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

NCT01432158 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2015-11-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Mason Medical Research Trust

    collaborator UNKNOWN

  • University of Oxford

    lead OTHER

Principal Investigators

  • Andrew J Pollard, BSc MBBS PhD MRCP FRCPCH · Department of Paediatrics, Oxford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01432158 on ClinicalTrials.gov