Diabetes mellitus as a vaccine-effect modifier: a review

ABSTRACT

Introduction

Diabetes mellitus (DM) is a highly prevalent, chronic condition in adults worldwide. Little is known about the potential role of diabetes as an effect modifier of vaccine protective responses.

Areas covered

We conducted a literature review of the immunogenicity, efficacy and effectiveness of immunization in individuals, in studies that compared subjects with DM (DM+) and without DM (DM-). We found few published studies, which were only for vaccines against hepatitis B, influenza, pneumococcal disease, or varicela zoster. Except for a consistent attenuation of the immune response to hepatitis B vaccine among DM+ individuals, we found little other consistent evidence for DM as an effect modifier of vaccine responses.

Expert opinion

There are substantial gaps in our knowledge of the impact of DM on the immune response to immunization or effect of vaccination.

KEYWORDS:

• Diabetes mellitus
• effect modifier
• efficacy
• effectiveness
• immunogenicity

Acknowledgments

Support with the search and extraction of data for the review was provided by Germano Ferreira; editorial support for the development of this manuscript was provided by Marc Baay. Both were at P95 Epidemiology and Pharmacovigilance, Leuven, Belgium at the time of their involvement and their activities were funded by Pfizer.

Author contributions

Study conceptualization and literature search strategy: all authors; literature search and data extraction: Sally Jackson and Thomas Verstraeten; analysis: Sally Jackson and Thomas Verstraeten; interpretation of results: all authors; first draft of manuscript: Thomas Verstraeten, Sally Jackson, and Jose Suaya; subsequent drafting and/or critical review of the manuscript: all authors. All authors approved the final version of the manuscript for submission.

Article Highlights

• The role of diabetes mellitus (DM) as an effect modifier of vaccine immunogenicity and efficacy or effectiveness was reviewed.

• Data were retrieved on hepatitis B, influenza, pneumococcal, and varicella zoster vaccines.

• Individuals with DM had a consistently decreased immunogenicity to hepatitis B vaccine, but there were no studies on hepatitis B vaccine efficacy or effectiveness.

• Inconsistent results were noted for influenza, pneumococcal, and varicella zoster vaccines.

• Well-designed and robust studies are needed to understand if DM could be a vaccine effect modifier.

Declaration of interest

Coauthors from Pfizer Inc may hold stock or stock options. Coauthors from P95 received contracted research fees from Pfizer for the conduct of the study.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This work is a Pfizer sponsored study, a collaboration with P95 Epidemiology and Pharmacovigilance, Leuven, Belgium, as reflected by authorship (Sally Jackson and Thomas Verstraeten). P95 Epidemiology and Pharmacovigilance received funding for manuscript development.