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Public health
Protocol
Adverse events associated with human papillomavirus vaccines: a protocol for systematic review with network meta-analysis incorporating all randomised controlled trials comparing with placebo, adjuvants and other vaccines
  1. Jiro Takeuchi1,
  2. Hisashi Noma2,
  3. Yuta Sakanishi3,4,
  4. Takashi Kawamura5
  1. 1 Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan
  2. 2 Department of Data Science, The Institute of Statistical Mathematic, Tachikawa, Japan
  3. 3 Sakanishi Internal Medicine and Pediatrics Clinic, Omuta, Japan
  4. 4 Community Medical Support Institute, Saga University Faculty of Medicine, Saga, Japan
  5. 5 Health Service, Kyoto University, Kyoto, Japan
  1. Correspondence to Dr Jiro Takeuchi; zi-takeuchi{at}hyo-med.ac.jp

Abstract

Introduction Adverse events following the injection (AEFIs) of human papillomavirus vaccine (HPVv) among female adolescents are still a major public health concern.

Methods According to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension statement for systematic reviews incorporating network meta-analyses, all prospective randomised trials will be included. The primary outcome for adverse events is topical pain during the observation period.

We will mainly search 17 electronic databases from January 2000 through September 2019 with suitable Medical Subject Headings and text words for PubMed. Two reviewers will independently check the reports at the title/abstract level and identify potentially applicable studies. Then we will obtain their full texts and decide whether to include them based on the same eligible criteria.

We will compare HPVv with placebo, HPVv with adjuvant and HPVv with other vaccines. Interstudy heterogeneity, publication biases or small study effects will be evaluated using conventional meta-analysis methods. The consistency of the network will be checked using tests for local and global inconsistency and the side-splitting method. To address the heterogeneity of treatment effects among the studies, we will use the multivariable random effect model.

Ethics and dissemination This pairwise or network meta-analysis does not require ethics approval. The data used here are not individual nor private. We will be able to determine which component of the vaccine induces adverse events, especially topical pain. This systematic review with network meta-analysis will provide valid answers regarding AEFIs for HPVv.

PROSPERO registration number CRD42018109265

  • human papillomavirus
  • network meta-analysis
  • protocol
  • randomised controlled trials
  • systematic review
  • vaccine

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/.

https://doi.org/10.1136/bmjopen-2018-026924

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    Footnotes

    • Contributors All authors substantially contributed to designing of the study. JT contributed to conception of the study and drafting of the article. HN, YS and TK contributed to critical revision of the article for important intellectual contents. All authors read and approved the final manuscript.

    • Funding The author(s) received grant for research from Japan Health Academy, Public interest foundation. The author(s) received no financial support for authorship nor publication of this article.

    • Competing interests None declared.

    • Patient consent for publication Not required.

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