Targeting of Immune Response After Pneumococcal Vaccination (PncHR)

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 4

Conditions: Pneumococcal Pneumonia

Treatments: Biological: Pneumococcal polysaccharide vaccine; Biological: pneumococcal conjugate vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT01402245

411/E5/02

383/E5/07 (Other Identifier)

Details and patient eligibility

About

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)

Full 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)

Enrollment: 42 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Pneumonia group

No Intervention group

Description:

Patients with Pnc pneumonia

PPV Group

Active Comparator group

Description:

Volunteers immunized with Pnc polysaccharide vaccine

Treatment:

Biological: Pneumococcal polysaccharide vaccine

PCV Group

Active Comparator group

Description:

Volunteers immunized with Pnc conjugate vaccine

Treatment:

Biological: pneumococcal conjugate vaccine