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  • Preclinical safety and immunogenicity of Streptococcus pyogenes (Strep A) peptide vaccines

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    Reynolds523098_Published.pdf (793.9Kb)
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    Version of Record (VoR)
    Author(s)
    Reynolds, S
    Pandey, M
    Dooley, J
    Calcutt, A
    Batzloff, M
    Ozberk, V
    Mills, JL
    Good, M
    Griffith University Author(s)
    Pandey, Manisha
    Batzloff, Michael R.
    Reynolds, Simone
    Ozberk, Victoria
    Calcutt, Ainslie M.
    Dooley, Jessica L.
    Good, Michael F.
    Mills, Jamie S.
    Year published
    2021
    Metadata
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    Abstract
    We have developed two candidate vaccines to protect against multiple strains of Strep A infections. The candidates are combinatorial synthetic peptide vaccines composed of a M protein epitope (J8 or p*17) and a non-M protein epitope (K4S2). To enhance immunogenicity, each peptide is conjugated to the carrier protein CRM197 (CRM) and formulated with aluminium hydroxide adjuvant Alhydrogel (Alum) to make the final vaccines, J8-CRM + K4S2-CRM/Alum and p*17-CRM + K4S2-CRM/Alum. The safety and toxicity of each vaccine was assessed. Sprague Dawley rats were administered three intramuscular doses, over a six-week study with a 4-week ...
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    We have developed two candidate vaccines to protect against multiple strains of Strep A infections. The candidates are combinatorial synthetic peptide vaccines composed of a M protein epitope (J8 or p*17) and a non-M protein epitope (K4S2). To enhance immunogenicity, each peptide is conjugated to the carrier protein CRM197 (CRM) and formulated with aluminium hydroxide adjuvant Alhydrogel (Alum) to make the final vaccines, J8-CRM + K4S2-CRM/Alum and p*17-CRM + K4S2-CRM/Alum. The safety and toxicity of each vaccine was assessed. Sprague Dawley rats were administered three intramuscular doses, over a six-week study with a 4-week recovery period. A control group received CRM only formulated with Alum (CRM/Alum). There was no evidence of systemic toxicity in the rats administered either vaccine. There was an associated increase in white blood cell, lymphocyte and monocyte counts, increased adrenal gland weights, adrenocortical hypertrophy, and increased severity of granulomatous inflammation at the sites of injection and the associated inguinal lymph nodes. These changes were considered non-adverse. All rats administered vaccine developed a robust and sustained immunological response. The absence of clinical toxicity and the development of an immunological response in the rats suggests that the vaccines are safe for use in a phase 1 clinical trial in healthy humans.
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    Journal Title
    Scientific Reports
    Volume
    11
    DOI
    https://doi.org/10.1038/s41598-020-80508-6
    Copyright Statement
    © 2021 by the authors. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
    Subject
    Immunology
    multiple strains
    M protein epitope (J8 or p*17)
    a non-M protein epitope (K4S2)
    CRM197 (CRM)
    Alhydrogel (Alum)
    white blood cell
    Publication URI
    http://hdl.handle.net/10072/410328
    Collection
    • Journal articles

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