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1.
Scientific Reports ; 12(1):7355-7355, 2022.
Article in English | PMC | ID: covidwho-1821613

ABSTRACT

We evaluated the performance of oral swab specimen both health-care worker (HCW) collected and self-collected for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) detection with rapid antigen test (RAT) as compared to reverse transcriptase polymerase chain reaction (RT-PCR). Of the 529 participants enrolled, 121 (22.8%) were RT-PCR positive. Among the RT-PCR positives, 62 (51.2%) were RAT positive using oral swab. When compared with RT-PCR, RAT with oral swab had sensitivity and specificity of 63.3 and 96.8% respectively among symptomatic individuals. No statistically significant difference was observed in RAT positivity with HCW collection and self-collection, p  = 0.606. Ct values were significantly lower in RT-PCR and RAT positive samples (ORF gene: 18.85 ± 4.36;E gene: 18.72 ± 4.84) as compared to RT-PCR positive and RAT negative samples (ORF gene: 26.98 ± 7.09;E gene: 26.97 ± 7.07), p  < 0.0001. Our study demonstrated moderate sensitivity of RAT with oral swab in symptomatic individuals. Oral swab was the preferred sampling by almost all participants in terms of convenience and comfort as compared to nasopharyngeal swab. Oral swabs have utility for SARS-CoV-2 antigen detection among symptomatic individuals residing in remote rural areas and can serve as an initial screening tool during COVID-19 spikes when cases rise exponentially and laboratory capacities for RT-PCR testing become overwhelmed.

2.
Indian J Med Res ; 153(5&6): 619-628, 2021 05.
Article in English | MEDLINE | ID: covidwho-1818381

ABSTRACT

Background & objectives: India witnessed a massive second surge of COVID-19 cases since March 2021 after a period of decline from September 2020. Data collected under the National Clinical Registry for COVID-19 (NCRC) were analysed to describe the differences in demographic and clinical features of COVID-19 patients recruited during these two successive waves. Methods: The NCRC, launched in September 2020, is an ongoing multicentre observational initiative, which provided the platform for the current investigation. Demographic, clinical, treatment and outcome data of hospitalized, confirmed COVID-19 patients were captured in an electronic data portal from 41 hospitals across India. Patients enrolled during September 1, 2020 to January 31, 2021 and February 1 to May 11, 2021 constituted participants of the two successive waves, respectively. Results: As on May 11, 2021, 18961 individuals were recruited in the registry, 12059 and 6903 reflecting in-patients from the first and second waves, respectively. Mean age of the patients was significantly lower in the second wave [48.7 (18.1) yr vs. 50.7 (18.0) yr, P<0.001] with higher proportion of patients in the younger age group intervals of <20, and 20-39 yr. Approximately 70 per cent of the admitted patients were ≥ 40 yr of age in both waves of the pandemic. The proportion of males were slightly lower in second wave as compared to the first [4400 (63.7%) vs. 7886 (65.4%), P=0.02]. Commonest presenting symptom was fever in both waves. In the second wave, a significantly higher proportion [2625 (48.6%) vs. 4420 (42.8%), P<0.003] complained of shortness of breath, developed ARDS [422(13%) vs. 880 (7.9%), P<0.001], required supplemental oxygen [1637 (50.3%) vs. 4771 (42.7%), P<0.001], and mechanical ventilation [260 (15.9%) vs. 530 (11.1%), P<0.001]. Mortality also significantly increased in the second wave [OR: 1.35 (95% CI: 1.19, 1.52)] in all age groups except in <20 yr. Interpretation & conclusions: The second wave of COVID-19 in India was slightly different in presentation than the first wave, with a younger demography, lesser comorbidities, and presentation with breathlessness in greater frequency.


Subject(s)
COVID-19 , Pandemics , Hospitalization , Humans , Male , Registries , SARS-CoV-2
3.
Front Public Health ; 10: 821611, 2022.
Article in English | MEDLINE | ID: covidwho-1776017

ABSTRACT

India experienced a second wave of COVID-19 infection with an unprecedented upsurge in the number of cases. We have analyzed the effect of different restrictive measures implemented in six Indian states. Further, based on available national and international data on disease transmission and clinical presentation, we have proposed a decision-making matrix for planning adequate resources to combat the future waves of COVID-19. We conclude that pragmatic and well calibrated localized restrictions, tailored as per specific needs may achieve a decline in disease transmission comparable to drastic steps like national lockdowns. Additionally, we have underscored the critical need for countries to generate local epidemiological, clinical and laboratory data alongwith community perception and uptake of various non-pharmaceutical interventions, for effective planning and policy making.


Subject(s)
COVID-19 , Public Health , COVID-19/diagnosis , COVID-19/epidemiology , Communicable Disease Control , Humans , India/epidemiology , Policy Making
4.
J Travel Med ; 2022 Mar 24.
Article in English | MEDLINE | ID: covidwho-1758785

ABSTRACT

The neutralizing antibody responses were significantly elevated after 3rd dose of BBV152/Covaxin against the B.1 (19.11 fold)variant including Delta (16.51 fold), Beta (14.70 fold) and Omicron (18.53 fold) Variants of concern in comparison with two dose vaccine, providing assurance of a protective immune response of booster in recipients.

