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Infectious diseases
Protocol
Assessment of humoral and cell-mediated immune responses to pertussis vaccination: a systematic review protocol
  1. Funbi Akinola1,2,
  2. Rudzani Muloiwa2,3,
  3. Gregory, D Hussey2,4,
  4. Violette Dirix5,
  5. Benjamin Kagina2,
  6. Edina Amponsah-Dacosta2
  1. 1 Division of Epidemiology and Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa
  2. 2 Vaccines for Africa Initiative, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa
  3. 3 Department of Paediatrics and Child Health, Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa
  4. 4 Division of Medical Microbiology and Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, Cape Town, South Africa
  5. 5 Laboratory of Vaccinology and Mucosal Immunity, Université Libre de Bruxelles, Brussels, Belgium
  1. Correspondence to Dr. Edina Amponsah-Dacosta; edina.amponsah-dacosta{at}uct.ac.za

Abstract

Introduction Globally, some studies show a resurgence of pertussis. The risks and benefits of using whole-cell pertussis (wP) or acellular pertussis (aP) vaccines in the control of the disease have been widely debated. Better control of pertussis will require improved understanding of the immune response to pertussis vaccines. Improved understanding and assessment of the immunity induced by pertussis vaccines is thus imperative. Several studies have documented different immunological outcomes to pertussis vaccination from an array of assays. We propose to conduct a systematic review of the different immunological assays and outcomes used in the assessment of the humoraland cell-mediated immune response following pertussis vaccination.

Methods and analysis The primary outcomes for consideration are quality and quantity of immune responses (humoral and cell-mediated) post-pertussis vaccination. Of interest as secondary outcomes are types of immunoassays used in assessing immune responses post-pertussis vaccination, types of biological samples used in assessing immune responses post-pertussis vaccination, as well as the types of antigens used to stimulate these samples during post-pertussis vaccination immune response assessments. Different electronic databases (including PubMed, Cochrane, EBSCO Host, Scopus and Web of Science) will be accessed for peer-reviewed published and grey literature evaluating immune responses to pertussis vaccines between 1990 and 2019. The quality of included articles will be assessed using standardised risk and quality assessment tools specific to the study design used in each article. Data extraction will be done using a data extraction form. The extracted data will be analysed using STATA V.14.0 and RevMan V.5.3 software. A subgroup analysis will be conducted based on the study population, type of vaccine (wP or aP) and type of immune response (cell-mediated or humoral). Guidelines for reporting systematic reviews in the revised 2009 Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement will be used in this study.

Ethics and dissemination Ethics approval is not required for this study as it is a systematic review. We will only make use of data already available in the public space. Findings will be reported via publication in a peer-reviewed journal and presented at scientific meetings and workshops.

Trial registration number CRD42018102455.

  • pertussis
  • acellular pertussis vaccine
  • whole-cell pertussis vaccine
  • humoral immune response
  • cell-mediated immune response

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-2018-028109

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    Footnotes

    • Contributors This study was conceived by EAD, BMK, RM and GDH. FA developed the review protocol with input from all co-authors. FA will conduct the systematic review under the supervision of EAD and BMK. FA will also conduct the statistical analysis and data analysis for the systematic review. The literature search, screening and data extraction will be performed by FA, EAD and BMK. RM, VD and GDH will provide expert opinion and will review drafts of the systematic review.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

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

    • Patient consent for publication Not required.