BMJ Open (Apr 2023)

COVID-19 vaccine effectiveness and variants in Nepal: study protocol for a test-negative case–control study with SARS-CoV-2 genetic sequencing

  • Andrew J Pollard,
  • Grace Li,
  • Sarah Kelly,
  • Merryn Voysey,
  • Sanjeev M Bijukchhe,
  • Peter J O'Reilly,
  • Katherine Theiss-Nyland,
  • Meeru Gurung,
  • Bhishma Pokhrel,
  • Samita Acharya,
  • Shreekrishna Maharjan,
  • Ashis Shrestha,
  • Bimal Pandey,
  • Mipsang Lama,
  • Ira Shrestha,
  • Agnes Eordogh,
  • Sonu Shrestha,
  • Elaine Shuo Feng,
  • Ganesh Shah,
  • Shrijana Shrestha

DOI
https://doi.org/10.1136/bmjopen-2022-068334
Journal volume & issue
Vol. 13, no. 4

Abstract

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Introduction Inactivated, viral vector and mRNA vaccines have been used in the Nepali COVID-19 vaccination programme but there is little evidence on the effectiveness of these vaccines in this setting. The aim of this study is to describe COVID-19 vaccine effectiveness in Nepal and provide information on infections with SARS-CoV-2 variants.Methods and analysis This is a hospital-based, prospective test-negative case–control study conducted at Patan Hospital, Kathmandu. All patients >18 years of age presenting to Patan Hospital with COVID-19-like symptoms who have received a COVID-19 antigen/PCR test are eligible for inclusion. The primary outcome is vaccine effectiveness of licensed COVID-19 vaccines against laboratory-confirmed COVID-19 disease.After enrolment, information will be collected on vaccine status, date of vaccination, type of vaccine, demographics and other medical comorbidities. The primary outcome of interest is laboratory-confirmed SARS-CoV-2 infection. Cases (positive for SARS-CoV-2) and controls (negative for SARS-CoV-2) will be enrolled in a 1:4 ratio. Vaccine effectiveness against COVID-19 disease will be analysed by comparing vaccination status with SARS-CoV-2 test results.Positive SARS-CoV-2 samples will be sequenced to identify circulating variants and estimate vaccine effectiveness against common variants.Measuring vaccine effectiveness and identifying SARS-CoV-2 variants in Nepal will help to inform public health efforts. Describing disease severity in relation to specific SARS-CoV-2 variants and vaccine status will also inform future prevention and care efforts.Ethics and dissemination Ethical approval was obtained from the University of Oxford Tropical Ethics Committee (OxTREC) (ref: 561-21) and the Patan Academy of Health Sciences Institutional Review Board (ref: drs2111121578). The protocol and supporting study documents were approved for use by the Nepal Health Research Council (NHRC 550-2021). Results will be disseminated in peer-reviewed journals and to the public health authorities in Nepal.