5.
PLoS One ; 17(3): e0264956, 2022.
Article in English | MEDLINE | ID: covidwho-1736515

ABSTRACT

BACKGROUND: COVID-19 has inundated the entire world disrupting the lives of millions of people. The pandemic has stressed the healthcare system of India impacting the psychological status and functioning of health care workers. The aim of this study is to determine the burnout levels and factors associated with the risk of psychological distress among healthcare workers (HCW) engaged in the management of COVID 19 in India. METHODS: A cross-sectional study was conducted from 1 September 2020 to 30 November 2020 by telephonic interviews using a web-based Google form. Health facilities and community centres from 12 cities located in 10 states were selected for data collection. Data on socio-demographic and occupation-related variables like age, sex, type of family, income, type of occupation, hours of work and income were obtained was obtained from 967 participants, including doctors, nurses, ambulance drivers, emergency response teams, lab personnel, and others directly involved in COVID 19 patient care. Levels of psychological distress was assessed by the General health Questionnaire -GHQ-5 and levels of burnout was assessed using the ICMR-NIOH Burnout questionnaire. Multivariable logistic regression analysis was performed to identify factors associated with the risk of psychological distress. The third quartile values of the three subscales of burnout viz EE, DP and PA were used to identify burnout profiles of the healthcare workers. RESULTS: Overall, 52.9% of the participants had the risk of psychological distress that needed further evaluation. Risk of psychological distress was significantly associated with longer hours of work (≥ 8 hours a day) (AOR = 2.38, 95% CI(1.66-3.41), income≥20000(AOR = 1.74, 95% CI, (1.16-2.6); screening of COVID-19 patients (AOR = 1.63 95% CI (1.09-2.46), contact tracing (AOR = 2.05, 95% CI (1.1-3.81), High Emotional exhaustion score (EE ≥16) (AOR = 4.41 95% CI (3.14-6.28) and High Depersonalisation score (DP≥7) (AOR = 1.79, 95% CI (1.28-2.51)). About 4.7% of the HCWs were overextended (EE>18); 6.5% were disengaged (DP>8) and 9.7% HCWs were showing signs of burnout (high on all three dimensions). CONCLUSION: The study has identified key factors that could have been likely triggers for psychological distress among healthcare workers who were engaged in management of COVID cases in India. The study also demonstrates the use of GHQ-5 and ICMR-NIOH Burnout questionnaire as important tools to identify persons at risk of psychological distress and occurrence of burnout symptoms respectively. The findings provide useful guide to planning interventions to mitigate mental health problems among HCW in future epidemic/pandemic scenarios in the country.


Subject(s)
Burnout, Professional/psychology , COVID-19/psychology , Health Personnel/psychology , Adult , Aged , Burnout, Professional/epidemiology , Burnout, Psychological/epidemiology , Cross-Sectional Studies , Depression/epidemiology , Female , Humans , India/epidemiology , Interviews as Topic , Male , Mental Health/trends , Middle Aged , Pandemics , Psychological Distress , SARS-CoV-2/pathogenicity , Surveys and Questionnaires
7.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-324369

ABSTRACT

The COVID-19 pandemic is a global health crisis that has severely affected mankind and posed a great challenge to the public health system of affected countries. The availability of a safe and effective vaccine is the need of the hour to overcome this crisis. Here, we have developed and assessed the protective efficacy and immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in rhesus macaques (Macaca mulata). Twenty macaques were divided into four groups of five animals each. One group was administered a placebo while three groups were immunized with three different vaccine candidates at 0 and 14 days. All the macaques were challenged with SARS-CoV-2 fourteen days after the second dose. The protective response was observed with increasing SARS-CoV-2 specific IgG and neutralizing antibody titers from 3rd-week post-immunization. Viral clearance was observed from bronchoalveolar lavage fluid, nasal swab, throat swab, and lung tissues at 7 days post-infection in the vaccinated groups. No evidence of pneumonia was observed by histopathological examination in vaccinated groups, unlike the placebo group which showed features of interstitial pneumonia and localization of viral antigen in the alveolar epithelium and macrophages by immunohistochemistry. Data from this study substantiate the immunogenicity of the vaccine candidates and BBV152 is being evaluated in Phase I clinical trials in India (NCT04471519).

