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

NCT01432158 Phase 3 COMPLETED

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.

Details

Lead sponsor	University of Oxford
Phase	Phase 3
Status	COMPLETED
Enrolment	4
Start date	2012-01

Conditions

• Pneumococcal Disease

Interventions

• Prevenar 13
• Pneumovax II

Primary outcomes

• Frequency of serotype-specific B cell subsets determined by FACS. — 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.

Countries

United Kingdom