Pneumococcal DiseasePhase 3NCT01432158
Pneumococcal Adult Kinetics Study - Understanding the B Cell Response to Pneumococcal Vaccines
A Phase 3 study testing Prevenar 13 and Pneumovax II in people with Pneumococcal Disease, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- Prevenar 13 and Pneumovax II
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Aug 2012
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Pneumococcal Disease
- Being tested
- Prevenar 13, Pneumovax II
- Keywords
- Invasive pneumococcal disease
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevenar 13Biological
This vaccine will be given to healthy adults without prior pneumococcal vaccination.
Pneumovax IIBiological
This vaccine will be given to healthy adults without prior pneumococcal vaccination.
| Study group | Role | What they receive |
|---|---|---|
| PCV-13 group | Experimental | 1 dose of Prevenar-13 Receives: Biological: Prevenar 13 |
| PPV-23 group | Experimental | 1 dose of Pneumovax-II Receives: Biological: Pneumovax II |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within first month after vaccination
Secondary outcomes (1)
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.
Measured: within first month after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startJan 2012
- Primary completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal DiseaseStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Mason Medical Research Trust
- Responsible party
- Sponsor
- Investigators
- Andrew J Pollard, BSc MBBS PhD MRCP FRCPCH, Principal investigator, Department of Paediatrics, Oxford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432158
- Sponsor's protocol ID
- 2011/04B
- Status last verified
- Nov 2015
- First submitted
- 8 Sep 2011
- Last updated
- 9 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01432158
- Acronym / sponsor ID
- 2011/04B
- Conditions
- Pneumococcal Disease
- Keywords
- Invasive pneumococcal disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Mason Medical Research Trust
- Study start
- Jan 2012
- Primary completion
- Aug 2012 (actual)
- First posted
- 12 Sep 2011 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCV-13 group | Experimental | Biological: Prevenar 131 dose of Prevenar-13 |
| PPV-23 group | Experimental | Biological: Pneumovax II1 dose of Pneumovax-II |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevenar 13This vaccine will be given to healthy adults without prior pneumococcal vaccination. | Biological | PCV-13 group |
| Pneumovax IIThis vaccine will be given to healthy adults without prior pneumococcal vaccination. | Biological | PPV-23 group |
Primary outcome
Frequency of serotype-specific B cell subsets determined by FACS.
Time frame: within first month after vaccination
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.
1 secondary outcome
Pneumococcal serotype-specific geometric mean concentrations (GMC)
Time frame: within first month after vaccination
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 9 Nov 2015.
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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 J Pollard, BSc MBBS PhD MRCP FRCPCH principal investigator
Department of Paediatrics, Oxford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prevenar 13 and Pneumovax II in people with Pneumococcal Disease, 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 8 inclusion and 13 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 9 Nov 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Frequency of serotype-specific B cell subsets determined by FACS. (time frame: within first month after vaccination). 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 9 Nov 2015.