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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05582239
Recruitment Status : Recruiting
First Posted : October 17, 2022
Last Update Posted : May 17, 2023
Sponsor:
Collaborators:
P95
I-REIVAC
EPICONCEPT
Institut de Recherche en Santé Publique, France
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

Study Description
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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
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
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Study Type : Observational
Estimated Enrollment : 2400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults
Actual Study Start Date : January 20, 2023
Estimated Primary Completion Date : January 20, 2026
Estimated Study Completion Date : January 20, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Vaccine effectiveness [ Time Frame: 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 :
  1. Covid-19 vaccine effectiveness [ Time Frame: 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

  2. Influenza vaccine effectiveness [ Time Frame: 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

  3. Prevalence of viral and bacterial co-infections [ Time Frame: up to 48 hours ]
    Prevalence of other viruses and bacteria detected by PCR, antigen tests, microbiology samples.

  4. Incidence of SARI by site [ Time Frame: up to 12 months ]
    Incidence rate of SARI by sites

  5. Clinical burden of SARI [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
Swab respiratory samples

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hospitalized patients presenting with SARI symptom onset in the first 14 days
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05582239


Contacts
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Contact: Claire Rekacewicz, MD + 33 1 42 34 83 75 claire.rekacewicz@inserm.fr
Contact: Mohamed Ben Mechlia, PhD + 33 1 44 23 61 38 mohamed.ben-mechlia@anrs.fr

Locations
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France
CHU Recruiting
Dijon, France
Principal Investigator: Lionel PIROTH, MD         
Groupement hospitalier Edouard Herriot Recruiting
Lyon, France
Principal Investigator: Philippe VANHEMS, MD         
Hôpital Gui de Chauliac Recruiting
Montpellier, France
Principal Investigator: Florence GALTIER, MD         
CHU Recruiting
Nantes, France
Principal Investigator: Maëva LEFEBVRE, MD         
Hôpital Cochin Recruiting
Paris, France, 75014
Principal Investigator: Liem LUONG, MD         
Hôpital Bichat Recruiting
Paris, France
Principal Investigator: Xavier DUVAL, MD         
CHU Recruiting
Rennes, France
Principal Investigator: Fabrice LAINE, MD         
CHU Recruiting
Saint-Étienne, France
Principal Investigator: Elisabeth BOTHELHO-NEVERS, MD         
Sponsors and Collaborators
ANRS, Emerging Infectious Diseases
P95
I-REIVAC
EPICONCEPT
Institut de Recherche en Santé Publique, France
More Information
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Responsible Party: ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier: NCT05582239    
Other Study ID Numbers: ANRS0285s
First Posted: October 17, 2022    Key Record Dates
Last Update Posted: May 17, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ANRS, Emerging Infectious Diseases:
Severe acute respiratory infection (SARI)
Vaccine effectiveness
Influenza
COVID-19
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pneumonia, Viral
Pneumonia
 Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases