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/NCT05968989</url>
    </required_header>
    <id_info>
      <org_study_id>10001614</org_study_id>
      <secondary_id>001614-I</secondary_id>
      <nct_id>NCT05968989</nct_id>
    </id_info>
    <brief_title>Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) in Healthy Adults</brief_title>
    <official_title>VRC 326 (001614): A Phase I Open-Label Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) in Healthy Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
        <agency_class>NIH</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Institutes of Health Clinical Center (CC)</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background:&#xD;
  &#xD;
        Influenza (flu) virus causes 3 to 5 million cases of severe illness and up to 650,000 deaths&#xD;
        per year worldwide. Current vaccines work well against single strains of flu virus. But no&#xD;
        single vaccine works well against all flu viruses that can cause illness.&#xD;
  &#xD;
        Objective:&#xD;
  &#xD;
        To test an experimental flu vaccine (FluMos-v2) in healthy adults.&#xD;
  &#xD;
        Eligibility:&#xD;
  &#xD;
        Healthy adults aged 18 to 50 years.&#xD;
  &#xD;
        Design:&#xD;
  &#xD;
        Participants will have 11 clinic visits in 10 months. They must agree not to get a licensed&#xD;
        flu vaccine while taking part in this study.&#xD;
  &#xD;
        FluMos-v2 will be given with a needle injected into a muscle in the upper arm. Participants&#xD;
        will receive a follow-up phone call the following day.&#xD;
  &#xD;
        Participants will be given a diary card, a ruler, and a thermometer. They will take their&#xD;
        temperature every day for 7 days after receiving the shot. They will measure any skin changes&#xD;
        at the injection site. They will record their findings and how they feel.&#xD;
  &#xD;
        Participants will receive a second FluMos-v2 shot after 4 months. They will repeat the other&#xD;
        follow-up steps.&#xD;
  &#xD;
        Participants will have 9 other clinic visits. Blood will be drawn at each visit.&#xD;
  &#xD;
        Participants should also come to the clinic if they develop flu-like symptoms during the&#xD;
        study.&#xD;
  &#xD;
        Participants may opt for an apheresis 2 weeks after each shot: Blood will be removed through&#xD;
        a needle in the vein of 1 arm. The blood will run through a machine that separates out the&#xD;
        white blood cells. The remaining blood is returned through a needle in the other arm.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Design:&#xD;
  &#xD;
        This is a Phase I, open-label, dose escalation study to evaluate the dose, safety,&#xD;
        tolerability, and immunogenicity of the mosaic hexavalent influenza vaccine VRC-&#xD;
        FLUMOS0116-00-VP (FluMos-v2). The hypotheses are that the FluMos-v2 vaccine is safe and&#xD;
        tolerable and will elicit an immune response. The primary objective is to evaluate the safety&#xD;
        and tolerability of the investigational vaccine in healthy adults. Secondary objectives are&#xD;
        related to immunogenicity of the investigational vaccine.&#xD;
  &#xD;
        Study Products:&#xD;
  &#xD;
        The investigational vaccine, FluMos-v2, was developed by the Vaccine Research Center (VRC),&#xD;
        National Institute of Allergy and Infectious Diseases (NIAID) and is composed of the&#xD;
        following 6 influenza strains:&#xD;
  &#xD;
        Influenza A:&#xD;
  &#xD;
          -  H1: A/Idaho/07/2018&#xD;
  &#xD;
          -  H2: A/Singapore/1/1957&#xD;
  &#xD;
          -  H3: A/Perth/1008/2019&#xD;
  &#xD;
          -  H3: A/Darwin/106/2020&#xD;
  &#xD;
        Influenza B:&#xD;
  &#xD;
          -  B/Victoria lineage: B/Colorado/06/2017&#xD;
  &#xD;
          -  B/Yamagata lineage: B/Phuket/3073/2013&#xD;
  &#xD;
        FluMos-v2 is supplied in a single-use vial at a target concentration of 180 mcg/mL and will&#xD;
        be administered intramuscularly (IM) in the deltoid muscle via needle and syringe.&#xD;
  &#xD;
        Subjects: Healthy adults between the ages of 18-50 years, inclusive, will be enrolled.&#xD;
  &#xD;
        Study Plan:&#xD;
  &#xD;
        The study will evaluate the safety, tolerability, and immunogenicity of FluMos-v2 in a dose&#xD;
        escalation design.&#xD;
  &#xD;
        The protocol requires 2 vaccination visits, approximately 9 follow-up visits, and 2 telephone&#xD;
