Completed

NCT Number: NCT01945307

Complement 2: Blood Donations to Develop 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Complement Mediated Bacterial Killing in Healthy Adults

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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;
- 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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

Wellcome Trust

Registry information

Official study title

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

Acronym: C2

Important dates

Study start: 2013
Primary completion: 2023
Study completion: 2023
First posted: Sep 18, 2013
Registry last updated: Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.