دورية أكاديمية
Immunogenicity and tolerability of a bivalent virus-like particle norovirus vaccine candidate in children from 6 months up to 4 years of age: A phase 2 randomized, double-blind trial
| العنوان: | Immunogenicity and tolerability of a bivalent virus-like particle norovirus vaccine candidate in children from 6 months up to 4 years of age: A phase 2 randomized, double-blind trial |
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| المؤلفون: | Pio López, Eduardo López-Medina, Xavier Sáez-Llorens, Rodrigo deAntonio, Taisei Masuda, Paul M. Mendelman, James Sherwood, Frank Baehner, Astrid Borkowski |
| المصدر: | Human Vaccines & Immunotherapeutics, Vol 19, Iss 1 (2023) |
| بيانات النشر: | Taylor & Francis Group, 2023. |
| سنة النشر: | 2023 |
| المجموعة: | LCC:Immunologic diseases. Allergy LCC:Therapeutics. Pharmacology |
| مصطلحات موضوعية: | norovirus, vaccine, children, immunogenicity, reactogenicity, virus-like particles, Immunologic diseases. Allergy, RC581-607, Therapeutics. Pharmacology, RM1-950 |
| الوصف: | We conducted a dose-finding phase 2 study of the HilleVax bivalent virus-like particle (VLP) vaccine candidate (HIL-214) in two cohorts of children, 6–≤12 months and 1–≤4 years of age (N = 120 per cohort), in Panama and Colombia (ClinicalTrials.gov, identifier NCT02153112). On Day 1, children randomized to one of the four equal groups received intramuscular injections of four different HIL-214 formulations containing 15/15, 15/50, 50/50, or 50/150 μg of GI.1/GII.4c genotype VLPs and 0.5 mg Al(OH)3. On Day 29, half the children in each group received a second vaccination (N = 60), while the other half received saline placebo injections to maintain the blind. VLP-specific ELISA Pan-Ig and histo-blood group binding antigen-blocking antibodies (HBGA) were measured on Days 1, 29, 57 and 210. On Day 29, after one dose, there were large Pan-Ig and HBGA responses in both age cohorts with some indication of dose-dependence, and higher geometric mean titers (GMT) in the older children. A further increase in titers was observed 28 days after a second dose in the 6–≤12-month-old groups, but less so in the 1–≤4-year-old groups; GMTs at Day 57 were broadly similar across doses and in both age groups. GMTs of Pan-Ig and HBGA persisted above baseline up to Day 210. All formulations were well tolerated with mostly mild-to-moderate transient solicited adverse events reported by parents/guardians, and no vaccine-related serious adverse events occurred. Further development of HIL-214 is warranted to protect the most susceptible young children against norovirus. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 2164-5515 2164-554X 21645515 |
| Relation: | https://doaj.org/toc/2164-5515; https://doaj.org/toc/2164-554X |
| DOI: | 10.1080/21645515.2023.2204787 |
| URL الوصول: | https://doaj.org/article/8bdc7287d8f147359bc3a2bc68a345d5 |
| رقم الأكسشن: | edsdoj.8bdc7287d8f147359bc3a2bc68a345d5 |
| قاعدة البيانات: | Directory of Open Access Journals |
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Full Text Finder | تدمد: | 21645515 2164554X |
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| DOI: | 10.1080/21645515.2023.2204787 |