20vPnC
The international 20vPnC study looks at how well this vaccine protects elderly adults against community-acquired pneumonia due to specific types of the disease-causing bacteria Streptococcus pneumoniae.
About This Study
Summary
Pneumonia is a common illness of the lungs that affects millions of people in the U.S. each year. People with pneumonia often have a cough, difficulty breathing, and fever. Many cases of pneumonia are due to bacterial infections that people catch at home or in public (community-acquired pneumonia, CAP). Almost 50% of all cases of bacterial pneumonia are due to Streptococcus pneumoniae. Elderly adults (65 years of age and older) are especially at risk for severe CAP and serious health consequences, including spread of the infection to the blood (bacteremia) and spinal fluid (meningitis) and even death. Furthermore, the elderly are 2.5 times more likely to be hospitalized for severe CAP than are younger people.
Vaccines like 20vPnC are an important tool in preventing infectious diseases like CAP. Vaccines also help to keep milder infections from becoming severe. New vaccines have to continually be developed because the germs that cause infections keep changing. The purpose of the 20vPnC study is to learn how well this vaccine protects elderly adults against 7 new types of S pneumoniae.
Patients eligible for the 20vPnC study include those who already received a pneumonia vaccine as well as those who have not. Once enrolled in the study, participants provide a urine sample for a S pneumoniae lab test. Participants’ active involvement in the study lasts 2 days, but research team members continue following their health status through medical record reviews for a maximum of 30 days of hospitalization.
To be included in 20vPnC, participants must be / have
- Adults 65 years and older
- Hospitalized for suspected CAP
- Radiographically confirmed pneumonia
To be included in 20vPnC, participants must not be / have
- Signs and symptoms of pneumonia that develop 48 hours or more after hospitalization
- Received pneumococcal vaccine 30 days or less before enrollment
- Unable to provide urine sample
Keywords
B7471015; Community-acquired pneumonia; Elderly; Pneumococcal; Pneumonia; Vaccine
For More About This Study or To Ask About Participation
Additional Information
Lead scientist at Carilion Clinic
Emily Shava, MBChB, MSc, ACRP-CP, is a physician–researcher in Carilion’s Department of Medicine. Her training includes a Master of Science in Clinical Trials from the London School of Hygiene & Tropical Medicine and certification as a Clinical Research Professional. Dr. Shava has extensive experience in clinical trials, HIV prevention, and community-engaged research. In addition, she has trained and mentored researchers in research ethics and community-relevant methodologies. Dr. Shava is excited to contribute toward developing new methods to prevent, diagnose, and manage medical conditions.
Official title of study
A Phase 4 Study Using a Test-negative Design to Evaluate the Effectiveness of a 20-valent Pneumococcal Conjugate Vaccine against Vaccine-type Radiologically-confirmed Community-acquired Pneumonia in Adults ≥ 65 Years of Age
Funding mechanism
Industry funded by Pfizer