        contacts, one occurring on the day after each vaccination. Solicited reactogenicity will be&#xD;
        evaluated using a 7-day diary card. Assessment of vaccine safety will include clinical&#xD;
        observation and monitoring of hematological and chemical parameters at clinical visits&#xD;
        throughout the study.&#xD;
  &#xD;
        The study schema is as follows:&#xD;
  &#xD;
        VRC 326 Vaccination Schema:&#xD;
  &#xD;
        Group 1: Subjects:12, Day 0: 60 mcg, Week 16: 60 mcg, Product: FluMos-v2&#xD;
  &#xD;
        Group 2: Subjects: 12, Day 0: 180 mcg, Week 16: 180 mcg, Product: FluMos-v2&#xD;
  &#xD;
        Total = 24 subjects (Enrollment up to 35 subjects is permitted if additional subjects are&#xD;
        needed for safety or immunogenicity evaluations.&#xD;
  &#xD;
        Study Duration:&#xD;
  &#xD;
        Subjects will be evaluated for 40 weeks following first vaccine administration, including&#xD;
        through the 2023-2024 influenza season.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 9, 2023</start_date>
    <completion_date type="Anticipated">December 16, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 16, 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To evaluate the safety and tolerability</measure>
      <time_frame>Through 40 weeks following the first vaccine administration</time_frame>
      <description>A 60 mcg dose of FluMos-v2 vaccine administered IM via needle on Day 0 and Week 16 to healthy adults.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To evaluate the safety and tolerability</measure>
      <time_frame>Through 40 weeks following the first vaccine administration</time_frame>
      <description>A 180 mcg dose of FluMos-v2 vaccine administered IM administered via needle on Day 0 and Week 16 to healthy adults.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To evaluate the antibody responses to FluMos-v2 vaccine</measure>
      <time_frame>At two weeks after each injection at Week 2 and Week 18</time_frame>
      <description>Antibody responses to a 180 mcg IM dose will be evaluated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To evaluate the antibody responses to FluMos-v2 vaccine</measure>
      <time_frame>At two weeks after each injection at Week 2 and Week 18</time_frame>
      <description>Antibody responses to a 60 mcg IM dose will be evaluated.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Influenza</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>60 mcg of FluMos-v2 on Day 0 and Week 16</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>180 mcg of FluMos-v2 on Day 0 and Week16</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>VRC-FLUMOS0116-00-VP( FLUMos-v2)</intervention_name>
      <description>The vaccine, FLUMos-v2, is composed of engineered pentamer yeast C. albican lumazine synthase assembled with 20 HA ectodomain trimers from the following 6 influenza strains:&#xD;
  Influenza A:&#xD;
  H1: A/Idaho/07/2018; H2: A/Singapore/1/1957; H3: A/Perth/1008/2019; H3: A/Darwin/106/2020&#xD;
  Influenza B:&#xD;
  B/Victoria lineage: B/Colorado/06/2017; B/Yamagata lineage: B/Phuket/3073/2013</description>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_label>Group 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          -  INCLUSION CRITERIA:&#xD;
  &#xD;
          A subject must meet all of the following criteria:&#xD;
  &#xD;
            -  Healthy adults between the ages of 18-50 years, inclusive&#xD;
  &#xD;
            -  Based on history and physical examination, in good general health and without history&#xD;
               of any of the conditions listed in the exclusion criteria&#xD;
  &#xD;
            -  Received at least one licensed influenza vaccine from 2018 through the 2022-2023&#xD;
               influenza season&#xD;
  &#xD;
            -  Able and willing to complete the informed consent process&#xD;
  &#xD;
            -  Available for clinic visits for 40 weeks after enrollment, including through the&#xD;
               2023-2024 influenza season&#xD;
  &#xD;
            -  Able to provide proof of identity to the satisfaction of the study clinician&#xD;
               completing the enrollment process&#xD;
  &#xD;
            -  Physical examination and laboratory results without clinically significant findings&#xD;
               and a Body Mass Index (BMI) &lt;= 35 within the 56 days before enrollment&#xD;
  &#xD;
            -  Agrees to not receive the 2023-2024 licensed influenza vaccination during study&#xD;
               participation due to potential confounding of study results&#xD;
  &#xD;
            -  Willing to have blood samples collected, stored indefinitely, and used for research&#xD;
               purposes&#xD;
  &#xD;
          Laboratory Criteria within 56 days before enrollment&#xD;
  &#xD;
            -  White blood cells (WBC) and differential within institutional normal range or&#xD;
               accompanied by the site Principal Investigator (PI) or designee approval&#xD;
  &#xD;
            -  Total lymphocyte count &gt;= 800 cells/microliter&#xD;
  &#xD;
            -  Platelets = 125,000 - 500,000 cells/microliter&#xD;
  &#xD;
            -  Hemoglobin within institutional normal range or accompanied by the PI or designee&#xD;
               approval&#xD;
  &#xD;
            -  Alanine aminotransferase (ALT) &lt;= 1.25 x institutional upper limit of normal (ULN)&#xD;
  &#xD;
            -  Aspartate aminotransferase (AST) &lt;= 1.25 x institutional ULN&#xD;
  &#xD;
            -  Alkaline phosphatase (ALP) &lt;1.1 x institutional ULN&#xD;
  &#xD;
            -  Total bilirubin within institutional normal range or accompanied by the PI or designee&#xD;
               approval&#xD;
  &#xD;
            -  Serum creatinine &lt;= 1.1 x institutional ULN&#xD;
  &#xD;
            -  Negative for HIV infection by an FDA-approved method of detection&#xD;
  &#xD;
          Criteria applicable to women of childbearing potential:&#xD;
  &#xD;
            -  Negative beta-human chorionic gonadotropin (Beta-HCG) pregnancy test (urine or serum)&#xD;
               on the day of enrollment&#xD;
  &#xD;
            -  Agrees to use an effective means of birth control from at least 21 days prior to&#xD;
               enrollment through the end of the study for sample collection.&#xD;
  &#xD;
          EXCLUSION CRITERIA&#xD;
  &#xD;
          A subject will be excluded if one or more of the following conditions apply:&#xD;
  &#xD;
          -Breast-feeding or planning to become pregnant during the study&#xD;
  &#xD;
          Subject has received any of the following substances:&#xD;
  &#xD;
            -  More than 10 days of systemic immunosuppressive medications or cytotoxic medications&#xD;
               within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment&#xD;
  &#xD;
            -  Blood products within 16 weeks prior to enrollment&#xD;
  &#xD;
            -  Live attenuated vaccines within 4 weeks prior to enrollment&#xD;
  &#xD;
            -  Inactivated vaccines within 2 weeks prior to enrollment&#xD;
  &#xD;
            -  Investigational research agents within 4 weeks prior to enrollment or planning to&#xD;
               receive investigational products while on the study (Note: SARS-CoV-2 vaccines&#xD;
               licensed and/or approved by emergency use authorization are not exclusionary, but are&#xD;
               subject to the criteria for timing of inactivated vaccines or mRNA vaccines)&#xD;
  &#xD;
            -  mRNA vaccines within 4 weeks prior to enrollment&#xD;
  &#xD;
            -  Current allergy treatment with allergen immunotherapy with antigen injections, unless&#xD;
               on maintenance schedule&#xD;
  &#xD;
            -  Current anti-TB prophylaxis or therapy&#xD;
  &#xD;
            -  Receipt of investigational ferritin-based nanoparticle influenza vaccines, with the&#xD;
               exception of participants previously enrolled in the VRC 316 study as follows: Group 2&#xD;
               (HA-F A/Sing prime, HA-F A/Sing boost), 3A (DNA A/Sing prime, HA-F A/Sing boost) or 4A&#xD;
               (HA-F A/Sing prime, HA-F A/Sing boost).&#xD;
  &#xD;
            -  Receipt of the mosaic quadrivalent influenza vaccine VRC-FLUMOS0111-00-VP (FluMos-v1)&#xD;
  &#xD;
            -  Receipt of any licensed influenza vaccine within 6 months prior to enrollment.&#xD;
  &#xD;
            -  Receipt of the 2023-2024 licensed influenza vaccine&#xD;
  &#xD;
          Subject has a history of any of the following clinically significant conditions:&#xD;
  &#xD;
            -  Serious reactions to vaccines that preclude receipt of the study vaccinations as&#xD;
               determined by the investigator&#xD;
  &#xD;
            -  Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema&#xD;
  &#xD;
            -  Asthma that is not well controlled&#xD;
  &#xD;
            -  Diabetes mellitus (type I or II), with the exception of gestational diabetes&#xD;
