Highlights of a Galician study measuring the effectiveness of high-load vaccines in people over 65 years of age.

With influenza infections continuing to be a public health problem, especially among older people, the GalFlu study was a pioneering initiative in Spain and Europe. The main purpose of this study is review the effectiveness of high-burden influenza vaccines in preventing serious infections, hospitalizations, and deaths, with a focus on older adults aged 65 to 79 years.. This type of vaccine, characterized by a large number of antigens, has been shown to be more effective in creating a durable immune response compared to conventional vaccines.

According to Federico Martinon Torres, principal investigator of the project and head of the Department of Pediatrics and director of the Department of Translational Pediatrics and Infectious Diseases at the University Teaching Hospital of Santiago de Compostela, The GalFlu Study is a Pragmatic Clinical Trialwhich aims to solve real public health problems in a practical and accessible way. Unlike conventional clinical trials, which are usually more rigorous and controlled, A pragmatic approach allows participants to be included in research in settings that are more representative of everyday life..

The first large-scale clinical trial of its kind

“The design of this study is innovative because This is the first time a large-scale clinical trial of this type has been conducted in Spain and is one of the most relevant in Europe.. Our goal is to answer a fundamental question: Is it worth investing in a more expensive vaccine, such as a high-load vaccine, for people aged 65 to 79 years, compared to a regular vaccine?

“This is the first time a large-scale clinical trial of this type has been carried out in Spain and one of the most relevant in Europe.”

Federico Martinon TorresHead of the Department of Pediatrics and Director of the Department of Translational Pediatrics and Infectious Diseases of the University Hospital of Santiago de Compostela

The purpose of the study is not only to compare the effectiveness of these two vaccines, but also demonstrate whether high-burden vaccines provide measurable benefits in terms of preventing serious complications such as hospitalization, influenza-associated pneumonia, andthe most important, death. Although these vaccines are already known to be safe and effective for people over 80 years of age, we want to determine whether the benefits justify their use in people aged 65 to 79 years.

Effectiveness of influenza vaccines

Regular influenza vaccines have been the main tool in the fight against seasonal influenza for many years, but in recent years it has been recognized that elderly peoplewhose immune system is usually more weakened, respond less effectively to these vaccines. To improve the immune response in this population, High load flu vaccines developedwhich contain more antigen. This modification aims to create a stronger and longer-lasting immune response, which is especially important for older adults or people with weakened immune systems.

“In this study, we are testing whether a high-load vaccine is more effective than a regular vaccine in a population aged 65 to 79 years. We know that it works well in people over 80 years of age.and it is already used in Galicia for this age group. But could it be equally beneficial for young people, even those over 65? That’s what we want to open,” Martinon said.

GalFlu Research

The GalFlu study is based on a pragmatic design that allows for the inclusion of large numbers of people without the strict limitations of traditional clinical trials.

. In this type of study, participants are less strictly selected, resulting in results that are more representative of the population. In the case of GalFlu Participants are people who are going to receive the vaccine in medical centers in Galicia.who will be randomized to receive either the high-load vaccine or the regular vaccine.

“The pragmatic design also means that once participants have been randomized and signed informed consent, follow-up is based on their clinical history. This means we don’t have to regularly visit patients or take samples from patients, making the research much more accessible and feasible,” Martinon explained. This approach is also reduces costs and increases training efficiencyallowing more people to be included.

Goal: attract 60,000 participants

The study is being conducted on a large scale, and in the first year of the study, 59,000 Galicians aged 65 to 79 years were included. The goal now is to enroll another 60,000 people in the second season of the study.. This figure is important for obtaining statistically reliable results and for assessing whether the benefits of a high-burden vaccine are justified in terms of reducing hospitalizations and deaths from influenza.

The success of the GalFlu study depends largely on collaboration between the research team and health authorities. Martinon emphasized that collaboration with the Galician Ministry of Health is essential for the viability of the project: “Without coordination between the public health department and our research group, a study of this type would not be possible. “This is a clear example of how public health should work from a pragmatic point of view,” he assured.

“Without the coordination between the Department of Public Health and our research team, this type of study would not have been possible.”

Federico Martinon TorresHead of the Department of Pediatrics and Director of the Department of Translational Pediatrics and Infectious Diseases of the University Hospital of Santiago de Compostela

The study also highlights the importance collaboration between different institutions, both academic and medicalto conduct research that can have a real impact on public health. “With this study, we answer not only Galicia’s question, but any country or organization that needs to make evidence-based decisions. The collaboration allows us to make this research useful on a much larger scale,” added Martinon.

First results

Although research is still ongoing, Early results have already shown a significant reduction in hospitalizations and serious complications. among people who received a high-load vaccine compared with a regular vaccine. These initial results support the hypothesis that High-load vaccines are more effective at preventing serious flu complications in older adults.

Early results have already shown a significant reduction in hospitalizations and serious complications.

The impact of this research may be transcendental because, If the results confirm the added benefit of the high-burden vaccine, it could change vaccination recommendations for older adults worldwide.. With a pragmatic design, close collaboration, and a large sample of participants, this study has the potential to impact global public health and, most importantly, improve the quality of life of older adults in the fight against influenza.

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