<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/NCT03246230</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00024239</org_study_id>
    <nct_id>NCT03246230</nct_id>
  </id_info>
  <brief_title>Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity</brief_title>
  <acronym>EPIC-HIPC</acronym>
  <official_title>Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Research Council Unit, The Gambia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute for Medical Research, Papua New Guinea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The University of Western Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Infection is the most common cause of death in early life, especially for newborns and can be&#xD;
      reduced by immunization but insufficient knowledge of how vaccines protect the very young&#xD;
      limits their optimal use. To gain insight into how vaccines induce protection of the most&#xD;
      vulnerable, this National Institutes of Health (NIH)/National Institute of Allergy &amp;&#xD;
      Infectious Diseases (NIAID)-funded Human Immunology Project Consortium (HIPC) study, based at&#xD;
      Boston Children's Hospital and conducted by the Expanded Program on Immunization Consortium&#xD;
      (EPIC), employs two novel approaches studying newborn responses to hepatitis B vaccine (HBV):&#xD;
      (a) systems biology that uses technologies which comprehensively measure global changes in&#xD;
      molecules such as transcriptomics (RNA) and proteomics (proteins), as well as cell&#xD;
      composition of the blood and (b) use of human newborn blood components, collected prior to&#xD;
      immunization, to model vaccine responses in vitro (outside the body). Characterizing&#xD;
      vaccine-induced molecular patterns (&quot;signatures&quot;) that correspond to vaccine-mediated&#xD;
      protection will accelerate development and optimization of vaccines against early life&#xD;
      infections of major global health importance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While the greatest number of vaccines is administered to the very young, vaccine preventable&#xD;
      infections remain a major cause of morbidity and mortality, especially for the newborn. To&#xD;
      improve vaccine-mediated protection early in life, the investigators will identify biomarkers&#xD;
      that predict protective efficacy and garner insight into the underlying mechanisms of&#xD;
      vaccine-mediated protection. Systems biology approaches (&quot;OMICs&quot;) applied to vaccinology,&#xD;
      i.e., systems vaccinology, has revolutionized the field with an unbiased identification of&#xD;
      pathways relevant to vaccine-induced immune responses. However, thus far systems vaccinology&#xD;
      has focused primarily on adults, with few studies conducted in children and infants, and none&#xD;
      in newborns. This study will bridge this gap by conducting a comprehensive systems&#xD;
      vaccinology study in newborns. Specifically, the investigators will determine the molecular&#xD;
      pathways that are associated with successful neonatal immunization with hepatitis B virus&#xD;
      vaccine (HBV). HBV is the ideal model because i) it is highly (&gt;90%) effective; ii) it has a&#xD;
      well-established correlate of protection (CoP; anti-hepatitis surface antigen antibody&#xD;
      (anti-HBs)); iii) there is substantial variation in anti-HBs titers and quantifiable&#xD;
      inter-subject variability is essential for systems biological approaches; iv) it is highly&#xD;
      relevant as HBV is given at birth in the U.S. and most developing countries; v) it is&#xD;
      amenable to in vivo manipulation with another regularly administered neonatal vaccine,&#xD;
      Bacille Calmette-Guérin (BCG), which will greatly enhance detection of relevant signatures.&#xD;
      As complex networks of functional interactions among genes and proteins drive the response to&#xD;
      immunization, the investigators will integrate transcriptomic, proteomic and immune&#xD;
      phenotyping approaches. Importantly, the investigators have successfully adapted these&#xD;
      experimental platforms to be fully operational within the small blood volumes obtainable in&#xD;
      newborns. The investigators have also developed in vitro systems amenable to experimental&#xD;
      manipulation on the cellular and molecular level to identify cause-effect relationships.&#xD;
      Pilot data prove feasibility of collecting the relevant high-quality samples according to&#xD;
      stringent standard operating procedures, processing them and delivering cogent OMIC data&#xD;
      suggesting vaccine-specific 'signatures' in the human newborn. This HIPC will identify&#xD;
      biomarkers of neonatal HBV immunogenicity by pursuing the following Overall Specific Aims:&#xD;
&#xD;
