COVID-19, Hematologic Diseases, Neurologic Disorder, Rheumatic Diseases, Solid Tumor
Conditions
Keywords
vaccination, COVID-19, frail patients
Brief summary
This is a multicentre observational study with the aim of evaluating the antibody and cellular response after vaccination for SARS-CoV-2 with Pfizer-BioNTech or Moderna vaccines in frail subjects with impaired immuno-competence, due to their underlying diseases or ongoing therapies.
Detailed description
The immune response to COVID-19 vaccination will be assessed at the following time points: T0: the day of vaccination T1: the day of the booster dose according to the schedule of the two vaccines (Pfizer/BioNTech or Moderna) T2: between 5 and 7 weeks after T0 for those vaccinated with Pfizer/BioNTech and between 6 and 8 weeks after T0 for those vaccinated with Moderna. * T3: 12 (± 1) weeks after T0 * T4: 24 (± 2) weeks from T0 * T5: 52 (± 2) weeks from T0 Prevention of SARS-CoV-2 infection will be assessed in terms of incidence of SARS-CoV-2 infections (NF molecular swab positive), and of SARS-CoV-2 infections requiring hospitalisation.
Interventions
BIOLOGICALCOVID-19 vaccines
This is an observational prospective study whose general objective is to assess the impact of COVID-19 vaccination in terms of induction of humoral and cell-mediated immune responses in selected fragile (altered immunocompetence) populations.
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Istituto Clinico Humanitas
IRCCS San Raffaele
Regina Elena Cancer Institute
Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani IRCCS
University of Roma La Sapienza
Fondazione IRCCS Policlinico San Matteo di Pavia
Istituti Fisioterapici Ospitalieri
Istituto Tumori Giovanni Paolo II, BARI
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Azienda USL Reggio Emilia - IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any subject undergoing SARS-CoV-2 vaccination with Pfizer-BioNTech or Moderna vaccines may be included in the study if they belong to at least one of the subgroups listed below: 1. Hematological tumors 2. Solid tumors 3. Rheumatological diseases 4. Neurological diseases
Exclusion criteria
* NA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SARS-CoV-2 vaccine immunization | 5-7 weeks after T0 for Pfizer/BioNTech vaccination; 6-8 weeks after T0 for Moderna vaccination | For assessing the immunologic response to the COVID-19 vaccination, the anti-S antibodies levels in the fragile population will be quantified at T2 and compared with the anti-S antibodies levels quantified at the same time point in a population of healthy subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anti-S antibodies immunological response | at 6 times points T0 before vaccine administration, T1 before the second dose of the vaccine and at times T2, T3, T4 and T5 which correspond to 5-7 weeks (Pfizer-BioNTech) or 6-8 weeks (Moderna), 12 weeks, 24 weeks and 52 weeks after the first dose | for each time point, the anti-S antibodies levels will be quantified and compared with the anti-S antibodies levels quantified at the same time point in a population of healthy subjects (see controls). |
| T cell immunological response | at 6 times points T0 before vaccine administration, T1 before the second dose of the vaccine and at times T2, T3, T4 and T5 which correspond to 5-7 weeks (Pfizer-BioNTech) or 6-8 weeks (Moderna), 12 weeks, 24 weeks and 52 weeks after the first dose | At each time point, the Spike and N-specific T-cell immunity of the 1300 enrolled subjects will be assessed and compared to that observed in a population of healthy subjects at the same time point (see controls). |
| immunological response in different subgroups | 1 year | Subgroup analysis on the immunological response will be performed according to the clinical characteristics of the patients, the main diagnosis subgroups according to the eligibility criteria and the treatments they have received. we will compare the immune response with the different clinical characteristics of the patients |
| impact of COVID-19 vaccination on patient health status | 1 weeks after frist dose and 1 week after second dose | The impact on health status will be assessed through a questionnaire compiled at T1 and T2 by the physician before the blood sampling. The questionnaire will assess the occurrence of a list of symptoms in the week after the first and second administration of the vaccine. |
| incidence of SARS-CoV-2 infection. | all 52 weeks | The incidence of SARS-CoV-2 infection will be assessed in terms of number and proportion of patients who during the 52 weeks. SARS-CoV-2 infection will be assessed with: positive to molecular NF swab. |
Countries
Italy
Outcome results
None listed