National Project on Vaccines, COVID-19 and Frail Patients

COVID-19 Clinical Trial

— VAX4FRAIL  

Official title:

A National, Multicentric, Observational, Prospective Study to Assess Immune Response to COVID-19 Vaccine in Frail Patients (VAX4FRAIL).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04848493
• Other study ID #: VAX4FRAIL study
• Status: Recruiting
• Start date: April 19, 2021
• Est. completion date: April 20, 2022

Study information

• Verified date: April 2021
• Source: Azienda Unità Sanitaria Locale Reggio Emilia
• Contact: Massimo Costantini, MD
• Phone: 0522296986
• Email: massimo.costantini[@]ausl.re.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1300
• Est. completion date: April 20, 2022
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• COVID-19
• Hematologic Diseases
• Nervous System Diseases
• Neurologic Disorder
• Rheumatic Diseases
• Solid Tumor

Intervention

Biological:
• COVID-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.

Locations

Country	Name	City	State
Italy	IRCCS Istituto Tumori Giovanni Paolo II	Bari
Italy	IRCCS Azienda Ospedaliera Universitaria	Bologna	Bologhna
Italy	Ospedale Policlinico San Martino IRCCS	Genova
Italy	Foindazione IRCCS Istituto Neurologico Carlo Besta	Milano
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano
Italy	IRCCS Istituto Clinico Humanitas	Milano
Italy	IRCCS Ospedale San Raffaele	Milano
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Azienda USL IRCCS di Reggio Emilia	Reggio Emilia
Italy	IRCCS Istituto Nazionale Tumori Regina Elena	Roma
Italy	IRCCS Istituto per le Malattie Infettive Lazzaro Spallanzani	Roma
Italy	Istituto Dermatologico San Gallicano	Roma

Sponsors (13)

Lead Sponsor

Collaborator

Azienda Unità Sanitaria Locale Reggio Emilia

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Fondazione IRCCS Policlinico San Matteo di Pavia, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy, IRCCS Azienda Ospedaliero-Universitaria di Bologna, IRCCS San Raffaele, Istituti Fisioterapici Ospitalieri, Istituto Clinico Humanitas, Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS, Istituto Tumori Giovanni Paolo II, BARI, Regina Elena Cancer Institute, University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2 vaccine immunization	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.	5-7 weeks after T0 for Pfizer/BioNTech vaccination; 6-8 weeks after T0 for Moderna vaccination
Secondary	anti-S antibodies immunological response	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).	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
Secondary	T cell immunological response	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).	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
Secondary	immunological response in different subgroups	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	1 year
Secondary	impact of COVID-19 vaccination on patient health status	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.	1 weeks after frist dose and 1 week after second dose
Secondary	incidence of SARS-CoV-2 infection.	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.	all 52 weeks