike Protein, Administered in two Sequential Doses as Nasal Spray to Adults 18 to 50 Years of Age
  primary purpose: Prevention
  masking: None (Open Label)
  measure: To determine the frequency of vaccine-related solicited adverse events (AEs)
  time frame: During study days 0 to 28 and 56 to 84 (28 days after each dose)
  description: Summary and line listing of individual clinical solicited of the frequency of solicited AEs
  measure: To determine the frequency of vaccine-related unsolicited AEs
  time frame: During study days 0 to 28 and 56 to 84 (28 days after each dose)
  description: Summary and line listing of individual clinical solicited of the frequency of unsolicited AEs
  measure: To determine the frequency of vaccine-related lower respiratory illness
  time frame: During study days 0 to 28 and 56 to 84 (28 days after each dose)
  description: Summary and line listing of individual clinical solicited of the frequency of vaccine-related lower respiratory illness
  measure: Vaccine virus shedding on 1 or more days
  time frame: On Days 4, 7, and 10, and 60, 63, and 66
  description: As assessed by culture, or rRT-PCR
  measure: Evidence of a >4-fold rise in HPIV3 antibody titers
  time frame: When comparing pre-vaccination titers day 29, 56 or 90
  description: Using PRNT60 or ELISA
  measure: Rise in serum neutralizing antibody titer to SARS-CoV-2 S protein
  time frame: On days 63, 70, 84, 180, 360
  description: Will be measured by ELISA and neutralization assay
  arm group label: Intranasal Vaccine
  arm group type: Experimental
  description: B/HPIV3/S-6P vaccine intranasally given in 2 doses, 56 days apart.
  intervention type: Biological
  intervention name: B/HPIV3/S-6P
  description: Intranasal vaccine.
  arm group label: Intranasal Vaccine
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kawsar Talaat, MD
  phone: 410-336-9164
  email: ktalaat@jhu.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: COVID-19