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1.
Nat Commun ; 13(1): 6952, 2022 Nov 14.
Article in English | MEDLINE | ID: covidwho-2119472

ABSTRACT

Data on safety and immunity elicited by a third booster dose of inactivated COVID-19 vaccine in children and adolescents are scarce. Here we conducted a study based on a double-blind, randomised, placebo-controlled phase 2 clinical trial (NCT04551547) to assess the safety and immunogenicity of a third dose of CoronaVac. In this study, 384 participants in the vaccine group were assigned to two cohorts. One received the third dose at a 10-months interval (cohort 1) and the other one at a 12-months interval (cohort 2). The primary endpoint is safety and immunogenicity following a third dose of CoronaVac. The secondary endpoint is antibody persistence following the primary two-dose schedule. Severities of local and systemic adverse reactions reported within 28 days after dose 3 were mild and moderate in both cohorts. A third dose of CoronaVac increased GMTs to 681.0 (95%CI: 545.2-850.7) in cohort 1 and 745.2 (95%CI: 577.0-962.3) in cohort 2. Seropositivity rates against the prototype were 100% on day 28 after dose 3. Seropositivity rates against the Omicron variant were 90.6% (cohort 1) and 91.5% (cohort 2). A homologous booster dose of CoronaVac is safe and induces a significant neutralising antibody levels increase in children and adolescents.


Subject(s)
COVID-19 Vaccines , COVID-19 , Humans , Adolescent , Child , SARS-CoV-2 , COVID-19/prevention & control , Antibodies, Neutralizing , Double-Blind Method , Antibodies, Viral
2.
PLoS One ; 17(6): e0270630, 2022.
Article in English | MEDLINE | ID: covidwho-1933366

ABSTRACT

BACKGROUND: Varicella is a contagious disease caused by varicella-zoster virus and varicella vaccine (VarV) is the most effective way to prevent and control varicella. Despite high VarV coverage there were still varicella outbreaks in schools and kindergartens. We aim to analyze the epidemiological characteristics of varicella outbreaks in Huangpu District, Shanghai, China from 2011 to 2020. METHODS: For varicella outbreaks, case information and vaccination history were collected. Mann-Kendall test and descriptive methods were used to analyzed the trend and epidemiological catachrestic of varicella outbreaks. RESULTS: A total of 57 varicella outbreaks were reported from 2011 to 2020, including 30 outbreaks (52.6%) in primary schools. The results of the Mann-Kendall trend test (z = 1.97, p = 0.049) showed an upward trend in the number of cases during the study period, but the trend change was not statistically significant. Emergency vaccination was carried out in 42 (73.7%) outbreaks which influenced the duration of the epidemic (F = 4.53, p = 0.0379). A total of 573 varicella cases were reported, including 357 cases (62.3%) who had received at least one dose of varicella vaccine. CONCLUSIONS: The number of varicella outbreaks has not changed significantly in the decade from 2011 to 2020. The strategy of varicella vaccination, the development and application of varicella vaccine, and the control measures after the occurrence of varicella outbreaks need to be optimized. In addition to vaccination, as a disease transmitted by contact, quarantine measures, good personal hygiene, environmental disinfection, and ventilation are also important.


Subject(s)
Chickenpox , Viral Vaccines , Chickenpox/epidemiology , Chickenpox/prevention & control , Chickenpox Vaccine , China/epidemiology , Disease Outbreaks/prevention & control , Herpesvirus 3, Human , Humans , Schools , Vaccination , Vaccines, Attenuated
3.
Shanghai Journal of Preventive Medicine ; 34(1):28-32, 2022.
Article in Chinese | GIM | ID: covidwho-1924841

ABSTRACT

Objective: To analyze the epidemiological investigation results and emergency response to a coronavirus disease 2019 (COVID-19) epidemic in Shanghai.

