Inflammation-related adverse reactions following vaccination potentially indicate a stronger immune response

Emerg Microbes Infect. 2021 Dec;10(1):365-375. doi: 10.1080/22221751.2021.1891002.

Abstract

Concerns about vaccine safety are an important reason for vaccine hesitancy, however, limited information is available on whether common adverse reactions following vaccination affect the immune response. Data from three clinical trials of recombinant vaccines were used in this post hoc analysis to assess the correlation between inflammation-related solicited adverse reactions (ISARs, including local pain, redness, swelling or induration and systematic fever) and immune responses after vaccination. In the phase III trial of the bivalent HPV-16/18 vaccine (Cecolin®), the geometric mean concentrations (GMCs) for IgG anti-HPV-16 and -18 (P<0.001) were significantly higher in participants with any ISAR following vaccination than in those without an ISAR. Local pain, induration, swelling and systemic fever were significantly correlated with higher GMCs for IgG anti-HPV-16 and/or anti-HPV-18, respectively. Furthermore, the analyses of the immunogenicity bridging study of Cecolin® and the phase III trial of a hepatitis E vaccine yielded similar results. Based on these results, we built a scoring model to quantify the inflammation reactions and found that the high score of ISAR indicates the strong vaccine-induced antibody level. In conclusion, this study suggests inflammation-related adverse reactions following vaccination potentially indicate a stronger immune response.

Keywords: Inflammation; adverse reaction; antibody; immune response; recombinant vaccine; vaccine hesitancy.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antibodies, Viral / immunology
  • Female
  • Hepatitis E / immunology*
  • Hepatitis E / prevention & control
  • Hepatitis E / virology
  • Human papillomavirus 16 / genetics
  • Human papillomavirus 16 / immunology*
  • Human papillomavirus 18 / genetics
  • Human papillomavirus 18 / immunology*
  • Humans
  • Immunity
  • Immunoglobulin G / immunology
  • Male
  • Middle Aged
  • Papillomavirus Infections / immunology*
  • Papillomavirus Infections / prevention & control
  • Papillomavirus Infections / virology
  • Papillomavirus Vaccines / administration & dosage
  • Papillomavirus Vaccines / adverse effects
  • Papillomavirus Vaccines / genetics
  • Papillomavirus Vaccines / immunology*
  • Vaccination / adverse effects
  • Vaccines, Synthetic / administration & dosage
  • Vaccines, Synthetic / adverse effects
  • Vaccines, Synthetic / genetics
  • Vaccines, Synthetic / immunology*
  • Viral Hepatitis Vaccines / administration & dosage
  • Viral Hepatitis Vaccines / adverse effects
  • Viral Hepatitis Vaccines / genetics
  • Viral Hepatitis Vaccines / immunology*
  • Young Adult

Substances

  • Antibodies, Viral
  • Immunoglobulin G
  • Papillomavirus Vaccines
  • Vaccines, Synthetic
  • Viral Hepatitis Vaccines
  • hecolin

Grant support

This work was supported by the National Natural Science Foundation [grant number 81991491]; the Joint Funds for the Health Education, Fujian province [grant number 2019-WJ-05]; CAMS Innovation Fund for Medical Sciences [grant number 2019RU022]; National Key Projects in Science and Technology [grant number 2018ZX09303005-002].