EFFECTIVENESS SAFETY AND IMMUNOGENICITY OF THE HALF DOSE OF THE VACCINE ChadOx1 nCoV-19 (AZD1222) for COVID-19

  • STATUS
    Recruiting
  • participants needed
    29637
  • sponsor
    Federal University of Espirito Santo
Updated on 28 November 2022
Accepts healthy volunteers

Summary

This study is clinical trial (intervention study with external comparison group) to test vaccination with reduced dose (half dose) of ChAdOx1 nCoV-19 (AZD1222), in a 2-dose schedule with an interval of 8 weeks, including all adults aged 18 to 49 years from Viana city - Esprito Santo (ES)/Brazil, on the incidence of new cases over 12 months following treatment, compared to an external group from same state and adjusted for socio-demographic and epidemiological variables.

Description

This study is clinical trial (intervention study with external comparison group) to test vaccination with reduced dose (half dose) of ChAdOx1 nCoV-19 (AZD1222), in a 2-dose schedule with an interval of 8 weeks, including all adults aged 18 to 49 years from Viana city - Esprito Santo (ES)/Brazil, on the incidence of new cases over 12 months following treatment, compared to an external group from same state and adjusted for socio-demographic and epidemiological variables. Cellular and humoral immunity will be studied in a representative sub-sample compared to an external reference group (cohort of health workers) vaccinated with standard dose. The outcomes will be evaluated at 28 days after the second dose and follow-up after 6 months and 12 months. The main outcome will be to decrease in 60% the incidence of new cases over 6 months after receiving the vaccine. The clinical epidemiological variables will be obtained from e-SUS VS, e-SUS notifica and datasus: number of cases, number of deaths with specific ICD for covid-19, number of hospital admissions for covid-19; number of ICU admissions for the treatment of SARS, total number of tests (RT-PCR) performed and positive. The cellular and humoral immune response will be assessed by viral neutralization assay (neutralizing antibody test), serological assay by chemiluminescence, determination of specific IgM and IgG profiles, measurement of systemic soluble factors (chemokines, cytokines and growth factors), stimulation antigen-specific peripheral blood mononuclear cells in vitro and investigation of memory T and B lymphocytes and intracytoplasmic cytokines. It is estimated to include 29,637 people in the study, to reach 85% vaccination cover of individuals aged 18-49 years. The subsample size immunogenicity test is 600 individuals from the eligible population, estimating losses of 15% and study power of 90%, alpha error of 1%. The hypothesis of the study is that the reduction in the incidence of covid-19 and the cellular and humoral immune response achieved with a half dose will be similar to the reduction expected with the standard dose.

Details
Condition Sars Cov 2
Treatment Half dose of ChAdOx1 nCoV-19 (AZD1222), Standard dose of ChAdOx1 nCoV-19 (AZD1222)
Clinical Study IdentifierNCT05059106
SponsorFederal University of Espirito Santo
Last Modified on28 November 2022

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