Study of Evaluation Indexes for Antibody Production in Sera After Immunization

Ewha Womans University

Status and phase: Completed; Phase 4

Conditions: Aged

Treatments: Biological: pneumococcal polysaccharide vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT00964769

EU-KF-05092341

05092KFDA341

Details and patient eligibility

About

The aim of this study is to evaluate analytical methods such as ELISA and OPKA that measure the activity of vaccine-induced pneumococcal antibodies. After validation of ELISA and OPKA, pneumococcal antibodies were measured by ELISA and OPKA in paired samples before and after immunization (pneumococcal PS vaccine) in children, adults and elderly.

Full description

To evaluate the immune response to the pneumococcal polysaccharide vaccine in the elderly, samples from children, young adults and elderly were obtained before and one month after vaccination. The quantitative and qualitative response to the vaccine were measured by the ELISA and opsonophagocytic killing assay for eight vaccine type serotypes (4, 6B, 9V, 14, 18C, 19A, 19F, 23F) and one vaccine-related serotype (6A).

Enrollment: 70 patients

Sex: All

Ages: 2 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• elderly subjects over the age 65 years who had not received pneumococcal vaccination
• adult subjects under the age of 45 years (healthy volunteers with no previous history of pneumococcal vaccination)
• children subjects over the age of 2 years with no previous history of pneumococcal vaccination

Exclusion criteria

• immunocompromised, asplenia, cancer, liver or renal failure, and history of hypersensitivity to vaccine

Trial design

70 participants in 1 patient group

Pneumococcal polysaccharide vaccine

Experimental group

Description:

The immunogenic response to the pneumococcal polysaccharide vaccine was compared between children, adults and elderly.

Treatment:

Biological: pneumococcal polysaccharide vaccine