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2.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-317874

ABSTRACT

Background: People living with HIV (PLWH) may have a poor or delayed response to vaccines, mainly when CD4+ T cell counts are low. There are limited data concerning the safety and immunogenicity of COVID-19 vaccines in PLWH.Methods: This prospective controlled study evaluated the safety and immunogenicity of the SARS-CoV-2 inactivated vaccine CoronaVac in PLWH compared with controls with no known immunosuppression. Immunogenicity was assessed with SARS-CoV-2 IgG seroconversion (SC), neutralizing antibodies (NAb) activity, and factor increase in IgG geometric mean titers (FI-GMT). We also investigated if levels of CD4+ T cell counts (< or ≥500 cells/mm3) were associated with CoronaVac immunogenicity.Findings: 511 participants (215 PLWH and 296 controls) were eligible for the immunogenicity analysis. At vaccine completion (D69), although the percentage of participants with SC and NAb positivity was high for both PLWH and controls, it was somewhat lower in PLWH. CD4+ T cell was identified as a relevant factor for immunogenicity, with lower SC and NAb positivity in PLWH with CD4+ counts <500 cells/mm3 compared to those with ≥500 cells/mm3. In a multivariable logistic regression model for NAb positivity after a complete two-dose regimen adjusted for age and sex, compared with PLWH with a CD4+ T cell count <500/mm3, those with CD4+ counts ≥500/mm3 had 2·26 times the odds of having positivity in NAb activity (95% CI 1·18-4·32;p=0·014), whereas controls had 3·21 times the odds of this outcome. No serious adverse reactions were reported during the study.Interpretation: Immunogenicity following CoronaVac in PLWH seems robust but reduced compared with controls;PLWH with CD4+ counts <500/mm 3 are at increased risk for a blunted antibody response following vaccination.Funding: Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP);Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq);and B3 - Bolsa de Valores do Brasil.Declaration of Interest: EGK is the Principal Investigator for the CoronaVac phase 3 clinical trial at University of Sao Paulo. VIAS is the Principal Investigator for the Janssen COVID-19 vaccine phase 3 clinical trial at University of Sao Paulo. INCOMPLETE, MISSING SOME AUTHORS FROM DOIEthical Approval: The national and local ethics committees approved the study.

3.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-308818

ABSTRACT

Background: Healthcare workers (HW) are a vulnerable group to develop burnout during the COVID-19 pandemic. The aims of this study were to evaluate the perception of HW about the antibody test, and, secondarily, the prevalence of burnout and factors associated with burnout among HW who took the test. Methods: : In this cross-sectional study, we evaluated burnout among HW in a 600-bed building entirely dedicated to COVID-19 inpatients care at Hospital das Clinicas (HC), located in São Paulo, Brazil. The HW answered an online questionnaire that included questions on burnout, a single-item scale based on the Maslach Burnout Inventory;demographic data, professional category, type of Protective Personal Equipment (PPE) used, distancing from social support;and emotional reactions to their serology result. Bivariate and multivariate analyses were done to evaluate the risk of burnout. Outcomes: Among 4,417 HW tested, 528 (12.0%) were positive for SARS-CoV-2 and 1,945 answered the questionnaire. Burnout was reported by 308 (15.8%);anxiety, tenseness, and depression associated with COVID-19 were reported by 344 (17.7%);292 (15.1%);and 181(9.3%) of the participants, respectively. The risk factors for burnout were: being a physician [adjOR:1.604;(95%CI 1.604-1.080;p=0.019)];a physiotherapist [adjOR:2.047;(95%CI:1.285–3.261;p=0.003)];perceiving a decrease in public safety[adjOR:1.983;(95%CI:1.229–3.199;p=0.005)];anxiety [adjOR:2.721;(95%CI:1.812–4.085;p=<0.001)], and depression associated with COVID-19[adjOR:2.071;(95%CI:1.308–3.279;p=0.002)];and having negative feeling towards had a previously negative SARS-CoV-2 serology[adjOR:1,989;(95%CI:1.484-2.664;p<0.001)]. Interpretation: Routine serological testing was one of the strategies used in our hospital to promote the well-being of HW. We observed that those who had negative feeling regarding testing negative to COVID-19 in previous serologies were at higher risk of burnout, suggesting that the risk of contracting the disease is a major stressor for HW.

4.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-305026

ABSTRACT

Background: Limited information is available on response to Covid-19 vaccines in autoimmune rheumatic disease patients(ARD) previously exposed to the SARS-CoV-2. We compared the dynamics of vaccine induced antibody production after immunization with CoronaVac in SARS-CoV-2 - seropositive ARD patients(ARD+) with two age/sex balanced groups: SARS-CoV-2 naïve ARD patients(NAÏVE-ARD) and SARS-CoV-2-seropositive control group(CTRL+).Methods: Participants of this phase 4 prospective controlled study were vaccinated with two doses of CoronaVac(28-days interval). Primary objective was immunogenicity dynamics evaluated by median neutralizing activity(NAb-activity)/anti-SARS-Cov-2 ln(IgG) titers[ln(IgG)] from D0-D28 and from D28-D69. Secondary objectives included safety and other immunogenicity parameters.Findings: Disease and therapy were similar in ARD+ and NAÏVE-ARD groups(p>0·05). A comparable dynamics was observed for ARD+ and CTRL+ with a plateau increase occurring from D0-D28[ARD+, NAb-activity:59·1% to 81·8%, mean difference -12·1%,p=0·002 and anti-S1/S2-GMT:52·3 to 128·9, ln(IgG) mean difference -0·9,p<0·001] and [CTRL+, NAb-activity:57·5 to 91·9%, mean difference -25·2%,p<0·001 and anti-S1/S2-GMT: 53·3 to 202·0, ln(IgG) mean difference -1·33,p<0·001]. Insignificant increments occurred from D28-D69 for ARD+ and CTRL+ regarding NAb-activity(p>0·999) and anti-S1/S2-GMT(p<0·999). In contrast, a distinct pattern was observed for NAÏVE-ARD with negligible increase from D0-D28 [NAÏVE-ARD: NAb-activity:15 vs. 15%, mean difference -8·3%,p<0·001 and anti-S1/S2-GMT:2·3 vs. 5·7, ln(IgG) mean difference -0·93,p<0·001] and a moderate increase from D28-D69[NAÏVE-ARD: NAb-activity:15·0 vs. 39·4%, mean difference -19·2%,p<0·001 and anti-S1/S2-GMT:5·7 vs. 29·6, ln(IgG) mean difference -1·65,p<0·001]. Supporting these findings, significant differences in NAb activity/ln(IgG) anti-S1/S2-GMT were observed between ARD+ vs. NAÏVE-ARD at D0:43·8%/3·14,p<0·001, D28:47·5%/3·12,p<0·001 and D69:29%/1·53,p<0·001, whereas no difference occurred between ARD+ vs. CTRL+ at D0:-0·5%/-0·02,p>0·999 and D69:-12·3%,p=0·167/0·32%,p=0·258 with minor difference at D28:-13·6%, p=0·067/-0·45,p=0·006.Interpretation: ARD+ patients mount a robust plateau response after a single dose of inactivated SARS-CoV-2 vaccine, independent of pre-existing ARD/therapy, whereas NAÏVE-ARD patients require the second dose to ensure a moderate antibody production. Our findings raise the possibility of a single dose regimen in ARD patients previously exposed to SARS-CoV-2.[clinicaltrials.gov#NCT04754698]Funding: FAPESP/CNPq/B3-Bolsa de Valores-Brasil.Declaration of Interest: The authors declare no competing interests.Ethical Approval: The protocol was approved by the National and Institutional Ethical Committee (CAAE: 42566621.0.0000.0068)

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