<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/NCT04435379</url>
  </required_header>
  <id_info>
    <org_study_id>VPM1002-DE-3.07CoV</org_study_id>
    <secondary_id>2020-001675-33</secondary_id>
    <nct_id>NCT04435379</nct_id>
  </id_info>
  <brief_title>Study to Assess VPM1002 in Reducing Hospital Admissions and/or Severe Respiratory Infectious Diseases in Elderly in COVID-19 Pandemic</brief_title>
  <official_title>A Phase III, Randomized, Double-blind, Placebo-controlled, Multicentre, Clinical Trial to Assess the Efficacy and Safety of VPM1002 in Reducing Hospital Admissions and/or Severe Respiratory Infectious Diseases in Elderly in the SARS-CoV-2 Pandemic by Modulating the Immune System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vakzine Projekt Management GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>FGK Clinical Research GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Vakzine Projekt Management GmbH</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>
      The aim of this study is to investigate whether vaccination of elderly with VPM1002 could&#xD;
      reduce hospital admissions and/or severe respiratory infectious diseases in the SARS-CoV-2&#xD;
      pandemic .&#xD;
&#xD;
      VPM1002 is a vaccine that is a further development of the old Bacillus Calmette-Guérin (BCG)&#xD;
      vaccine, which has been used successfully as a vaccine against tuberculosis for about 100&#xD;
      years, especially in developing countries. VPM1002 has been shown in various clinical studies&#xD;
      to be significantly safer than the BCG vaccine.&#xD;
&#xD;
      VPM1002 strengthens the body's immune defence and vaccination with BCG reduces the frequency&#xD;
      of respiratory diseases. It is therefore assumed that a VPM1002 vaccination could also&#xD;
      provide (partial) protection against COVID-19 disease caused by the &quot;new corona virus&quot;&#xD;
      SARS-CoV 2.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Based on the evidence that BCG [Bacille Calmette-Guérin] vaccine&#xD;
&#xD;
        1. can potentiate immune responses to other vaccines through induction of trained innate&#xD;
           immunity and heterologous adaptive immunity, and&#xD;
&#xD;
        2. can reduce the incidence of respiratory infections, exert antiviral effects in&#xD;
           experimental models, and reduce viremia in an experimental human model of viral&#xD;
           infection, it is hypothesized that BCG vaccination may induce (partial) protection&#xD;
           against the susceptibility to and/or severity of SARS-CoV-2 infections.&#xD;
&#xD;
      VPM1002 is being developed with the aim to replace BCG by a vaccine that has a better safety&#xD;
      profile and superior efficacy. Evidence from pre-clinical and clinical studies demonstrate&#xD;
      that VPM1002 is safer and is more immunogenic than the existing BCG vaccine (for more&#xD;
      information, please revert to the IB). It is therefore anticipated that VPM1002 will also&#xD;
      perform better in reducing the severity of the symptoms of an infection with the SARS-CoV-2&#xD;
      than the BCG vaccine. Further, manufacturing of VPM1002 using state-of-the-art production&#xD;
      methods will help hasten the production of millions of doses in a very short time and thus&#xD;
      would be beneficial in the current SARS-CoV-2 pandemic situation.&#xD;
&#xD;
      The current trial will assess the efficacy and safety of VPM1002 to reduce the hospital&#xD;
      admissions and clinical consequences of SARS-CoV-2 infections in the elderly population in&#xD;
      the SARS-CoV-2 pandemic by modulating the immune system.&#xD;
&#xD;
      A total of 2038 adults aged 60 or above will be enrolled across involved clinical trial sites&#xD;
      in Germany. Informed consent will be obtained from the subjects willing to take part in the&#xD;
      trial. This will be followed by assessment of the eligibility criteria. Subjects who fulfil&#xD;
      the inclusion/exclusion criteria will be centrally randomized in a 1:1 ratio to receive a&#xD;
      single dose (0.1 ml) of either VPM1002 or Placebo.&#xD;
&#xD;
      All subjects will be requested to sign into a web-based tool designed for this trial. Every&#xD;
      subject is encouraged to name a designated caregiver who may provide follow-up data in case&#xD;
      of hospitalisation or severe illness of the study subject. All subjects will be followed-up&#xD;
      entirely remotely. The questionnaires will be designed to collect data regarding&#xD;
      hospitalisation, adverse events (AE)/serious adverse events (SAE), ICU admissions and other&#xD;
      secondary endpoints. The investigators will review the outcome and safety data.&#xD;
&#xD;
      The duration of follow-up will be 240 days. Subjects with confirmed SARS-CoV-2 infection&#xD;
      (with or without symptoms) will be followed for at least 6 weeks (from the date of test&#xD;
      result), independent of the total trial duration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 18, 2020</start_date>
  <completion_date type="Actual">October 12, 2021</completion_date>
  <primary_completion_date type="Actual">October 12, 2021</primary_completion_date>
  <phase>Phase 3</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>Subjects who fulfil the inclusion/exclusion criteria will be centrally randomized in a 1:1 ratio to receive a single dose (0.1 ml) of either VPM1002 or Placebo.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>The reconstitution of trial intervention will be done by unblinded site personnel who will not be involved in the collection or evaluation of outcome data. Administration of the trial intervention will be done by blinded site personnel.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of days with severe respiratory disease at hospital and/or at home</measure>
    <time_frame>From day 0 to day 240</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of hospital admissions</measure>
    <time_frame>From day 0 to day 240</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of documented SARS-CoV-2 infection</measure>
    <time_frame>From day 0 to day 240</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days with self-reported fever (≥ 38 ºC)</measure>
    <time_frame>From day 0 to day 240</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days with self-reported acute respiratory symptoms</measure>
    <time_frame>From day 0 to day 240</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of self-reported acute respiratory symptoms</measure>
    <time_frame>From day 0 to day 240</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of death for any reason</measure>
    <time_frame>From day 0 to day 240</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of death due to documented SARS-CoV-2 infection</measure>
    <time_frame>From day 0 to day 240</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of ICU admission for any reason</measure>
    <time_frame>From day 0 to day 240</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection</measure>
