Jpn. J. Infect. Dis., 53, 189-195, 2000

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Review

Systemic Allergic Reactions to Gelatin Included in Vaccines as a Stabilizer

Masahiro Sakaguchi* and Sakae Inouye¹

Department of Immunology and ¹Infectious Disease Surveillance Center, National Institute of Infectious Diseases, Toyama 1-23-1, Shinjuku-ku, Tokyo 162-8640, Japan

(Received September 28, 2000. Accepted November 7, 2000)

CONTENTS:
1. Systemic immediate-type reactions to gelatin in live-virus vaccines
  1.1 Introduction
  1.2 Systemic immediate-type reactions to gelatin in live-virus vaccines
  1.3 Estimate of the minimum incidence of anaphylaxis to gelatin 
      in live-virus vaccines 
  1.4 Relationship between anti-gelatin IgE production and DTaP vaccination history 
2. Systemic nonimmediate-type reactions to gelatin in live-virus vaccines
3. Systemic immediate-type reactions to gelatin in inactivated vaccines
4. Systemic immediate-type reactions to gelatin-containing non-vaccine items
5. Analysis of gelatin allergenicity

SUMMARY: Most of the children who showed systemic immediate-type reactions, including anaphylactic shock, to measles, mumps, rubella, and varicella vaccines had IgE antibodies to gelatin; thus we suspected that the allergic symptoms are caused by gelatin antigen, which is usually included in these live-virus vaccines as a stabilizer. We hypothesized that the anti-gelatin IgE is elicited by immunization with DTaP (diphtheria-tetanus-acellular pertussis) vaccines, which contained a small amount of gelatin as a spillover protein after purification of pertussis toxin. To test this hypothesis, we conducted a case-control study to determine whether children with anti-gelatin IgE had received gelatin-containing DTaP vaccines, and it was indeed found that all such children in the study had immunization histories that included the gelatin-containing DTaP vaccines. Based on these findings, the vaccine manufacturers had removed gelatin from all the DTaP and live-virus vaccines produced in Japan by 2000.

* Corresponding author: Tel: +81-3-5285-1111, Fax : +81-3-5285-1156,
E-mail: msakaguc@nih.go.jp

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