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Complement 2: Blood Donations to Develop Vaccines Against Infectious Diseases (C2)

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ClinicalTrials.gov Identifier: NCT01945307
Recruitment Status : Recruiting
First Posted : September 18, 2013
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Wellcome Trust
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

We need human blood to understand the immune response to infection and to test promising new vaccines against infectious diseases in the laboratory. One test is called the Serum Bactericidal Assay (or SBA), which is measure of how effective antibodies are at killing certain bacteria and can be an important measure of how effective a new vaccine may be.

The samples would be used in the laboratory analysis of clinical trials of vaccines used in adults and children, and some samples in pre-clinical (animal) experiments testing new vaccines before they enter human-stage testing. Most people have some form of protection against most bacteria already, so not everyone is a suitable blood donor for this laboratory test. We therefore start by taking a small blood sample and test this one before asking for more blood if we found yours suitable for the work we do.


Condition or disease
Complement Mediated Bacterial Killing in Healthy Adults

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sourcing Human Blood Products to Support the Development of New Vaccines Against Infectious Diseases
Study Start Date : October 2013
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2020

Group/Cohort
Healthy adults
Healthy adults aged 18 to 70 years



Primary Outcome Measures :
  1. To identify healthy adult volunteers whose blood can be used in complement dependent assays [ Time Frame: At first visit ]

    The intrinsic Serum Bactericidal Assay (SBA) of defined infectious bacterial organisms as either a;

    1. complement source with no "intrinsic killing" of defined infectious bacterial organisms
    2. complement source with no killing of defined infectious bacterial organisms following IgG depletion
    3. complement source with "intrinsic killing" of defined infectious bacterial organisms, to act as a positive control


Secondary Outcome Measures :
  1. Further exploratory immunology for the development of immunological assays against infectious diseases [ Time Frame: At first visit ]

    To analyse the following in healthy adults;

    • Immunoglobulin G (IgG) antibody concentration against defined target meningococcal, typhoid and shigella strain antigens
    • Complement factor H concentration
    • The relationship between the concentrations of specific anti-meningococcal, anti-typhoid and anti-shigella antibodies and factor H to the ability to mediate intrinsic killing in the SBA assay
    • Any further exploratory immunology to develop laboratory assays measuring the immune responses to vaccination


Biospecimen Retention:   Samples Without DNA
Serum only, no DNA or other blood components are stored.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adult volunteers, who are willing and able to give informed consent for participation in the study.
Criteria

Inclusion Criteria:

  • Willing and able to give informed consent for participation in the study
  • Aged between 18 and 70 years
  • In good health as determined by medical history and clinical judgment of the Investigators
  • Able to attend the scheduled visits and to comply with all study procedures
  • If found to be a suitable complement that they are willing to be approached for further donations

Exclusion Criteria:

  • Body weight less than 50kgs
  • Have any known or suspected impairment or alteration of immune function, resulting from, as examples:congenital or acquired immunodeficiency, receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months or long-term systemic corticosteroid therapy, receipt of immunoglobulin or any blood product transfusion within the last 3 months
  • Female participants who are pregnant
  • Any chronic illness that could, in the opinion of the Investigators, interfere with immune function or with the donation of large volumes of blood (e.g. thrombocytopaenia or coagulopathy, malabsorption disorders, chronic anaemia)
  • An individual who is on the delegation log for the study
  • Planned blood donation within 4 months of undergoing testing to assess whether the individual is a suitable Complement donor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945307


Contacts
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Contact: Parvinder Aley 01865 611400 info@paediatrics.ox.ac.uk

Locations
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United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine (CCVTM) Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7LE
Contact: Parvinder Aley    01865 611400      
Principal Investigator: Andrew Pollard, PhD         
Sponsors and Collaborators
University of Oxford
Wellcome Trust
Investigators
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Principal Investigator: Andrew Pollard, PhD University of Oxford

Additional Information:
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01945307     History of Changes
Other Study ID Numbers: 2012/11
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: October 2018

Keywords provided by University of Oxford:
Complement
Serum Bactericidal Assay

Additional relevant MeSH terms:
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Communicable Diseases
Infection
Complement System Proteins
Immunologic Factors
Physiological Effects of Drugs