    <time_frame>From day 0 to day 240</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of hospital admission due to documented SARSCoV- 2 infection</measure>
    <time_frame>From day 0 to day 240</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2038</enrollment>
  <condition>Infection, Respiratory Tract</condition>
  <arm_group>
    <arm_group_label>VPM1002</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The active ingredient of the recombinant BCG vaccine, VPM1002, is Mycobacterium bovis rBCGΔureC::hly, freeze-dried and standardized to the number of viable mycobacteria (colony forming units; CFU) per application.&#xD;
Dose: 2-8 x 10e5 CFU VPM1002 administered in 0.1 ml reconstituted suspension.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Physiological saline 0.1ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VPM1002</intervention_name>
    <description>The investigational product will be administered via intradermal injection with a 1.0-ml syringe, sub-graduated into hundredths of ml (1/100 ml), and fitted with a short bevel needle (25G/0.50 mm or 26G/0.45 mm, 10 mm in length).</description>
    <arm_group_label>VPM1002</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The investigational product will be administered via intradermal injection with a 1.0-ml syringe, sub-graduated into hundredths of ml (1/100 ml), and fitted with a short bevel needle (25G/0.50 mm or 26G/0.45 mm, 10 mm in length).</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female adult (≥ 60 years)&#xD;
&#xD;
          2. Subject is contractually capable, able to understand information on study and has&#xD;
             signed informed consent sheet&#xD;
&#xD;
          3. Subject has access to an internet-enabled electronic device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known active or latent Mycobacterium tuberculosis infection&#xD;
&#xD;
          2. Fever (&gt; 38 °C) or respiratory tract infection within the past 24 hours&#xD;
&#xD;
          3. Current active viral or bacterial infection&#xD;
&#xD;
          4. Expected vaccination during the study period; vaccinations against influenza and&#xD;
             pneumococcal disease are allowed with ≥ 4 weeks between these vaccinations and the&#xD;
             trial vaccination&#xD;
&#xD;
          5. Participation in another interventional study within 30 days before screening and&#xD;
             during this study&#xD;
&#xD;
          6. Known hypersensitivity or allergy to (components of) the VPM1002 vaccine or serious&#xD;
             adverse reactions to prior Bacille Calmette-Guérin (BCG) administration&#xD;
&#xD;
          7. Severely immunocompromised subjects, including:&#xD;
&#xD;
               1. subjects with known infection by the human immunodeficiency virus (HIV-1);&#xD;
&#xD;
               2. subjects with solid organ transplantation;&#xD;
&#xD;
               3. subjects with bone marrow transplantation;&#xD;
&#xD;
               4. subjects under chemotherapy, immunotherapy, or radiotherapy;&#xD;
&#xD;
               5. subjects with primary immunodeficiency;&#xD;
&#xD;
               6. treatment with any anti-cytokine therapies;&#xD;
&#xD;
               7. treatment with oral or intravenous steroids defined as daily doses of 10 mg&#xD;
                  prednisone or equivalent for longer than 3 months, or likely use of oral or&#xD;
                  intravenous steroids in the next 4 weeks;&#xD;
&#xD;
          8. History of malignancies, unless the subject has been free of the disease for ≥ 2&#xD;
             years; exception: subjects with adequately treated basal or squamous cell cancer or&#xD;
             other localized non-melanoma skin cancer and adequately treated carcinoma in situ of&#xD;
             the cervix may participate in the trial&#xD;
&#xD;
          9. Previous positive SARS-CoV-2 test result&#xD;
&#xD;
         10. Person is an employee of the sponsor, a relative of the sponsor or investigator, or is&#xD;
             employed in the same department as the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leander Grode, Dr. rer. nat.</last_name>
    <role>Study Director</role>
    <affiliation>Vakzine Projekt Management GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hautarztpraxis Dres. Leitz &amp; Kollegen</name>
      <address>
        <city>Stuttgart</city>
        <state>Baden-Württemberg</state>
        <zip>70178</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MECS Cottbus GmbH</name>
      <address>
        <city>Cottbus</city>
        <state>Brandenburg</state>
        <zip>03050</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Studienzentrum Dr. Keller</name>
      <address>
        <city>Frankfurt</city>
        <state>Hessen</state>
        <zip>60389</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Hannover Mitte GmbH</name>
      <address>
        <city>Hannover</city>
        <state>Niedersachsen</state>
        <zip>30159</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <state>Niedersachsen</state>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizentrum Essen Borbeck</name>
      <address>
        <city>Essen</city>
        <state>Nordrhein-Westfalen</state>
        <zip>45355</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BAG Dres. med. Quist PartG</name>
      <address>
        <city>Mainz</city>
        <state>Rheinland-Pfalz</state>
        <zip>55128</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SIBAmed GmbH &amp; Co. KG</name>
      <address>
        <city>Leipzig</city>
        <state>Sachsen</state>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SocraTec R&amp;D GmbH</name>
      <address>
        <city>Erfurt</city>
        <state>Thüringen</state>
        <zip>99084</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>emovis GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>10629</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Berlin GbR</name>
      <address>
        <city>Berlin</city>
        <zip>10787</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Hamburg GmbH</name>
      <address>
        <city>Hamburg</city>
        <zip>20253</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>October 25, 2021</last_update_submitted>
  <last_update_submitted_qc>October 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>infectious respiratory diseases</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is uncertainty whether the European Union General Data Protection Regulation allows dissemination of individual participant data to other researchers. Some reasons why the EU Regulation would not allow this are the lack of suitable safeguards when personal data are transferred to any researcher asking for it and the impairment of the rights of the subjects for erasure of their data once they are disseminated.</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/NCT04435379
org study id: VPM1002-DE-3.07CoV
secondary id: 2020-001675-33
nct id: NCT04435379
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate whether vaccination of elderly with VPM1002 could
      reduce hospital admissions and/or severe respiratory infectious diseases in the SARS-CoV-2
      pandemic .

