Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Andrew Pollard
ORCID ID
Contact details
Oxford Vaccine Group
Department of Paediatrics
University of Oxford
Centre for Clinical Vaccinology and Tropical Medicine
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom
+44 (0)1865 857420
ovg@paediatrics.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6097A1-800
Study information
Scientific title
Acronym
Protecting adults against pneumococcal disease
Study hypothesis
To assess the antibody response (absolute antibody concentration) to a 23-valent pneumococcal polysaccharide vaccine (Pn23) after a 0, 1 or 2 dose priming immunisation with heptavalent pneumococcal conjugate vaccine (Pnc7).
Ethics approval
Ethics approval received from the Oxfordshire A Local Research Ethics Committee (LREC) on the 14th September 2006 (ref: 06/Q1604/121).
Study design
Randomised clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pneumococcal disease
Intervention
Interventions used are the Heptavalent pneumococcal conjugate vaccine (Prevenar ®, Wyeth Vaccines) and 23-valent pneumococcal polysaccharide vaccine (Pneumovax® II, Sanofi Pasteur MSD). Participants will be randomised to receive either:
1. Two doses of the 7-serotype vaccine (Prevenar®) followed by one dose of the 23-serotype vaccine (Pneumovax® II)
2. One dose of the 23-serotype vaccine (Pneumovax® II) followed by two doses of the 7-serotype vaccine (Prevenar®)
3. One dose of the 7-serotype vaccine (Prevenar®) followed by one dose of the 23-serotype vaccine (Pneumovax® II, followed by a further dose of the 7-serotype vaccine (Prevenar®)
All vaccines will be administered at 0, 6 and 12 months.
Intervention type
Drug
Phase
Not Specified
Drug names
Heptavalent pneumococcal conjugate vaccine (Prevenar ®), 23-valent pneumococcal polysaccharide vaccine (Pneumovax® II)
Primary outcome measure
Absolute antibody concentration to Pn23 after a one or 2 dose priming immunisation with Pnc7.
Secondary outcome measures
1. Characterisation and measurement of the B cell responses and assessment of memory induction following the three different immunisation regimes
2. Number and nature of any adverse events occurring during the study
Overall trial start date
01/09/2006
Overall trial end date
31/08/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy adults aged 50 - 70 years inclusive
2. In good health as determined by:
2.1. Medical history
2.2. History-directed physical examination
2.3. Clinical judgment of the investigator
3. Able (in the Investigators opinion) and willing to comply with all study requirements including be available for all the visits scheduled in the study
4. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
348
Participant exclusion criteria
1. Have previously received any pneumococcal vaccine
2. Have received vaccination with a vaccine containing either CRM197 or Diphtheria toxoid within the past 12 months
3. Have a previous ascertained or suspected disease caused C. diphtheriae, or Pneumococcus
4. Have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component
5. Have a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example):
5.1. Receipt of any immunosuppressive therapy
5.2. Receipt of immunostimulants
5.3. 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)
6. Have a suspected or known human immunodeficiency virus (HIV) infection or HIV related disease
7. Have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months
8. Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
9. Have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
10. Participation in another clinical trial investigating a vaccine, a drug, a medical device, or a medical procedure
Recruitment start date
01/09/2006
Recruitment end date
31/08/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford Vaccine Group
Oxford
OX3 7LJ
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
Clinical Trials Office
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 7LJ
United Kingdom
+44 (0)1865 743004
heather.house@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Wyeth Vaccines (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 result in http://www.ncbi.nlm.nih.gov/pubmed/21367726
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22457293
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22704520
Publication citations
-
Result
Lazarus R, Clutterbuck E, Yu LM, Bowman J, Bateman EA, Diggle L, Angus B, Peto TE, Beverley PC, Mant D, Pollard AJ, A randomized study comparing combined pneumococcal conjugate and polysaccharide vaccination schedules in adults., Clin. Infect. Dis., 2011, 52, 6, 736-742, doi: 10.1093/cid/cir003.
-
Results
Clutterbuck EA, Lazarus R, Yu LM, Bowman J, Bateman EA, Diggle L, Angus B, Peto TE, Beverley PC, Mant D, Pollard AJ, Pneumococcal conjugate and plain polysaccharide vaccines have divergent effects on antigen-specific B cells., J. Infect. Dis., 2012, 205, 9, 1408-1416, doi: 10.1093/infdis/jis212.
-
Results
Trück J, Lazarus R, Clutterbuck EA, Bowman J, Kibwana E, Bateman EA, Pollard AJ, The zwitterionic type I Streptococcus pneumoniae polysaccharide does not induce memory B cell formation in humans., Immunobiology, 2013, 218, 3, 368-372, doi: 10.1016/j.imbio.2012.05.008.