<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/NCT04408963</url>
  </required_header>
  <id_info>
    <org_study_id>200096</org_study_id>
    <secondary_id>20-I-0096</secondary_id>
    <nct_id>NCT04408963</nct_id>
  </id_info>
  <brief_title>VRC 611: Human Monoclonal Antibody (mAb) VRC-HIVMAB0102-00-AB (CAP256V2LS)Administered Via Subcutaneous and Intravenous Injection in Healthy Adults</brief_title>
  <official_title>VRC 611: A Phase 1 Safety and Pharmacokinetic Study to Evaluate a Human Monoclonal Antibody (mAb) VRC-HIVMAB0102-00-AB (CAP256V2LS) Administered Via Subcutaneous and Intravenous Injection 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;
      HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a&#xD;
      way to prevent HIV infection. Antibodies are made by the human body to fight germs.&#xD;
      Researches want to test an antibody, CAP256V2LS.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To test CAP256V2LS to see if it is safe and how the body responds to it.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Healthy people ages 18-60.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with a medical history, physical exam, and blood tests. Some&#xD;
      will have a pregnancy test.&#xD;
&#xD;
      Participants will be assigned to one of two groups. Based on their group, they will get 1&#xD;
      dose of CAP256V2LS in 1 of 2 ways:&#xD;
&#xD;
        -  Some participants will get CAP256V2LS as an infusion. A thin tube will be placed in an&#xD;
           arm vein. CAP256V2LS will be given into the vein using a pump.&#xD;
&#xD;
        -  Some participants will get CAP256V2LS injected under the skin. A small needle will&#xD;
           inject CAP256V2LS into the fatty tissue of the belly, arm, or thigh. They will get 1 to&#xD;
           4 injections.&#xD;
&#xD;
      On the day they get CAP256V2LS, participants will give blood samples at different time&#xD;
      points. This visit will last about 8 hours.&#xD;
&#xD;
      Participants will be asked to check their temperature every day for 7 days after receiving&#xD;
      CAP256V2LS. They will use a tool to measure any redness, swelling, or bruising they may have&#xD;
      at the injection site.&#xD;
&#xD;
      Participants will have visits at least 2-3 times during the first week after they get&#xD;
      CAP256V2LS. Then they will have about 9 more visits over the next 6 months. Visits will&#xD;
      include blood tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design:&#xD;
&#xD;
      This open-label study will evaluate CAP256V2LS (VRC-HIVMAB0102-00-AB) in healthy adults. The&#xD;
      primary hypothesis is that subcutaneous (SC) and intravenous (IV) administrations of&#xD;
      CAP256V2LS will be safe and well-tolerated in healthy adults. A secondary hypothesis is that&#xD;
      CAP256V2LS will be detectable in human sera with a definable half-life.&#xD;
&#xD;
      Study Product:&#xD;
&#xD;
      The CAP256V2LS broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the&#xD;
      HIV-1 envelope, is human in origin, and contains two amino acid modifications within the&#xD;
      C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo.&#xD;
      This bNAb was developed by the VRC/NIAID/NIH in collaboration with The Centre for the AIDS&#xD;
      Programme of Research in South Africa (CAPRISA) and is manufactured under cGMP regulations at&#xD;
      the VRC Pilot Plant operated under contract by the Vaccine Clinical Materials Program (VCMP),&#xD;
      Leidos Biomedical Research, Inc., Frederick. MD. The CAP256V2LS drug product is supplied at a&#xD;
      concentration of 100 mg/mL in a sterile, aqueous, buffered solution of 6.25 mL in single-use&#xD;
      10 mL glass vials. R-Gene 10 will be added as a stabilizing agent to IV doses of CAP256V2LS.&#xD;
      R-Gene10 (Arginine Hydrochloride Injection, USP) for intravenous infusion contains L-Arginine&#xD;
      Hydrochloride, USP in Water for Injection (equivalent to a 10% solution).&#xD;
&#xD;
      Subjects:&#xD;
&#xD;
      Healthy subjects, 18-60 years of age&#xD;
&#xD;
      Study Plan:&#xD;
&#xD;
      This open-label study will include 2 dosing regimens with CAP256V2LS administered at 5 mg/kg&#xD;