8.
Murhekar, Manoj, Bhatnagar, Tarun, Thangaraj, Jeromie Wesley Vivian, Saravanakumar, V.; Kumar, Muthusamy Santhosh, Selvaraju, Sriram, Rade, Kirankumar, Kumar, C. P. Girish, Sabarinathan, R.; Turuk, Alka, Krishnan, Nivethitha, Robinson, Aby, Srinivasan, Nivetha, Asthana, Smita, Balachandar, Rakesh, Bangar, Sampada Dipak, Bansal, Avi Kumar, Bhat, Jyothi, Chopra, Vishal, Das, Dasarathi, Deb, Alok Kumar, Devi, Kangjam Rekha, Dwivedi, Gaurav Raj, Khan, Muhammad Salim, Kumar, Sunil, Laxmaiah, Avula, Madhukar, Major, Mahapatra, Amarendra, Rangaraju, Chethana, Turuk, Jyotirmayee, Yadav, Suresh, Anand, P. K.; Andhalkar, Rushikesh, Arlappa, Nimmathota, Bashir, Khalid, Baradwaj, Dinesh Kumar, Bharti, Pravin, Bhattacharya, Debdutta, Behera, Sthita Pragnya, Chahal, Ashrafjit, Chakraborty, Debjit, Chaudhury, Anshuman, Deval, Hirawati, Dhatrak, Sarang, Dhikav, Vikas, Dayal, Rakesh, Giridharan, Prathiksha, Haq, Inaamul, Jagjeevan, Babu, Jain, Agam, Kalliath, Arshad, Kanungo, Srikanta, Karunakaran, T.; Kshatri, Jaya Singh, Kumar, Niraj, Kumar, Vijay, Kumar, V. G. Vinod, Lakshmi, Gangeti Gandhi Jayanthi Naga, Mehta, Ganesh, Mitra, Anindya, Nagbhushanam, K.; Nirmala, A. R.; Palo, Subrat Kumar, Pandey, Ashok Kumar, Prasad, Ganta Venkata, Pucha, Uday Kumar, Qurieshi, Mariya Amin, Sabaharwal, Vikas, Sahay, Seema, Sangwan, Ramesh Kumar, Saxena, Rochak, Sekar, Krithikaa, Shukla, Vijay Kumar, Singh, Hari Bhan, Singh, Prashant Kumar, Singh, Pushpendra, Singh, Rajeev, Thakor, Mahendra, Varma, Dantuluri Sheethal, Viramgami, Ankit, Menon, Pradeep, Yadav, Rajiv, Yadav, Surabhi, Singh, Manjula, Chakrabarti, Amit, Das, Aparup, Dutta, Shanta, Kant, Rajni, Khan, A. M.; Narain, Kanwar, Narasimhaiah, Somashekar, Padmapriyadarshini, Chandrasekaran, Pandey, Krishna, Pati, Sanghamitra, Rajkumar, Hemalatha, Ramesh, T.; Sharma, Arun Kumar, Sharma, Y. K.; Singh, Shalini, Panda, Samiran, Reddy, D. C. S.; Bhargava, Balram.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-317589

ABSTRACT

Background: India witnessed a severe second wave of COVID-19 during March and June 2021. We did the fourth nationwide serosurvey to estimate prevalence of SARS-CoV-2 antibodies in the general population aged >=6 years and health care workers (HCWs). Methods: We did a cross-sectional study between 14 June and 6 July 2021 in 700 clusters in the same 70 districts across 21 states/Union Territory. From each district, a minimum of 400 individuals aged >=6 years from general population and 100 HCWs from the district public health facilities were included. The serum samples were tested for the presence of IgG antibodies against S1-RBD and nucleocapsid protein of SARS-CoV-2 using chemiluminescence immunoassay. We estimated the weighted and test adjusted seroprevalence of IgG antibodies against S1-RBD and/or nucleocapsid protein along with 95% CI. Findings: Of the 28,975 sera tested, the weighted and test adjusted prevalence of IgG antibodies against S1-RBD and/or nucleocapsid protein among the general population aged >=6 years was 67.6% (95% CI: 66.4 – 68.7). The seroprevalence increased with age and was not different in rural and urban areas. Compared to unvaccinated adults (62.3%, 95% CI: 60.9 – 63.7), seroprevalence was significantly higher among individuals who received one (81.0%, 95% CI: 79.6 - 82.3) and two doses (89.8%, 95% CI: 88.4 - 91.1). The seroprevalence of IgG antibodies among 7,252 health care workers was 85.2% (95% CI: 83.5 - 86.7). Interpretation: Nearly one third of the population is still seronegative. It is necessary to accelerate the coverage of COVID-19 vaccination among adults and continue adherence to non-pharmaceutical interventions.Funding: Indian Council of Medical Research. Declaration of Interest: None to declare. Ethical Approval: The Institutional Human Ethics Committee of the ICMR National Institute ofEpidemiology, Chennai approved the study protocol.

