Targeting of Immune Response After Pneumococcal Vaccination | NCT01402245

Studies
Targeting of Immune Response After Pneumococcal Vaccination

NCT01402245

Sponsor

Helsinki University Central Hospital

Status

Completed

Last Update Posted

Jul 26, 2011Estimated

Enrollment

42Actual

Phase

Phase 4

Conditions

Pneumococcal Pneumonia

Interventions

Pneumococcal polysaccharide vaccine
pneumococcal conjugate vaccine

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
383/E5/07	Other Identifier	Ethics Committee, Dept. of Medicine, HUCH

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jul 25, 2011

First Submission Date that Met QC Criteria

Jul 25, 2011

First Posted Date

Jul 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2011

Last Update Posted Date

Jul 26, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia. The study aims to compare lymphocyte homing in pneumonia and in those receiving Pnc polysaccharide vaccine (PPV) or Pnc conjugate vaccine (PCV)

Detailed Description

Pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia. The study compares the homing profiles of Pnc-specific plasmablasts in 15 patients with pneumonia and in 15 volunteers receiving Pnc polysaccharide vaccine (PPV) and 12 volunteers receiving Pnc conjugate vaccine (PCV)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pneumonia group	No Intervention	Patients with Pnc pneumonia
PPV Group	Active Comparator	Volunteers immunized with Pnc polysaccharide vaccine	Biological: Pneumococcal polysaccharide vaccine
PCV Group	Active Comparator	Volunteers immunized with Pnc conjugate vaccine	Biological: pneumococcal conjugate vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pneumococcal polysaccharide vaccine	Biological	Pneumococcal polysaccharide vaccine 0.5 ml i.m.	PPV Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Expression of homing receptors on circulating plasmablasts in Pnc pneumonia and after vaccination	HR on circulating Pnc-specific plasmablasts are determined in patients with pneumonia on day 7-10, in vaccinees on days 0 and 7	Day 0 and Day 7-10

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females ≥ 18 and <65 years of age.
General good health.
Written informed consent.
No previous vaccination against Pnc
No previous history of Pnc pneumonia
In pneumonia: Diagnosis of Pnc pneumonia within a week

Exclusion Criteria:

< 18 years, ≥65 of age.
In vaccinees: Acute disease at the time of enrollment.
Pregnancy or lactation.
Known immunodeficiency or immune suppressive treatment.
Any chronic illness that might interfere with the immune response
Alcohol or drug abuse
Any clinically significant history of known or suspected anaphylaxis or hypersensitivity (based on the investigator's judgement).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anu Kantele, MD PhD	Helsinki University Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Helsinki, Haartman institute, Dept. of Bacteriology and Immunology		Helsinki		00014	Finland

Condition Browse Module

MeSH Terms

ID	Term
D011018	Pneumonia, Pneumococcal
D011014	Pneumonia

Ancestor Terms

ID	Term
D011008	Pneumococcal Infections
D013290	Streptococcal Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D022242	Pneumococcal Vaccines
D000069443	Heptavalent Pneumococcal Conjugate Vaccine

Ancestor Terms

ID	Term
D022541	Streptococcal Vaccines
D001428	Bacterial Vaccines
D014612	Vaccines
D001688	Biological Products

Browse Leaves

Not provided

Browse Branches

Not provided