      IV and 5 mg/kg SC. A single dose of the study product will be administered on Day 0 as shown&#xD;
      below.&#xD;
&#xD;
      VRC 611 Study Design&#xD;
&#xD;
        -  Group 1&#xD;
&#xD;
             -  Study Product: CAP256V2LS&#xD;
&#xD;
             -  Subjects per Group: 5&#xD;
&#xD;
             -  Dose (mg/kg) and Route Administered: 5 mg/kg IV&#xD;
&#xD;
             -  Day 0: X&#xD;
&#xD;
        -  Group 2&#xD;
&#xD;
             -  Study Product: CAP256V2LS&#xD;
&#xD;
             -  Subjects per Group: 5&#xD;
&#xD;
             -  Dose (mg/kg) and Route Administered: 5 mg/kg SC&#xD;
&#xD;
             -  Day 0: X&#xD;
&#xD;
      Total Subjects: 10 (Enrollment up to 20 subjects is permitted in case additional evaluations&#xD;
      for safety or pharmacokinetic (PK) evaluations are needed.)&#xD;
&#xD;
      Duration:&#xD;
&#xD;
      Study participation will be approximately 24 weeks from the Day 0 product administration&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 22, 2022</start_date>
  <completion_date type="Actual">November 28, 2022</completion_date>
  <primary_completion_date type="Actual">November 28, 2022</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>Parallel 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 of CAP256V2LS</measure>
    <time_frame>Through 24 weeks after product administration</time_frame>
    <description>5mg/kg IV of CAP256V2LS administered to healthy adults.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate the safety and tolerability of CAP256V2LS</measure>
    <time_frame>Through 24 weeks after product administration</time_frame>
    <description>5mg/kg SC of CAP256V2LS administered to healthy adults.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the pharmacokinetics of CAP256V2LS</measure>
    <time_frame>Throughout the study</time_frame>
    <description>The pharmacokinetics of CAP256V2LS administered.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>HIV</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 mg/kg IV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 mg/kg SC</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VRC-HIVMAB0102-00-AB</intervention_name>
    <description>The CAP256V2LS broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo.</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 to be included:&#xD;
&#xD;
          1. Able and willing to complete the informed consent process&#xD;
&#xD;
          2. Able to provide proof of identity to the satisfaction of the study clinician&#xD;
             completing the enrollment process&#xD;
&#xD;
          3. Available for clinical follow-up through the last study visit&#xD;
&#xD;
          4. 18 to 60 years of age&#xD;
&#xD;
          5. Based on medical history and physical examination, in good health and without&#xD;
             clinically significant findings within 84 days prior to enrollment.&#xD;
&#xD;
          6. Weight 115 kg&#xD;
&#xD;
          7. Willing to have blood samples collected, stored indefinitely, and used for research&#xD;
             purposes&#xD;
&#xD;
             Laboratory Criteria within 84 days prior to enrollment:&#xD;
&#xD;
          8. White Blood Cell (WBC) 2,500-12,000/mm3&#xD;
&#xD;
          9. WBC differential either within institutional normal range or accompanied by the&#xD;
             Principal Investigator (PI) or designee approval&#xD;
&#xD;
         10. Platelets = 125,000 500,000/mm3&#xD;
&#xD;
         11. Hemoglobin within institutional normal range or accompanied by the PI or designee&#xD;
             approval&#xD;
&#xD;
         12. Creatinine 1.1 x upper limit of normal (ULN) based on the institutional normal range&#xD;
&#xD;
         13. Alanine aminotransferase (ALT) 1.25 x ULN based on the institutional normal range&#xD;
&#xD;
         14. Negative for HIV infection by an FDA approved method of detection&#xD;
&#xD;
             Criteria Specific to Women of Childbearing Potential:&#xD;
&#xD;
         15. Negative beta-human chorionic gonadotropin ( &lt;=-HCG) pregnancy test (urine or serum)&#xD;
             on day of enrollment, and prior to product administration&#xD;
