Immunogenicity After Revaccination With 23-valent Pneumococcal Polysaccharide Vaccine: Healthy Elderly People Versus Diabetic Patients

May 3, 2021 updated by: Joon Young Song, Korea University Guro Hospital

Non-randomized Clinical Trial to Compare the Immunogenicity of Revaccination With 23-valent Pneumococcal Polysaccharide Vaccine Between Healthy Elderly and Those With Diabetes in Korea

Pneumococcal disease causes thousands of infections, such as meningitis, bloodstream infections, pneumonia, and ear infections in US annually. As pneumococcal vaccines provide serotype-specific protection, it is important to induce sufficient immune responses for the most clinically relevant serotypes. All adults aged 65 years or older are recommended to receive PPSV23 vaccination irrespective of underlying medical conditions. Thus, since May 2013, South Korea introduced PPSV23 in the national immunization program for elderly individuals aged ≥65 years. Following PPSV23 vaccination, serotype-specific IgG concentrations and OPA titers increase and then decline over time thereby decreasing protective efficacy, although these might remain above pre-vaccination levels until 5 years from PPSV23 administration. The decline of pneumococcal immunity may be more prominent among chronically ill patients, including those with diabetes. Currently however, revaccination is not recommended. In this study, we aimed to evaluate the serotype specific immunogenicity between healthy elderly people and old adults with diabetes after revaccination with PPSV23 at the age of 70-75 years. Serotype-specific IgG concentrations and opsonophagocytic killing activity (OPA) titers will be assessed.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

254

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 08308
        • Koera University Guro Hospital
        • Contact:
        • Principal Investigator:
          • Joon Young Song, MD.PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

68 years to 73 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Elderly people aged 70-75 years
  • Had received PPSV23 in the previous 5-7 years

Exclusion Criteria:

  • Immunocompromised patients
  • Subjects receiving immunosuppressive agents
  • Subjects with a history of vaccination with pneumococcal conjugate vaccine
  • Subjects with a history of pneumococcal disease (positive culture from blood or other sterile fluid)
  • Fever (defined as an oral temperature >37.5℃) within 24 h before PPSV23 vaccination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: healthy old adults aged 70-75 years who received PPSV23
Recruitment of 254 healthy 70-75-year healthy old adults who meet the selection and exclusion criteria and voluntarily agree to participate in this study. Vaccination -Based on guidelines for vaccination. Injecting muscles on the triceps Visit 4 weeks after vaccination ․ Blood sample collection for evaluation of immunogenicity (10 mL) ․ Comparison of GMT and seroconversion rates of IgG antibody titers against 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F and 23F) -Comparison of GMT and seroconversion rates of opsonophagocytic killing assay (OPA) for four pneumococcal serotypes (serotypes 5, 6B, 18C, 19A)
Drug: ProDiax-23 (PPSV23)
diabetic old adults aged 70-75 years who received PPSV23 in previous 5-7 years (Persons 65-70 years old who have been inoculated with PPSV23 and 5-7 years have passed) and healthy old adults aged 70-75 years who received PPSV23 in previous 5-7 years (Persons 65-70 years old who have been inoculated with PPSV23 and 5-7 years have passed)
Experimental: old adults who have diabetes mellitus aged 70-75 years who rec
Recruitment of 254 healthy 70-75-year diabetic old adults who meet the selection and exclusion criteria and voluntarily agree to participate in this study. Vaccination -Based on guidelines for vaccination. Injecting muscles on the triceps Visit 4 weeks after vaccination ․ Blood sample collection for evaluation of immunogenicity (10 mL) ․ Comparison of GMT and seroconversion rates of IgG antibody titers against 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F and 23F) -Comparison of GMT and seroconversion rates of opsonophagocytic killing assay (OPA) for four pneumococcal serotypes (serotypes 5, 6B, 18C, 19A)
Drug: ProDiax-23 (PPSV23)
diabetic old adults aged 70-75 years who received PPSV23 in previous 5-7 years (Persons 65-70 years old who have been inoculated with PPSV23 and 5-7 years have passed) and healthy old adults aged 70-75 years who received PPSV23 in previous 5-7 years (Persons 65-70 years old who have been inoculated with PPSV23 and 5-7 years have passed)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serotype-specific immunogenicity assessed by opsonophagocytic killing assay.
Time Frame: up to one month after vaccination
After PPSV23 vaccination, blood samples (10 mL) will be collected before vaccination and at 4 weeks post-vaccination. Serotype-specific opsonophagocytic activity (OPA) will be evaluated from those blood samples by opsonophagocytic killing assay for 4 serotypes (5, 6B, 18C, 19A).
up to one month after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serotype-specific IgG antibody concentrations assessed by ELISA.
Time Frame: up to one month after vaccination
After PPSV23 vaccination, blood samples (10 mL) will be collected before vaccination and at 4 weeks post-vaccination. Serotype-specific IgG antibody concentrations for 13 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F and 23F) will be measured.
up to one month after vaccination
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: up to one month after vaccination
Solicited local or systemic reactions to the vaccines will be monitored using diary cards during the14 days post-vaccination. Participants will be asked to record pain, tenderness and redness diameter at both injection sites and systemic symptoms such as headache, malaise, chills, muscle aches, and arthralgia. Severity will be recorded according to the Food and Drug Administration Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Subjects will be also asked to record any unsolicited adverse event during the 14 days after vaccination.
up to one month after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Joon Young Song, MD, PhD., Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

April 30, 2022

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

November 24, 2020

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020GR0143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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