Clinical trial NCT04875858: Immunogenicity After Revaccination With 23-valent Pneumococcal Polysaccharide Vaccine: Healthy Elderly People Versus Diabetic Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pneumococcal Infections
Keywords: Streptococcus pneumoniae
Diabetes Mellitus
Immunogenicity, Vaccine
Pneumococcal Vaccines
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2021-05-06
Enrollment: 254
Sex: ALL
Minimum age (years): 70
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Serotype-specific immunogenicity assessed by opsonophagocytic killing assay.
timeFrame: up to one month after vaccination
Secondary outcomes:
measure: Serotype-specific IgG antibody concentrations assessed by ELISA.
timeFrame: up to one month after vaccination
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: up to one month after vaccination
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Koera University Guro Hospital
Study officials:
affiliation: Professor
name: Joon Young Song, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song JY, Cheong HJ, Tsai TF, Chang HA, Choi MJ, Jeon JH, Kang SH, Jeong EJ, Noh JY, Kim WJ. Immunogenicity and safety of concomitant MF59-adjuvanted influenza vaccine and 23-valent pneumococcal polysaccharide vaccine administration in older adults. Vaccine. 2015 Aug 26;33(36):4647-52. doi: 10.1016/j.vaccine.2015.05.003. Epub 2015 May 14.
citation: Kawakami K, Kishino H, Kanazu S, Toshimizu N, Takahashi K, Sterling T, Wang M, Musey L. Revaccination with 23-valent pneumococcal polysaccharide vaccine in the Japanese elderly is well tolerated and elicits immune responses. Vaccine. 2016 Jul 19;34(33):3875-81. doi: 10.1016/j.vaccine.2016.05.052. Epub 2016 Jun 10.
citation: Choi WS, Choi JH, Kwon KT, Seo K, Kim MA, Lee SO, Hong YJ, Lee JS, Song JY, Bang JH, Choi HJ, Choi YH, Lee DG, Cheong HJ; Committee of Adult Immunization; Korean Society of Infectious Diseases. Revised adult immunization guideline recommended by the korean society of infectious diseases, 2014. Infect Chemother. 2015 Mar;47(1):68-79. doi: 10.3947/ic.2015.47.1.68. Epub 2015 Mar 30. No abstract available.