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

Korea University

Status and phase: Unknown; Phase 4

Conditions: Pneumococcal Infections

Treatments: Drug: ProDiax-23 (PPSV23)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04875858

2020GR0143

Details and patient eligibility

About

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.

Enrollment: 254 estimated patients

Sex: All

Ages: 70 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

254 participants in 2 patient groups

healthy old adults aged 70-75 years who received PPSV23

Active Comparator group

Description:

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)

Treatment:

Drug: ProDiax-23 (PPSV23)

old adults who have diabetes mellitus aged 70-75 years who rec

Experimental group

Description:

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)

Treatment:

Drug: ProDiax-23 (PPSV23)