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

Pneumococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432158
• Other study ID #: 2011/04B
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2011
• Last updated: November 6, 2015
• Start date: January 2012

Study information

• Verified date: November 2015
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumococcal Disease

Intervention

Biological:
• Prevenar 13
This vaccine will be given to healthy adults without prior pneumococcal vaccination.
• Pneumovax II
This vaccine will be given to healthy adults without prior pneumococcal vaccination.

Locations

Country	Name	City	State
United Kingdom	Oxford Vaccine Group	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Mason Medical Research Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of serotype-specific B cell subsets determined by FACS.	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.	within first month after vaccination	No
Secondary	Pneumococcal serotype-specific geometric mean concentrations (GMC)	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.	within first month after vaccination	No