Back to resultsPneumococcal Adult Kinetics Study - Understanding the B Cell Response to Pneumococcal Vaccines
Primary Purpose
Pneumococcal Disease
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Prevenar 13
Pneumovax II
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Disease focused on measuring Invasive pneumococcal disease
Eligibility Criteria
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:
- medical history
- history-directed physical examination
- clinical judgment of the investigator
- 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):
- Receipt of immunostimulants
- Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy (prednisolone or equivalent for more than two consecutive weeks within the past 3 months).
- 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
Sites / Locations
- Oxford Vaccine Group
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
PCV-13 group
PPV-23 group
Arm Description
1 dose of Prevenar-13
1 dose of Pneumovax-II
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01432158
First Posted
September 8, 2011
Last Updated
November 6, 2015
Sponsor
University of Oxford
Collaborators
Mason Medical Research Trust
1. Study Identification
Unique Protocol Identification Number
NCT01432158
Brief Title
Pneumococcal Adult Kinetics Study - Understanding the B Cell Response to Pneumococcal Vaccines
Official Title
A Detailed Kinetics Study to Assess the Antibody and the B Cell Response to Either a 13-valent Conjugate Vaccine or a 23-valent Plain Pneumococcal Polysaccharide Vaccine Administered to Healthy Adults Without Prior Pneumococcal Vaccination
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Mason Medical Research Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease
Keywords
Invasive pneumococcal disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PCV-13 group
Arm Type
Experimental
Arm Description
1 dose of Prevenar-13
Arm Title
PPV-23 group
Arm Type
Experimental
Arm Description
1 dose of Pneumovax-II
Intervention Type
Biological
Intervention Name(s)
Prevenar 13
Intervention Description
This vaccine will be given to healthy adults without prior pneumococcal vaccination.
Intervention Type
Biological
Intervention Name(s)
Pneumovax II
Intervention Description
This vaccine will be given to healthy adults without prior pneumococcal vaccination.
Primary Outcome Measure Information:
Title
Frequency of serotype-specific B cell subsets determined by FACS.
Description
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.
Time Frame
within first month after vaccination
Secondary Outcome Measure Information:
Title
Pneumococcal serotype-specific geometric mean concentrations (GMC)
Description
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.
Time Frame
within first month after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
medical history
history-directed physical examination
clinical judgment of the investigator
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):
Receipt of immunostimulants
Congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy (prednisolone or equivalent for more than two consecutive weeks within the past 3 months).
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew J Pollard, BSc MBBS PhD MRCP FRCPCH
Organizational Affiliation
Department of Paediatrics, Oxford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oxford Vaccine Group
City
Oxford
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Pneumococcal Adult Kinetics Study - Understanding the B Cell Response to Pneumococcal Vaccines
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