      VPM1002 is a vaccine that is a further development of the old Bacillus Calmette-Guérin (BCG)
      vaccine, which has been used successfully as a vaccine against tuberculosis for about 100
      years, especially in developing countries. VPM1002 has been shown in various clinical studies
      to be significantly safer than the BCG vaccine.

      VPM1002 strengthens the body's immune defence and vaccination with BCG reduces the frequency
      of respiratory diseases. It is therefore assumed that a VPM1002 vaccination could also
      provide (partial) protection against COVID-19 disease caused by the "new corona virus"
      SARS-CoV 2.
Based on the evidence that BCG [Bacille Calmette-Guérin] vaccine

        1. can potentiate immune responses to other vaccines through induction of trained innate
           immunity and heterologous adaptive immunity, and

        2. can reduce the incidence of respiratory infections, exert antiviral effects in
           experimental models, and reduce viremia in an experimental human model of viral
           infection, it is hypothesized that BCG vaccination may induce (partial) protection
           against the susceptibility to and/or severity of SARS-CoV-2 infections.

      VPM1002 is being developed with the aim to replace BCG by a vaccine that has a better safety
      profile and superior efficacy. Evidence from pre-clinical and clinical studies demonstrate
      that VPM1002 is safer and is more immunogenic than the existing BCG vaccine (for more
      information, please revert to the IB). It is therefore anticipated that VPM1002 will also
      perform better in reducing the severity of the symptoms of an infection with the SARS-CoV-2
      than the BCG vaccine. Further, manufacturing of VPM1002 using state-of-the-art production
      methods will help hasten the production of millions of doses in a very short time and thus
      would be beneficial in the current SARS-CoV-2 pandemic situation.

