Finding more effective vaccines for the constantly moving target of influenza with longer-term immunity is a cause worth pursuing. For example, the mRNA technology opens opportunities to develop and manufacture effective vaccines closer to the flu season, with a better match to the circulating viruses. But what are successful clinical trials made of? Mika Rämet, M.D., Ph.D., Professor of Paediatrics and Experimental Immunology and Chief Medical Officer at FVR – Finnish Vaccine Research discusses three key success factors.
Clinical trial site selection and study participant enrollment, together with efficient site management are some of the key considerations for any clinical vaccine trial. Partnering with an experienced research service provider helps to ensure the study enrollment targets are met with no compromise to the quality of the data.
1. Successful enrollment and availability of study participants
Misconceptions or lack of vaccine awareness is one of the biggest hurdles in the enrollment of volunteers for studies. Another is the lack of sufficient outreach/public relations strategies of the recruiting clinic(s). Finland offers unique opportunities in this regard, at least in three respects:
- through educated and health-conscious people willing to participate in studies
- high level of digitalization, also in terms of segmenting and reaching the target groups for each study effectively
- generally a low drop-out rate once participants have committed to a study
In addition, comprehensive, high-quality national health data registers enable extensive pragmatic trials and Real-World Evidence studies on the impact of vaccines also post-licensure.
Influenza vaccines have been administered as part of the national vaccination program in Finland since the 1980s free of charge to individuals for whom influenza poses a significant threat or whose health would otherwise benefit significantly from receiving the vaccination. Individuals not included in these groups may get a vaccine through their employer as part of their occupational healthcare, or purchase the vaccine from a pharmacy on prescription.
2. Enrollment intake capacity and infrastructure of the study partner
Another key factor in clinical vaccine trial success is the capacity of the recruiting clinic/s to enroll study participants. All the preparatory work is time wasted if the clinic is not able to receive satisfactory numbers of participants. In single-clinic scenarios, this can happen e.g. in case of sudden headcount changes, illnesses or other unpredictable events. FVR’s advantage here is the network of ten clinics around Finland that can be treated as one entity, while offering plenty of flexibility. Another clear advantage is our core focus on clinical vaccine research: it is our one and only priority.
3. Clinical study experience and quality
The quality of clinical trials depends on data integrity, which in turn is sum of several factors (e.g. clear roles and responsibilities, policies and procedures, training, quality auditing, document/record management and reporting).
Of FVR’s staff of 113 vaccine research experts, 96% say they’re proud of the quality of the research we conduct (2022 employee survey). What contributes to this? Long, accumulated experience, strict adherence to Good Clinical Practices (GCP) as well as study protocols, combined with a framework of continuous learning, to name a few factors. It is also beneficial to have a network of experienced colleagues whom you can consult on a broad range of medical expertise – from pediatrics, neonatology, obstetrics and gynecology to immunology, otorhinolaryngology and more.
FVR has participated in several clinical influenza vaccine studies over the years. These include e.g. the safety and efficacy of adjuvanted quadrivalent vaccines, as well as children’s vaccines administered as a nasal spray. Under the guidance of my colleague M.D. Ph.D. Arto Palmu, we have also participated in the extensive FinFluHD study enrolling over 30,000 older adults in season 2019-2020 (double-blinded, randomized, registry-based trial), which unfortunately was interrupted due to the COVID-19 pandemic. The aim was to assess the relative effectiveness of high-dose (QIV-HD) vs standard-dose quadrivalent influenza vaccine (QIV-SD) in preventing cardio-respiratory hospitalizations in a large cohort of adults aged ≥65 years.
In EU alone, seasonal influenza is responsible for up to 50 million symptomatic cases, and 15 000–70 000 deaths of causes associated with influenza (European Centre for Disease Prevention and Control). We are committed to collaboration that aims at finding effective prevention.
FVR – Finnish Vaccine Research
FVR is a special-assignment company of the Finnish state, specialized in clinical vaccine trials. The company’s network of ten clinics around Finland sets good prerequisites for successful studies.
FVR offers clinical expertise in phases 1-4 of vaccine research as well as Real-World Evidence (RWE) studies and pragmatic vaccine trials, utilizing Finland’s exceptional health registers and data resources.
Merged in 2022, FVR brings together the extensive vaccine research expertise of both Tampere University’s Vaccine Research Centre and the clinical vaccine research group of the Finnish Institute for Health and Welfare (THL).
Chief Medical Officer at
FVR – Finnish Vaccine Research
M.D., Ph.D. Professor of Paediatrics and Experimental Immunology