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1.
EuropePMC; 2022.
Preprint in English | EuropePMC | ID: ppcovidwho-332637

ABSTRACT

SUMMARY Background Vaccination has helped to mitigate the COVID-19 pandemic. Ten traditional and novel vaccines have been listed by the World Health Organization for emergency use. Additional alternative approaches may better address ongoing vaccination globally, where there remains an inequity in vaccine distribution. GBP510 is a recombinant protein vaccine, which consists of self-assembling, two-component nanoparticles displaying the receptor-binding domain (RBD) in a highly immunogenic array. Methods We conducted a randomized, placebo-controlled, observer-blinded, phase 1/2 trial to evaluate the safety and immunogenicity of GBP510 (2-doses at a 28-day interval) adjuvanted with or without AS03 in adults aged 19–85 years. The main outcomes included solicited and unsolicited adverse events;anti-SARS-CoV-2 RBD IgG antibody and neutralizing antibody responses;T-cell immune responses. Findings Of 328 participants who underwent randomization, 327 participants received at least 1 dose of vaccine. Each received either 10 μg GBP510 adjuvanted with AS03 (n = 101), 10 μg unadjuvanted GBP510 (n = 10), 25 μg GBP510 adjuvanted with AS03 (n = 104), 25 μg unadjuvanted GBP510 (n = 51), or placebo (n = 61). Most solicited adverse events were mild-to-moderate in severity and transient. Higher reactogenicity was observed in the GBP510 adjuvanted with AS03 groups compared to the non-adjuvanted and placebo groups. Reactogenicity was higher post-dose 2 compared to post-dose 1, particularly for systemic adverse events. The geometric mean concentrations of anti-SARS-CoV-2-RBD IgG antibody reached 2163.6/2599.2 BAU/mL in GBP510 adjuvanted with AS03 recipients (10 μg/25 μg) by 14 days after the second dose. Two-dose vaccination with 10 μg or 25 μg GBP510 adjuvanted with AS03 induced high titers of neutralizing antibody via pseudovirus (1369.0/1431.5 IU/mL) and wild-type virus (949.8/861.0 IU/mL) assays. Interpretation GBP510 adjuvanted with AS03 was well tolerated and highly immunogenic. These results support further development of the vaccine candidate, which is currently being evaluated in Phase 3. Funding Coalition for Epidemic Preparedness Innovations RESEARCH IN CONTEXT Evidence before this study We searched PubMed for research articles published by December 31, 2021, using the terms “COVID-19” or “SARS-CoV-2,” “vaccine,” and “clinical trial.” In previously reported randomized clinical trials, we found that mRNA vaccines were more immunogenic than adenovirus-vectored vaccines. Solicited adverse events were more frequent and more severe in intensity after the first dose compared to the second dose for adenovirus-vectored vaccines, whereas they increased after the second dose of mRNA or recombinant spike-protein nanoparticle vaccines. Added value of this study This is the first human study evaluating the immunogenicity and safety of recombinant SARS-CoV-2 protein nanoparticle with and without adjuvant AS03, designed to elicit functional cross-protective responses via receptor-binding domain (RBD). Both 10 and 25 μg of GBP510 with AS03 formulations were well tolerated with an acceptable safety profile. Potent humoral immune responses against the SARS-CoV-2 RBD were induced and peaked by day 42 (14 days after the second dose). In addition, GBP510 adjuvanted with AS03 elicited a noticeable Th1 response, with production of IFN-γ, TNF-α, and IL-2. IL-4 was inconsistent and IL-5 nearly inexistent response across all groups. Implications of the available evidence The results from this phase 1/2 trial indicate that GBP510 adjuvanted with AS03 has an acceptable safety profile with no vaccine-related serious adverse events. Two-dose immunization with GBP510 adjuvanted with AS03 induced potent humoral and cellular immune responses against SARS-CoV-2.

3.
J Infect Dis ; 2022 Feb 16.
Article in English | MEDLINE | ID: covidwho-1752117

ABSTRACT

A prospective cohort study was conducted for adults diagnosed with COVID-19. Convalescent blood was obtained at 4, 6, and 11 months after SARS-CoV-2 infection. The seropositivity of anti-spike antibody was maintained in all patients (100%) until 11 months after COVID-19. Neutralizing antibody levels against the wild-type SARS-CoV-2 gradually decreased but remained positive in more than 50% of patients 11 months after diagnosis: 98.5% (67/68) at 4 months, 86.8% (46/53) at 6 months, and 58.8% (40/68). However, cross-neutralizing activity against the Beta and Delta variants was attenuated 2.53-fold and 2.93-fold, respectively, compared to the wild-type strain.

4.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-318062

ABSTRACT

Background: There is insufficient data on the longevity of immunity acquired following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We aimed to evaluate the duration of SARS-CoV-2-specific humoral and cellular immunity according to the clinical severity of coronavirus disease 2019 (COVID-19).Methods: Convalescent blood was collected prospectively from 97 patients who had recovered from COVID-19. The level of humoral immunity to SARS-CoV-2 was measured using the anti-SARS-CoV-2 nucleocapsid immunoglobulin G (IgG) assay and the plaque reduction neutralization test with sera collected at three periods: within 8 weeks, at 9-20 weeks, and at 22-27 weeks after diagnosis. IFN-γ ELISpot assays were conducted using overlapping peptides covering spike, nucleocapsid, and membrane proteins of SARS-CoV-2.Findings: The study population comprised asymptomatic (n=14), symptomatic/non-pneumonic (n=42), and pneumonic (n=41) patients. The anti-SARS-CoV-2 IgG and neutralizing antibody (NAb) titers lasted until six months after diagnosis, with positivity rates of 66·7% and 86·9%, respectively. The level of humoral immunity at six months after diagnosis were significantly higher in the pneumonic group than in the symptomatic/non-pneumonic group. Older age, prolonged viral shedding and accompanying pneumonia were more frequently found in patients with sustained humoral immunity. SARS-CoV-2 specific T-cell response was strongly observed in pneumonic patients and prominent in individuals with sustained humoral immunity.Interpretation: Most (> 85%) patients carries NAb until six months after diagnosis of SARS-CoV-2 infection, providing insights for establishing vaccination strategies against COVID-19.Funding Statement: This study was supported by a grant of the Korea National Institute of Health, Korea Disease Control and Prevention Agency (project number: 2020-ER5314-00), Korea University Guro Hospital (Korea research-driven hospital) (No. O2001061), and the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI20C0452).Declaration of Interests: The authors declare no competing interests.Ethics Approval Statement: The study protocol was approved by the Institutional Review Board of the Korea University Guro Hospital (approval number: 2020GR0130). All participants provided written informed consent.

5.
EuropePMC;
Preprint in English | EuropePMC | ID: ppcovidwho-327580

ABSTRACT

Natural infection with SARS-CoV-2 or vaccination induces virus-specific immunity protecting hosts from infection and severe disease. While the infection-preventing immunity gradually declines, the severity-reducing immunity is relatively well preserved. Here, based on the different longevity of these distinct immunities, we develop a mathematical model to estimate courses of endemic transition of COVID-19. Our analysis demonstrates that high viral transmission unexpectedly reduces the rates of progression to severe COVID-19 during the course of endemic transition despite increased numbers of infection cases. Our study also shows that high viral transmission amongst populations with high vaccination coverages paradoxically accelerates the endemic transition of COVID-19 with reduced numbers of severe cases. These results provide critical insights for driving public health policies in the era of ‘living with COVID-19’.

8.
Signal Transduct Target Ther ; 6(1): 203, 2021 05 22.
Article in English | MEDLINE | ID: covidwho-1387226
9.
J Infect Dis ; 224(5): 754-763, 2021 09 01.
Article in English | MEDLINE | ID: covidwho-1381010

ABSTRACT

BACKGROUND: There is insufficient data on the longevity of immunity acquired after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. METHODS: We aimed to evaluate the duration of SARS-CoV-2-specific humoral and cellular immunity according to the clinical severity of coronavirus disease 2019 (COVID-19). The study population comprised asymptomatic (n = 14), symptomatic/nonpneumonic (n = 42), and pneumonic (n = 41) patients. RESULTS: The anti-SARS-CoV-2 immunoglobulin class G and neutralizing antibody (NAb) titers lasted until 6 months after diagnosis, with positivity rates of 66.7% and 86.9%, respectively. Older age, prolonged viral shedding, and accompanying pneumonia were more frequently found in patients with sustained humoral immunity. Severe acute respiratory syndrome coronavirus 2-specific T-cell response was strongly observed in pneumonic patients and prominent in individuals with sustained humoral immunity. CONCLUSIONS: In conclusion, most (>85%) patients carry NAb until 6 months after diagnosis of SARS-CoV-2 infection, providing insights for establishing vaccination strategies against COVID-19.


Subject(s)
COVID-19/immunology , SARS-CoV-2/immunology , Adult , Antibodies, Neutralizing/immunology , Antibodies, Viral/immunology , COVID-19/diagnosis , COVID-19/virology , Female , Humans , Immunity, Cellular , Immunity, Humoral , Immunoglobulin G/immunology , Longitudinal Studies , Male , Middle Aged , Prospective Studies , T-Lymphocytes/immunology , Virus Shedding
10.
J Korean Med Sci ; 36(34): e245, 2021 Aug 30.
Article in English | MEDLINE | ID: covidwho-1379958

ABSTRACT

Since February 26, 2021, when vaccination against coronavirus disease 2019 (COVID-19) began in South Korea, patients who visited the Korea University Guro Hospital with suspected adverse events after COVID-19 vaccination were monitored actively with interest. We encountered five unusual cases of polyarthralgia and myalgia syndrome in patients who received the ChAdOx1 nCOV-19 (AstraZeneca) vaccine. The patients (median age 67 years) were not previously diagnosed with arthropathy and rheumatologic diseases. They developed fever, myalgia, joint pain, and swelling three to seven days after vaccination. The symptoms persisted for up to 47 days despite antipyretic treatment. Arthralgia occurred in multiple joints, including small and large joints. A whole-body Technetium-99m methylene diphosphonate bone scan revealed unusual uptakes in the affected joints. Non-steroidal anti-inflammatory drugs with or without prednisolone relieved the symptoms of all patients. Further monitoring is required to clarify the long-term prognosis of this syndrome.


Subject(s)
Arthralgia/etiology , COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Myalgia/etiology , Vaccination/adverse effects , Adult , Aged , Antipsychotic Agents/therapeutic use , Arthralgia/drug therapy , COVID-19/virology , Female , Humans , Joints/diagnostic imaging , Joints/pathology , Myalgia/drug therapy , Republic of Korea , SARS-CoV-2/isolation & purification , Tomography, X-Ray Computed
11.
J Clin Med ; 10(16)2021 Aug 12.
Article in English | MEDLINE | ID: covidwho-1354996

ABSTRACT

Although some intravenous drugs have been used to treat coronavirus disease 2019 (COVID-19), no effective antiviral agents are currently available in the outpatient setting. We aimed to evaluate the efficacy and adverse events of 14-day ciclesonide treatment vs. standard care for patients with mild-to-moderate COVID-19. A randomized, open-label, multicenter clinical trial of ciclesonide inhalers was conducted in patients with mild-to-moderate COVID-19. Patients were enrolled within 3 days of diagnosis or within 7 days from symptom onset and randomly assigned to receive either ciclesonide (320 µg inhalation twice per day for 14 days) or standard care. The primary endpoint was the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) eradication rate on day 14 from study enrollment. Clinical status was assessed once daily, and serial nasopharyngeal viral load was evaluated by quantitative reverse transcription polymerase chain reaction. There were 35 and 26 patients in the ciclesonide and standard care groups, respectively. The SARS-CoV-2 eradication rate at day 14 was significantly higher in the ciclesonide group (p = 0.021). In multivariate analysis, SARS-CoV-2 negative conversion within 14 days was 12 times more likely in the ciclesonide group (95% confidence interval, 1.187-125.240). Additionally, the clinical failure rate (high-flow nasal oxygen therapy or mechanical ventilation) was significantly lower in the ciclesonide group (p = 0.034). In conclusion, ciclesonide inhalation shortened SARS-CoV-2 viral shedding duration, and it may inhibit the progression to acute respiratory failure in patients with mild-to-moderate COVID-19. Clinical Trial Registration NCT04330586.

12.
J Clin Med ; 10(15)2021 Jul 29.
Article in English | MEDLINE | ID: covidwho-1335126

ABSTRACT

Social distancing is an effective measure to mitigate the spread of novel viral infections in the absence of antiviral agents and insufficient vaccine supplies. Subway utilization density may reflect social activity and the degree of social distancing in the general population.; This study aimed to evaluate the correlations between subway use density and the activity of the influenza epidemic or coronavirus disease 2019 (COVID-19) pandemic using a time-series regression method. The subway use-based social distancing score (S-SDS) was calculated using the weekly ridership of 11 major subway stations. The temporal association of S-SDS with influenza-like illness (ILI) rates or the COVID-19 pandemic activity was analyzed using structural vector autoregressive modeling and the Granger causality (GC) test. During three influenza seasons (2017-2020), the time-series regression presented a significant causality from S-SDS to ILI (p = 0.0484). During the COVID-19 pandemic in January 2020, S-SDS had been suppressed at a level similar to or below the average of the previous four years. In contrast to the ILI rate, there was a negative correlation between COVID-19 activity and S-SDS. GC analysis revealed a negative causal relationship between COVID-19 and S-SDS (p = 0.0098).; S-SDS showed a significant time-series association with the ILI rate but not with COVID-19 activity. When public transportation use is sufficiently suppressed, additional social mobility restrictions are unlikely to significantly affect COVID-19 pandemic activity. It would be more important to strengthen universal mask-wearing and detailed public health measures focused on risk activities, particularly in enclosed spaces.

