<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/NCT03284515</url>
  </required_header>
  <id_info>
    <org_study_id>17.0060</org_study_id>
    <nct_id>NCT03284515</nct_id>
  </id_info>
  <brief_title>Vaccination In Pregnancy Gene Signature: VIP Signature Study</brief_title>
  <official_title>Vaccination In Pregnancy Gene Signature: VIP Signature Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St George's, University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Innovative Medicine Initiative</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Max Planck Institute for Infection Biology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St George's, University of London</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A study investigating gene expression profiles in pregnant women in response to a pertussis&#xD;
      containing vaccination in pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vaccinations are a vital part of ensuring population health, but there is a continued need&#xD;
      for new and improved vaccines to be developed and this process of design and development can&#xD;
      be both slow and expensive. Vaccination in pregnancy against pathogens such as pertussis,&#xD;
      influenza and tetanus is a routine part of antenatal care in many countries. The principle&#xD;
      behind this approach is that through vaccination the amount of disease specific antibody is&#xD;
      increased in the woman and there is therefore an increase in transplacental transfer to the&#xD;
      fetus providing protection for infants after birth. In the UK vaccination against pertussis&#xD;
      is recommended from 16 weeks gestation and against influenza at any gestation within the&#xD;
      influenza season. There is evidence that pertussis vaccination in pregnancy is highly&#xD;
      effective against pertussis in infants too young to be protected by the routine infant&#xD;
      immunisation programme (Amirthalingam G et al, 2014, Dabrera G et al, 2015). There is also&#xD;
      evidence that this is a safe strategy in pregnancy to protect newborn infants (Donegan K et&#xD;
      al, 2014) with no evidence of adverse clinical outcomes for mother or infant.&#xD;
&#xD;
      The BioVacSafe project has been designed to develop techniques which can be used to&#xD;
      understand more about biomarkers of safety in individuals' response to vaccines. This will&#xD;
      improve our understanding of how reactogenicity can be identified earlier, how adverse&#xD;
      reactions can be identified and classified and how individuals interact with vaccines,&#xD;
      specifically in conditions of health and disease. Since the start of the BioVacSafe project&#xD;
      the importance of vaccination in pregnancy has become better understood and it has become&#xD;
      important to include pregnant women as participants in this project. Pregnancy is a time of&#xD;
      altered immunity and it may be that there are differences in gene signatures following&#xD;
      vaccination in pregnant women compared with non-pregnant women. Insights into this could be&#xD;
      extremely important in the development of new vaccines for this population.&#xD;
&#xD;
      Safety of vaccination in pregnancy is of primary importance to pregnant women and their&#xD;
      partners, clinical trials investigators, ethics committees, vaccine manufacturers and&#xD;
      regulators. Determining specific genetic signatures following vaccination may accelerate&#xD;
      vaccine development by predicting possible adverse events early in the development process.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2017</start_date>
  <completion_date type="Actual">March 21, 2018</completion_date>
  <primary_completion_date type="Actual">January 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Gene expression profiles</measure>
    <time_frame>24 hours</time_frame>
    <description>Gene expression profiles in blood samples from pregnant women following vaccination.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Pregnancy Related</condition>
  <condition>Vaccination</condition>
  <arm_group>
    <arm_group_label>All women</arm_group_label>
    <description>Women who are between 16-32 weeks gestation and who have not previously received a pertussis vaccination in pregnancy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Vaccination with a pertussis containing vaccine</intervention_name>
    <description>Vaccination with a pertussis containing vaccine</description>
    <arm_group_label>All women</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples will be taken from the women prior to and 24 hours following vaccination.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women at between 16-32 weeks gestation who have not yet received the pertussis&#xD;
        vaccination in pregnancy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant at a gestation of 16-32 weeks&#xD;
&#xD;
          -  No contraindications to vaccination according to the green book&#xD;
&#xD;
          -  No known immunodeficiency&#xD;
&#xD;
          -  Able to understand the details of the study and willing to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having received a pertussis containing vaccine within the last 12 months&#xD;
&#xD;
          -  Contraindications to vaccination according to the green book&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St George's, University of London</name>
      <address>
        <city>London</city>
        <zip>SW170RE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>January 8, 2021</last_update_submitted>
  <last_update_submitted_qc>January 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Personal details of the participants will be collected to allow us to contact them if necessary. This information will be stored securely and will not leave St. George's, University of London. Some limited demographic and medical information may be shared with researchers at Imperial College London and the Max Planck Institute for Infection Biology both of which are part of this study and the wider BioVacSafe consortium.</ipd_description>
  </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/NCT03284515
org study id: 17.0060
nct id: NCT03284515
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A study investigating gene expression profiles in pregnant women in response to a pertussis
      containing vaccination in pregnancy.
Vaccinations are a vital part of ensuring population health, but there is a continued need
      for new and improved vaccines to be developed and this process of design and development can
      be both slow and expensive. Vaccination in pregnancy against pathogens such as pertussis,
      influenza and tetanus is a routine part of antenatal care in many countries. The principle
      behind this approach is that through vaccination the amount of disease specific antibody is
      increased in the woman and there is therefore an increase in transplacental transfer to the
      fetus providing protection for infants after birth. In the UK vaccination against pertussis
      is recommended from 16 weeks gestation and against influenza at any gestation within the
      influenza season. There is evidence that pertussis vaccination in pregnancy is highly
      effective against pertussis in infants too young to be protected by the routine infant
      immunisation programme (Amirthalingam G et al, 2014, Dabrera G et al, 2015). There is also
      evidence that this is a safe strategy in pregnancy to protect newborn infants (Donegan K et
      al, 2014) with no evidence of adverse clinical outcomes for mother or infant.

      The BioVacSafe project has been designed to develop techniques which can be used to
      understand more about biomarkers of safety in individuals' response to vaccines. This will
      improve our understanding of how reactogenicity can be identified earlier, how adverse
      reactions can be identified and classified and how individuals interact with vaccines,
      specifically in conditions of health and disease. Since the start of the BioVacSafe project
      the importance of vaccination in pregnancy has become better understood and it has become
      important to include pregnant women as participants in this project. Pregnancy is a time of
      altered immunity and it may be that there are differences in gene signatures following
      vaccination in pregnant women compared with non-pregnant women. Insights into this could be
      extremely important in the development of new vaccines for this population.

      Safety of vaccination in pregnancy is of primary importance to pregnant women and their
      partners, clinical trials investigators, ethics committees, vaccine manufacturers and
      regulators. Determining specific genetic signatures following vaccination may accelerate
      vaccine development by predicting possible adverse events early in the development process.
observational model: Cohort
time perspective: Prospective
measure: Gene expression profiles
time frame: 24 hours
description: Gene expression profiles in blood samples from pregnant women following vaccination.
arm group label: All women
description: Women who are between 16-32 weeks gestation and who have not previously received a pertussis vaccination in pregnancy.
intervention type: Biological
intervention name: Vaccination with a pertussis containing vaccine
description: Vaccination with a pertussis containing vaccine
arm group label: All women
Blood samples will be taken from the women prior to and 24 hours following vaccination.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No
ipd description: Personal details of the participants will be collected to allow us to contact them if necessary. This information will be stored securely and will not leave St. George's, University of London. Some limited demographic and medical information may be shared with researchers at Imperial College London and the Max Planck Institute for Infection Biology both of which are part of this study and the wider BioVacSafe consortium.