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| Name | Class |
|---|---|
| Mason Medical Research Trust | UNKNOWN |
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This is an open-label phase III clinical trial. The purpose of this trial is to investigate in detail the kinetics of the immune response to Prevenar-13, a pneumococcal conjugate vaccine, compared to Pneumovax-II, a pneumococcal plain polysaccharide vaccine. With their consent, healthy adults (n=2 in each group) aged over 18 years who have not received any pneumococcal vaccine in the past will receive either vaccine at their first visit. Blood will be taken before vaccination and at day 0,1,2,4,6,8,10,12,14,16,18,20,23,26,30,35 as well as 2,6 and 12 months following vaccination. With specific consent, a small volume of blood will be used to store DNA and RNA for analysis of the genetic associations with immune responses and adverse reactions to vaccines as well as the RNA expression following a vaccination. Serum or plasma will be used to assess antibody level and available whole blood will be used for B cell assays and to examine immunoglobulin gene usage in B cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCV-13 group | Experimental | 1 dose of Prevenar-13 |
|
| PPV-23 group | Experimental | 1 dose of Pneumovax-II |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevenar 13 | Biological | This vaccine will be given to healthy adults without prior pneumococcal vaccination. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of serotype-specific B cell subsets determined by FACS. | To assess and compare the kinetics of serotype-specific B cell subsets following a dose of PCV-13 or PPCV-23 given to healthy adults. | within first month after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumococcal serotype-specific geometric mean concentrations (GMC) | To assess and compare the kinetics of serotype-specific antibody (subclass) geometric mean concentrations (GMC) in response to a dose of PCV-13 or PPCV-23 given to healthy adults. | within first month after vaccination |
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Inclusion Criteria:
Above 18 years of age.
Participant is willing and able to give informed consent for participation after the nature of the study has been explained;
In good health as determined by:
Able (in the Investigators opinion) and willing to comply with all study requirements including be available for all the visits scheduled in the study
Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion Criteria:
Have previously received a pneumococcal vaccine
Have received vaccination with a vaccine containing either CRM197 or diphtheria toxoid within the past 12 months,
Have had previous ascertained disease caused by C. diphtheriae, or S. pneumoniae in the past 5 years documented in their medical notes
Have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
Have a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example):
Have a suspected or known HIV infection or HIV related disease;
Have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months
Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
Have any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Participation in another clinical trial investigating a vaccine, a drug, a medical device, or a medical procedure
Pregnancy as confirmed by a positive pregnancy test
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| Name | Affiliation | Role |
|---|---|---|
| Andrew J Pollard, BSc MBBS PhD MRCP FRCPCH | Department of Paediatrics, Oxford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Vaccine Group | Oxford | United Kingdom |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
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| Pneumovax II | Biological | This vaccine will be given to healthy adults without prior pneumococcal vaccination. |
|
| D007239 | Infections |