  &#xD;
            -  Thyroid disease that is not well controlled&#xD;
  &#xD;
            -  Idiopathic urticaria within the past year&#xD;
  &#xD;
            -  Autoimmune disease or immunodeficiency&#xD;
  &#xD;
            -  Hypertension that is not well controlled&#xD;
  &#xD;
            -  Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or&#xD;
               platelet disorder requiring special precautions) or significant bruising or bleeding&#xD;
               difficulties with IM injections or blood draws&#xD;
  &#xD;
            -  Malignancy that is active or history of malignancy that is likely to recur during the&#xD;
               period of the study&#xD;
  &#xD;
            -  Seizure disorder other than 1) febrile seizures, 2) seizures secondary to alcohol&#xD;
               withdrawal more than 3 years ago, or 3) seizures that have not required treatment&#xD;
               within the last 3 years&#xD;
  &#xD;
            -  Asplenia, functional asplenia or any condition resulting in the absence or removal of&#xD;
               the spleen&#xD;
  &#xD;
            -  Guillain-Barre Syndrome&#xD;
  &#xD;
            -  Any medical, psychiatric, or social condition, occupational reason, or other&#xD;
               responsibility that, in the judgment of the investigator, is a contraindication to&#xD;
               protocol participation or impairs a subject s ability to give informed consent,&#xD;
               including but not limited to clinically significant forms of infectious diseases, drug&#xD;
               or alcohol abuse, autoimmune diseases, psychiatric disorders, or heart disease.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Richard L Wu, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Institute of Allergy and Infectious Diseases (NIAID)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pamela Costner, R.N.</last_name>
      <phone>(301) 451-8715</phone>
      <email>pcostner@mail.nih.gov</email>
    </overall_contact>
    <location>
      <facility>
        <name>National Institutes of Health Clinical Center</name>
        <address>
          <city>Bethesda</city>
          <state>Maryland</state>
          <zip>20892</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>VRC Clinic</last_name>
        <phone>301-451-8715</phone>
        <email>vaccines@nih.gov</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_001614-I.html</url>
      <description>NIH Clinical Center Detailed Web Page</description>
    </link>
    <reference>
      <citation>Kanekiyo M, Wei CJ, Yassine HM, McTamney PM, Boyington JC, Whittle JR, Rao SS, Kong WP, Wang L, Nabel GJ. Self-assembling influenza nanoparticle vaccines elicit broadly neutralizing H1N1 antibodies. Nature. 2013 Jul 4;499(7456):102-6. doi: 10.1038/nature12202. Epub 2013 May 22.</citation>
      <PMID>23698367</PMID>
    </reference>
    <reference>
      <citation>Corbett KS, Moin SM, Yassine HM, Cagigi A, Kanekiyo M, Boyoglu-Barnum S, Myers SI, Tsybovsky Y, Wheatley AK, Schramm CA, Gillespie RA, Shi W, Wang L, Zhang Y, Andrews SF, Joyce MG, Crank MC, Douek DC, McDermott AB, Mascola JR, Graham BS, Boyington JC. Design of Nanoparticulate Group 2 Influenza Virus Hemagglutinin Stem Antigens That Activate Unmutated Ancestor B Cell Receptors of Broadly Neutralizing Antibody Lineages. mBio. 2019 Feb 26;10(1):e02810-18. doi: 10.1128/mBio.02810-18.</citation>
      <PMID>30808695</PMID>
    </reference>
    <reference>
      <citation>Yassine HM, Boyington JC, McTamney PM, Wei CJ, Kanekiyo M, Kong WP, Gallagher JR, Wang L, Zhang Y, Joyce MG, Lingwood D, Moin SM, Andersen H, Okuno Y, Rao SS, Harris AK, Kwong PD, Mascola JR, Nabel GJ, Graham BS. Hemagglutinin-stem nanoparticles generate heterosubtypic influenza protection. Nat Med. 2015 Sep;21(9):1065-70. doi: 10.1038/nm.3927. Epub 2015 Aug 24.</citation>
      <PMID>26301691</PMID>
    </reference>
    <verification_date>August 23, 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Seasonal Influenza</keyword>
    <keyword>Experimental Vaccine</keyword>
    <keyword>Immune Response</keyword>
    <keyword>Virus</keyword>
    <keyword>Universal Influenza Vaccine</keyword>
    <keyword>Respiratory Illness</keyword>
    <keyword>Healthy Adults</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Influenza, Human</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05968989
  org study id: 10001614
  secondary id: 001614-I
  nct id: NCT05968989
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  Background:
  
