- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05697705
Effectiveness of the Oxford-AstraZeneca COVID-19 Vaccine as a 2nd Booster, the REFORCO-Brazil Study (REFORCO-B)
Real-world Effectiveness oF the OxfoRd-astrazeneca Covid-19 Vaccine as a Second bOoster Dose in Brazil (REFORCO-BRAZIL)
Study Overview
Status
Conditions
Detailed Description
In Brazil, second COVID-19 boosters became available to specific risk groups in early 2022. By June 2022, immunocompromised individuals aged 12 years and above, individuals aged 50 years and above, and healthcare workers were eligible for a second booster. The vaccines available for second booster doses in Brazil are produced by AstraZeneca (AZ), Janssen, Pfizer and Sinovac.
While several studies have estimated absolute vaccine effectiveness (aVE) or relative vaccine effectiveness (rVE) of second boosters of mRNA COVID-19 vaccines, only a single study has, to date, estimated aVE of AZ vaccine as a second booster dose, and no studies have estimated rVE for AZ vaccine as a second booster dose. As the pandemic progresses, more individuals are choosing to become vaccinated (and boosted) against COVID-19 and thus there is greater need to evaluate the additional protection offered by a second booster dose amongst individuals previously administered a first booster. This is particularly important in the context of waning protection of a first booster dose.
The primary objective is to estimate relative vaccine effectiveness (rVE) against COVID-19 hospitalization of the AZ COVID-19 vaccine as a second booster dose relative to a first booster dose only, of any COVID-19 vaccine, administered at least four months ago.
This study will also evaluate rVE of other vaccines used in Brazil as a second booster doses. The study will further evaluate rVE of all vaccines (including the AZ-COVID-19 vaccine) as a first booster dose relative to a complete primary series only, of any COVID-19 vaccine administered at least four months ago."
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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São Paulo, Brazil, 05403-010
- Techtrials Pesquisa e Tecnologia Ltda.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Population A is for evaluating second booster doses and will consist of individuals aged 18 years and over with immunocompromising conditions, healthcare workers aged 18 years and over, and individuals aged 50 years and over.
Population B is for evaluating first booster doses and will consist of all individuals aged 18 and over.
Description
Inclusion Criteria:
- Hospitalized for SARS between 01 January 2022 and 31 December 2022 (Population A) or hospitalised for SARS between 01 August 2021 and 31 December 2022 (Population B).
- Eligible for a second COVID-19 vaccine booster dose at the time of SARS hospitalization (i.e., aged 50+ or aged 18+ and either a HCW or with an IC) for second booster objectives [Population A] OR eligible for a first COVID-19 vaccine booster dose at the time of SARS hospitalisation (i.e., aged 18+) for first booster objectives [Population B].
- Results available for a RT-PCR and/or antigen test for SARS-CoV-2 conducted on a sample taken up to 14 days after symptom onset.
- Individuals have required matching variables (e.g. age and sex).
Exclusion Criteria:
- Hospitalized for COVID-19 within 3 months prior to date of current hospital admission for SARS
- Nosocomially-acquired infection (where SARS case is flagged as nosocomial and/or where symptom onset date is after hospitalisation date)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Population A
For evaluating second booster doses
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Used as 2nd booster, 1st booster, or primary series
Used as 2nd booster, 1st booster, or primary series.
Used as 2nd booster, 1st booster, or primary series.
Used as 2nd booster, 1st booster, or primary series.
|
Population B
For evaluating first booster doses
|
Used as 2nd booster, 1st booster, or primary series
Used as 2nd booster, 1st booster, or primary series.
Used as 2nd booster, 1st booster, or primary series.
Used as 2nd booster, 1st booster, or primary series.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COVID-19 confirmed by a positive antigen test or RT-PCR test in an individual hospitalized for SARS
Time Frame: Sample date within 14 days prior to and up to 2 days after hospitalization.
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Study includes SARS hospitalizations between August 2021 and December 2022 for evaluation of 1st booster dose effectiveness, and SARS hospitalizations between January 2022 and December 2022 for evaluation of 2nd booster dose effectiveness.
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Sample date within 14 days prior to and up to 2 days after hospitalization.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D8111R00028
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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