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Pneumococcal Conjugated Vaccine 13 (PCV13) for Patients With Multiple Myeloma (MM)

Immunogenicity and Safety of Pneumococcal Conjugated Vaccine 13 (PCV13) in Patients With Multiple Myeloma

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07154537
Enrollment
101
Registered
2025-09-04
Start date
2016-03-23
Completion date
2027-07-31
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

multiple myeloma, Immunogenicity, pneumococcal conjugated vaccine 13 (PCV13), safety

Brief summary

Multiple myeloma patients often get serious infections that can be deadly. A British study looked at newly diagnosed patients and found that bacterial infections were the main cause of death in the first 60 days, mostly from pneumonia (66%) and blood poisoning (23%). The most common bacteria causing these infections were pneumococcus, staph, and E. coli. Medical experts recommend that multiple myeloma patients get pneumonia vaccines. However, some studies show these vaccines don't work well in these patients, raising questions about whether they're really helpful. It's also unclear if patients need one shot or multiple shots like other high-risk patients. This study at National Taiwan University Hospital will randomly give multiple myeloma patients either one or two doses of the 13-valent pneumonia vaccine. Researchers will check if the vaccine is safe and if it helps the immune system fight infections, while trying to figure out what makes the vaccine work better in some patients than others.

Detailed description

Infection has always been a common and potentially life-threatening problem for multiple myeloma patients. A British study on newly diagnosed multiple myeloma patients investigated the causes of death within 60 days of enrollment and found that bacterial infection was the most common cause of death, followed by kidney failure, myocardial infarction, or stroke. Among patients who died from bacterial infections, 66% died from pneumonia, 23% from sepsis, and 11% from other infections. Among bacterial infection patients with culture results, Streptococcus pneumoniae was the most common pathogen, followed by Staphylococcus aureus and Escherichia coli. The International Myeloma Working Group recommends that multiple myeloma patients receive pneumococcal vaccination. Some research findings have shown that pneumococcal vaccination in multiple myeloma patients is ineffective or very limited in effectiveness, questioning the recommendation for routine pneumococcal vaccination. Furthermore, it remains unknown whether multiple doses of vaccine are needed, as in hematopoietic stem cell transplant patients. Therefore, for multiple myeloma patients at National Taiwan University Hospital, this study aims to randomly assign patients to receive either one or two doses of 13-valent pneumococcal conjugate vaccine, evaluate its safety and immune response generation, and identify factors related to vaccine efficacy.

Interventions

BIOLOGICAL2-dose PCV13

2 doses PCV13 with one month apart

BIOLOGICAL1-dose PCV13

1 dose PCV13

Sponsors

Ministry of Health and Welfare, Taiwan
CollaboratorOTHER_GOV
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with multiple myeloma * Stable clinical condition to have vaccination at outpatient clinic

Exclusion criteria

* Those who have received pneumococcal vaccine within the past five years * Unable to communicate verbally with the subject * Subject has an active infection * Pregnant women

Design outcomes

Primary

MeasureTime frame
Immunogenicity to serotype 6B, 14, 23F, 19Fbefore every dose of PCV13, and 4 weeks, every 12 weeks for one year, and every year for 5 years after the last dose of PCV13

Secondary

MeasureTime frameDescription
Safety of PCV13within one week after each dose of PCV13adverse effects within one week after each dose of PCV13
invasive pneumococcal diseasesafter the last dose of PCV13 for 5 years
Mortalityafter the last dose of PCV13 for 5 yearsdeath and causes of death
Pneumoniaafter the last dose of PCV13 for 5 years

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026