Clinical trial NCT01945307: Complement 2: Blood Donations to Develop Vaccines Against Infectious Diseases
Official title: Sourcing Human Blood Products to Support the Development of New Vaccines Against Infectious Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complement Mediated Bacterial Killing in Healthy Adults
Keywords: Complement
Serum Bactericidal Assay
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
First posted: 2013-09-18
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers, who are willing and able to give informed consent for participation in the study.

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.


Eligibility 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

Primary outcomes:
measure: To identify healthy adult volunteers whose blood can be used in complement dependent assays
timeFrame: At first visit
Secondary outcomes:
measure: Further exploratory immunology for the development of immunological assays against infectious diseases
timeFrame: At first visit
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Andrew Pollard, PhD
role: PRINCIPAL_INVESTIGATOR
References: