A phase 2/3, participant-blind, observer-blind, randomised, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine) in adults in India

Kulkarni, Prasad S.; Padmapriyadarsini, Chandrasekaran; Vekemans, Johan; Bavdekar, Ashish; Gupta, Madhu; Kulkarni, Praveen; Bs, Garg; Gogtay, Nithya J; Tambe, Muralidhar; Lalwani, Sanjay; Singh, Kiranjit; Munshi, Renuka; Meshram, Sushant; Selvavinayagam, TS; Pandey, Krishna; Bhimarasetty, Devi Madhavi; Ramakrishnan, S. R.; Bhamare, Chetanraj; Dharmadhikari, Abhijeet; Vadakkedath, Rajeev; C, Bonhomme; Thakar, Madhuri; Kurle, Swarali; Kelly, Elizabeth J.; Gautam, Manish; Gupta, Nivedita; Panda, Samiran; Bhargava, Balram; Shaligram, Umesh; Kapse, Dhananjay; Gunale, Bhagwat

doi:10.1016/j.eclinm.2021.101218

Cited by 28 publications

(37 citation statements)

References 14 publications

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“…The seroconversion for neutralizing antibodies was 85.6%. 15 The results in the present study for SII-NVX-CoV2373 as well as for NVX-CoV2373 are on the same lines. However, the efficacy of Covaxin and Covishield was 77.8% (95% CI 65.2–86.4) 16 and 74.0% (95% CI, 65.3 to 80.5), 17 respectively while the same of NVX-CoV2373 was 89.7% (95% CI, 80.2 to 94.6) 6 and 90.4% (95% CI 82.9 to 94.6) 7 in UK and USA/Mexico, respectively indicating that, in addition to humoral immunogenicity, that there may be other facets of the immune response contributing to the efficacy of the vaccine.…”

Section: Discussionsupporting

confidence: 77%

Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study

Kulkarni

Kadam

Godbole

et al. 2023

The Lancet Regional Health - Southeast Asia

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Section: Discussionsupporting

confidence: 77%

Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study

Kulkarni

Kadam

Godbole

et al. 2023

The Lancet Regional Health - Southeast Asia

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“…The original AZD1222 vaccine in trial also showed a booster effect from the second dose [ 7 ]. Non-inferiority of Covishield ® over original AZD1222 vaccine is proven in a good quality, double-blinded, randomized controlled trial [ 20 ]. This study also showed a 4 fold rise in ASAb (9786 AU to 38,576 AU) titre after second dose of vaccine.…”

Section: Discussionmentioning

confidence: 99%

Durability of ChAdOx1 nCoV-19 (Covishield®) Vaccine Induced Antibody Response in Health Care Workers

et al. 2022

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(i) Background: ChAdOx1 nCoV-19 (Covishield®) vaccine is widely used in India. We studied the Covishield® induced antibody response and its durability among health care workers (HCWs) (ii) Method: HCWs received two doses (0.5 mL) four weeks apart. Blood specimens, collected before each dose, day (D)60, D150 and D270 after second dose, were tested for anti-spike antibody (ASAb) titre and neutralising antibody (%) (NAb) using Elecsys Anti-SARS-CoV-2 S (Roche) and SARS-CoV-2 NAb ELISA Kit (Invitrogen), respectively. Data are expressed as proportions and median (interquartile range) and compared using non-parametric (iii) Result: Among 135 HCWs (83 males; age 45 (37–53); 36 had pre-existing ASAb), 29 (21.5%) acquired COVID-19 after 60 (39–68) days of vaccination. ASAb titre before second dose and at D60, D150, D270 were 77.2 (19.4–329.4), 512 (114.5–9212), 149 (51.6–2283) and 2079 (433.9–8644) U/mL, respectively. Compared to those without pre-existing ASAb, titres were significantly higher before second dose (5929 vs. 41, p < 0.001), D60 (3395 vs. 234, p = 0.007) and D150 (1805 vs. 103, p < 0.001) in participants with pre-existing ASAb; NAb were also higher (80 vs. 18, p < 0.001) before second dose. Between those who acquired infection or not after vaccination, ASAb titres were comparable before second dose (77 vs. 78, p = 0.362) but significantly higher at D60 (14,019 vs. 317, p < 0.001) and D150 (2062 vs. 121, p = 0.002) in the former group, though NAb percentage were higher at D60 (87 vs. 27, p < 0.001) and D150 (79 vs. 25, p = 0.007) only (iv) Conclusions: Covishield® induces a higher antibody titre in those with pre-existing ASAb. The vaccine induced antibody starts falling 5 months after vaccination.

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“…The efficacy of Covishield was found to be around 93%, after both the doses, based on the VIN‐WIN cohort study carried out on over 1.59 million healthcare and frontline workers of the Indian Armed Forces. 5 Kulkarni et al 6 reported that SII‐ChAdOx1 nCoV‐19 has a good safety profile and is highly immunogenic in the adult Indian population in comparison to AZD122. Desai et al 7 showed 50% efficacy of two doses of BBV152 (Covaxin) against symptomatic RT‐PCR confirmed SARS‐CoV‐2 during the second wave in India.…”

Section: Introductionmentioning

confidence: 99%

Adverse events and breakthrough infections associated with COVID‐19 vaccination in the Indian population

Arora

Taneja

Bhardwaj

et al. 2022

Journal of Medical Virology

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Vaccines against COVID‐19 provide immunity to deter severe morbidities associated with the infection. However, it does not prevent infection altogether in all exposed individuals. Furthermore, emerging variants of SARS‐CoV‐2 impose a threat concerning the competency of the vaccines in combating the infection. This study aims to determine the variability in adverse events and the extent of breakthrough infections in the Indian population. A retrospective study was conducted using a pre‐validated questionnaire encompassing social, demographic, general health, the status of SARS‐CoV‐2 infection, vaccination, associated adverse events, and breakthrough infections in the Indian population. Informed consent and ethical approval were obtained as per Indian Council of Medical Research (ICMR) guidelines. Participants, who provided the complete information, were Indian citizens, above 18 years, and if vaccinated, administered with either Covishield or Covaxin, were considered for the study. Data have been compiled in Microsoft Excel and analyzed for statistical differences using STATA 11. The responses from 2051 individuals fulfilling the inclusion criteria were analyzed. Among 2051, 1119 respondents were vaccinated and 932 respondents were non‐vaccinated. Among 1119 vaccinated respondents, 7 were excluded because of missing data. Therefore, out of 1112 vaccinated, 413 experienced adverse events with a major fraction of younger individuals, age 18–40 years, getting affected (74.82%; 309/413). Furthermore, considerably more females than males encountered adverse consequences to vaccination ( p < 0.05). Among vaccinated participants, breakthrough infections were observed in 7.91% (88/1112; 57.96% males and 42.04% females) with the older age group, 61 years and above (odds ratio, 3.25 [1.32–8.03]; p = 0.011), and males were found to be at higher risk. Further research is needed to find the age and sex‐related factors in determining vaccine effectiveness and adverse events.

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A phase 2/3, participant-blind, observer-blind, randomised, controlled study to assess the safety and immunogenicity of SII-ChAdOx1 nCoV-19 (COVID-19 vaccine) in adults in India

Cited by 28 publications

References 14 publications

Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study

Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled study

Durability of ChAdOx1 nCoV-19 (Covishield®) Vaccine Induced Antibody Response in Health Care Workers

Adverse events and breakthrough infections associated with COVID‐19 vaccination in the Indian population

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