Cuba Begins Clinical Trial of New 11-Valent Pneumococcal Vaccine in Adults
Key Insights
Cuba has initiated a Phase II-III clinical trial to assess the safety, immunogenicity, and efficacy of a new 11-valent pneumococcal vaccine, Quimio-Vio (search), in adults aged 50-74.
The trial aims to expand the availability of pneumococcal vaccination to the adult population, addressing the high morbidity and mortality associated with pneumococcal diseases in older adults.
The study will involve approximately 1,000 volunteers and, if successful, will lead to an application for sanitary registration to make the vaccine available nationwide.
Cuba is advancing its efforts to combat pneumococcal disease with the initiation of a Phase II-III clinical trial for a new version of its pneumococcal vaccine, Quimio-Vio (search), targeting adults aged 50 to 74. The trial, authorized by the Center for State Control of Medicines, Equipment and Medical Devices (Cecmed (search)) and approved by the Ministry of Public Health, aims to evaluate the safety, immunogenicity, and efficacy of the 11-valent vaccine in this older population, who are particularly vulnerable to pneumococcal infections.
The study is being conducted at the Institute of Hematology and Immunology and will extend to three health areas in Havana’s Plaza de la Revolución municipality. According to Dr. Meiby de la Caridad Rodríguez González, Director of Clinical Research at the Finlay Vaccine Institute (IFV), the trial will include approximately 1,000 volunteers who meet specific selection criteria, such as controlled underlying diseases and no acute infections or allergies to vaccine components.
Addressing Pneumococcal Disease in Aging Population
Pneumococcal disease poses a significant health burden in Cuba, particularly among older adults. Data from the National Statistics and Information Office (ONEI) indicates that 24.4% of the Cuban population was 60 years or older by the end of 2023. This aging demographic, coupled with immunosenescence and a higher prevalence of chronic diseases, increases the risk of invasive pneumococcal disease. Dr. Rodríguez emphasized that pneumococcal diseases are the fourth leading cause of death in Cuba, with the highest mortality rates observed in adults over 60, primarily due to pneumonia (search) and influenza (search).
Individuals aged 65 and over face a 3.8 times higher risk of pneumococcal pneumonia (search) compared to healthy adults aged 18 to 64, and are 10 times more likely to be hospitalized with the condition compared to adults aged 18 to 49. The risk escalates further in those with chronic conditions like diabetes mellitus (search) (2.8 times higher risk) and cardiovascular diseases (search) (3.8 times higher risk).
Quimio-Vio Vaccine Details and Administration
The new Quimio-Vio (search) vaccine is designed to protect against 11 of the most prevalent Streptococcus pneumoniae (search) serotypes globally and in Cuba, which cause a range of infections including sinusitis, otitis media, pneumonia (search), and infections of the central nervous system and bloodstream. The vaccination involves a single intramuscular dose administered in the arm. Expected adverse events are generally mild and infrequent, including local reactions at the injection site (pain, redness, inflammation) and potential systemic effects like fatigue, fever, and headache.
Prior Success with Pediatric Pneumococcal Vaccine
In July 2024, Cecmed (search) granted sanitary registration to the 7-valent Quimi-Vio conjugate vaccine for use in children aged one to five years, following nearly 13 years of clinical trials. Since September 2024, over 95,000 infants aged two years have been vaccinated nationwide, demonstrating a strong safety profile. Studies in Cienfuegos, Cuba, showed a 63% reduction in hospitalization rates due to respiratory disease and a 73% reduction in invasive pneumococcal disease one year after immunizing children with the 7-valent vaccine.
The IFV plans to request authorization for medical registration from Cecmed (search) upon completion of the current trial, aiming to provide a new vaccine option for adults and contribute to healthy aging in Cuba. The Quimi-Vio project began in 2012 and is a very complex vaccine, which, when introduced in countries that have already used it, has made childhood health indicators significantly improve in terms of morbidity from respiratory diseases, and infant mortality from infections.