      The current trial will assess the efficacy and safety of VPM1002 to reduce the hospital
      admissions and clinical consequences of SARS-CoV-2 infections in the elderly population in
      the SARS-CoV-2 pandemic by modulating the immune system.

      A total of 2038 adults aged 60 or above will be enrolled across involved clinical trial sites
      in Germany. Informed consent will be obtained from the subjects willing to take part in the
      trial. This will be followed by assessment of the eligibility criteria. Subjects who fulfil
      the inclusion/exclusion criteria will be centrally randomized in a 1:1 ratio to receive a
      single dose (0.1 ml) of either VPM1002 or Placebo.

      All subjects will be requested to sign into a web-based tool designed for this trial. Every
      subject is encouraged to name a designated caregiver who may provide follow-up data in case
      of hospitalisation or severe illness of the study subject. All subjects will be followed-up
      entirely remotely. The questionnaires will be designed to collect data regarding
      hospitalisation, adverse events (AE)/serious adverse events (SAE), ICU admissions and other
      secondary endpoints. The investigators will review the outcome and safety data.

      The duration of follow-up will be 240 days. Subjects with confirmed SARS-CoV-2 infection
      (with or without symptoms) will be followed for at least 6 weeks (from the date of test
      result), independent of the total trial duration.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects who fulfil the inclusion/exclusion criteria will be centrally randomized in a 1:1 ratio to receive a single dose (0.1 ml) of either VPM1002 or Placebo.
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: The reconstitution of trial intervention will be done by unblinded site personnel who will not be involved in the collection or evaluation of outcome data. Administration of the trial intervention will be done by blinded site personnel.
measure: Number of days with severe respiratory disease at hospital and/or at home
time frame: From day 0 to day 240
measure: Cumulative incidence of hospital admissions
time frame: From day 0 to day 240
measure: Cumulative incidence of documented SARS-CoV-2 infection
time frame: From day 0 to day 240
measure: Number of days with self-reported fever (≥ 38 ºC)
time frame: From day 0 to day 240
measure: Number of days with self-reported acute respiratory symptoms
time frame: From day 0 to day 240
measure: Cumulative incidence of self-reported acute respiratory symptoms
time frame: From day 0 to day 240
measure: Cumulative incidence of death for any reason
time frame: From day 0 to day 240
measure: Cumulative incidence of death due to documented SARS-CoV-2 infection
time frame: From day 0 to day 240
measure: Cumulative incidence of ICU admission for any reason
time frame: From day 0 to day 240
measure: Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection
time frame: From day 0 to day 240
measure: Cumulative incidence of hospital admission due to documented SARSCoV- 2 infection
time frame: From day 0 to day 240
arm group label: VPM1002
arm group type: Experimental
description: The active ingredient of the recombinant BCG vaccine, VPM1002, is Mycobacterium bovis rBCGΔureC::hly, freeze-dried and standardized to the number of viable mycobacteria (colony forming units; CFU) per application.
Dose: 2-8 x 10e5 CFU VPM1002 administered in 0.1 ml reconstituted suspension.
arm group label: Placebo
arm group type: Placebo Comparator
description: Physiological saline 0.1ml
intervention type: Biological
intervention name: VPM1002
description: The investigational product will be administered via intradermal injection with a 1.0-ml syringe, sub-graduated into hundredths of ml (1/100 ml), and fitted with a short bevel needle (25G/0.50 mm or 26G/0.45 mm, 10 mm in length).
arm group label: VPM1002
intervention type: Biological
intervention name: Placebo
description: The investigational product will be administered via intradermal injection with a 1.0-ml syringe, sub-graduated into hundredths of ml (1/100 ml), and fitted with a short bevel needle (25G/0.50 mm or 26G/0.45 mm, 10 mm in length).
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Leander Grode, Dr. rer. nat.
role: Study Director
affiliation: Vakzine Projekt Management GmbH
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Respiratory Tract Infections
sharing ipd: No
ipd description: There is uncertainty whether the European Union General Data Protection Regulation allows dissemination of individual participant data to other researchers. Some reasons why the EU Regulation would not allow this are the lack of suitable safeguards when personal data are transferred to any researcher asking for it and the impairment of the rights of the subjects for erasure of their data once they are disseminated.