9.
Murhekar, Manoj, Bhatnagar, Tarun, Thangaraj, Jeromie Wesley Vivian, Saravanakumar, V.; Kumar, Muthusamy Santhosh, Selvaraju, Sriram, Rade, Kiran, Kumar, C. P. Girish, Sabarinathan, R.; Turuk, Alka, Asthana, Smita, Balachandar, Rakesh, Bangar, Sampada Dipak, Bansal, Avi Kumar, Chopra, Vishal, Das, Dasarathi, Deb, Alok Kumar, Devi, Kangjam Rekha, Dhikav, Vikas, Dwivedi, Gaurav Raj, Khan, Muhammad Salim, Kumar, Sunil, Laxmaiah, Avula, Madhukar, Major, Mahapatra, Amarendra, Rangaraju, Chethana, Turuk, Jyotirmayee, Yadav, Rajiv, Andhalkar, Rushikesh, Arunraj, K.; Baradwaj, Dinesh Kumar, Bharti, Pravin, Bhattacharya, Debdutta, Bhat, Jyothi, Chahal, Ashrafjit, Chakraborty, Debjit, Chaudhury, Anshuman, Deval, Hirawati, Dhatrak, Sarang, Dayal, Rakesh, Elantamilan, D.; Giridharan, Prathiksha, Haq, Inaamul, Hudda, Ramesh Kumar, Jagjeevan, Babu, Kalliath, Arshad, Kanungo, Srikanta, Krishnan, Nivethitha, Kshatri, Jaya Singh, Kumar, Alok, Kumar, Niraj, Kumar, V. G. Vinoth, Lakshmi, Gangeti Gandhi Jayanthi Naga, Mehta, Ganesh, Mishra, Nandan Kumar, Mitra, Anindya, Nagbhushanam, K.; Nimmathota, Arlappa, Nirmala, A. R.; Pandey, Ashok Kumar, Prasad, Ganta Venkata, Qurieshi, Mariya Amin, Reddy, Sirasanambatti Devarajulu, Robinson, Aby, Sahay, Seema, Saxena, Rochak, Sekar, Krithikaa, Shukla, Vijay Kumar, Singh, Hari Bhan, Singh, Prashant Kumar, Singh, Pushpendra, Singh, Rajeev, Srinivasan, Nivetha, Varma, Dantuluri Sheethal, Viramgami, Ankit, Wilson, Vimith Cheruvathoor, Yadav, Surabhi, Yadav, Suresh, Zaman, Kamran, Chakrabarti, Amit, Das, Aparup, Dhaliwal, R. S.; Dutta, Shanta, Kant, Rajni, Khan, A. M.; Narain, Kanwar, Narasimhaiah, Somashekar, Padmapriyadarshini, Chandrasekaran, Pandey, Krishna, Pati, Sanghamitra, Patil, Shripad, Rajkumar, Hemalatha, Ramarao, Tekumalla, Sharma, Y. K.; Singh, Shalini, Panda, Samiran, Reddy, D. C. S.; Bhargava, Balram.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-317588

ABSTRACT

Background: Repeated cross-sectional serosurveys in the same geographic area establish the trend of the evolving pandemic. We present the findings of the third round of a national serosurvey to estimate the seroprevalence of SARS-CoV-2 infection among the general population and health care workers of India. Methods: We conducted the third population-based serosurvey between Dec 18, 2020 and Jan 6, 2021 in the same 700 villages or wards from 70 districts in 21 states across India, which were selected for the first and second serosurveys. We enrolled from each district, at least 400 individuals aged ≥ 10 years from general population and 100 HCWs from sub-district level public health facilities. Serum samples from general population were tested for the presence of IgG antibodies against nucleocapsid (N) and spike protein (S1-RBD) of SARS-CoV-2 using the Abbott and Siemens assays respectively, whereas sera from HCWs were tested for anti-S1-RBD. For general population, sera positive for either of the antibodies were considered positive, while sera positive for anti-S1-RBD were considered as positive for HCW. Weighted seroprevalence estimates were adjusted for sensitivity and specificity of respective assays. Findings: Of the 28,598 sera from general population, 4585 (16%) had IgG antibodies against N, 6647 (23.2%) against S1-RBD and 7436 (26%) against either. The weighted and assay characteristic adjusted seroprevalence against either of the antibodies was 24.1 (95%CI: 23.0% to 25.3%). Seroprevalence was lower in rural areas (21.4%, 95% CI: 20.3% to 22.6%) compared to urban non-slum (29.4%, 95% CI: 26.9% - 32.1%) and slum areas (34.6%, 95% CI: 31.0% to 38.3%). Among 7385 HCWs, the seroprevalence of anti-S1-RBD IgG antibodies was 25.6% (95% CI: 23.5% to 27.8%). Interpretation: Nearly one in four individuals aged 10 years or older from general population as well as HCWs were exposed to SARS-CoV-2 by December 2020 amounting to 271 million infections in India.Funding Statement: Indian Council of Medical ResearchDeclaration of Interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare no competing interestsEthics Approval Statement: The project was approved by Institutional Human Ethics Committee at ICMR-National Institute of Epidemiology.

10.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-317587

ABSTRACT

Background: The first round of national serosurvey in India was conducted in May-June 2020 among adults from 21 States. The second serosurvey was conducted in August-September 2020 to estimate the nationwide seroprevalence for SARS-CoV-2 infection in the general population aged ten years and above. Methods: The household serosurvey was conducted among individuals aged ten years and above in the same 700 villages and wards from 70 districts selected during the first serosurvey. Blood samples were tested using the Abbott SARS-CoV-2 IgG assay. Seroprevalence was estimated after applying the sampling weights and adjusting for clustering and assay characteristics. In order to compare the adult seroprevalence between the two surveys, we randomly selected one adult serum sample from each household. Findings: The weighted and adjusted prevalence of infection among 29,082 individuals aged ten years and above was 6·6% (95% CI: 5·8% - 7·4%). The seroprevalence among adults was 7·1% (95% CI: 6·2% – 8·2%). Seroprevalence was similar across age groups, sex, and occupation. Seroprevalence was highest in urban slum areas followed by urban non-slum and rural areas. We estimated a cumulative 74·3 million infections in the country, with 26 – 32 infections for every reported COVID-19 case by August 2020.Interpretation: Nearly one in 15 individuals aged ten years and above had SARS-CoV-2 infection by August 2020. The adult seroprevalence increased ten times between May and August 2020. Lower infection to case ratio in August compared to May reflects a substantial increase in testing across the country.Funding: The study was funded by the Indian Council of Medical Research, New Delhi, India. The study sponsor was involved in reviewing the study design, writing of the manuscript and the decision to submit the paper for publication.Declaration of Interests: The authors declare no competing interests.Ethics Approval Statement: The authors obtained written informed consent from individuals aged 18 years and older. We obtained assent from children aged between 10–17 years, and written informed consent from their parents or guardians prior to the survey. The Central Ethics Committee of Health Research of Indian Council of Medical Research and the Institutional Human Ethics Committee of ICMR-National Institute of Epidemiology, Chennai approved the study protocol.

11.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-317246

ABSTRACT

The availability of a safe and effective vaccine would be the eventual measure to deal with SARS-CoV-2 threat. Here, we have developed and assessed the immunogenicity and protective efficacy of an inactivated SARS-CoV-2 vaccine (BBV152) in hamsters. Three dose vaccination regime with three formulations of BBV152 induced significant titres of SARS-CoV-2 specific IgG and neutralizing antibodies. The formulation with imidazoquinoline adsorbed on alum adjuvant remarkably generated a quick and robust immune response. Th 1 biased immune response was demonstrated by the detection of IgG2 antibodies. Post-SARS-CoV-2 infection, vaccinated hamsters did not show any histopathological changes in the lungs. The protection of the hamsters was evident by the rapid clearance of the virus from lower respiratory tract, reduced virus load in upper respiratory tract, absence of lung pathology and robust humoral immune response. These findings confirm the immunogenic potential of BBV152 and further protection of hamsters challenged with SARS-CoV-2.

12.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-304912

ABSTRACT

Background: The Coronavirus disease 2019 (COVID-19) pandemic poses a serious public health concern worldwide. Certain regions of the globe were severely affected in terms of prevalence and mortality than other. Although the cause for this pattern is not clearly understood, lessons learned from previous epidemics and emerging evidences suggest the major role of ecological factors like ambient air pollutants (AAP) and meteorological parameters in increased COVID-19 incidence. The present study aimed to understand the impact of these factors on SARS-CoV-2 transmission and their associated mortality in major cities of India. Methods: : This study used secondary AAP, meteorological and COVID-19 data from official websites for the period January-November 2020, which were divided into Pre-lockdown (January-March 2020), Phase I (April to June 2020) and Phase II (July to November 2020). After comprehensive screening, five major cities that includes 48 CPCB monitoring stations collecting daily data of ambient temperature, particulate matter PM 2.5 and 10 were analysed. Spearman and Kendall’s rank correlation test was performed to understand the association between SARS-CoV-2 transmission and AAP and, meteorological variables. Similarly, case fatality rate (CFR) was determined to compute the correlation between AAP and COVID-19 related morality. Results: : The level of air pollutants in major cities were significantly reduced during Phase I compared to Pre-lock down and increased upon Phase II in all the cities. During the Phase II in Delhi, the strong significant positive correlation was observed between the AAP and SARS-CoV-2 transmission. However, in Bengaluru, Hyderabad, Kolkata and Mumbai AAP levels were moderate and no correlation was noticed. The relation between AT and SARS-CoV-2 transmission was inconclusive as both positive and negative correlation observed. In addition, Delhi and Kolkata showed a positive association between long-term exposure to the AAP and COVID-19 CFR. Conclusion: Our findings support the hypothesis that the particulate matter upon exceeding the satisfactory level serves as an important cofactor in increasing the risk of SARS-CoV-2 transmission and related mortality. These findings would help public health experts to understand the SARS-CoV-2 transmission against ecological variables in India and provides supporting evidence to healthcare policymakers and government agencies for formulating strategies to combat the COVID-19.

