Volume 7 Supplement 1

2013 WAO Symposium on Immunotherapy and Biologics

Open Access

Poster 2011: A DNA vaccine immunotherapy for japanese red cedar allergy

  • Lawrence Weiner1,
  • Bruce Mackler1,
  • Bill Hearl1 and
  • David Fitz-Patrick2
World Allergy Organization Journal20147:41

https://doi.org/10.1186/1939-4551-7-S1-P23

Published: 3 February 2014

Methods

A Phase I study was conducted with i plasmid DNA vaccine, containing the CryJ2 allergen from Japanese Red Cedar inserted into the Lysosomal Associated Membrane nucleic acid sequence. Previouslyy sensitized Japanesei, were consented in English/Japanese, received four doses and assessed over 132 days for the safety of this vaccine. Group 1 contained non-sensitive and Groups 2 & 3 sensitive subjects as defined by +/- skin test to JRC, Mountain cedar and CryJ2 allergens. All subjects received 4 doses at 14 day intervals.

Safety data through 132 days after the 1st vaccination showed 85% of the adverse events (AE’s) were mild, mainly injection site erythema, swelling and pain, the majority occurring in Group 3.t All AEs were of a transient nature, requiring no medical attention. CryJ2-LAMP-Vax did not induce IgE CryJ2 specific titer changes, nor CryJ2 specific IgG titers. Prior to each vaccination and at 72 and 132 days, subjects tested negative for anti-LAMP antibodies. These clinical and biomarker data suggested that the plasmid vaccine was safe.

Results

At 132 days, the skin prick tests indicated that the CryJ2-LAMP-Vax converted 10 of 12 subjects’ JRC positive skin test reactions to negative, with a similar conversion pattern in 6/11 Mountain cedar skin test positive; Mountain cedar Jun a 2 allergen shares a 91% homology with CryJ2. These subjects presumptively were sensitive to the Jun a2 allergen, 91% homologous to CryJ2.

Conclusions

The most striking observation at Day 132 was the conversion of positive skin test reactions to unrelated allergens-Southern Grass mix, Western Ragweed mix, Southern California Tree Mix and Dust Mite Mix, to negative at day 132. In Groups 2 & 3, the conversion was 10/17 subjects. The vaccinated non-CryJ2 sensitive subjects exhibited no skin test conversions. These skin test conversions from positive to negative at day 132 for allergens unrelated to CryJ2, possibly represents a general T cell immune response due to the DNA vaccine.

The Phase I clinical data and laboratory results support the conclusion that vaccination with CryJ2-LAMP-Vax is safe and changes the immune status. The majority of AE’s were mild skin injection reactions, primarily in the high dose /Group 3. There were no anaphylactic reactions from the vaccination. The lack of any significant IgE anti-CryJ2 responses in both vaccinated non-atopic sensitive and atopic sensitive subjects indicated a conversion of the immune status to CryJ2 from a Th2 into a Th1 response. The skin test conversions of 21 subjects JRC/MC/CryJ2 skin tests to negative at day 132, suggests that the DNA-LAMP vaccine modulated the immune system. Further, it is suggested that the positive to negative skin test conversions for allergens unrelated to CryJ2 specificity, possibly represents a general bystander T cell regulatory response.

Authors’ Affiliations

(1)
Immunomic
(2)
East west research

Copyright

© Weiner et al; licensee BioMed Central Ltd. 2014

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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