14.
J Korean Med Sci ; 36(15): e110, 2021 Apr 19.
Article in English | MEDLINE | ID: covidwho-1194584

ABSTRACT

Hospital-based surveillance for adverse events was conducted on healthcare workers after they received the first dose of coronavirus disease 2019 (COVID-19) vaccine. Among the two new platform vaccines (messenger RNA- and adenoviral vector-based vaccines), the rates of systemic adverse events were significantly higher among adenovirus-vectored vaccine recipients. Fatigue (87.6% vs. 53.8%), myalgia (80.8% vs. 50.0%), headache (72.0% vs. 28.8%), and fever (≥ 38.0°C, 38.7% vs. 0%) were the most common adverse events among adenovirus-vectored vaccine recipients, but most symptoms resolved within 2 days. Both types of COVID-19 vaccines were generally safe, and serious adverse events rarely occurred.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Health Personnel , SARS-CoV-2/immunology , Vaccination/adverse effects , Adult , Aged , Female , Humans , Male , Middle Aged
15.
Korean J Intern Med ; 36(2): 271-285, 2021 03.
Article in English | MEDLINE | ID: covidwho-1138796

ABSTRACT

The Republic of Korea (ROK) experienced a public health crisis due to Middle East respiratory syndrome (MERS) in 2015 and is currently going through the coronavirus disease 2019 (COVID-19) pandemic. Lessons learned from the disastrous MERS outbreak were ref lected in the preparedness system, and the readiness capabilities that were subsequently developed enabled the country to successfully flatten the epidemic curve of COVID-19 in late February and March 2020. In this review, we summarize and compare the epidemiology and response of the ROK to the 2015 MERS outbreak and the COVID-19 epidemic in early 2020. We emphasize that, because further COVID-19 waves seem inevitable, it is urgent to develop comprehensive preparedness and response plans for the worst-case scenarios of the COVID-19 pandemic. Simultaneously strengthening healthcare capacity to endure the peak demand and implementing smart strategies to sustain social distancing and public hygiene are necessary until safe and effective therapeutics and vaccines against COVID-19 are available.


Subject(s)
COVID-19/therapy , Coronavirus Infections/therapy , Middle East Respiratory Syndrome Coronavirus/pathogenicity , Public Health , SARS-CoV-2/pathogenicity , COVID-19/epidemiology , COVID-19/transmission , COVID-19/virology , Coronavirus Infections/epidemiology , Coronavirus Infections/transmission , Coronavirus Infections/virology , Host-Pathogen Interactions , Humans , Republic of Korea/epidemiology , Treatment Outcome
16.
Int J Infect Dis ; 104: 742-745, 2021 Mar.
Article in English | MEDLINE | ID: covidwho-1068926

ABSTRACT

OBJECTIVES: To compare epidemiologic features of the second and third waves of the coronavirus disease 2019 (COVID-19) pandemic in South Korea. METHODS: Nationwide COVID-19 data were collected between 6 May and 30 December 2020. The degree of social activity was estimated using an Internet search trend analysis program for leisure-related keywords, including 'eating-out', 'trip' and 'get directions' (transportation). Demographics, transmission chains, case fatality rates, social activity levels and public health responses were compared between the second (13 August-18 September 2020) and third (4 November 2020-present) waves. RESULTS: In comparison with the second wave, the third wave was characterized by delayed strengthening of social distancing policies (3 vs. 15 days), longer duration (36 vs. >56 days) and a higher case fatality rate (0.91% vs. 1.26%). There were significant differences in transmission chains between the second and third waves (P < 0.01). In comparison with the second wave, the proportion of local clusters (24.8% vs. 45.7%) was lower in the third wave, and personal contact transmission (38.5% vs. 25.9%) and unknown routes of transmission (23.5% vs. 20.8%) were higher in the third wave. CONCLUSION: Early and timely interventions with strengthened social distancing policies should be implemented to suppress and control the COVID-19 pandemic effectively.


