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

Sourcing Human Blood Products to Support the Development of New Vaccines Against Infectious Diseases

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.

Study Overview

• Status: Completed
• Conditions: Complement Mediated Bacterial Killing in Healthy Adults

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• United Kingdom
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX3 7LE
      • Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers, who are willing and able to give informed consent for participation in the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To identify healthy adult volunteers whose blood can be used in complement dependent assays	The intrinsic Serum Bactericidal Assay (SBA) of defined infectious bacterial organisms as either a; complement source with no "intrinsic killing" of defined infectious bacterial organisms; complement source with no killing of defined infectious bacterial organisms following IgG depletion; complement source with "intrinsic killing" of defined infectious bacterial organisms, to act as a positive control	At first visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Further exploratory immunology for the development of immunological assays against infectious diseases	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	At first visit

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Wellcome Trust
• Investigators: Principal Investigator: Andrew Pollard, PhD, University of Oxford

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: September 13, 2013
• First Submitted That Met QC Criteria: September 13, 2013
• First Posted (Estimate): September 18, 2013

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Complement; Serum Bactericidal Assay
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 2012/11