A Phase 1, Double-blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of HEV-239 (Hecolin®) Vaccine in Healthy US Adults
© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprintsoup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com..
INTRODUCTION: Establishing the safety and immunogenicity of a hepatitis E virus vaccine in multiple populations could facilitate broader access and prevent maternal and infant mortality.
METHODS: We conducted a phase 1, randomized, double-blinded, placebo-controlled (4:1 vaccine: placebo) trial of 30 µg HEV-239 (Hecolin®, Xiamen Innovax Biotech Company Limited, China) administered intramuscularly in healthy US adults aged 18-45 years. Participants were vaccinated on days 1, 29, and 180. Participants reported solicited local and systemic reactions for 7 days following vaccination and were followed through 12 months after enrollment for safety and immunogenicity (IgG, IgM).
RESULTS: Solicited local and systemic reactions between treatment and placebo group were similar and overall mild. No participants experienced serious adverse events related to HEV-239. All participants receiving HEV-239 seroconverted at one month following the first dose and remained seropositive throughout the study. HEV-239 elicited a robust hepatitis E IgG response that peaked one month following the second dose (Geometric Mean Concentration (GMC) 6.16; 95% CI 4.40-8.63), was boosted with the third dose (GMC 11.50; 95% CI 7.90-16.75) and persisted through 6 months.
CONCLUSIONS: HEV-239 is safe and elicits a durable immune response through at least 6 months after the third dose in healthy US adults.
CLINICAL TRIALS REGISTRATION: NCT03827395. Safety Study of Hepatitis E Vaccine (HEV239) - Full Text View - ClinicalTrials.gov.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
The Journal of infectious diseases - (2024) vom: 27. März |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kao, Carol M [VerfasserIn] |
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| Anmerkungen: |
Date Revised 27.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT03827395 Citation Status Publisher |
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| doi: |
10.1093/infdis/jiae148 |
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| 100 | 1 | |a Kao, Carol M |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A Phase 1, Double-blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of HEV-239 (Hecolin®) Vaccine in Healthy US Adults |
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| 520 | |a © The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprintsoup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com. | ||
| 520 | |a INTRODUCTION: Establishing the safety and immunogenicity of a hepatitis E virus vaccine in multiple populations could facilitate broader access and prevent maternal and infant mortality | ||
| 520 | |a METHODS: We conducted a phase 1, randomized, double-blinded, placebo-controlled (4:1 vaccine: placebo) trial of 30 µg HEV-239 (Hecolin®, Xiamen Innovax Biotech Company Limited, China) administered intramuscularly in healthy US adults aged 18-45 years. Participants were vaccinated on days 1, 29, and 180. Participants reported solicited local and systemic reactions for 7 days following vaccination and were followed through 12 months after enrollment for safety and immunogenicity (IgG, IgM) | ||
| 520 | |a RESULTS: Solicited local and systemic reactions between treatment and placebo group were similar and overall mild. No participants experienced serious adverse events related to HEV-239. All participants receiving HEV-239 seroconverted at one month following the first dose and remained seropositive throughout the study. HEV-239 elicited a robust hepatitis E IgG response that peaked one month following the second dose (Geometric Mean Concentration (GMC) 6.16; 95% CI 4.40-8.63), was boosted with the third dose (GMC 11.50; 95% CI 7.90-16.75) and persisted through 6 months | ||
| 520 | |a CONCLUSIONS: HEV-239 is safe and elicits a durable immune response through at least 6 months after the third dose in healthy US adults | ||
| 520 | |a CLINICAL TRIALS REGISTRATION: NCT03827395. Safety Study of Hepatitis E Vaccine (HEV239) - Full Text View - ClinicalTrials.gov | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a immunization | |
| 700 | 1 | |a Rostad, Christina A |e verfasserin |4 aut | |
| 700 | 1 | |a Nolan, Lauren E |e verfasserin |4 aut | |
| 700 | 1 | |a Peters, Etza |e verfasserin |4 aut | |
| 700 | 1 | |a Kleinhenz, Jennifer |e verfasserin |4 aut | |
| 700 | 1 | |a Sherman, Jacob D |e verfasserin |4 aut | |
| 700 | 1 | |a Tippett, Ashley |e verfasserin |4 aut | |
| 700 | 1 | |a Shih, J Wai Kuo |e verfasserin |4 aut | |
| 700 | 1 | |a Yildirim, Inci |e verfasserin |4 aut | |
| 700 | 1 | |a Agbakoba, Vivien |e verfasserin |4 aut | |
| 700 | 1 | |a Beresnev, Tatiana |e verfasserin |4 aut | |
| 700 | 1 | |a Ballou, Cassandra |e verfasserin |4 aut | |
| 700 | 1 | |a Kamidani, Satoshi |e verfasserin |4 aut | |
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| 700 | 1 | |a Natrajan, Muktha |e verfasserin |4 aut | |
| 700 | 1 | |a Scherer, Erin M |e verfasserin |4 aut | |
| 700 | 1 | |a Rouphael, Nadine |e verfasserin |4 aut | |
| 700 | 1 | |a Anderson, Evan J |e verfasserin |4 aut | |
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