13.
Lancet ; 398(10317): 2173-2184, 2021 12 11.
Article in English | MEDLINE | ID: covidwho-1586227

ABSTRACT

BACKGROUND: We report the clinical efficacy against COVID-19 infection of BBV152, a whole virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) in Indian adults. METHODS: We did a randomised, double-blind, placebo-controlled, multicentre, phase 3 clinical trial in 25 Indian hospitals or medical clinics to evaluate the efficacy, safety, and immunological lot consistency of BBV152. Adults (age ≥18 years) who were healthy or had stable chronic medical conditions (not an immunocompromising condition or requiring treatment with immunosuppressive therapy) were randomised 1:1 with a computer-generated randomisation scheme (stratified for the presence or absence of chronic conditions) to receive two intramuscular doses of vaccine or placebo administered 4 weeks apart. Participants, investigators, study coordinators, study-related personnel, the sponsor, and nurses who administered the vaccines were masked to treatment group allocation; an unmasked contract research organisation and a masked expert adjudication panel assessed outcomes. The primary outcome was the efficacy of the BBV152 vaccine in preventing a first occurrence of laboratory-confirmed (RT-PCR-positive) symptomatic COVID-19 (any severity), occurring at least 14 days after the second dose in the per-protocol population. We also assessed safety and reactogenicity throughout the duration of the study in all participants who had received at least one dose of vaccine or placebo. This report contains interim results (data cutoff May 17, 2021) regarding immunogenicity and safety outcomes (captured on days 0 to 56) and efficacy results with a median of 99 days for the study population. The trial was registered on the Indian Clinical Trials Registry India, CTRI/2020/11/028976, and ClinicalTrials.gov, NCT04641481 (active, not recruiting). FINDINGS: Between Nov 16, 2020, and Jan 7, 2021, we recruited 25 798 participants who were randomly assigned to receive BBV152 or placebo; 24 419 received two doses of BBV152 (n=12 221) or placebo (n=12 198). Efficacy analysis was dependent on having 130 cases of symptomatic COVID-19, which occurred when 16 973 initially seronegative participants had at least 14 days follow-up after the second dose. 24 (0·3%) cases occurred among 8471 vaccine recipients and 106 (1·2%) among 8502 placebo recipients, giving an overall estimated vaccine efficacy of 77·8% (95% CI 65·2-86·4). In the safety population (n=25 753), 5959 adverse events occurred in 3194 participants. BBV152 was well tolerated; the same proportion of participants reported adverse events in the vaccine group (1597 [12·4%] of 12 879) and placebo group (1597 [12·4%] of 12 874), with no clinically significant differences in the distributions of solicited, unsolicited, or serious adverse events between the groups, and no cases of anaphylaxis or vaccine-related deaths. INTERPRETATION: BBV152 was highly efficacious against laboratory-confirmed symptomatic COVID-19 disease in adults. Vaccination was well tolerated with no safety concerns raised in this interim analysis. FUNDING: Bharat Biotech International and Indian Council of Medical Research.


Subject(s)
COVID-19 Vaccines/immunology , COVID-19/prevention & control , Immunogenicity, Vaccine , Vaccines, Inactivated/immunology , Adjuvants, Immunologic , Adult , COVID-19 Nucleic Acid Testing , Double-Blind Method , Female , Humans , India , Male
14.
J Infect Public Health ; 15(2): 164-171, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1587224

ABSTRACT

BACKGROUND: Considering the potential threat from emerging Severe Acute Respiratory Syndrome-Corona Virus-2 (SARS-CoV-2) variants and the rising COVID-19 cases, SARS-CoV-2 genomic surveillance is ongoing in India. We report herewith the isolation of the P.2 variant (B.1.1.28.2) from international travelers and further its pathogenicity evaluation and comparison with D614G variant (B.1) in hamster model. METHODS: Virus isolation was performed in Vero CCL81 cells and genomic characterization by next generation sequencing. The pathogenicity and host immune response of the isolate was assessed in Syrian hamster model and compared with B.1 variant. RESULTS: B.1.1.28.2 variant was isolated from nasal/throat swabs of international travelers returned to India from United Kingdom and Brazil. The B.1.1.28.2 variant induced body weight loss, viral replication in the respiratory tract and caused severe lung pathology in infected Syrian hamster model in comparison, with B.1 variant infected hamsters. The sera from B.1.1.28.2 infected hamsters efficiently neutralized the D614G variant virus whereas 6-fold reduction in the neutralization was seen in case of D614G variant infected hamsters' sera with the B.1.1.28.2 variant. CONCLUSIONS: B.1.1.28.2 lineage variant could be successfully isolated and characterization could be performed. Pathogenicity of the isolate was demonstrated in Syrian hamster model and the findings of neutralization reduction is of great concern and point towards the need for screening the vaccines for efficacy.


Subject(s)
COVID-19 , SARS-CoV-2 , Animals , Cricetinae , Disease Models, Animal , Humans , Lung , Virulence
15.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-297086

ABSTRACT

The aim of this study was to identify the SARS-CoV-2 lineages circulating in the pediatric population of India during the second wave of the pandemic. Clinical and demographic details linked with the nasopharyngeal/oropharyngeal swabs (NPS/OPS) collected from SARS-CoV-2 cases (n=583) aged 0-18 year and tested positive by real-time RT-PCR were retrieved from March to June 2021.Symptoms were reported among 37.2% of patients and 14.8% reported to be hospitalized. The E gene CT value had significant statistical difference at the point of sample collection when compared to that observed in the sequencing laboratory. Out of these 512 sequences 372 were VOCs, 51 were VOIs. Most common lineages observed were Delta, followed by Kappa, Alpha and B.1.36, seen in 65.82%, 9.96%, 6.83% and 4.68%, respectively in the study population. Overall, it was observed that Delta strain was the leading cause of SARS-CoV-2 infection in Indian children during the second wave of the pandemic. We emphasize on the need of continuous genomic surveillance in SARS-CoV-2 infection even amongst children.

16.
2021.
Preprint in English | Other preprints | ID: ppcovidwho-296360

ABSTRACT

Covishield comprises the larger proportion in the vaccination program in India. Hence, it is of utmost importance to understand neutralizing capability of vaccine against the B.1.617.1 variant which is considered to responsible for surge of the cases in India. The neutralizing-antibody (NAb) titer against B.1.167.1 and prototype B.1 variant (D614G) was determined of the vaccine sera (4 weeks after second dose) of COVID-19 naïve subjects (n=43) and COVID-19 recovered subjects (n=18). The results demonstrated that sera of COVID-19 recovered subjects (n=18) who received two doses of Covishield have higher NAb response compared to the COVID-19 naive with a significant difference (p<0.0001) in NAb titer against B.1 and B.1.617.1 In-spite of reduction in the neutralizing titer against B.1.617.1 variant;Covishield vaccine-induced antibodies are likely to be protective to limit the severity and mortality of the disease in the vaccinated individuals.

17.
EClinicalMedicine ; 42: 101218, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1540604

ABSTRACT

BACKGROUND: This phase 2/3 immunobridging study evaluated the safety and immunogenicity of the ChAdOx1 nCoV-19 Coronavirus Vaccine (Recombinant) (SII-ChAdOx1 nCoV-19), manufactured in India at the Serum Institute of India Pvt Ltd (SIIPL), following technology transfer from the AstraZeneca. METHODS: This participant-blind, observer-blind study randomised participants 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (ChAdOx1 nCoV-19) (immunogenicity/reactogenicity cohort) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort). The study participants were enrolled from 14 hospitals across India between August 25 and October 31, 2020. Two doses of study products were given 4 weeks apart. The primary objectives were to demonstrate non-inferiority of SII-ChAdOx1 nCoV-19 to AZD1222 in terms of geometric mean titre (GMT) ratio of anti-SARS-CoV-2 spike IgG antibodies 28 days after the second dose (defined as lower limit of 95% CI >0·67) and to determine the incidence of serious adverse events (SAEs) causally related to SII-ChAdOx1 nCoV-19. The anti-spike IgG response was assessed using a multiplexed electrochemiluminescence-based immunoassay. Safety follow-up continued until 6 months after first dose. Trial registration: CTRI/2020/08/027170. FINDINGS: 1601 participants were enrolled: 401 to the immunogenicity/reactogenicity cohort and 1200 to the safety cohort. After two doses, seroconversion rates for anti-spike IgG antibodies were more than 98·0% in both the groups. SII-ChAdOx1 nCoV-19 was non-inferior to AZD1222 (GMT ratio 0·98; 95% CI 0·78-1·23). SAEs were reported in ≤ 2·0% participants across the three groups; none were causally related. A total of 34 SARS-CoV-2 infections were reported; of which 6 occurred more than 2 weeks after the second dose; none were severe. INTERPRETATION: SII-ChAdOx1 nCoV-19 has a non-inferior immune response compared to AZD1222 and an acceptable safety/reactogenicity profile. Pharmacovigilance should be maintained to detect any safety signals. FUNDING: SIIPL funded the contract research organisation and laboratory costs, while the site costs were funded by the Indian Council of Medical Research. The study vaccines were supplied by SIIPL and AstraZeneca.