        -  Aim 1. Characterize pre-vaccine OMIC and immune signatures in vivo that predict&#xD;
           immunogenicity of HBV in human newborns. In adult systems vaccinology studies, baseline&#xD;
           immune status of vaccine recipients predicted vaccine immunogenicity at least as well or&#xD;
           even better than changes induced by the vaccine. For Aim 1 the investigators will&#xD;
           determine the pre-vaccine (Day 0) characteristics of whole blood gene expression, plasma&#xD;
           proteome as well as the composition of the white blood cell compartment and their&#xD;
           functional status in correlation with the HBV-induced neonatal antibody response.&#xD;
&#xD;
        -  Aim 2. Characterize the post-vaccine impact of HBV on OMIC and immune signatures in vivo&#xD;
           that predict immunogenicity of HBV in human newborns. In adults, analysis of&#xD;
           vaccine-induced signatures (i.e. post-vaccine) has provided new insights for several&#xD;
           vaccines, including HBV. The investigators will for the first time apply this approach&#xD;
           to newborns and expand it by manipulating the neonatal response to HBV in vivo by&#xD;
           co-administering BCG, as it substantially changes immunogenicity of HBV thereby testing&#xD;
           cause-effect relationships in vivo. For Aim 2 the investigators will characterize whole&#xD;
           blood gene expression and the plasma and leukocyte proteome as well as white blood cell&#xD;
           composition and functional status at Days 1, -3 and -7 postvaccine contrasting infants&#xD;
           that received nothing (delayed vaccines to 7 days of age), HBV, BCG or (HBV + BCG) at&#xD;
           birth and correlate this with anti-HBs titers.&#xD;
&#xD;
        -  Aim 3. Interrogate functional correlations identified in silico via novel human in vitro&#xD;
           platforms that accurately model age-specific vaccine responses and are amenable to a&#xD;
           wide range of experimental manipulation allowing mechanistic cause-effect relationships&#xD;
           to be probed on the molecular level.&#xD;
&#xD;
      Overall, these integrated studies will identify vaccine-induced molecular pathways&#xD;
      correlating with protective immune responses in newborns and will generate and test new&#xD;
      mechanistic hypotheses regarding vaccine action in vivo and in vitro. This study will&#xD;
      ultimately inform, accelerate and optimize early life immunization resulting in major public&#xD;
      health benefit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 6, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Actual">August 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Newborn infants will have delayed immunization, with catch-up immunization at day of life 7 (DOL7), or immunization at birth with hepatitis B vaccine (HBV), Bacille Calmette-Guérin (BCG) or (HBV +BCG). All participants will have peripheral blood collected at birth (DOL0) and each group will be divided into sub-groups with follow-up peripheral blood collection at DOL1, DOL3, or DOL7.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Molecular signature correlating with anti-hepatitis B vaccine antibody response</measure>
    <time_frame>1 month of age</time_frame>
    <description>We will employ bioinformatics to define molecular signatures correlating with anti-HBV responses</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">890</enrollment>
  <condition>Newborn Vaccine Immunogenicity</condition>
  <arm_group>
    <arm_group_label>NO VACCINES AT BIRTH</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These will be newborns who will not receive any vaccines at birth and will have delayed immunization with catch-up (i.e., HBV, BCG and polio vaccine) by Day of Life 7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HBV VACCINE AT BIRTH</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in this arm will receive licensed hepatitis B vaccine (HBV) at birth (Day of Life (DOL)-0) with catch up immunization (i.e., BCG and polio vaccine) at DOL-1, -3, or -7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BCG VACCINE AT BIRTH</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in this arm will receive licensed Bacillus Calmette-Guérin (BCG) vaccine at birth (Day of Life(DOL)-0) with catch up immunization (i.e., HBV and polio vaccine) at DOL-1, -3 or- 7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>(HBV + BCG) VACCINES AT BIRTH</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants in this arm will receive licensed hepatitis B vaccine (HBV) and licensed Bacillus Calmette-Guérin (BCG) vaccine at birth (Day of Life (DOL- 0) with catch up immunization (i.e., polio vaccine) at DOL-1, -3, or -7.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Hepatitis B vaccine (HBV)</intervention_name>
    <description>Licensed pediatric HBV vaccine will be administered at birth (Day of Life 0) or delayed to Day of Life 7.</description>
    <arm_group_label>(HBV + BCG) VACCINES AT BIRTH</arm_group_label>
    <arm_group_label>HBV VACCINE AT BIRTH</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Bacillus Calmette-Guérin (BCG)</intervention_name>
    <description>Licensed BCG vaccine will be administered at birth (Day of Life 0) or delayed to Day of Life 7.</description>
    <arm_group_label>(HBV + BCG) VACCINES AT BIRTH</arm_group_label>
    <arm_group_label>BCG VACCINE AT BIRTH</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &lt;24 hours of age&#xD;
&#xD;
          -  &gt;37 weeks gestational age&#xD;
&#xD;
          -  HIV unexposed&#xD;
&#xD;
          -  Healthy (no malformations, normal temperature range and vital signs for age)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Premature (&lt;37 weeks gestational age)&#xD;
&#xD;
          -  Hepatitis B antigen-positive mother&#xD;
&#xD;
          -  HIV-positive or HIV-exposed&#xD;
&#xD;
          -  Febrile, unstable vital signs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Days</minimum_age>
    <maximum_age>1 Day</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ofer Levy, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tobias R Kollmann, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>The University of Western Australia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Beate Kampmann, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Medical Research Council (MRC) Gambia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical Research Council Unit, The Gambia</name>
      <address>
        <city>Fajara</city>
        <zip>000273</zip>
        <country>Gambia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Medical Research</name>
      <address>
        <city>Goroka</city>
        <state>Eastern Highlands</state>
        <country>Papua New Guinea</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Gambia</country>
    <country>Papua New Guinea</country>
  </location_countries>
  <reference>
    <citation>Amenyogbe N, Levy O, Kollmann TR. Systems vaccinology: a promise for the young and the poor. Philos Trans R Soc Lond B Biol Sci. 2015 Jun 19;370(1671):20140340. doi: 10.1098/rstb.2014.0340.</citation>
    <PMID>25964462</PMID>
  </reference>
  <reference>
    <citation>Lee AH, Shannon CP, Amenyogbe N, Bennike TB, Diray-Arce J, Idoko OT, Gill EE, Ben-Othman R, Pomat WS, van Haren SD, Cao KL, Cox M, Darboe A, Falsafi R, Ferrari D, Harbeson DJ, He D, Bing C, Hinshaw SJ, Ndure J, Njie-Jobe J, Pettengill MA, Richmond PC, Ford R, Saleu G, Masiria G, Matlam JP, Kirarock W, Roberts E, Malek M, Sanchez-Schmitz G, Singh A, Angelidou A, Smolen KK; EPIC Consortium; Brinkman RR, Ozonoff A, Hancock REW, van den Biggelaar AHJ, Steen H, Tebbutt SJ, Kampmann B, Levy O, Kollmann TR. Dynamic molecular changes during the first week of human life follow a robust developmental trajectory. Nat Commun. 2019 Mar 12;10(1):1092. doi: 10.1038/s41467-019-08794-x.</citation>
    <PMID>30862783</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>January 12, 2023</last_update_submitted>
  <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Ofer Levy</investigator_full_name>
    <investigator_title>Staff Physician</investigator_title>
  </responsible_party>
  <keyword>newborn vaccine responses</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>BCG Vaccine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03246230
org study id: IRB-P00024239
nct id: NCT03246230
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Infection is the most common cause of death in early life, especially for newborns and can be
      reduced by immunization but insufficient knowledge of how vaccines protect the very young
      limits their optimal use. To gain insight into how vaccines induce protection of the most
      vulnerable, this National Institutes of Health (NIH)/National Institute of Allergy &
      Infectious Diseases (NIAID)-funded Human Immunology Project Consortium (HIPC) study, based at
      Boston Children's Hospital and conducted by the Expanded Program on Immunization Consortium
      (EPIC), employs two novel approaches studying newborn responses to hepatitis B vaccine (HBV):
      (a) systems biology that uses technologies which comprehensively measure global changes in
      molecules such as transcriptomics (RNA) and proteomics (proteins), as well as cell
      composition of the blood and (b) use of human newborn blood components, collected prior to
      immunization, to model vaccine responses in vitro (outside the body). Characterizing
      vaccine-induced molecular patterns ("signatures") that correspond to vaccine-mediated
      protection will accelerate development and optimization of vaccines against early life
      infections of major global health importance.
While the greatest number of vaccines is administered to the very young, vaccine preventable
      infections remain a major cause of morbidity and mortality, especially for the newborn. To
      improve vaccine-mediated protection early in life, the investigators will identify biomarkers
      that predict protective efficacy and garner insight into the underlying mechanisms of
      vaccine-mediated protection. Systems biology approaches ("OMICs") applied to vaccinology,
      i.e., systems vaccinology, has revolutionized the field with an unbiased identification of
      pathways relevant to vaccine-induced immune responses. However, thus far systems vaccinology
      has focused primarily on adults, with few studies conducted in children and infants, and none
      in newborns. This study will bridge this gap by conducting a comprehensive systems
      vaccinology study in newborns. Specifically, the investigators will determine the molecular
      pathways that are associated with successful neonatal immunization with hepatitis B virus
      vaccine (HBV). HBV is the ideal model because i) it is highly (>90%) effective; ii) it has a
      well-established correlate of protection (CoP; anti-hepatitis surface antigen antibody
      (anti-HBs)); iii) there is substantial variation in anti-HBs titers and quantifiable
      inter-subject variability is essential for systems biological approaches; iv) it is highly
      relevant as HBV is given at birth in the U.S. and most developing countries; v) it is
      amenable to in vivo manipulation with another regularly administered neonatal vaccine,
      Bacille Calmette-Guérin (BCG), which will greatly enhance detection of relevant signatures.
      As complex networks of functional interactions among genes and proteins drive the response to
      immunization, the investigators will integrate transcriptomic, proteomic and immune
      phenotyping approaches. Importantly, the investigators have successfully adapted these
      experimental platforms to be fully operational within the small blood volumes obtainable in
      newborns. The investigators have also developed in vitro systems amenable to experimental
      manipulation on the cellular and molecular level to identify cause-effect relationships.
      Pilot data prove feasibility of collecting the relevant high-quality samples according to
      stringent standard operating procedures, processing them and delivering cogent OMIC data
      suggesting vaccine-specific 'signatures' in the human newborn. This HIPC will identify
      biomarkers of neonatal HBV immunogenicity by pursuing the following Overall Specific Aims:

        -  Aim 1. Characterize pre-vaccine OMIC and immune signatures in vivo that predict
           immunogenicity of HBV in human newborns. In adult systems vaccinology studies, baseline
           immune status of vaccine recipients predicted vaccine immunogenicity at least as well or
           even better than changes induced by the vaccine. For Aim 1 the investigators will
           determine the pre-vaccine (Day 0) characteristics of whole blood gene expression, plasma
           proteome as well as the composition of the white blood cell compartment and their
           functional status in correlation with the HBV-induced neonatal antibody response.

        -  Aim 2. Characterize the post-vaccine impact of HBV on OMIC and immune signatures in vivo
           that predict immunogenicity of HBV in human newborns. In adults, analysis of
           vaccine-induced signatures (i.e. post-vaccine) has provided new insights for several
           vaccines, including HBV. The investigators will for the first time apply this approach
           to newborns and expand it by manipulating the neonatal response to HBV in vivo by
           co-administering BCG, as it substantially changes immunogenicity of HBV thereby testing
           cause-effect relationships in vivo. For Aim 2 the investigators will characterize whole
           blood gene expression and the plasma and leukocyte proteome as well as white blood cell
           composition and functional status at Days 1, -3 and -7 postvaccine contrasting infants
           that received nothing (delayed vaccines to 7 days of age), HBV, BCG or (HBV + BCG) at
           birth and correlate this with anti-HBs titers.

        -  Aim 3. Interrogate functional correlations identified in silico via novel human in vitro
           platforms that accurately model age-specific vaccine responses and are amenable to a
           wide range of experimental manipulation allowing mechanistic cause-effect relationships
           to be probed on the molecular level.

      Overall, these integrated studies will identify vaccine-induced molecular pathways
      correlating with protective immune responses in newborns and will generate and test new
      mechanistic hypotheses regarding vaccine action in vivo and in vitro. This study will
      ultimately inform, accelerate and optimize early life immunization resulting in major public
      health benefit.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Newborn infants will have delayed immunization, with catch-up immunization at day of life 7 (DOL7), or immunization at birth with hepatitis B vaccine (HBV), Bacille Calmette-Guérin (BCG) or (HBV +BCG). All participants will have peripheral blood collected at birth (DOL0) and each group will be divided into sub-groups with follow-up peripheral blood collection at DOL1, DOL3, or DOL7.
primary purpose: Basic Science
masking: None (Open Label)
measure: Molecular signature correlating with anti-hepatitis B vaccine antibody response
time frame: 1 month of age
description: We will employ bioinformatics to define molecular signatures correlating with anti-HBV responses
arm group label: NO VACCINES AT BIRTH
arm group type: No Intervention
description: These will be newborns who will not receive any vaccines at birth and will have delayed immunization with catch-up (i.e., HBV, BCG and polio vaccine) by Day of Life 7.
arm group label: HBV VACCINE AT BIRTH
arm group type: Other
description: Participants in this arm will receive licensed hepatitis B vaccine (HBV) at birth (Day of Life (DOL)-0) with catch up immunization (i.e., BCG and polio vaccine) at DOL-1, -3, or -7.
arm group label: BCG VACCINE AT BIRTH
arm group type: Other
description: Participants in this arm will receive licensed Bacillus Calmette-Guérin (BCG) vaccine at birth (Day of Life(DOL)-0) with catch up immunization (i.e., HBV and polio vaccine) at DOL-1, -3 or- 7.
arm group label: (HBV + BCG) VACCINES AT BIRTH
arm group type: Other
description: Participants in this arm will receive licensed hepatitis B vaccine (HBV) and licensed Bacillus Calmette-Guérin (BCG) vaccine at birth (Day of Life (DOL- 0) with catch up immunization (i.e., polio vaccine) at DOL-1, -3, or -7.
intervention type: Biological
intervention name: Hepatitis B vaccine (HBV)
description: Licensed pediatric HBV vaccine will be administered at birth (Day of Life 0) or delayed to Day of Life 7.
arm group label: (HBV + BCG) VACCINES AT BIRTH
arm group label: HBV VACCINE AT BIRTH
intervention type: Biological
intervention name: Bacillus Calmette-Guérin (BCG)
description: Licensed BCG vaccine will be administered at birth (Day of Life 0) or delayed to Day of Life 7.
arm group label: (HBV + BCG) VACCINES AT BIRTH
arm group label: BCG VACCINE AT BIRTH
criteria: 
gender: All
minimum age: 0 Days
maximum age: 1 Day
healthy volunteers: Accepts Healthy Volunteers
last name: Ofer Levy, MD, PhD
role: Principal Investigator
affiliation: Boston Children's Hospital
last name: Tobias R Kollmann, MD, PhD
role: Study Director
affiliation: The University of Western Australia
last name: Beate Kampmann, MD, PhD
role: Study Chair
affiliation: Medical Research Council (MRC) Gambia
facility: 
facility: 
country: Gambia
country: Papua New Guinea
citation: Amenyogbe N, Levy O, Kollmann TR. Systems vaccinology: a promise for the young and the poor. Philos Trans R Soc Lond B Biol Sci. 2015 Jun 19;370(1671):20140340. doi: 10.1098/rstb.2014.0340.
PMID: 25964462
citation: Lee AH, Shannon CP, Amenyogbe N, Bennike TB, Diray-Arce J, Idoko OT, Gill EE, Ben-Othman R, Pomat WS, van Haren SD, Cao KL, Cox M, Darboe A, Falsafi R, Ferrari D, Harbeson DJ, He D, Bing C, Hinshaw SJ, Ndure J, Njie-Jobe J, Pettengill MA, Richmond PC, Ford R, Saleu G, Masiria G, Matlam JP, Kirarock W, Roberts E, Malek M, Sanchez-Schmitz G, Singh A, Angelidou A, Smolen KK; EPIC Consortium; Brinkman RR, Ozonoff A, Hancock REW, van den Biggelaar AHJ, Steen H, Tebbutt SJ, Kampmann B, Levy O, Kollmann TR. Dynamic molecular changes during the first week of human life follow a robust developmental trajectory. Nat Commun. 2019 Mar 12;10(1):1092. doi: 10.1038/s41467-019-08794-x.
PMID: 30862783
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Ofer Levy
investigator title: Staff Physician
mesh term: BCG Vaccine
sharing ipd: No