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Effectiveness, Immunogenicity and Safety of the Second Booster Dose of the Vaccine Against COVID-19 in the Elderly

CompletedN/A

Sponsor: Federal University of Espirito Santo

Conditions: COVID-19, Vaccine Adverse Reaction, Vaccine-Preventable Diseases

Interventions: ChAdOx1 nCoV-19 or Comirnaty or Janssen COVID-19 Vaccine

Countries: Brazil

The objective of this observational case-crossover study is to evaluate the effectiveness, safety and immunogenicity of the second booster dose in the elderly. There are an estimated 490,000 eligible individuals aged 60 and over statewide for the effectiveness study. Two hundred and sixty participants will be invited to participate in biological sample for the immunogenicity study. This sub-sample will be compared with 260 biorepository samples from a cohort of immunosuppressed patients with autoimmune diseases who received the fourth dose, in a study conducted by the same team of researchers. The main effectiveness outcome will be the number of hospitalizations; and secondary outcomes will be deaths, number of reported cases, number of cases confirmed by RT-PCR. The safety assessment will be carried out by monitoring adverse events. The cellular and humoral immune response will be evaluated by viral neutralization assay (search for neutralizing antibodies), serological assay by chemiluminescence, determination of specific IgM and IgG profile, dosage of soluble systemic factors (chemokines, cytokines and growth factors), stimulation in vitro antigen-specific peripheral blood mononuclear cells and investigation of memory T and B lymphocytes and intracytoplasmic cytokines. The study hypothesis is that elderly people who received the second booster dose have a lower incidence rate of hospitalizations and death than those who received the primary regimen (two doses or one of Janssen) or a booster dose, and that the immune response humoral and cellular function of the elderly is similar to those who are immunosuppressed.

Eligibility overview

Sex: ALL

Age: 60 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Age equal to or greater than 60 years
* Residents of Espírito Santo, Brazil

Exclusion Criteria:

* Being under active treatment (chemotherapy and/or radiotherapy) for the treatment of any type of neoplasm
* Being admitted to an institutionalization establishment for the elderly (hospitals, nursing homes, shelters or similar).
* Patients with mental illness with inability to understand the consent form

Locations (1)

Vitória, Espírito Santo, Brazil