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COMPLETEDPHASE3

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

NCT01432158•University of Oxford

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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;
+3 more criteria

Locations (1)

Oxford Vaccine Group

Oxford, United Kingdom

Key Dates

Start Date

January 1, 2012

Primary Completion Date

August 1, 2012

Last Updated

November 9, 2015

Enrollment

ACTUAL participants

Conditions

Pneumococcal Disease

Interventions

Prevenar 13

BIOLOGICAL

Pneumovax II

BIOLOGICAL

Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15

NCT06731374

Pneumococcal DiseasePneumococcal Carriage

View study

RECRUITINGPHASE3

A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People

NCT06044077

Pneumococcal Disease

View study

ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 9, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Carriage to Assess Protection of New Pneumococcal Vaccines - PCV15

A Clinical Trial to Evaluate the Immunogenicity and Safety of the 23-valent Pneumococcal Polysaccharide Vaccine in Healthy People

Phase 2 Trial to Evaluate Safety and Immunogenicity of Inventprise's (IVT) 25-valent Pneumococcal Conjugate Vaccine (IVT PCV-25) in Healthy Infants

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)

A Study to Learn About How Safe and Effective is 20vPnC and 13vPnC Vaccines in Chinese Adults

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan