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1.
Vaccines (Basel) ; 10(2)2022 Feb 14.
Article in English | MEDLINE | ID: covidwho-1699506

ABSTRACT

The emergence of rapidly spreading variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) poses a major challenge to the ability of vaccines and therapeutic antibodies to provide immunity. These variants contain mutations of specific amino acids that might impede vaccine efficacy. BriLife® (rVSV-ΔG-spike) is a newly developed SARS-CoV-2 vaccine candidate currently in phase II clinical trials. It is based on a replication-competent vesicular stomatitis virus (VSV) platform. The rVSV-ΔG-spike contains several spontaneously acquired spike mutations that correspond to SARS-CoV-2 variants' mutations. We show that human sera from BriLife® vaccinees preserve comparable neutralization titers towards alpha, gamma, and delta variants and show less than a three-fold reduction in the neutralization capacity of beta and omicron compared to the original virus. Taken together, we show that human sera from BriLife® vaccinees overall maintain a neutralizing antibody response against all tested variants. We suggest that BriLife®-acquired mutations may prove advantageous against future SARS-CoV-2 VOCs.

2.
Vox Sang ; 117(2): 185-192, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1685455

ABSTRACT

BACKGROUND AND OBJECTIVES: Passive immunization using investigational COVID-19 convalescent plasma (CCP) is a promising therapeutic strategy and could improve outcome if transfused early and contain high levels of anti-SARS-CoV-2 antibodies. We report the management of a national CCP collection and distribution program in Israel. MATERIALS AND METHODS: From 1 April 2020 to 15 January 2021, 4020 volunteer donors donated 5221 CCP units and 837 (20.8%) donors donated more than once. Anti-nucleocapsid IgG antibodies were determined using chemiluminescent immunoassay method (Abbott). A statistical model based on repeated IgG tests in sequential donations was created to predict the time of antibody decline below sample/cut-off (S/CO) level of 4.0. RESULTS: Ninety-six percent of CCP donors suffered a mild disease or were asymptomatic. Older donors had higher antibody levels. Higher antibody levels (S/CO ≥4) were detected in 35.2% of the donors. Low positive (S/CO ≥1.4-3.99) were found in 37%, and 27.8% had undetectable antibodies (S/CO ≤1.4). The model predicted decrease antibody thresholds of 0.55%/day since the first CCP donation, providing guidance for the effective timing of future collections from donors with high antibody levels. CONCLUSIONS: An efficient CCP collection and distribution program was achieved, based on performing initial and repeated plasma collections, preferably from donors with higher antibody levels, and only antibody-rich units were supplied for therapeutic use. The inventory met the quantity and quality standards of the authorities, enabled to respond to the growing demand of the medical system and provide a product that may contribute to improve prognosis in patients with COVID-19.


Subject(s)
COVID-19 , Blood Donors , COVID-19/therapy , Humans , Immunization, Passive , Israel , SARS-CoV-2
3.
Vaccine ; 40(3): 428-431, 2022 01 24.
Article in English | MEDLINE | ID: covidwho-1612087

ABSTRACT

Currently approved anti-COVID-19 vaccines have been found to be safe and effective and almost 60% of Israeli residents are already vaccinated with BNT162b2 vaccine. This observational study was designed to evaluate the adverse events of vaccine reported by 61 healthcare workers at least 7 days after the 2nd vaccination, and to investigate the correlation of adverse events and anti-SARS-CoV-2 IgG antibody levels. The median participant's age was 51.25 years, 16 men and 45 women; 77% (44% of male and 84.5% of female participants) reported adverse events. Injection site pain, fatigue and fever were the most common symptoms, and significantly higher antibody levels (average 19,387 AU/mL) were found in participants who had fever compared to those who did not experience fever (average antibody levels of 9,977 AU/mL, p < 0.001). This finding corresponds to previous observations of higher anti-SARS-CoV-2 IgG antibody levels in COVID-19 patients presented with fever.


Subject(s)
COVID-19 , COVID-19 Vaccines , Female , Health Personnel , Humans , Male , Middle Aged , RNA, Messenger , SARS-CoV-2 , Vaccination
4.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-293181

ABSTRACT

BriLife® (rVSV- ΔG-spike) is a SARS-CoV-2 vaccine candidate based on vesicular stomatitis virus (VSV) platform. We show that sera from BriLife® vaccinees maintain neutralization capacity against alpha, beta, gamma and delta SARS-CoV-2 variants. BriLife® spontaneously-acquired spike mutations, corresponding with key SARS-CoV-2 variants mutations, may contribute to its efficacy against SARS-CoV-2 variants.

9.
EClinicalMedicine ; 26: 100525, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-753681

ABSTRACT

BACKGROUND: We assessed outcome of patients with moderate and severe COVID-19 following treatment with convalescent plasma (CP) and the association with IgG levels in transfused CP. METHODS: A prospective cohort study. Primary outcome was improvement at day 14 defined as alive, not on mechanical ventilation, and moderate, mild, or recovered from COVID-19. Antibody levels in CP units were unknown at the time of treatment. IgG against the spike protein S1 was subsequently measured by ELISA. Neutralizing antibodies titers were determined in a subset. Outcome was assessed in relation to the mean antibody level transfused to the patients (≤4.0 versus >4.0). FINDINGS: Of 49 patients, 11 (22.4%) had moderate, 38 (77.6%) had severe disease, 28 were ventilated. At day 14, 24 (49.0%) patients improved, 9 (18.4%) died, and 13 (26.5%) were ventilated. In 14/98 (14.3%) CP units IgG was < 1.1 (cutoff calibration) and in 60 (61.2%) ≤4.0. IgG level and neutralizing antibody titer were correlated (0.85 p < 0.001). In patients receiving ≤4.0 antibody levels, 11/30 improved (36.7%) versus 13/19 (68.4%) in patients receiving >4.0 odds ratio (OR) 0.267 [95% confidence interval (CI) 0.079-0.905], P = 0.030. In patients diagnosed >10 days prior to treatment, 4/14 (22.4%) improved in the ≤4.0 antibody group, versus 6/7 (85.7%) in the >4.0 antibody group, OR 0.048 (95% CI, 0.004-0.520), P = 0.007. No serious adverse events were reported. INTERPRETATION: Treatment with CP with higher levels of IgG against S1 may benefit patients with moderate and severe COVID-19. IgG against S1 level in CP predicts neutralization antibodies titers.

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