&#xD;
         16. Agrees to use an effective means of birth control from at least 21 days prior to&#xD;
             enrollment through the duration of study participation&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        A subject will be excluded if one or more of the following conditions apply:&#xD;
&#xD;
          1. Woman who is breast-feeding or planning to become pregnant during study participation&#xD;
&#xD;
          2. Any history of a severe allergic reaction with generalized urticaria, angioedema or&#xD;
             anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the&#xD;
             study&#xD;
&#xD;
          3. Hypertension that is not well controlled&#xD;
&#xD;
          4. Receipt of any investigational study product within 28 days prior to enrollment. Note:&#xD;
             SARS-CoV-2 vaccines approved by emergency use authorization are not exclusionary.&#xD;
&#xD;
          5. Receipt of any live attenuated vaccines within 28 days prior to enrollment.&#xD;
&#xD;
          6. Receipt of any vaccine within 2 weeks prior to enrollment/product administration&#xD;
&#xD;
          7. Prior receipt of a licensed or investigational monoclonal antibody&#xD;
&#xD;
          8. Prior receipt of an HIV vaccine&#xD;
&#xD;
          9. Any medical, psychiatric, 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;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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>
  <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>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2020-I-0096.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <reference>
    <citation>Ko SY, Pegu A, Rudicell RS, Yang ZY, Joyce MG, Chen X, Wang K, Bao S, Kraemer TD, Rath T, Zeng M, Schmidt SD, Todd JP, Penzak SR, Saunders KO, Nason MC, Haase AT, Rao SS, Blumberg RS, Mascola JR, Nabel GJ. Enhanced neonatal Fc receptor function improves protection against primate SHIV infection. Nature. 2014 Oct 30;514(7524):642-5. doi: 10.1038/nature13612. Epub 2014 Aug 13.</citation>
    <PMID>25119033</PMID>
  </reference>
  <reference>
    <citation>Doria-Rose NA, Schramm CA, Gorman J, Moore PL, Bhiman JN, DeKosky BJ, Ernandes MJ, Georgiev IS, Kim HJ, Pancera M, Staupe RP, Altae-Tran HR, Bailer RT, Crooks ET, Cupo A, Druz A, Garrett NJ, Hoi KH, Kong R, Louder MK, Longo NS, McKee K, Nonyane M, O'Dell S, Roark RS, Rudicell RS, Schmidt SD, Sheward DJ, Soto C, Wibmer CK, Yang Y, Zhang Z; NISC Comparative Sequencing Program; Mullikin JC, Binley JM, Sanders RW, Wilson IA, Moore JP, Ward AB, Georgiou G, Williamson C, Abdool Karim SS, Morris L, Kwong PD, Shapiro L, Mascola JR. Developmental pathway for potent V1V2-directed HIV-neutralizing antibodies. Nature. 2014 May 1;509(7498):55-62. doi: 10.1038/nature13036. Epub 2014 Mar 2.</citation>
    <PMID>24590074</PMID>
  </reference>
  <reference>
    <citation>Doria-Rose NA, Bhiman JN, Roark RS, Schramm CA, Gorman J, Chuang GY, Pancera M, Cale EM, Ernandes MJ, Louder MK, Asokan M, Bailer RT, Druz A, Fraschilla IR, Garrett NJ, Jarosinski M, Lynch RM, McKee K, O'Dell S, Pegu A, Schmidt SD, Staupe RP, Sutton MS, Wang K, Wibmer CK, Haynes BF, Abdool-Karim S, Shapiro L, Kwong PD, Moore PL, Morris L, Mascola JR. New Member of the V1V2-Directed CAP256-VRC26 Lineage That Shows Increased Breadth and Exceptional Potency. J Virol. 2015 Oct 14;90(1):76-91. doi: 10.1128/JVI.01791-15. Print 2016 Jan 1.</citation>
    <PMID>26468542</PMID>
  </reference>
  <verification_date>May 17, 2023</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 24, 2023</last_update_submitted>
  <last_update_submitted_qc>May 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HIV Prevention</keyword>
  <keyword>Broadly-Neutralizing Human Monoclonal Antibodies</keyword>
  <keyword>First in Human</keyword>
  <keyword>Anti-Drug Antibody Response</keyword>
  <keyword>Antibodies</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 22, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT04408963/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04408963
org study id: 200096
secondary id: 20-I-0096
nct id: NCT04408963
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Background:

      HIV is a serious disease with no cure or vaccine to prevent it. Using antibodies could be a
      way to prevent HIV infection. Antibodies are made by the human body to fight germs.
      Researches want to test an antibody, CAP256V2LS.

      Objective:

      To test CAP256V2LS to see if it is safe and how the body responds to it.

      Eligibility:

      Healthy people ages 18-60.

      Design:

      Participants will be screened with a medical history, physical exam, and blood tests. Some
      will have a pregnancy test.

      Participants will be assigned to one of two groups. Based on their group, they will get 1
      dose of CAP256V2LS in 1 of 2 ways:

        -  Some participants will get CAP256V2LS as an infusion. A thin tube will be placed in an
           arm vein. CAP256V2LS will be given into the vein using a pump.

        -  Some participants will get CAP256V2LS injected under the skin. A small needle will
           inject CAP256V2LS into the fatty tissue of the belly, arm, or thigh. They will get 1 to
           4 injections.

      On the day they get CAP256V2LS, participants will give blood samples at different time
      points. This visit will last about 8 hours.

      Participants will be asked to check their temperature every day for 7 days after receiving
      CAP256V2LS. They will use a tool to measure any redness, swelling, or bruising they may have
      at the injection site.

      Participants will have visits at least 2-3 times during the first week after they get
      CAP256V2LS. Then they will have about 9 more visits over the next 6 months. Visits will
      include blood tests.
Design:

      This open-label study will evaluate CAP256V2LS (VRC-HIVMAB0102-00-AB) in healthy adults. The
      primary hypothesis is that subcutaneous (SC) and intravenous (IV) administrations of
      CAP256V2LS will be safe and well-tolerated in healthy adults. A secondary hypothesis is that
      CAP256V2LS will be detectable in human sera with a definable half-life.

      Study Product:

      The CAP256V2LS broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the
      HIV-1 envelope, is human in origin, and contains two amino acid modifications within the
      C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo.
      This bNAb was developed by the VRC/NIAID/NIH in collaboration with The Centre for the AIDS
      Programme of Research in South Africa (CAPRISA) and is manufactured under cGMP regulations at
      the VRC Pilot Plant operated under contract by the Vaccine Clinical Materials Program (VCMP),
      Leidos Biomedical Research, Inc., Frederick. MD. The CAP256V2LS drug product is supplied at a
      concentration of 100 mg/mL in a sterile, aqueous, buffered solution of 6.25 mL in single-use
      10 mL glass vials. R-Gene 10 will be added as a stabilizing agent to IV doses of CAP256V2LS.
      R-Gene10 (Arginine Hydrochloride Injection, USP) for intravenous infusion contains L-Arginine
      Hydrochloride, USP in Water for Injection (equivalent to a 10% solution).

      Subjects:

      Healthy subjects, 18-60 years of age

      Study Plan:

      This open-label study will include 2 dosing regimens with CAP256V2LS administered at 5 mg/kg
      IV and 5 mg/kg SC. A single dose of the study product will be administered on Day 0 as shown
      below.

