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Protocol for a systematic review and meta-analysis of fractional dose compared with standard dose inactivated polio vaccination in children
  1. Thandiwe Runyararo Mashunye1,
  2. Duduzile Edith Ndwandwe2,
  3. Kopano Rebaona Dube2,
  4. Muki Shey3,
  5. Mary Shelton4,
  6. Charles Shey Wiysonge1,2,5
  1. 1 Department of Epidemiology and Biostatistics, School of Public Health and Family Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, Western Cape, South Africa
  2. 2 Cochrane South Africa, South African Medical Research Council, Tygerberg, Western Cape, South Africa
  3. 3 Department of Medicine, University of Cape Town, Faculty of Medicine, Cape Town, Western Cape, South Africa
  4. 4 Health Sciences Library, University of Cape Town, Cape Town, Western Cape, South Africa
  5. 5 Division of Epidemiology and Biostatistics,Department of Global Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, Western Cape, South Africa
  1. Correspondence to Dr Thandiwe Runyararo Mashunye; tmashunye1{at}gmail.com

Abstract

Introduction WHO recommends the introduction of at least one single dose of inactivated polio vaccine (IPV) in routine immunisation schedules. Thus, there has been an increased demand and concurrent supply shortages of IPV worldwide. One of the strategies to improve access is the use of fractional instead of full doses of IPV. We aim to compare the effects of fractional with standard doses of IPV.

Methods and analysis We will include randomised trials, non-randomised trials, case-control studies and cohort studies that compared fractional with full doses of IPV among children aged 5 years or younger. We will search for eligible studies among published and grey literature. Two authors will independently screen the results of the search, select studies, extract data and assess risk of bias. We will stratify analyses by study design, type of poliovirus, type of outcome measure and number of IPV doses given. For each type of poliovirus, we will pool the outcome data from studies using random-effects meta-analyses. Statistical heterogeneity will be assessed using the χ2 test of homogeneity and quantified using the I2 statistic. To investigate statistical heterogeneity, subgroup analyses will be performed based on the timing of the first fractional dose, age of administration, immunisation schedules and country income status. Sensitivity analyses will be used to assess if the effect of IPV fractional dosing is affected by study design, risk of bias and methods of meta-analysis.

Ethics and dissemination We obtained approval from the University of Cape Town Human Research Ethics Committee (HREC REF: 412/2018). The findings of this review will provide evidence for decision-making with regards to IPV dosage, eventually improving access to the vaccine by stretching vaccine supplies. The results will be published in the University of Cape Town online library and in a peer reviewed journal.

PROSPERO registration number CRD42018092647.

  • inactivated polio vaccine
  • fractional dosing
  • dose-sparing
  • polio eradication
  • vaccine shortage
  • ipv

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors TRM led the development of the protocol, wrote the first draft, coordinated and integrated comments from co-authors, approved the final version for publication and is the guarantor of the manuscript. TRM and MS developed the search strategy. DEN, KRD and MS critically revised successive drafts of the manuscript, provided important intellectual input and approved the final version of the manuscript. CSW conceived the study, provided supervision and mentorship to TRM, critically revised successive drafts of the manuscript, provided important intellectual input and approved the final version of the manuscript.

  • Funding This work is supported by the South African Medical Research Council (salaries for Thandiwe Mashunye, Duduzile Ndwandwe, Kopano Dube and Charles S. Wiysonge) and the National Research Foundation of South Africa (Grant numbers: 106035 and 108571).

  • Competing interests None declared.

  • Ethics approval All procedures were approval by the University of Cape Town Human Research Ethics Committee (HREC REF: 412/2018).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement No additional data are available.

  • Patient consent for publication Not required.

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