4.
Front Immunol ; 13: 829665, 2022.
Article in English | MEDLINE | ID: covidwho-1686487

ABSTRACT

Background: Understanding the long-term kinetic characteristics of SARS-CoV-2 antibodies and the impact of inactivated vaccines on SARS-CoV-2 antibodies in convalescent patients can provide information for developing and improving vaccination strategies in such populations. Methods: In this cohort, 402 convalescent patients who tested positive for SARS-CoV-2 by RT-PCR from 1 January to 22 June 2020 in Jiangsu, China, were enrolled. The epidemiological data included demographics, symptom onset, and vaccination history. Blood samples were collected and tested for antibody levels of specific IgG, IgM, RBD-IgG, S-IgG, and neutralizing antibodies using a the commercial magnetic chemiluminescence enzyme immunoassay. Results: The median follow-up time after symptom onset was 15.6 months (IQR, 14.6 to 15.8). Of the 402 convalescent patients, 44 (13.84%) received an inactivated vaccine against COVID-19. A total of 255 (80.19%) patients were IgG-positive and 65 (20.44%) were IgM-positive. The neutralizing antibody was 83.02%. Compared with non-vaccinated individuals, the IgG antibody levels in vaccinated people were higher (P=0.007). Similarly, antibody levels for RBD-IgG, S-IgG, and neutralizing antibodies were all highly increased in vaccinated individuals (P<0.05). IgG levels were significantly higher after vaccination than before vaccination in the same population. IgG levels in those who received 'single dose and ≥14d' were similar to those with two doses (P>0.05). Similar conclusions were drawn for RBD-IgG and the neutralizing antibody. Conclusion: 15.6 months after symptom onset, the majority of participants remained positive for serum-specific IgG, RBD-IgG, S-IgG, and neutralizing antibodies. For convalescent patients, a single dose of inactivated vaccine against COVID-19 can further boost antibody titres.


Subject(s)
Antibodies, Neutralizing/immunology , Antibodies, Viral/immunology , COVID-19 Vaccines/immunology , COVID-19/immunology , Adolescent , Adult , Aged , Aged, 80 and over , Antibodies, Neutralizing/blood , Antibodies, Viral/blood , Child , China , Cohort Studies , Female , Humans , Immunoglobulin G/blood , Immunoglobulin G/immunology , Immunoglobulin M/blood , Immunoglobulin M/immunology , Male , Middle Aged , SARS-CoV-2/immunology , Vaccines, Inactivated/immunology , Young Adult
5.
Vaccine ; 39(44): 6520-6528, 2021 10 22.
Article in English | MEDLINE | ID: covidwho-1433882

ABSTRACT

BACKGROUND: The WHO declared COVID-19 a pandemic on March 11th, 2020. This serious outbreak and the precipitously increasing numbers of deaths worldwide necessitated the urgent need to develop an effective severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. The development of COVID-19 vaccines has moved quickly. In this study, we assessed the efficacy, safety, and immunogenicity of an inactivated (SARS-CoV-2) vaccine. METHODS: We conducted a randomized, double-blind, placebo-controlled trial to evaluate the efficacy, immunogenicity, and safety of an inactivated SARS-CoV-2 vaccine and its lot-to-lot consistency. A total of 1620 healthy adults aged 18-59 years were randomly assigned to receive 2 injections of the trial vaccine or placebo on a day 0 and 14 schedule. This article was based on an interim report completed within 3 months following the last dose of study vaccine. The interim analysis includes safety and immunogenicity data for 540 participants in the immunogenicity subset and an efficacy analysis of the 1620 subjects. For the safety evaluation, solicited and unsolicited adverse events were collected after the first and second vaccination within 14 and 28 days, respectively. Blood samples were collected for an antibody assay before and 14 days following the second dose. RESULTS: Most of the adverse reactions were in the solicited category and were mild in severity. Pain at the injection site was the most frequently reported symptom. Antibody IgG titer determined by enzyme-linked immunosorbent assay was 97.48% for the seroconversion rate. Using a neutralization assay, the seroconversion rate was 87.15%. The efficacy in preventing symptomatic confirmed cases of COVID-19 occurring at least 14 days after the second dose of vaccine using an incidence rate was 65.30%. CONCLUSIONS: From the 3-month interim analysis, the vaccine exhibited a 65.30% efficacy at preventing COVID-19 illness with favorable safety and immunogenicity profiles.


Subject(s)
COVID-19 Vaccines , COVID-19 , Adult , Antibodies, Neutralizing , Antibodies, Viral , Double-Blind Method , Humans , Immunogenicity, Vaccine , Indonesia/epidemiology , SARS-CoV-2 , Vaccines, Inactivated/adverse effects
6.
Fuzzy Sets and Systems ; 2021.
Article in English | ScienceDirect | ID: covidwho-1385588

ABSTRACT

All current work on calculating approximate sets of a rough set inevitably requires the participation of all elements in the universe. However, it is cumbersome and causes a huge waste of resources when the universe is quite big and the computed set is small enough. By introducing the notion of invariant subspace in rough set theory, we skillfully reduce the range of elements involved in the computations of approximations of a rough set from the whole universe U to a suitable invariant subspace V of U, and then give the modular method within the reduced range. Moreover, we present the modular Boolean matrix method, such that the calculation of upper and lower approximations of rough sets can be converted into operations on modular matrices. Finally, the results in covering approximation space are generalized to fuzzy β-covering approximation space to calculate the upper and lower approximations of the crisp sets. In particular, an algorithm for calculating the value of β is proposed to make the involved information have the highest distinction degree. This β is more reliable and meaningful than the empirical one, and an example about COVID-19 is put forward to simply illustrate its application.

7.
Lancet Infect Dis ; 21(12): 1645-1653, 2021 12.
Article in English | MEDLINE | ID: covidwho-1284631

ABSTRACT

BACKGROUND: A vaccine against SARS-CoV-2 for children and adolescents will play an important role in curbing the COVID-19 pandemic. Here we aimed to assess the safety, tolerability, and immunogenicity of a candidate COVID-19 vaccine, CoronaVac, containing inactivated SARS-CoV-2, in children and adolescents aged 3-17 years. METHODS: We did a double-blind, randomised, controlled, phase 1/2 clinical trial of CoronaVac in healthy children and adolescents aged 3-17 years old at Hebei Provincial Center for Disease Control and Prevention in Zanhuang (Hebei, China). Individuals with SARS-CoV-2 exposure or infection history were excluded. Vaccine (in 0·5 mL aluminum hydroxide adjuvant) or aluminum hydroxide only (alum only, control) was given by intramuscular injection in two doses (day 0 and day 28). We did a phase 1 trial in 72 participants with an age de-escalation in three groups and dose-escalation in two blocks (1·5 µg or 3·0 µg per injection). Within each block, participants were randomly assigned (3:1) by means of block randomisation to receive CoronaVac or alum only. In phase 2, participants were randomly assigned (2:2:1) by means of block randomisation to receive either CoronaVac at 1·5 µg or 3·0 µg per dose, or alum only. All participants, investigators, and laboratory staff were masked to group allocation. The primary safety endpoint was adverse reactions within 28 days after each injection in all participants who received at least one dose. The primary immunogenicity endpoint assessed in the per-protocol population was seroconversion rate of neutralising antibody to live SARS-CoV-2 at 28 days after the second injection. This study is ongoing and is registered with ClinicalTrials.gov, NCT04551547. FINDINGS: Between Oct 31, 2020, and Dec 2, 2020, 72 participants were enrolled in phase 1, and between Dec 12, 2020, and Dec 30, 2020, 480 participants were enrolled in phase 2. 550 participants received at least one dose of vaccine or alum only (n=71 for phase 1 and n=479 for phase 2; safety population). In the combined safety profile of phase 1 and phase 2, any adverse reactions within 28 days after injection occurred in 56 (26%) of 219 participants in the 1·5 µg group, 63 (29%) of 217 in the 3·0 µg group, and 27 (24%) of 114 in the alum-only group, without significant difference (p=0·55). Most adverse reactions were mild and moderate in severity. Injection site pain was the most frequently reported event (73 [13%] of 550 participants), occurring in 36 (16%) of 219 participants in the 1·5 µg group, 35 (16%) of 217 in the 3·0 µg group, and two (2%) in the alum-only group. As of June 12, 2021, only one serious adverse event of pneumonia has been reported in the alum-only group, which was considered unrelated to vaccination. In phase 1, seroconversion of neutralising antibody after the second dose was observed in 27 of 27 participants (100·0% [95% CI 87·2-100·0]) in the 1·5 µg group and 26 of 26 participants (100·0% [86·8-100·0]) in the 3·0 µg group, with the geometric mean titres of 55·0 (95% CI 38·9-77·9) and 117·4 (87·8-157·0). In phase 2, seroconversion was seen in 180 of 186 participants (96·8% [93·1-98·8]) in the 1·5 µg group and 180 of 180 participants (100·0% [98·0-100·0]) in the 3·0 µg group, with the geometric mean titres of 86·4 (73·9-101·0) and 142·2 (124·7-162·1). There were no detectable antibody responses in the alum-only groups. INTERPRETATION: CoronaVac was well tolerated and safe and induced humoral responses in children and adolescents aged 3-17 years. Neutralising antibody titres induced by the 3·0 µg dose were higher than those of the 1·5 µg dose. The results support the use of 3·0 µg dose with a two-immunisation schedule for further studies in children and adolescents. FUNDING: The Chinese National Key Research and Development Program and the Beijing Science and Technology Program.


Subject(s)
COVID-19 Vaccines/immunology , COVID-19/prevention & control , SARS-CoV-2/immunology , Vaccines, Inactivated/immunology , Adjuvants, Immunologic/administration & dosage , Adjuvants, Immunologic/adverse effects , Adolescent , Antibodies, Neutralizing/blood , Antibodies, Viral/blood , COVID-19/immunology , COVID-19 Vaccines/administration & dosage , COVID-19 Vaccines/adverse effects , Child , Child, Preschool , China , Dose-Response Relationship, Immunologic , Double-Blind Method , Female , Humans , Immunization , Immunogenicity, Vaccine , Injections, Intramuscular , Male , Vaccines, Inactivated/administration & dosage , Vaccines, Inactivated/adverse effects
8.
PLoS One ; 15(12): e0243883, 2020.
Article in English | MEDLINE | ID: covidwho-1167013

ABSTRACT

OBJECTIVE: To estimate the prevalence of disability and anxiety in Covid-19 survivors at discharge from hospital and analyze relative risk by exposures. DESIGN: Multi-center retrospective cohort study. SETTING: Twenty-eight hospitals located in eight provinces of China. METHODS: A total of 432 survivors with laboratory-confirmed SARS CoV-2 infection participated in this study. At discharge, we assessed instrumental activities of daily living (IADL) with Lawton's IADL scale, dependence in activities of daily living (ADL) with the Barthel Index, and anxiety with Zung's self-reported anxiety scale. Exposures included comorbidity, smoking, setting (Hubei vs. others), disease severity, symptoms, and length of hospital stay. Other risk factors considered were age, gender, and ethnicity (Han vs. Tibetan). RESULTS: Prevalence of at least one IADL problem was 36.81% (95% CI: 32.39-41.46). ADL dependence was present in 16.44% (95% CI: 13.23-20.23) and 28.70% (95% CI: 24.63-33.15) were screened positive for clinical anxiety. Adjusted risk ratio (RR) of IADL limitations (RR 2.48, 95% CI: 1.80-3.40), ADL dependence (RR 2.07, 95% CI 1.15-3.76), and probable clinical anxiety (RR 2.53, 95% CI 1.69-3.79) were consistently elevated in survivors with severe Covid-19. Age was an additional independent risk factor for IADL limitations and ADL dependence; and setting (Hubei) for IADL limitations and anxiety. Tibetan ethnicity was a protective factor for anxiety but a risk factor for IADL limitations. CONCLUSION: A significant proportion of Covid-19 survivors had disability and anxiety at discharge from hospital. Health systems need to be prepared for an additional burden resulting from rehabilitation needs of Covid-19 survivors.


