RESPIVAC: Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults

Sponsor

ANRS, Emerging Infectious Diseases (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05582239

Collaborator

P95 (Industry), I-REIVAC (Other), EPICONCEPT (Other), Institut de Recherche en Santé Publique, France (Other)

2,400

Enrollment

Locations

Anticipated Duration (Months)

300

Patients Per Site

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is a prospective, multicentric, observational test negative design study on adults hospitalized for Severe Acute Respiratory Infection (SARI), regardless of their vaccination status.

Condition or Disease	Intervention/Treatment	Phase
Severe Acute Respiratory Infection (SARI) Influenza COVID-19

Detailed Description

Participation to the study will be systematically proposed to all patients hospitalized fitting inclusion criteria. Patient's screening will be done in emergency department or hospital department with direct admission. Medical investigators explain the objectives of the studies, procedure and propose the patient to participate in the study. Socio-demographic data, clinical and virological data will be collected in an electronic clinical research form.

A follow-up at 1 and 3 months after hospitalization discharge will be scheduled to evaluate health status.

The remainder of respiratory samples that have been performed for care will be used for further testing depending on epidemiological situation and will be stored at -80°C.

Study Design

Study Type:

Observational

Anticipated Enrollment :

2400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults

Anticipated Study Start Date :

Nov 30, 2022

Anticipated Primary Completion Date :

Nov 30, 2025

Anticipated Study Completion Date :

Nov 30, 2025

Outcome Measures

Primary Outcome Measures

Vaccine effectiveness [up to 48 hours]
Comparison of the number of virologically confirmed cases of vaccine preventable Severe Acute Respiratory Infections (SARI) among hospitalized vaccinated patients compared with unvaccinated patients.

Secondary Outcome Measures

Covid-19 vaccine effectiveness [up to 48 hours]
Comparison of numbers of hospitalized cases with documented COVID-19 infection in vaccinated and unvaccinated patients according to: Age comorbidities Vaccine schedule (numbers of doses and brand) date of vaccination SARS-CoV-2 Variant
Influenza vaccine effectiveness [up to 48 hours]
Comparison of numbers of hospitalized cases with documented flu in vaccinated and unvaccinated according to: Age Comorbidities Vaccine brand Date of vaccination Previous vaccination Viral strain
Prevalence of viral and bacterial co-infections [up to 48 hours]
Prevalence of other viruses and bacteria detected by PCR, antigen tests, microbiology samples.
Incidence of SARI by site [up to 12 months]
Incidence rate of SARI by sites
Clinical burden of SARI [up to 3 months]
European Quality of Life by 5 Dimension (EQ5D) score assessed at 1 month and 3 months after hospitalization discharge. Scale from 0 to 100 with 0 corresponding to the worst quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years old
Admitted in a hospital for at least 24 h
Presents SARI criteria within onset within the last 14 days before sampling and less than 48 h after hospitalisations:

At least one of the following signs (without treatment): fever or feverishness, malaise, headache, myalgia or sign of fatigue (loss of weight or anorexia or confusion or dizziness) Associated with at least one respiratory symptom or sign (cough, sore throat or shortness of breath; or tachypnoea or signs of low oxygen saturation)

completed non-opposition form
Respiratory samples within 14 days after symptoms onset, in the context of care

Exclusion Criteria:

Contraindication of vaccination

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU	Dijon	France
2	Groupement hospitalier Edouard Herriot	Lyon	France
3	Hôpital Gui de Chauliac	Montpellier	France
4	CHU	Nantes	France
5	Hôpital Cochin	Paris	France	75014
6	Hôpital Bichat	Paris	France
7	CHU	Rennes	France
8	CHU	Saint-Étienne	France