Condition category
Infections and Infestations
Date applied
04/07/2006
Date assigned
28/07/2006
Last edited
24/07/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.paediatrics.ox.ac.uk/ovg/

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 measures

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

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

http://www.admin.ox.ac.uk/rso/contactus/ctrg.shtml

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes