- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01432158
Pneumococcal Adult Kinetics Study - Understanding the B Cell Response to Pneumococcal Vaccines
November 6, 2015 updated by: University of Oxford
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Oxford, United Kingdom
- Oxford Vaccine Group
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PCV-13 group
1 dose of Prevenar-13
|
This vaccine will be given to healthy adults without prior pneumococcal vaccination.
|
Experimental: PPV-23 group
1 dose of Pneumovax-II
|
This vaccine will be given to healthy adults without prior pneumococcal vaccination.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of serotype-specific B cell subsets determined by FACS.
Time Frame: within first month after vaccination
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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.
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within first month after vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pneumococcal serotype-specific geometric mean concentrations (GMC)
Time Frame: within first month after vaccination
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrew J Pollard, BSc MBBS PhD MRCP FRCPCH, Department of Paediatrics, Oxford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
September 8, 2011
First Submitted That Met QC Criteria
September 9, 2011
First Posted (Estimate)
September 12, 2011
Study Record Updates
Last Update Posted (Estimate)
November 9, 2015
Last Update Submitted That Met QC Criteria
November 6, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011/04B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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