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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Mason Medical Research Trust
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01432158
First received: September 8, 2011
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Pneumococcal Disease
Biological: Prevenar 13
Biological: Pneumovax II
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Frequency of serotype-specific B cell subsets determined by FACS. [ Time Frame: within first month after vaccination ] [ Designated as safety issue: No ]
    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:
  • Pneumococcal serotype-specific geometric mean concentrations (GMC) [ Time Frame: within first month after vaccination ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 4
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432158

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

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01432158     History of Changes
Other Study ID Numbers: 2011/04B
Study First Received: September 8, 2011
Last Updated: August 13, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:
Invasive pneumococcal disease

ClinicalTrials.gov processed this record on September 18, 2014