Subject(s)
Anxiety Disorders , COVID-19 , Disabled Persons , SARS-CoV-2 , Survivors , Activities of Daily Living , Adult , Age Factors , Aged , Anxiety Disorders/epidemiology , Anxiety Disorders/psychology , COVID-19/mortality , COVID-19/psychology , China/epidemiology , Female , Humans , Male , Middle Aged , Prevalence , Retrospective Studies , Risk Factors
9.
Epidemiol Infect ; 149: e48, 2021 02 10.
Article in English | MEDLINE | ID: covidwho-1129262

ABSTRACT

To understand the characteristics and influencing factors related to cluster infections in Jiangsu Province, China, we investigated case reports to explore transmission dynamics and influencing factors of scales of cluster infection. The effectiveness of interventions was assessed by changes in the time-dependent reproductive number (Rt). From 25th January to 29th February, Jiangsu Province reported a total of 134 clusters involving 617 cases. Household clusters accounted for 79.85% of the total. The time interval from onset to report of index cases was 8 days, which was longer than that of secondary cases (4 days) (χ2 = 22.763, P < 0.001) and had a relationship with the number of secondary cases (the correlation coefficient (r) = 0.193, P = 0.040). The average interval from onset to report was different between family cluster cases (4 days) and community cluster cases (7 days) (χ2 = 28.072, P < 0.001). The average time interval from onset to isolation of patients with secondary infection (5 days) was longer than that of patients without secondary infection (3 days) (F = 9.761, P = 0.002). Asymptomatic patients and non-familial clusters had impacts on the size of the clusters. The average reduction in the Rt value in family clusters (26.00%, 0.26 ± 0.22) was lower than that in other clusters (37.00%, 0.37 ± 0.26) (F = 4.400, P = 0.039). Early detection of asymptomatic patients and early reports of non-family clusters can effectively weaken cluster infections.


Subject(s)
COVID-19/epidemiology , Coinfection/epidemiology , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/virology , Child , Child, Preschool , China/epidemiology , Cluster Analysis , Female , Humans , Infant , Male , Middle Aged , Young Adult
10.
Chinese Journal of Hygienic Insecticides & Equipments ; 26(6):497-505, 2020.
Article in Chinese | CAB Abstracts | ID: covidwho-1080025

ABSTRACT

The ongoing pandemic of COVID-19 reminds us of the importance of public health and paying more attention on the threat of zoonoses to human beings. Bats, as one of the most important reservoirs for emerging zoonotic pathogens, play an important role in the spread of a variety of lethal viruses, such as lyssavirus, hennipavirus, coronavirus and filovirus.In this paper, based on the latest research progress, the biological ecology of bats and the species of viruses carried by bats were reviewed. According to the current situation, some suggestions on targeted prevention and control for bat-borne pathogens were put forward. Besides monitoring and detecting bat population and pathogens, doing basic research and technical reserves, it is necessary to develop natural resources rationally and reduce the potential harm of bats to human beings.

11.
ACS Appl Bio Mater ; 3(9): 5633-5638, 2020 09 21.
Article in English | MEDLINE | ID: covidwho-1047923

ABSTRACT

To combat the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, we formulated the S1 subunit of the virus with two adjuvants, amphiphilic adjuvant monophosphoryl lipid A for Toll-like receptor 4 and CpG oligodeoxynucleotide for Toll-like receptor 9, into cationic liposomes to produce a potent, safer, and translatable nanovaccine. The nanovaccine can efficiently elicit a humoral immune response and strong IgA antibodies in mice. The sera from the vaccinated mice significantly inhibit SARS-CoV-2 from infecting Vero cells. Moreover, relative to the free S1 with a traditional Alum adjuvant, the nanovaccine can elicit strong T-cell immunity by activating both CD4+ and CD8+ cells.


