A Prospective Cohort Study of the 20-Valent Pneumococcal Conjugate Vaccine

JRCT ID: jRCT1031240601

Registered date:14/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Asthma, COPD, Interstitial pneumonia
• Date of first enrollment: 07/01/2025
• Target sample size: 100
• Study type: Observational

Outcome(s)

• Primary Outcome: Geometric Mean Antibody Titer 1 Month

Secondary Outcome

1. Antibody seroconversion at 1 month
2. Geometric mean antibody titer at 6 months
3. Antibody seroconversion at 6 months
4. Adverse reactions

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable

Include criteria

Subjects who meet all of the following criteria (1-4):
1 Meet both conditions (a and b):
a. Aged 65 years or older
b. Diagnosed with a respiratory disease (COPD, asthma, or interstitial pneumonia)
2 Outpatients of Kameda General Hospital
3 Individuals who voluntarily receive the PCV20 (Prevnar 20) vaccine as their initial dose
4 Individuals who provide written informed consent to participate in the study of their own free will

Exclude criteria

Subjects who meet any of the following criteria:
1) Known history of anaphylaxis to any component of the PCV20 (Prevnar 20) vaccine or diphtheria toxoid
2) Presence of fever at the time of vaccination
3) Presence of an acute severe illness at the time of vaccination
4) History of prior vaccination with the 13-valent pneumococcal conjugate vaccine (PCV13) or the 15-valent pneumococcal conjugate vaccine (PCV15)
5) History of receiving PPSV23 (23-valent pneumococcal polysaccharide vaccine) two or more times
6) History of receiving PPSV23 within the past year
7) Patients with malignant tumors
8) Patients with other severe comorbidities (including cirrhosis, those undergoing dialysis, or severe heart failure) as determined by the principal investigator or sub-investigators to be serious
9) Patients with COPD or asthma who have active autoimmune diseases under treatment (patients with interstitial pneumonia may have autoimmune diseases)
10) History of microbiologically confirmed invasive pneumococcal disease
11) History of splenectomy
12) History of experiencing an acute illness requiring antibiotics or steroids within the past month
13) Any other condition deemed inappropriate for participation in the study by the principal investigator or sub-investigators

Related Information

• Primary Sponsor: Nakashima Kei
• Source(s) of Monetary Support: Subsidy for Health and Labour Sciences Research Grants