        Influenza (flu) virus causes 3 to 5 million cases of severe illness and up to 650,000 deaths
        per year worldwide. Current vaccines work well against single strains of flu virus. But no
        single vaccine works well against all flu viruses that can cause illness.
  
        Objective:
  
        To test an experimental flu vaccine (FluMos-v2) in healthy adults.
  
        Eligibility:
  
        Healthy adults aged 18 to 50 years.
  
        Design:
  
        Participants will have 11 clinic visits in 10 months. They must agree not to get a licensed
        flu vaccine while taking part in this study.
  
        FluMos-v2 will be given with a needle injected into a muscle in the upper arm. Participants
        will receive a follow-up phone call the following day.
  
        Participants will be given a diary card, a ruler, and a thermometer. They will take their
        temperature every day for 7 days after receiving the shot. They will measure any skin changes
        at the injection site. They will record their findings and how they feel.
  
        Participants will receive a second FluMos-v2 shot after 4 months. They will repeat the other
        follow-up steps.
  
        Participants will have 9 other clinic visits. Blood will be drawn at each visit.
  
        Participants should also come to the clinic if they develop flu-like symptoms during the
        study.
  
        Participants may opt for an apheresis 2 weeks after each shot: Blood will be removed through
        a needle in the vein of 1 arm. The blood will run through a machine that separates out the
        white blood cells. The remaining blood is returned through a needle in the other arm.
  Design:
  
        This is a Phase I, open-label, dose escalation study to evaluate the dose, safety,
        tolerability, and immunogenicity of the mosaic hexavalent influenza vaccine VRC-
        FLUMOS0116-00-VP (FluMos-v2). The hypotheses are that the FluMos-v2 vaccine is safe and
        tolerable and will elicit an immune response. The primary objective is to evaluate the safety
        and tolerability of the investigational vaccine in healthy adults. Secondary objectives are
        related to immunogenicity of the investigational vaccine.
  
        Study Products:
  
        The investigational vaccine, FluMos-v2, was developed by the Vaccine Research Center (VRC),
        National Institute of Allergy and Infectious Diseases (NIAID) and is composed of the
        following 6 influenza strains:
  
        Influenza A:
  
          -  H1: A/Idaho/07/2018
  
          -  H2: A/Singapore/1/1957
  
          -  H3: A/Perth/1008/2019
  
          -  H3: A/Darwin/106/2020
  
        Influenza B:
  
          -  B/Victoria lineage: B/Colorado/06/2017
  
          -  B/Yamagata lineage: B/Phuket/3073/2013
  
        FluMos-v2 is supplied in a single-use vial at a target concentration of 180 mcg/mL and will
        be administered intramuscularly (IM) in the deltoid muscle via needle and syringe.
  
        Subjects: Healthy adults between the ages of 18-50 years, inclusive, will be enrolled.
  
        Study Plan:
  
        The study will evaluate the safety, tolerability, and immunogenicity of FluMos-v2 in a dose
        escalation design.
  
        The protocol requires 2 vaccination visits, approximately 9 follow-up visits, and 2 telephone
        contacts, one occurring on the day after each vaccination. Solicited reactogenicity will be
        evaluated using a 7-day diary card. Assessment of vaccine safety will include clinical
        observation and monitoring of hematological and chemical parameters at clinical visits
        throughout the study.
  
        The study schema is as follows:
  
        VRC 326 Vaccination Schema:
  
        Group 1: Subjects:12, Day 0: 60 mcg, Week 16: 60 mcg, Product: FluMos-v2
  
        Group 2: Subjects: 12, Day 0: 180 mcg, Week 16: 180 mcg, Product: FluMos-v2
  
        Total = 24 subjects (Enrollment up to 35 subjects is permitted if additional subjects are
        needed for safety or immunogenicity evaluations.
  
