• The study is part of a national research initiative promoted by the Instituto de Salud Carlos III (Carlos III Health Institute) in which 17 health centres and nursing homes of 10 Autonomous Communities participate

Primary Health Care and the Navarrabiomed biomedical research centre, through their Clinical Trials Platform, have launched the observational study in the Regional Community ENE-COVID Senior on the third dose of the vaccine against COVID-19. The study is carried out within the framework of the national vaccination program and is aimed at generating knowledge about the immunization capacity acquired in elderly patients over time.
The initiative is part of national research conducted by the Carlos III Health Institute (ISCIII) in coordination with the ministries of Health and Science and Innovation, and entitled “Prospective Study to establish the immune status in the elderly after receiving a full course of vaccination ene-covid senior”. ENE-COVID Senior is a differentiated branch of the ENE-COVID national seroprevalence study (National Sero-Epidemiology survey of SARS-CoV-2 virus infection in Spain) being carried out since the onset of the pandemic.
 
Study characteristics

Specifically, the ENE-COVID Senior study will serve to establish the humoral and cellular immune status against SARS-CoV-2 in people aged 65 years or older having received the third dose of the vaccine for one year. Accordingly, the aim is to recruit a total of 1,600 patients coming from 17 centres from over 10 Autonomous Communities.
To do this, biological samples will be obtained and analysed from people who have received a full course of vaccination against Covid-19 at least 6 months before inclusion in the study. Samples will be taken at different times over 12 months. The participants come from nursing homes, Primary Health Care centres and hospitals, and are divided by age groups: 65-74, ≥75-84 and ≥ 85 years. The control group includes people under 65 years of age, mainly social and health workers from nursing homes and hospitals where the study is carried out.

In Navarra, the participation of patients is limited to the Barañain II health centre and the study is led by Dr. Itziar Blanco Platero, principal investigator and director of the aforementioned centre. “The objective is to generate knowledge as consistent as possible regarding the magnitude and duration of humoral and cellular immunity and to obtain information to establish future actions related to vaccination,” says Dr. Blanco.
The Clinical Trials Platform of Navarrabiomed has managed the start-up of the study through the Clinical Research Units and Clinical Trials Platform (SCReN) of the ISCIII, to which it belongs, providing the human and material resources necessary for its implementation. The choice of the Barañain II health centre also responds to the existing vaccination strategy in Navarra at the moment and the proximity of Navarrabiomed, an aspect that has facilitated the development and logistics necessary for study implementation.
 
Promotion of public health research in Navarra

To date and since the onset of the pandemic, the Clinical Trials Platform de Navarrabiomed has managed the initiation of more than thirty COVID-19 initiatives, two of them being multicentre trials led by research staff from Navarra and promoted by Navarrabiomed. The team is actively working so that researchers from the public health network of Navarra participate in Covid-19 clinical studies from which the group of patients of the Navarra Health Service-Osasunbidea can benefit. “Nowadays the decentralization of clinical trials is encouraged and Navarra is a community whose public health system is capable of hosting clinical trials with medicines, which is a promising for many Navarrese patients”, according to the Navarrabiomed Clinical Trials Platform.
 
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