NCT01432158

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pneumococcal Disease

Interventions

Type	Name	Description
BIOLOGICAL	Prevenar 13	This vaccine will be given to healthy adults without prior pneumococcal vaccination.
BIOLOGICAL	Pneumovax II	This vaccine will be given to healthy adults without prior pneumococcal vaccination.

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-08-01
• First posted: 2011-09-12
• Last updated: 2015-11-09

Locations

1 site across 1 country: United Kingdom