Subject(s)
COVID-19/immunology , Immunity, Mucosal/immunology , Nanomedicine , Animals , Antibodies, Neutralizing/biosynthesis , Antibodies, Viral/biosynthesis , COVID-19/virology , Chlorocebus aethiops , Female , Humans , Liposomes , Mice , Mice, Inbred BALB C , SARS-CoV-2/isolation & purification , SARS-CoV-2/pathogenicity , Vero Cells
12.
Disabil Rehabil ; 43(1): 126-132, 2021 01.
Article in English | MEDLINE | ID: covidwho-962277

ABSTRACT

PURPOSE: The healthcare system and service capacity are overwhelmed by the Covid-19 pandemic. There is a substantial unmet need for rehabilitation service to all patients affected by Covid-19 directly or indirectly. This article aims to describe how to rapidly reconfigure and bring rehabilitation services back during the pandemic. METHOD: The Steer committee meeting was held for the development of a strategic preparedness plan and safety management based on principles and evidence of rehabilitation, which will lead to effective mitigation of consequences resulted from Covid-19. RESULTS: Five measures were taken in Southwest China during the pandemic, which includes the "First contact responsibility" and management system; the full-coverage system for nosocomial infection control; the "Closed-off management" system; the full-coverage system for body temperature monitoring; the adoption of 5G-based telerehabilitation. With the implementation of these measures, the capacity and capability were enhanced to safely reopen and operate rehabilitation facilities in Southwest China. CONCLUSION: Further measurement of quality of care and outcomes during and beyond the pandemic is needed in transforming the healthcare system and improving rehabilitation services. Hopefully, the positive message conveyed by this paper could encourage and support communities and the society of physical medicine and rehabilitation worldwide during this challenging time. IMPLICATIONS FOR REHABILITATION Rehabilitation services are essential and there is an unmet need posed by the Covid-19 pandemic. A feasible strategic plan and safety management measures are critical to reconfigure the capacity and capability of rehabilitation services suspended by Covid-19. The adoption of tele-rehabilitation technology has the potential to reshape public health emergency responses and the delivery of care. Measurement of quality and outcomes is of great importance to inform transformation and adaptation of rehabilitation services during and after the Covid-19 pandemic.


Subject(s)
COVID-19 , Civil Defense , Rehabilitation/organization & administration , Telerehabilitation , China , Delivery of Health Care , Emergency Service, Hospital/organization & administration , Evidence-Based Medicine , Humans , Pandemics , Public Health , SARS-CoV-2
13.
Archives of Medical Science ; 16(6), 2020.
Article in English | GIM | ID: covidwho-961783

ABSTRACT

Introduction: This study aims to provide further clarifications on some new clinical characteristics of COVID-19 recently discovered by our research group. Material and methods: In this single-centred, retrospective study, we collected all confirmed cases of COVID-19 diagnosed in Dazhou, Sichuan, China from January 23 to February 25, 2020. All the cases were either imported from Wuhan or transmitted in family clusters. We analysed general information on all patients. Meanwhile, the contents of lactic acid, Fib-C, and D-dimer in the serum of patients were detected.

