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The COVID-19 pandemic has caused significant morbidity and mortality worldwide, especially among health-care workers. One of the most important preventive measures is vaccination. This study examined factors associated with the incidence rate of SARS-CoV-2 infection after mRNA-1273 booster vaccination (preceded by the CoronaVac primary vaccination) and the antibody profile of health-care workers at one of the tertiary hospitals in Indonesia. This was a combined retrospective cohort and cross-sectional study. Three hundred health-care workers who were given the mRNA-1273 booster vaccine a minimum of 5 months prior to this study were randomly selected. Participants were then interviewed about their history of COVID-19 vaccination, history of SARS-CoV-2 infection, and comorbidities. Blood samples were taken to assess IgG sRBD antibody levels. The median antibody level was found to be 659 BAU/mL (min 37 BAU/mL, max 5680 BAU/mL, QIR 822 BAU/mL) after the booster, and this was not related to age, sex, comorbidities, or adverse events following immunization (AEFI) after the booster. SARS-CoV-2 infection after the booster was correlated with higher antibody levels. In sum, 56 participants (18.6%) experienced SARS-CoV-2 infection after the mRNA-1273 booster vaccination within 5 months. Incidence per person per month was 3.2%. Age, sex, diabetes mellitus type 2, hypertension, obesity, and post-booster AEFI were not related to COVID-19 incidence after the booster. History of SARS-CoV-2 infection before the booster vaccination was significantly associated with a reduced risk of SARS-CoV-2 infection after booster vaccination, with a relative risk (RR) of 0.21 (95% CI 0.09-0.45, p < 0.001).
RESUMO
Background: Persistent immune activation and inflammation in HIV-infection are linked to excess cardiovascular risk and other non-communicable diseases. Periodic asymptomatic CMV-reactivity in HIV infected patients over a lifetime may contribute to non-AIDS defining morbidity. Despite undetectable levels of HIV and CMV, these patients continue to have increased levels of biomarkers and immune activations. Statin administration is thought to reduce subclinical atherosclerosis by decreasing LDL-C levels. It may also add beneficial effects against CMV infection. Methods: We are conducting a double-blind placebo-controlled trial in which patients are randomized to receive either atorvastatin or placebo with a ratio of 1:1. This trial aims to study the effect of atorvastatin in statin-naive virally-suppressed HIV-infected patients with stable ART and CMV seropositivity on carotid intima media thickness (CIMT), tool that evaluates subclinical atherosclerosis. The study recruits 80 patients at HIV integrated care unit of Cipto Mangunkusumo hospital. All eligible subjects have CIMT evaluation as primary outcome, along with flow mediated vasodilatation (FMD), liver fibrosis and steatosis evaluation, fasting lipid, neurocognitive test, community periodontal index (CPI), and residual immune activation as secondary outcomes in 48 weeks. Ethics and dissemination: This study has received an ethical approval from Health Research Ethics Commitee-Universitas Indonesia and Cipto Mangunkusumo Hospital. Before joining the study, all participants fill in an informed consent form. At the end of study analysis, the trial results will be published and disseminated in peer-reviewed journals. Discussion: The main purpose of our study is to evaluate the effect of atorvastatin administration on CIMT changes in statin naïve virally suppressed HIV-infected patients with stable ART and CMV seropositivity Registration: ClinicalTrials.gov ID NCT04101136; registered on 24 September 2019.