Pneumococcal Adult Kinetics Study - Understanding the B Cell Response to Pneumococcal Vaccines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01432158
Recruitment Status : Completed
First Posted : September 12, 2011
Last Update Posted : November 9, 2015
Mason Medical Research Trust
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment Phase
Pneumococcal Disease Biological: Prevenar 13 Biological: Pneumovax II Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : January 2012
Actual Primary Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PCV-13 group
1 dose of Prevenar-13
Biological: Prevenar 13
This vaccine will be given to healthy adults without prior pneumococcal vaccination.

Experimental: PPV-23 group
1 dose of Pneumovax-II
Biological: Pneumovax II
This vaccine will be given to healthy adults without prior pneumococcal vaccination.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01432158

United Kingdom
Oxford Vaccine Group
Oxford, United Kingdom
Sponsors and Collaborators
University of Oxford
Mason Medical Research Trust
Principal Investigator: Andrew J Pollard, BSc MBBS PhD MRCP FRCPCH Department of Paediatrics, Oxford University

Responsible Party: University of Oxford Identifier: NCT01432158     History of Changes
Other Study ID Numbers: 2011/04B
First Posted: September 12, 2011    Key Record Dates
Last Update Posted: November 9, 2015
Last Verified: November 2015

Keywords provided by University of Oxford:
Invasive pneumococcal disease

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs