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Evaluation of the humoral response to COVID-19 vaccines in Brazil

Evaluation of the humoral response to the ChAdOx1-nCov19 (AstraZeneca-Oxford/Fiocruz) and Coronavac (Butantan) vaccines against COVID-19 in Brazil: a prospective and retrospective cohort

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
REBEC
Registry ID
RBR-33ndb47
Enrollment
Unknown
Registered
2022-02-22
Start date
2021-02-25
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RNA Virus Infections

Interventions

This is an observational retrospective and prospective cohort study to evaluate the humoral response in six groups exposed to the most widely used COVID-19 immunization regimens in Brazil: two standa
G12.513
D020133

Sponsors

Fundação Oswaldo Cruz
Lead Sponsor
Fundação Oswaldo Cruz
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Men and women aged 18 years and over; A resident of the metropolitan region of Rio de Janeiro or the state of Ceará; Have received at least one dose of ChAdOx1-nCov19 (AstraZeneca-Oxford /Fiocruz) or Coronavac (Butantan) vaccine in the states of Rio de Janeiro or Ceará; Accept to participate in the study by signing the Informed Consent Form.

Exclusion criteria

Exclusion criteria: Men and women with unavailability to comply with the follow-up schedule

Design outcomes

Primary

MeasureTime frame
Evaluation of the spike protein-specific anti-SARS-CoV 2 IgG titer after each vaccination regimen

Secondary

MeasureTime frame
Secondary Outcome 1: Describe the time to seroconversion of spike protein-specific anti-SARS-CoV 2 IgG antibodies after vaccination;Secondary Outcome 2: Analyze the cellular immunity after 3, 6 and 9 months of vaccination with the 3rd dose of the vaccine;Secondary Outcome 3: Verify the frequency of adverse events from COVID-19 vaccination;Secondary Outcome 4: Verify the frequency of positive RT-PCR examination, after vaccination and over one year after vaccination 3rd dose of vaccine;Secondary Outcome 5: Verify the time between positive RT-PCR test and 1st, 2nd and/or 3rd dose of vaccination and throughout one year after the 3rd dose of the vaccine;Secondary Outcome 6: Identify the titer of neutralizing antibodies after the 1st, 2nd and 3rd dose of vaccination

Countries

Brazil

Contacts

Public ContactAndre Daher

Fundação Oswaldo Cruz

andre.daher@fiocruz.br+5521 2598-4242

Outcome results

None listed

Source: REBEC (via WHO ICTRP)