      VRC 611 Study Design

        -  Group 1

             -  Study Product: CAP256V2LS

             -  Subjects per Group: 5

             -  Dose (mg/kg) and Route Administered: 5 mg/kg IV

             -  Day 0: X

        -  Group 2

             -  Study Product: CAP256V2LS

             -  Subjects per Group: 5

             -  Dose (mg/kg) and Route Administered: 5 mg/kg SC

             -  Day 0: X

      Total Subjects: 10 (Enrollment up to 20 subjects is permitted in case additional evaluations
      for safety or pharmacokinetic (PK) evaluations are needed.)

      Duration:

      Study participation will be approximately 24 weeks from the Day 0 product administration
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: To evaluate the safety and tolerability of CAP256V2LS
time frame: Through 24 weeks after product administration
description: 5mg/kg IV of CAP256V2LS administered to healthy adults.
measure: To evaluate the safety and tolerability of CAP256V2LS
time frame: Through 24 weeks after product administration
description: 5mg/kg SC of CAP256V2LS administered to healthy adults.
measure: To evaluate the pharmacokinetics of CAP256V2LS
time frame: Throughout the study
description: The pharmacokinetics of CAP256V2LS administered.
arm group label: Group 1
arm group type: Experimental
description: 5 mg/kg IV
arm group label: Group 2
arm group type: Experimental
description: 5 mg/kg SC
intervention type: Biological
intervention name: VRC-HIVMAB0102-00-AB
description: The CAP256V2LS broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo.
arm group label: Group 1
arm group label: Group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard L Wu, M.D.
role: Principal Investigator
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2020-I-0096.html
description: NIH Clinical Center Detailed Web Page
citation: Ko SY, Pegu A, Rudicell RS, Yang ZY, Joyce MG, Chen X, Wang K, Bao S, Kraemer TD, Rath T, Zeng M, Schmidt SD, Todd JP, Penzak SR, Saunders KO, Nason MC, Haase AT, Rao SS, Blumberg RS, Mascola JR, Nabel GJ. Enhanced neonatal Fc receptor function improves protection against primate SHIV infection. Nature. 2014 Oct 30;514(7524):642-5. doi: 10.1038/nature13612. Epub 2014 Aug 13.
PMID: 25119033
citation: Doria-Rose NA, Schramm CA, Gorman J, Moore PL, Bhiman JN, DeKosky BJ, Ernandes MJ, Georgiev IS, Kim HJ, Pancera M, Staupe RP, Altae-Tran HR, Bailer RT, Crooks ET, Cupo A, Druz A, Garrett NJ, Hoi KH, Kong R, Louder MK, Longo NS, McKee K, Nonyane M, O'Dell S, Roark RS, Rudicell RS, Schmidt SD, Sheward DJ, Soto C, Wibmer CK, Yang Y, Zhang Z; NISC Comparative Sequencing Program; Mullikin JC, Binley JM, Sanders RW, Wilson IA, Moore JP, Ward AB, Georgiou G, Williamson C, Abdool Karim SS, Morris L, Kwong PD, Shapiro L, Mascola JR. Developmental pathway for potent V1V2-directed HIV-neutralizing antibodies. Nature. 2014 May 1;509(7498):55-62. doi: 10.1038/nature13036. Epub 2014 Mar 2.
PMID: 24590074
citation: Doria-Rose NA, Bhiman JN, Roark RS, Schramm CA, Gorman J, Chuang GY, Pancera M, Cale EM, Ernandes MJ, Louder MK, Asokan M, Bailer RT, Druz A, Fraschilla IR, Garrett NJ, Jarosinski M, Lynch RM, McKee K, O'Dell S, Pegu A, Schmidt SD, Staupe RP, Sutton MS, Wang K, Wibmer CK, Haynes BF, Abdool-Karim S, Shapiro L, Kwong PD, Moore PL, Morris L, Mascola JR. New Member of the V1V2-Directed CAP256-VRC26 Lineage That Shows Increased Breadth and Exceptional Potency. J Virol. 2015 Oct 14;90(1):76-91. doi: 10.1128/JVI.01791-15. Print 2016 Jan 1.
PMID: 26468542
responsible party type: Sponsor
provided document: 