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Peer-reviewedCC BY 4.0NPJ Vaccines

Safety and immunogenicity testing of a melioidosis subunit vaccine candidate in cynomolgus macaques

  • Sineenart Sengyee1
  • Caitlyn E. Orne1
  • Sarah B. Weiby1
  • Lindsey K. Schmidt1
  • Federico Urbano-Munoz1
  • Jiri Vlach2
  • Christian Heiss2
  • Parastoo Azadi2
  • Narisara Chantratita3,4
  • Mary N. Burtnick1,3
  • Paul J. Brett1,3
4 affiliations
  1. 1Department of Microbiology and Immunology, University of Nevada, Reno School of Medicine, Reno, NV USA
  2. 2Complex Carbohydrate Research Center, University of Georgia, Athens, GA USA
  3. 3Department of Microbiology and Immunology, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
  4. 4Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
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Abstract

Burkholderia pseudomallei, the etiologic agent of melioidosis, is a Gram-negative bacterial pathogen that causes severe disease in humans and animals. In this study, we evaluated the safety and immunogenicity of our lead melioidosis subunit vaccine candidate in cynomolgus macaques. To accomplish this, the 6-deoxyheptan capsular polysaccharide (CPS) from Burkholderia thailandensis E555 was purified using a phenol-free extraction process and then conjugated to CRM197 to generate CPS-CRM197. Highly purified, His-tagless B. pseudomallei Hcp1 (Hcp1-TL) was also produced. Animals immunized with CPS-CRM197 combined with Hcp1-TL and adjuvanted with Alhydrogel plus CpG DNA (ODN 2006) developed robust CPS-specific IgG and opsonizing antibody responses, alongside strong Hcp1-specific IgG and measurable IFN-γ-secreting T-cell responses. Importantly, the vaccine formulations tested were well tolerated, with no adverse events after three doses. Collectively, these studies establish good manufacturing practices-compatible processes for our vaccine antigens and demonstrate the safety and immunogenicity of the subunit vaccine in non-human primates, supporting continued advancement towards a human clinical trial.

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Cite

BibTeXRIS
BibTeX
@article{sengyee2026safety,
  title = {{Safety and immunogenicity testing of a melioidosis subunit vaccine candidate in cynomolgus macaques}},
  author = {Sineenart Sengyee and Caitlyn E. Orne and Sarah B. Weiby and Lindsey K. Schmidt and Federico Urbano-Munoz and Jiri Vlach and Christian Heiss and Parastoo Azadi and Narisara Chantratita and Mary N. Burtnick and Paul J. Brett},
  journal = {NPJ Vaccines},
  year = {2026},
  month = jul,
  doi = {10.1038/s41541-026-01526-5},
  url = {https://doi.org/10.1038/s41541-026-01526-5},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Safety and immunogenicity testing of a melioidosis subunit vaccine candidate in cynomolgus macaques
AU  - Sineenart Sengyee
AU  - Caitlyn E. Orne
AU  - Sarah B. Weiby
AU  - Lindsey K. Schmidt
AU  - Federico Urbano-Munoz
AU  - Jiri Vlach
AU  - Christian Heiss
AU  - Parastoo Azadi
AU  - Narisara Chantratita
AU  - Mary N. Burtnick
AU  - Paul J. Brett
PY  - 2026
DA  - 2026/07/14
JO  - NPJ Vaccines
DO  - 10.1038/s41541-026-01526-5
UR  - https://doi.org/10.1038/s41541-026-01526-5
AB  - Burkholderia pseudomallei, the etiologic agent of melioidosis, is a Gram-negative bacterial pathogen that causes severe disease in humans and animals. In this study, we evaluated the safety and immunogenicity of our lead melioidosis subunit vaccine candidate in cynomolgus macaques. To accomplish this, the 6-deoxyheptan capsular polysaccharide (CPS) from Burkholderia thailandensis E555 was purified using a phenol-free extraction process and then conjugated to CRM197 to generate CPS-CRM197. Highly purified, His-tagless B. pseudomallei Hcp1 (Hcp1-TL) was also produced. Animals immunized with CPS-CRM197 combined with Hcp1-TL and adjuvanted with Alhydrogel plus CpG DNA (ODN 2006) developed robust CPS-specific IgG and opsonizing antibody responses, alongside strong Hcp1-specific IgG and measurable IFN-γ-secreting T-cell responses. Importantly, the vaccine formulations tested were well tolerated, with no adverse events after three doses. Collectively, these studies establish good manufacturing practices-compatible processes for our vaccine antigens and demonstrate the safety and immunogenicity of the subunit vaccine in non-human primates, supporting continued advancement towards a human clinical trial.
SN  - 2059-0105
ER  -