Study of Evaluation Indexes for Antibody Production in Sera After Immunization

Phase 4

Completed

• Conditions: Aged
• Interventions: Biological: pneumococcal polysaccharide vaccine

• Registration Number: NCT00964769
• Lead Sponsor: Ewha Womans University

Brief Summary

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.

Detailed 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).

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2005-05
• Study Completion: 2005-06
• Status Verified: 2009-08
• Study First Submitted: 2009-08-24
• Study First Submitted QC: 2009-08-24
• Last Update Submitted: 2009-08-24
• Study First Posted: 2009-08-25
• Last Update Posted: 2009-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Evaluate the immune response to the pneumococcal polysaccharide vaccine in children, young adults and elderly.	1 month after vaccination

Secondary Outcome Measures

Name	Time	Method
Evaluate the immune response to the pneumococcal polysaccharide vaccine with two methods (ELISA and Opsonophagocytic Killing Assay)	1 month after vaccination

Trial Locations

Locations (1)

Ewha Womans University Dongdaemun Hospital; 🇰🇷 Seoul, Korea, Republic of