RESUMO
BackgroundData from previous studies of the MVC-COV1901 vaccine, a subunit vaccine against SARS-CoV-2 based on the stable prefusion spike protein (S-2P) adjuvanted with CpG 1018 adjuvant and aluminum hydroxide, suggest that the vaccine is generally safe and elicits a good immune response in healthy adults and adolescents. By comparing with AZD1222, this study adds to the findings from previous trials and further evaluates the breadth of protection offered by MVC-COV1901. MethodsIn this phase 3, parallel group, randomized, double-blind, active-controlled trial conducted in 2 sites in Paraguay, we assigned adults aged 18 to 91 years in a 1:1 ratio to receive intramuscular doses of MVC-COV1901 or AZD1222 administered as scheduled in the clinical trial. Serum samples were collected on the day of vaccination and 14 days after the second dose. Primary and secondary safety and immunogenicity endpoints were assessed. In addition, other outcomes investigated were cross-reactive immunity against the Omicron strain and the induction of IgG subclasses. ResultsA total of 1,030 participants underwent randomization. Safety data was derived from this set while primary immunogenicity data involved a per-protocol immunogenicity (PPI) subset including 225 participants. Among the participants, 58% are seropositive at baseline. When compared against AZD1222, MVC-COV1901 exhibited superiority in terms of neutralizing antibody titers and non-inferiority in terms of seroconversion rates. Reactogenicity was generally mild and no serious adverse event was attributable to MVC-COV1901. Both vaccines have a Th1-biased response predominated by the production of IgG1 and IgG3 subclasses. Omicron-neutralizing titers were 44.5 times lower compared to wildtype-neutralizing titers among seronegative individuals at baseline. This fold-reduction was 3.0 times among the seropositive. ConclusionResults presented here demonstrate the safe and robust immunogenicity from MVC-COV1901. Previous infection coupled with vaccination of this vaccine may offer protection against the Omicron strain though its durability is still unknown. ClinicalTrials.gov registrationNCT05011526
RESUMO
BackgroundIt remains unclear whether COVID-19 is associated with psychiatric symptoms during or after the acute illness phase. Being affected by the disease exposes the individual to an uncertain prognosis and a state of quarantine. These factors can predispose individuals to the development of mental symptoms during or after the acute phase of the disease. There is a need for prospective studies assessing mental health symptoms in COVID-19 patients in the post-infection period. MethodsIn this retrospective cohort study, nasopharyngeal swabs for COVID-19 tests were collected at patients homes under the supervision of trained healthcare personnel. Patients who tested positive for COVID-19 and were classified as mild cases (N=895) at treatment intake were further assessed for the presence of mental health disorders (on average, 56.6 days after the intake). We investigated the association between the number of COVID-19 symptoms at intake and depression, anxiety and PTSD, adjusting for previous mental health status, time between baseline and outcome, and other confounders. Multivariate logistic regression and generalized linear models were employed for categorical and continuous outcomes, respectively. FindingsDepression, anxiety and PTSD were reported by 26.2% (N=235), 22.4% (N=201), and 17.3% (N=155) of the sample. Reporting an increased number of COVID-related symptoms was associated with depression (aOR=1.059;95%CI=1.002-1.119), anxiety (aOR=1.072;95%CI=1.012-1.134), and PTSD (aOR=1.092;95%CI=1.024-1.166). Sensitivity analyses supported findings for both continuous and categorical measures. InterpretationExposure to an increased number of COVID-19 symptoms may predispose individuals to depression, anxiety and PTSD after the acute phase of the disease. These patients should be monitored for the development of mental health disorders after COVID-19 treatment discharge. Early interventions, such as brief interventions of psychoeducation on coping strategies, could benefit these individuals. FundingThe city health department of Sao Caetano do Sul (Secretaria Municipal de Saude da Prefeitura de Sao Caetano do Sul) funded the establishment and implementation of the COVID-19 platform.