14.
Lancet Infect Dis ; 21(2): 181-192, 2021 02.
Article in English | MEDLINE | ID: covidwho-939389

ABSTRACT

BACKGROUND: With the unprecedented morbidity and mortality associated with the COVID-19 pandemic, a vaccine against COVID-19 is urgently needed. We investigated CoronaVac (Sinovac Life Sciences, Beijing, China), an inactivated vaccine candidate against COVID-19, containing inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), for its safety, tolerability and immunogenicity. METHODS: In this randomised, double-blind, placebo-controlled, phase 1/2 clinical trial, healthy adults aged 18-59 years were recruited from the community in Suining County of Jiangsu province, China. Adults with SARS-CoV-2 exposure or infection history, with axillary temperature above 37·0°C, or an allergic reaction to any vaccine component were excluded. The experimental vaccine for the phase 1 trial was manufactured using a cell factory process (CellSTACK Cell Culture Chamber 10, Corning, Wujiang, China), whereas those for the phase 2 trial were produced through a bioreactor process (ReadyToProcess WAVE 25, GE, Umea, Sweden). The phase 1 trial was done in a dose-escalating manner. At screening, participants were initially separated (1:1), with no specific randomisation, into two vaccination schedule cohorts, the days 0 and 14 vaccination cohort and the days 0 and 28 vaccination cohort, and within each cohort the first 36 participants were assigned to block 1 (low dose CoronaVac [3 µg per 0·5 mL of aluminium hydroxide diluent per dose) then another 36 were assigned to block 2 (high-dose Coronavc [6 µg per 0·5 mL of aluminium hydroxide diluent per dse]). Within each block, participants were randomly assigned (2:1), using block randomisation with a block size of six, to either two doses of CoronaVac or two doses of placebo. In the phase 2 trial, at screening, participants were initially separated (1:1), with no specific randomisation, into the days 0 and 14 vaccination cohort and the days 0 and 28 vaccination cohort, and participants were randomly assigned (2:2:1), using block randomisation with a block size of five, to receive two doses of either low-dose CoronaVac, high-dose CoronaVac, or placebo. Participants, investigators, and laboratory staff were masked to treatment allocation. The primary safety endpoint was adverse reactions within 28 days after injection in all participants who were given at least one dose of study drug (safety population). The primary immunogenic outcome was seroconversion rates of neutralising antibodies to live SARS-CoV-2 at day 14 after the last dose in the days 0 and 14 cohort, and at day 28 after the last dose in the days 0 and 28 cohort in participants who completed their allocated two-dose vaccination schedule (per-protocol population). This trial is registered with ClinicalTrials.gov, NCT04352608, and is closed to accrual. FINDINGS: Between April 16 and April 25, 2020, 144 participants were enrolled in the phase 1 trial, and between May 3 and May 5, 2020, 600 participants were enrolled in the phase 2 trial. 743 participants received at least one dose of investigational product (n=143 for phase 1 and n=600 for phase 2; safety population). In the phase 1 trial, the incidence of adverse reactions for the days 0 and 14 cohort was seven (29%) of 24 participants in the 3 ug group, nine (38%) of 24 in the 6 µg group, and two (8%) of 24 in the placebo group, and for the days 0 and 28 cohort was three (13%) of 24 in the 3 µg group, four (17%) of 24 in the 6 µg group, and three (13%) of 23 in the placebo group. The seroconversion of neutralising antibodies on day 14 after the days 0 and 14 vaccination schedule was seen in 11 (46%) of 24 participants in the 3 µg group, 12 (50%) of 24 in the 6 µg group, and none (0%) of 24 in the placebo group; whereas at day 28 after the days 0 and 28 vaccination schedule, seroconversion was seen in 20 (83%) of 24 in the 3 µg group, 19 (79%) of 24 in the 6 µg group, and one (4%) of 24 in the placebo group. In the phase 2 trial, the incidence of adverse reactions for the days 0 and 14 cohort was 40 (33%) of 120 participants in the 3 µg group, 42 (35%) of 120 in the 6 µg group, and 13 (22%) of 60 in the placebo group, and for the days 0 and 28 cohort was 23 (19%) of 120 in the 3 µg group, 23 (19%) of 120 in the 6 µg group, and 11 (18%) of 60 for the placebo group. Seroconversion of neutralising antibodies was seen for 109 (92%) of 118 participants in the 3 µg group, 117 (98%) of 119 in the 6 µg group, and two (3%) of 60 in the placebo group at day 14 after the days 0 and 14 schedule; whereas at day 28 after the days 0 and 28 schedule, seroconversion was seen in 114 (97%) of 117 in the 3 µg group, 118 (100%) of 118 in the 6 µg group, and none (0%) of 59 in the placebo group. INTERPRETATION: Taking safety, immunogenicity, and production capacity into account, the 3 µg dose of CoronaVac is the suggested dose for efficacy assessment in future phase 3 trials. FUNDING: Chinese National Key Research and Development Program and Beijing Science and Technology Program.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/immunology , COVID-19/prevention & control , Immunogenicity, Vaccine , SARS-CoV-2/immunology , Vaccines, Inactivated/adverse effects , Vaccines, Inactivated/immunology , Adolescent , Adult , Antibodies, Neutralizing/immunology , Antibodies, Viral , COVID-19/epidemiology , COVID-19 Vaccines/administration & dosage , China/epidemiology , Female , Healthy Volunteers , Humans , Immunization Schedule , Immunoglobulin G , Immunoglobulin M , Male , Middle Aged , Seroconversion , Vaccination , Vaccines, Inactivated/administration & dosage , Young Adult
15.
Transbound Emerg Dis ; 68(2): 773-781, 2021 Mar.
Article in English | MEDLINE | ID: covidwho-690269

