دورية أكاديمية
أعرض في EDS

Intranasal parainfluenza virus type 5 (PIV5)-vectored RSV vaccine is safe and immunogenic in healthy adults in a phase 1 clinical study.

التفاصيل البيبلوغرافية
العنوان: Intranasal parainfluenza virus type 5 (PIV5)-vectored RSV vaccine is safe and immunogenic in healthy adults in a phase 1 clinical study.
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
الوصف
تدمد:2375-2548
DOI:10.1126/sciadv.adj7611