Efficacy, safety, and immunogenicity of the DNA SARS-CoV-2 vaccine (ZyCoV-D): the interim efficacy results of a phase 3, randomised, double-blind, placebo-controlled study in India

Khobragade, Akash; Bhate, Suresh; Ramaiah, Vijendra; Deshpande, Shrikant; Giri, Krishna; Phophle, Himanshu; Supe, Pravin Dinkar; Godara, Inderjeet; Revanna, Ramesh; Nagarkar, Rajnish; Sanmukhani, Jayesh; Dey, Ayan; Rajanathan, T.M.C.; Kansagra, Kevinkumar; Koradia, Parshottam

doi:10.1016/s0140-6736(22)00151-9

Cited by 150 publications

(140 citation statements)

References 5 publications

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“…Elven of these full-texts, were excluded because 1) five studies had insufficient data, 2) four studies had no control (or placebo) group, 3) three studies tested the efficacy of vaccine on HIV positive patients. After Finally, nineteen studies were included in our study [18] , [19] , [20] , [21] , [22] , [23] , [24] , [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] , [35] , [36] . The characteristics of the selected studies are shown in Table1 .…”

Section: Resultsmentioning

confidence: 99%

“…Three studies reported the results of phase I clinical trial, three studies were phase II and III each and one study reported the results of a phases II/III clinical trial. Among the included studies, seven studies were conducted in China [19] , [28] , [29] , [30] , [31] , [32] , [33] ; three studies in the United States [18] , [23] , [27] ; two in the United Kingdom [20] , [25] ; one in Iran [36] , one in Japan [35] , one in India [34] , one in Europe [22] and two in Australia [21] , [26] . One study was from multiple centers including the United States, Brazil, Argentina, Germany, Turkey and South Africa [24] .…”

Section: Resultsmentioning

confidence: 99%

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Adverse events following COVID-19 vaccination: A systematic review and meta-analysis

Kouhpayeh

Ansari

2022

International Immunopharmacology

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Adverse events following COVID-19 vaccination: A systematic review and meta-analysis

Kouhpayeh

Ansari

2022

International Immunopharmacology

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“…The study selection process is shown in Figure 1. Of these, seven randomized clinical trials (10950 participants) were officially published 15–21 . The participants of the included studies were restricted to children and adolescents who varied between 6 months and 18 years of age.…”

Section: Resultsmentioning

confidence: 99%

“…One published study from India was identified. It is a multicenter Phase 3 double‐blind, randomized, placebo‐controlled trial 21 . The interim results of healthy participants aged 12–17 years ( n = 935) were analyzed to report the safety of ZyCoV‐D in this age group.…”

Section: Resultsmentioning

confidence: 99%

Safety and efficacy of COVID‐19 vaccines in children and adolescents: A systematic review of randomized controlled trials

Tian

Yang

Chen

2022

Journal of Medical Virology

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To systematically review and synthesize the safety and efficacy of coronavirus disease‐2019 (COVID‐19) vaccines in children and adolescents. PubMed, EMBASE, Web of Science, Cochrane Library databases, the International Clinical Trials Registry Platform (ICTRP), the Chinese Clinical Trials Registry (ChiCTR), and https://ClinicalTrials.gov website were searched to collect accessible randomized controlled trials (RCTs) about the safety and efficacy of human COVID‐19 vaccines in children and adolescents until May 1, 2022. Three steps, including duplicate removal, title and abstract screening, and full‐text review, were used to screen the studies. The Cochrane risk‐of‐bias tool for RCTs was used to assess the bias risk of the included studies. Microsoft Excel 16.57 (2021) software was used for data extraction and analysis. (PROSPERO Code No: CRD42021295422). COVID‐19 vaccines were evaluated in a total of 10 950 children and adolescents in seven published studies and over 49 530 participants in 26 ongoing randomized controlled trials. Descriptive findings of the included published studies were reported stratified by vaccine type. The overall, local, and systemic adverse events following immunization (AEFIs) reported in most trials were similar between the vaccine and placebo groups. Most of the reactions reported were mild to moderate, whereas a few were severe. The common adverse events were injection‐site pain, fever, headache, cough, fatigue, and muscle pain. Few clinical trials reported serious adverse events, but most of them were unrelated to vaccination. In terms of efficacy, the investigated messenger RNA (mRNA) vaccine was found to be 90.7%–100% efficacious in preventing COVID‐19 among children and adolescents, revealing good efficacy profiles in this age group. Among children and adolescents, the safety of current COVID‐19 vaccines is acceptable, and studies have suggested that mRNA vaccines can provide high protection against COVID‐19 infection in pediatric age groups.

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“…The advantage of naked DNA delivered by EP is that it enables the vaccine to be administered many times without limiting immune responses, which may potentially occur with a viral vector. A plasmid DNA vaccine (ZyCoV-D) against SARS-CoV-2 developed by Zydus Cadila has been approved for emergency use authorization (EUA) by the office of the Drug Controller General of India (DCGI), with a vaccination protocol consisting of three doses every 28 days [ 12 ].…”

Section: Introductionmentioning

confidence: 99%

DNA-Vaccine-Induced Immune Response Correlates with Lower Viral SARS-CoV-2 Titers in a Ferret Model

Compagnone¹,

Pinto²,

Salvatori³

et al. 2022

Vaccines

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The COVID-19 pandemic is entering a new era with the approval of many SARS-CoV-2 vaccines. In spite of the restoration of an almost normal way of life thanks to the immune protection elicited by these innovative vaccines, we are still facing high viral circulation, with a significant number of deaths. To further explore alternative vaccination platforms, we developed COVID-eVax—a genetic vaccine based on plasmid DNA encoding the RBD domain of the SARS-CoV-2 spike protein. Here, we describe the correlation between immune responses and the evolution of viral infection in ferrets infected with the live virus. We demonstrate COVID-eVax immunogenicity as means of antibody response and, above all, a significant T-cell response, thus proving the critical role of T-cell immunity, in addition to the neutralizing antibody activity, in controlling viral spread.

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Efficacy, safety, and immunogenicity of the DNA SARS-CoV-2 vaccine (ZyCoV-D): the interim efficacy results of a phase 3, randomised, double-blind, placebo-controlled study in India

Cited by 150 publications

References 5 publications

Adverse events following COVID-19 vaccination: A systematic review and meta-analysis

Adverse events following COVID-19 vaccination: A systematic review and meta-analysis

Safety and efficacy of COVID‐19 vaccines in children and adolescents: A systematic review of randomized controlled trials

DNA-Vaccine-Induced Immune Response Correlates with Lower Viral SARS-CoV-2 Titers in a Ferret Model

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