ABSTRACT

We investigated an outbreak of COVID-19 infection, which was traced back to a bathing pool at an entertainment venue, to explore the epidemiology of the outbreak, understand the transmissibility of the virus and analyse the influencing factors. Contact investigation and management were conducted to identify potential cases. Epidemiological investigation was carried out to determine the epidemiological and demographic characteristics of the outbreak. We estimated the secondary attack rate (SAR), incubation time and time-dependent reproductive number (Rt ) and explored the predisposing factors for cluster infection. The incubation time was 5.4 days and the serial interval (SI) was 4.4 days, with the rate of negative-valued SIs at 24.5%. The SAR at the bathing pool (3.3%) was relatively low due to its high temperature and humidity. The SAR was higher in the colleagues' cluster (20.5%) than in the family cluster (11.8%). Super-spreaders had a longer isolation delay time (p = .004). The Rt of the cluster decreased from the highest value of 3.88 on January 27, 2020 to 1.22 on February 6. Our findings suggest that the predisposing factors of the outbreak included close contact with an infected person, airtight and crowded spaces, temperature and humidity in the space and untimely isolation of patients and quarantine of contacts at the early stage of transmission. Measures to reduce the risk of infection at these gatherings and subsequent tracking of close contacts were effective.


Subject(s)
COVID-19/diagnosis , Disease Outbreaks , SARS-CoV-2 , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/transmission , Child , Child, Preschool , China/epidemiology , Contact Tracing , Disease Transmission, Infectious , Female , Humans , Infant , Male , Middle Aged , Young Adult
16.
Science ; 369(6499): 77-81, 2020 07 03.
Article in English | MEDLINE | ID: covidwho-197649

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in an unprecedented public health crisis. Because of the novelty of the virus, there are currently no SARS-CoV-2-specific treatments or vaccines available. Therefore, rapid development of effective vaccines against SARS-CoV-2 are urgently needed. Here, we developed a pilot-scale production of PiCoVacc, a purified inactivated SARS-CoV-2 virus vaccine candidate, which induced SARS-CoV-2-specific neutralizing antibodies in mice, rats, and nonhuman primates. These antibodies neutralized 10 representative SARS-CoV-2 strains, suggesting a possible broader neutralizing ability against other strains. Three immunizations using two different doses, 3 or 6 micrograms per dose, provided partial or complete protection in macaques against SARS-CoV-2 challenge, respectively, without observable antibody-dependent enhancement of infection. These data support the clinical development and testing of PiCoVacc for use in humans.


Subject(s)
Antibodies, Neutralizing/blood , Antibodies, Viral/blood , Betacoronavirus/immunology , Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Viral Vaccines , Animals , Antibodies, Neutralizing/biosynthesis , Antibodies, Neutralizing/immunology , Antibodies, Viral/biosynthesis , Antibodies, Viral/immunology , Betacoronavirus/isolation & purification , COVID-19 , COVID-19 Vaccines , Chlorocebus aethiops , Coronavirus Infections/immunology , Coronavirus Infections/virology , Dose-Response Relationship, Immunologic , Female , Immunogenicity, Vaccine , Immunoglobulin G/biosynthesis , Immunoglobulin G/blood , Immunoglobulin G/immunology , Macaca mulatta , Male , Mice , Mice, Inbred BALB C , Pilot Projects , Pneumonia, Viral/virology , Rats , Rats, Wistar , SARS-CoV-2 , Vaccines, Inactivated/administration & dosage , Vaccines, Inactivated/adverse effects , Vaccines, Inactivated/immunology , Vero Cells , Viral Load , Viral Vaccines/administration & dosage , Viral Vaccines/adverse effects , Viral Vaccines/immunology
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