        Study Duration:
  
        Subjects will be evaluated for 40 weeks following first vaccine administration, including
        through the 2023-2024 influenza season.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: To evaluate the safety and tolerability
  time frame: Through 40 weeks following the first vaccine administration
  description: A 60 mcg dose of FluMos-v2 vaccine administered IM via needle on Day 0 and Week 16 to healthy adults.
  measure: To evaluate the safety and tolerability
  time frame: Through 40 weeks following the first vaccine administration
  description: A 180 mcg dose of FluMos-v2 vaccine administered IM administered via needle on Day 0 and Week 16 to healthy adults.
  measure: To evaluate the antibody responses to FluMos-v2 vaccine
  time frame: At two weeks after each injection at Week 2 and Week 18
  description: Antibody responses to a 180 mcg IM dose will be evaluated.
  measure: To evaluate the antibody responses to FluMos-v2 vaccine
  time frame: At two weeks after each injection at Week 2 and Week 18
  description: Antibody responses to a 60 mcg IM dose will be evaluated.
  arm group label: Group 1
  arm group type: Experimental
  description: 60 mcg of FluMos-v2 on Day 0 and Week 16
  arm group label: Group 2
  arm group type: Experimental
  description: 180 mcg of FluMos-v2 on Day 0 and Week16
  intervention type: Biological
  intervention name: VRC-FLUMOS0116-00-VP( FLUMos-v2)
  description: The vaccine, FLUMos-v2, is composed of engineered pentamer yeast C. albican lumazine synthase assembled with 20 HA ectodomain trimers from the following 6 influenza strains:
  Influenza A:
  H1: A/Idaho/07/2018; H2: A/Singapore/1/1957; H3: A/Perth/1008/2019; H3: A/Darwin/106/2020
  Influenza B:
  B/Victoria lineage: B/Colorado/06/2017; B/Yamagata lineage: B/Phuket/3073/2013
  arm group label: Group 1
  arm group label: Group 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Richard L Wu, M.D.
  role: Principal Investigator
  affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
  last name: Pamela Costner, R.N.
  phone: (301) 451-8715
  email: pcostner@mail.nih.gov
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_001614-I.html
  description: NIH Clinical Center Detailed Web Page
  citation: Kanekiyo M, Wei CJ, Yassine HM, McTamney PM, Boyington JC, Whittle JR, Rao SS, Kong WP, Wang L, Nabel GJ. Self-assembling influenza nanoparticle vaccines elicit broadly neutralizing H1N1 antibodies. Nature. 2013 Jul 4;499(7456):102-6. doi: 10.1038/nature12202. Epub 2013 May 22.
  PMID: 23698367
  citation: Corbett KS, Moin SM, Yassine HM, Cagigi A, Kanekiyo M, Boyoglu-Barnum S, Myers SI, Tsybovsky Y, Wheatley AK, Schramm CA, Gillespie RA, Shi W, Wang L, Zhang Y, Andrews SF, Joyce MG, Crank MC, Douek DC, McDermott AB, Mascola JR, Graham BS, Boyington JC. Design of Nanoparticulate Group 2 Influenza Virus Hemagglutinin Stem Antigens That Activate Unmutated Ancestor B Cell Receptors of Broadly Neutralizing Antibody Lineages. mBio. 2019 Feb 26;10(1):e02810-18. doi: 10.1128/mBio.02810-18.
  PMID: 30808695
  citation: Yassine HM, Boyington JC, McTamney PM, Wei CJ, Kanekiyo M, Kong WP, Gallagher JR, Wang L, Zhang Y, Joyce MG, Lingwood D, Moin SM, Andersen H, Okuno Y, Rao SS, Harris AK, Kwong PD, Mascola JR, Nabel GJ, Graham BS. Hemagglutinin-stem nanoparticles generate heterosubtypic influenza protection. Nat Med. 2015 Sep;21(9):1065-70. doi: 10.1038/nm.3927. Epub 2015 Aug 24.
  PMID: 26301691
  responsible party type: Sponsor
  mesh term: Influenza, Human
  sharing ipd: No