دورية أكاديمية
Intranasal parainfluenza virus type 5 (PIV5)-vectored RSV vaccine is safe and immunogenic in healthy adults in a phase 1 clinical study.
العنوان: | Intranasal parainfluenza virus type 5 (PIV5)-vectored RSV vaccine is safe and immunogenic in healthy adults in a phase 1 clinical study. |
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المؤلفون: | Spearman P; Department of Pediatrics, Cincinnati Children's Hospital, 3333 Burnet Avenue, Cincinnati, OH 45229, USA.; Department of Pediatrics, University of Cincinnati College of Medicine, 3333 Burnet Avenue, Cincinnati, OH 45229, USA., Jin H; Blue Lake Biotechnology Inc., 111 Riverbend Rd., Athens, GA 30602, USA., Knopp K; Blue Lake Biotechnology Inc., 111 Riverbend Rd., Athens, GA 30602, USA., Xiao P; New Iberia Research Center, University of Louisiana at Lafayette, New Iberia, LA 70560, USA., Gingerich MC; Blue Lake Biotechnology Inc., 111 Riverbend Rd., Athens, GA 30602, USA., Kidd J; Department of Pediatrics, Cincinnati Children's Hospital, 3333 Burnet Avenue, Cincinnati, OH 45229, USA., Singh K; Department of Pediatrics, Cincinnati Children's Hospital, 3333 Burnet Avenue, Cincinnati, OH 45229, USA.; Department of Pediatrics, University of Cincinnati College of Medicine, 3333 Burnet Avenue, Cincinnati, OH 45229, USA., Tellier M; Blue Lake Biotechnology Inc., 111 Riverbend Rd., Athens, GA 30602, USA., Radziewicz H; Blue Lake Biotechnology Inc., 111 Riverbend Rd., Athens, GA 30602, USA., Wu S; Blue Lake Biotechnology Inc., 111 Riverbend Rd., Athens, GA 30602, USA., McGregor M; Blue Lake Biotechnology Inc., 111 Riverbend Rd., Athens, GA 30602, USA., Freda B; Blue Lake Biotechnology Inc., 111 Riverbend Rd., Athens, GA 30602, USA., Wang Z; Blue Lake Biotechnology Inc., 111 Riverbend Rd., Athens, GA 30602, USA., John SP; New Iberia Research Center, University of Louisiana at Lafayette, New Iberia, LA 70560, USA., Villinger FJ; New Iberia Research Center, University of Louisiana at Lafayette, New Iberia, LA 70560, USA., He B; Blue Lake Biotechnology Inc., 111 Riverbend Rd., Athens, GA 30602, USA. |
المصدر: | Science advances [Sci Adv] 2023 Oct 27; Vol. 9 (43), pp. eadj7611. Date of Electronic Publication: 2023 Oct 25. |
نوع المنشور: | Clinical Trial, Phase I; Journal Article |
اللغة: | English |
بيانات الدورية: | Publisher: American Association for the Advancement of Science Country of Publication: United States NLM ID: 101653440 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2375-2548 (Electronic) Linking ISSN: 23752548 NLM ISO Abbreviation: Sci Adv Subsets: MEDLINE |
أسماء مطبوعة: | Original Publication: Washington, DC : American Association for the Advancement of Science, [2015]- |
مواضيع طبية MeSH: | Respiratory Syncytial Virus Vaccines*/adverse effects , Respiratory Syncytial Virus Infections*/prevention & control , Parainfluenza Virus 5* , Respiratory Syncytial Virus, Human*, Humans ; Adult ; Middle Aged ; Aged ; CD8-Positive T-Lymphocytes ; Antibodies, Viral ; Viral Fusion Proteins |
مستخلص: | Respiratory syncytial virus (RSV) can lead to serious disease in infants, and no approved RSV vaccine is available for infants. This first in-human clinical trial evaluated a single dose of BLB201, a PIV5-vectored RSV vaccine administrated via intranasal route, for safety and immunogenicity in RSV-seropositive healthy adults (33 to 75 years old). No severe adverse events (SAEs) were reported. Solicited local and systemic AEs were reported by <50% of participants and were mostly mild in intensity. Vaccine virus shedding was detected in 17% of participants. Nasal RSV-specific immunoglobulin A responses were detected in 48%, the highest level observed in adults among all intranasal RSV vaccines evaluated in humans. RSV-neutralizing antibodies titers in serum rose ≥1.5-fold. Peripheral blood RSV F-specific CD4 + and CD8 + T cells increased from ≤0.06% at baseline to ≥0.26 and 0.4% after vaccination, respectively, in >93% participants. The safety and immunogenicity profile of BLB201 in RSV-seropositive adults supports the further clinical development of BLB201. |
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المشرفين على المادة: | 0 (Respiratory Syncytial Virus Vaccines) 0 (Antibodies, Viral) 0 (Viral Fusion Proteins) |
تواريخ الأحداث: | Date Created: 20231025 Date Completed: 20231027 Latest Revision: 20231103 |
رمز التحديث: | 20240628 |
مُعرف محوري في PubMed: | PMC10599610 |
DOI: | 10.1126/sciadv.adj7611 |
PMID: | 37878713 |
قاعدة البيانات: | MEDLINE |
تدمد: | 2375-2548 |
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DOI: | 10.1126/sciadv.adj7611 |