Clinical trial NCT01432158: Pneumococcal Adult Kinetics Study - Understanding the B Cell Response to Pneumococcal Vaccines
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Keywords: Invasive pneumococcal disease
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Mason Medical Research Trust
First posted: 2011-09-12
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Frequency of serotype-specific B cell subsets determined by FACS.
timeFrame: within first month after vaccination
Secondary outcomes:
measure: Pneumococcal serotype-specific geometric mean concentrations (GMC)
timeFrame: within first month after vaccination
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Vaccine Group
Study officials:
affiliation: Department of Paediatrics, Oxford University
name: Andrew J Pollard, BSc MBBS PhD MRCP FRCPCH
role: PRINCIPAL_INVESTIGATOR
References: