Complement Mediated Bacterial Killing in Healthy AdultsC2NCT01945307
Complement 2: Blood Donations to Develop Vaccines Against Infectious Diseases
An observational study of Complement Mediated Bacterial Killing in Healthy Adults, run by University of Oxford at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Complement Mediated Bacterial Killing in Healthy Adults
- How many people
- 101 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2013to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult volunteers, who are willing and able to give informed consent for participation in the study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: 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.
- Keywords
- Complement, Serum Bactericidal Assay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Healthy adults aged 18 to 70 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At first visit
Secondary outcomes (1)
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
Measured: At first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startOct 2013
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complement Mediated Bacterial Killing in Healthy AdultsStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Andrew Pollard, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945307
- Sponsor's protocol ID
- 2012/11
- Acronym
- C2
- Status last verified
- Oct 2020
- First submitted
- 13 Sep 2013
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sourcing Human Blood Products to Support the Development of New Vaccines Against Infectious Diseases
- ClinicalTrials.gov ID
- NCT01945307
- Acronym / sponsor ID
- C2 / 2012/11
- Keywords
- Complement, Serum Bactericidal Assay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- Oct 2013
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 18 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | –Healthy adults aged 18 to 70 years |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers, who are willing and able to give informed consent for participation in the study.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Further exploratory immunology for the development of immunological assays against infectious diseases
Time frame: At first visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Pollard, PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complement Mediated Bacterial Killing in Healthy Adults, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify healthy adult volunteers whose blood can be used in complement dependent assays (time frame: At first visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.