Pneumococcal Infections
Conditions
Keywords
Streptococcus pneumoniae, Diabetes Mellitus, Immunogenicity, Vaccine, Pneumococcal Vaccines
Brief summary
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.
Interventions
DRUGProDiax-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)
Sponsors
Merck Sharp & Dohme LLC
Korea University Guro Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serotype-specific immunogenicity assessed by opsonophagocytic killing assay. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serotype-specific IgG antibody concentrations assessed by ELISA. | 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. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 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. |
Countries
South Korea
Contacts
Primary ContactHye Seong, MD, PhD.
Outcome results
None listed