COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-5y9y7p7

José Neto

cerbino@fiocruz.br

2021-12-13

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

Age 18 years or older, Have completed the primary vaccination course against COVID-19 with the Coronavac/Butantan, AstraZeneca/Fiocruz or Pfizer vaccines for at least three months, Accepting to participate in the study by signing the Informed Consent Form (ICF),

Uncontrolled chronic illness (defined as illness that required a significant change in therapy or hospitalization for worsening illness during the 3 months prior to inclusion), Individuals with any severe or progressive neurological disorder, difficult to control seizure disorder or a history of Guillian-Barré syndrome or demyelinating diseases of the central nervous system, Individuals with congenital or acquired immunodeficiency*, or individuals who have received treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g. eg, for cancer or an autoimmune disease, within the last 12 months or planned receipt during the study period. If a short-term course (< 14 days) of systemic corticosteroids has been for the treatment of an acute illness, participants should not be included in the study until corticosteroid therapy has been discontinued for at least 30 days prior to the study. A single dose of systemic steroids in a single day is allowed, as well as inhaled/nebulized, intra-articular, intrabursal or topical (skin or eyes) corticosteroids are allowed, Participants who report pregnancy in progress or planning to become pregnant within the next 60 days after inclusion in the study, and postpartum women (up to 45 days after delivery). In the case of women of childbearing age, with an active sexual life and without consistent use of contraceptives, at the researcher's discretion, the participant may be excluded or, alternatively, included, if she agrees to use contraceptives for a period of 60 days after inclusion . In these cases, if necessary, the contraceptive will be provided by the responsible researcher free of charge, Blood transfusion or use of blood products in the last 6 months, Having had a heterologous primary vaccination schedule against Covid-19, Have received a higher number of doses than currently recommended for Covid-19, Having had a serious adverse event to any formulation of the Covid-19 vaccine, Hypersensitivity to the active ingredient or to any of the excipients of the Covid-19 vaccines used in the study, Any condition that, in the investigator's opinion, could compromise the follow-up of the study. * Individuals with HIV infection can be included as long as they have been on regular antiretroviral therapy for at least 3 months, with an undetectable viral load in the last 12 months and CD4 > 350 cells/mm3 at the last exam. Criteria for postponing vaccination, with subsequent reassessment, should be considered: Individuals with acute, mild febrile illnesses until they are 72 hours without fever, Individuals diagnosed with COVID-19 within 4 weeks of symptom onset,

6

Secretaria Municipal de Saúde do Rio de Janeiro

18

100

Brazil

Healthy volunteers

N/A

0

Expected outcome 1: Increased geometric mean (GMT) of anti-SARS-Cov-2 antibody titers 28 days after a booster dose of COVID-19 vaccine for each study group; measured by assay binding antibody detection of electrochemiluminescence and detection of neutralizing antibodies to SARS-CoV-2.;Expected Outcome 2: Frequency (%) of local and systemic adverse events requested within 7 days after each vaccine dose; for each group of participants.;Expected outcome 4: frequency (%) of serious adverse events throughout the study period for each group of participants.;Expected Outcome 3: Frequency (%) of unsolicited adverse events within 28 days after each vaccine dose; for each group of participants.

Phase 4

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