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

Pneumococcal Infections Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04875858
• Other study ID #: 2020GR0143
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2021
• Source: Korea University Guro Hospital
• Contact: Hye Seong, MD, PhD.
• Phone: +82-10-4840-5965
• Email: msmjoonhoo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 254
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Koera University Guro Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Guro Hospital	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. Review. Erratum in: Infect Chemother. 2015 Jun;47(2):154. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serotype-specific immunogenicity assessed by opsonophagocytic killing assay.	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	Serotype-specific IgG antibody concentrations assessed by ELISA.	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
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	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