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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Influenza; Severe Acute Respiratory Infection (SARI)

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 Type: Observational
• Enrollment (Anticipated): 2400

Contacts and Locations

• Study Contact: Name: Claire Rekacewicz, MD; Phone Number: + 33 1 42 34 83 75; Email: claire.rekacewicz@inserm.fr
• Study Contact Backup: Name: Mohamed Ben Mechlia, PhD; Phone Number: + 33 1 44 23 61 38; Email: mohamed.ben-mechlia@anrs.fr

Study Locations

• France
  • Dijon, France
    • Recruiting
    • CHU
    • Principal Investigator: Lionel PIROTH, MD
  • Lyon, France
    • Recruiting
    • Groupement Hospitalier Edouard Herriot
    • Principal Investigator: Philippe VANHEMS, MD
  • Montpellier, France
    • Recruiting
    • Hopital Gui de Chauliac
    • Principal Investigator: Florence GALTIER, MD
  • Nantes, France
    • Recruiting
    • CHU
    • Principal Investigator: Maëva LEFEBVRE, MD
  • Paris, France, 75014
    • Recruiting
    • Hopital Cochin
    • Principal Investigator: Liem LUONG, MD
  • Paris, France
    • Recruiting
    • Hopital Bichat
    • Principal Investigator: Xavier DUVAL, MD
  • Rennes, France
    • Recruiting
    • CHU
    • Principal Investigator: Fabrice LAINE, MD
  • Saint-Étienne, France
    • Recruiting
    • CHU
    • Principal Investigator: Elisabeth BOTHELHO-NEVERS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Hospitalized patients presenting with SARI symptom onset in the first 14 days

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Covid-19 vaccine effectiveness	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	up to 48 hours
Influenza vaccine effectiveness	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	up to 48 hours
Prevalence of viral and bacterial co-infections	Prevalence of other viruses and bacteria detected by PCR, antigen tests, microbiology samples.	up to 48 hours
Incidence of SARI by site	Incidence rate of SARI by sites	up to 12 months
Clinical burden of SARI	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.	up to 3 months

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Collaborators: P95; I-REIVAC; EPICONCEPT; Institut de Recherche en Santé Publique, France

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Anticipated): January 20, 2026
• Study Completion (Anticipated): January 20, 2026

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Influenza; COVID-19; Severe acute respiratory infection (SARI); Vaccine effectiveness
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: ANRS0285s

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No