18.
Environ Health ; 20(1): 120, 2021 11 19.
Article in English | MEDLINE | ID: covidwho-1526639

ABSTRACT

BACKGROUND: The Coronavirus disease 2019 (COVID-19) pandemic poses a serious public health concern worldwide. Certain regions of the globe were severely affected in terms of prevalence and mortality than other. Although the cause for this pattern is not clearly understood, lessons learned from previous epidemics and emerging evidences suggest the major role of ecological factors like ambient air pollutants (AAP) and meteorological parameters in increased COVID-19 incidence. The present study aimed to understand the impact of these factors on SARS-CoV-2 transmission and their associated mortality in major cities of India. METHODS: This study used secondary AAP, meteorological and COVID-19 data from official websites for the period January-November 2020, which were divided into Pre-lockdown (January-March 2020), Phase I (April to June 2020) and Phase II (July to November 2020) in India. After comprehensive screening, five major cities that includes 48 CPCB monitoring stations collecting daily data of ambient temperature, particulate matter PM2.5 and 10 were analysed. Spearman and Kendall's rank correlation test was performed to understand the association between SARS-CoV-2 transmission and AAP and, meteorological variables. Similarly, case fatality rate (CFR) was determined to compute the correlation between AAP and COVID-19 related morality. RESULTS: The level of air pollutants in major cities were significantly reduced during Phase I compared to Pre-lock down and increased upon Phase II in all the cities. During the Phase II in Delhi, the strong significant positive correlation was observed between the AAP and SARS-CoV-2 transmission. However, in Bengaluru, Hyderabad, Kolkata and Mumbai AAP levels were moderate and no correlation was noticed. The relation between AT and SARS-CoV-2 transmission was inconclusive as both positive and negative correlation observed. In addition, Delhi and Kolkata showed a positive association between long-term exposure to the AAP and COVID-19 CFR. CONCLUSION: Our findings support the hypothesis that the particulate matter upon exceeding the satisfactory level serves as an important cofactor in increasing the risk of SARS-CoV-2 transmission and related mortality. These findings would help public health experts to understand the SARS-CoV-2 transmission against ecological variables in India and provides supporting evidence to healthcare policymakers and government agencies for formulating strategies to combat the COVID-19.


Subject(s)
Air Pollutants , COVID-19 , Meteorological Concepts , Air Pollutants/analysis , COVID-19/mortality , COVID-19/transmission , Cities , Environmental Monitoring , Humans , India/epidemiology , Particulate Matter/analysis
19.
Lancet Infect Dis ; 21(5): 637-646, 2021 05.
Article in English | MEDLINE | ID: covidwho-1510469

ABSTRACT

BACKGROUND: To mitigate the effects of COVID-19, a vaccine is urgently needed. BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) or alum (Algel). METHODS: We did a double-blind, multicentre, randomised, controlled phase 1 trial to assess the safety and immunogenicity of BBV152 at 11 hospitals across India. Healthy adults aged 18-55 years who were deemed healthy by the investigator were eligible. Individuals with positive SARS-CoV-2 nucleic acid and/or serology tests were excluded. Participants were randomly assigned to receive either one of three vaccine formulations (3 µg with Algel-IMDG, 6 µg with Algel-IMDG, or 6 µg with Algel) or an Algel only control vaccine group. Block randomisation was done with a web response platform. Participants and investigators were masked to treatment group allocation. Two intramuscular doses of vaccines were administered on day 0 (the day of randomisation) and day 14. Primary outcomes were solicited local and systemic reactogenicity events at 2 h and 7 days after vaccination and throughout the full study duration, including serious adverse events. Secondary outcome was seroconversion (at least four-fold increase from baseline) based on wild-type virus neutralisation. Cell-mediated responses were evaluated by intracellular staining and ELISpot. The trial is registered at ClinicalTrials.gov (NCT04471519). FINDINGS: Between July 13 and 30, 2020, 827 participants were screened, of whom 375 were enrolled. Among the enrolled participants, 100 each were randomly assigned to the three vaccine groups, and 75 were randomly assigned to the control group (Algel only). After both doses, solicited local and systemic adverse reactions were reported by 17 (17%; 95% CI 10·5-26·1) participants in the 3 µg with Algel-IMDG group, 21 (21%; 13·8-30·5) in the 6 µg with Algel-IMDG group, 14 (14%; 8·1-22·7) in the 6 µg with Algel group, and ten (10%; 6·9-23·6) in the Algel-only group. The most common solicited adverse events were injection site pain (17 [5%] of 375 participants), headache (13 [3%]), fatigue (11 [3%]), fever (nine [2%]), and nausea or vomiting (seven [2%]). All solicited adverse events were mild (43 [69%] of 62) or moderate (19 [31%]) and were more frequent after the first dose. One serious adverse event of viral pneumonitis was reported in the 6 µg with Algel group, unrelated to the vaccine. Seroconversion rates (%) were 87·9, 91·9, and 82·8 in the 3 µg with Algel-IMDG, 6 µg with Algel-IMDG, and 6 µg with Algel groups, respectively. CD4+ and CD8+ T-cell responses were detected in a subset of 16 participants from both Algel-IMDG groups. INTERPRETATION: BBV152 led to tolerable safety outcomes and enhanced immune responses. Both Algel-IMDG formulations were selected for phase 2 immunogenicity trials. Further efficacy trials are warranted. FUNDING: Bharat Biotech International.


Subject(s)
COVID-19 Vaccines/immunology , COVID-19/prevention & control , SARS-CoV-2/immunology , Adolescent , Adult , Antibodies, Neutralizing/blood , Antibodies, Viral/blood , COVID-19 Vaccines/adverse effects , Double-Blind Method , Female , Humans , Immunoglobulin G/blood , Male , Middle Aged , Toll-Like Receptor 7/agonists , Toll-Like Receptor 8/agonists , Vaccination , Vaccines, Inactivated/immunology , Young Adult
20.
Indian J Med Res ; 153(5&6): 703-704, 2021 05.
Article in English | MEDLINE | ID: covidwho-1497486
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