Subject(s)
COVID-19/epidemiology , Public Health , SARS-CoV-2 , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/prevention & control , Child , Child, Preschool , Female , Humans , Infant , Infant, Newborn , Male , Middle Aged , Physical Distancing , Republic of Korea/epidemiology , Young Adult
17.
Int J Infect Dis ; 102: 275-281, 2021 Jan.
Article in English | MEDLINE | ID: covidwho-893940

ABSTRACT

OBJECTIVES: We aimed to compare the antiviral effect of hydroxychloroquine (HCQ) and lopinavir/ritonavir (LPV/r) in patients with COVID-19. METHODS: Nationwide retrospective case-control study was conducted to compare the effect of HCQ and LPV/r on viral shedding duration among patients with mild-to-moderate COVID-19 using the reimbursement data of National Health Insurance Service. After propensity score matching (PSM), multivariate analysis was conducted to determine statistically significant risk factors associated with prolonged viral shedding. RESULTS: Overall, 4197 patients with mild-to-moderate COVID-19 were included. Patients were categorized into three groups: LPV/r (n = 1268), HCQ (n = 801), and standard care without HCQ or LPV/r (controls, n = 2128). The median viral shedding duration was 23 (IQR 17-32), 23 (IQR 16-32), and 18 (IQR 12-25) days in the LPV/r, HCQ, and control groups, respectively. Even after PSM, the viral shedding duration was not significantly different between LPV/r and HCQ groups: 23 (IQR, 17-32) days versus 23 (IQR, 16-32) days. On multivariate analysis, old age, malignancy, steroid use, and concomitant pneumonia were statistically significant risk factors for prolonged viral shedding. CONCLUSION: The viral shedding duration was similar between HCQ and LPV/r treatment groups. There was no benefit in improving viral clearance compared to the control group.


Subject(s)
Antiviral Agents/therapeutic use , COVID-19/drug therapy , Hydroxychloroquine/therapeutic use , Lopinavir/administration & dosage , Propensity Score , Ritonavir/administration & dosage , SARS-CoV-2 , Adult , COVID-19/virology , Drug Therapy, Combination , Female , Humans , Male , Middle Aged , Retrospective Studies , Virus Shedding/drug effects , Young Adult
18.
J Korean Med Sci ; 35(33): e311, 2020 Aug 24.
Article in English | MEDLINE | ID: covidwho-729635

ABSTRACT

Serosurveillance studies reveal the actual disease burden and herd immunity level in the population. In Seoul, Korea, a cross-sectional investigation showed 0.07% anti-severe acute respiratory syndrome coronavirus-2 antibody seropositivity among 1,500 outpatients of the university hospitals. Low seroprevalence reflects well-implemented social distancing. Serosurveillance should be repeated as the pandemic progresses.


Subject(s)
Antibodies, Viral/blood , Betacoronavirus/immunology , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19 , Child , Child, Preschool , Coronavirus Infections/epidemiology , Coronavirus Infections/immunology , Cross-Sectional Studies , Female , Hospitals, University , Humans , Infant , Infant, Newborn , Male , Middle Aged , Outpatients , Pandemics , Pneumonia, Viral/epidemiology , Pneumonia, Viral/immunology , SARS-CoV-2 , Seoul/epidemiology , Seroepidemiologic Studies , Young Adult
20.
Int J Infect Dis ; 98: 294-296, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-627850

ABSTRACT

Since it first emerged in December 2019, coronavirus disease 2019 (COVID-19) has spread rapidly worldwide. During the pandemic of an emerging infectious disease, it is very important to prevent nosocomial outbreaks and operate hospitals safely to maintain their functions. In this article, we present the strategies for safe hospital operations based on the experiences of the Republic of Korea early in the COVID-19 pandemic. Each hospital should maintain multiple layers of defenses to prevent even small cracks in the hospital's quarantine system.


Subject(s)
Coronavirus Infections/prevention & control , Coronavirus Infections/transmission , Cross Infection/prevention & control , Cross Infection/transmission , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Pneumonia, Viral/transmission , Betacoronavirus/physiology , COVID-19 , Coronavirus Infections/epidemiology , Coronavirus Infections/virology , Cross Infection/epidemiology , Cross Infection/virology , Hospitals , Humans , Pandemics/statistics & numerical data , Pneumonia, Viral/epidemiology , Pneumonia, Viral/virology , Quarantine , Republic of Korea/epidemiology , SARS-CoV-2
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