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. |
---|---|
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. |
References: | Virology. 2007 May 25;362(1):139-50. (PMID: 17254623) J Exp Med. 2002 Sep 16;196(6):859-65. (PMID: 12235218) Vaccine. 2014 May 23;32(25):3050-7. (PMID: 24717150) Rev Med Virol. 2018 Mar;28(2):. (PMID: 29316047) Clin Microbiol Rev. 2000 Jul;13(3):371-84. (PMID: 10885982) J Virol. 2013 Jan;87(1):363-71. (PMID: 23077318) Vaccine. 1990 Jun;8(3):231-6. (PMID: 2363300) J Virol. 2017 Nov 14;91(23):. (PMID: 28931689) N Engl J Med. 2023 Apr 20;388(16):1465-1477. (PMID: 37018468) PLoS One. 2012;7(11):e50144. (PMID: 23185558) J Infect Dis. 2001 Jan 1;183(1):16-22. (PMID: 11076709) J Infect. 2019 May;78(5):382-392. (PMID: 30742894) Pediatrics. 2013 Aug;132(2):e341-8. (PMID: 23878043) J Infect Dis. 2015 Dec 1;212(11):1719-25. (PMID: 25977264) N Engl J Med. 2023 Feb 16;388(7):609-620. (PMID: 36791161) J Virol. 2017 Sep 12;91(19):. (PMID: 28747496) Vaccine. 2013 Jun 10;31(26):2822-7. (PMID: 23602668) Nat Commun. 2015 Dec 21;6:10224. (PMID: 26687547) Influenza Other Respir Viruses. 2021 Jul;15(4):539-551. (PMID: 33764693) Sci Transl Med. 2015 Aug 12;7(300):300ra126. (PMID: 26268313) J Infect Dis. 2022 Dec 13;226(12):2054-2063. (PMID: 35543281) Sci Adv. 2021 Jul 2;7(27):. (PMID: 34215591) Front Immunol. 2022 Mar 29;13:823652. (PMID: 35422803) Lancet. 2017 Sep 2;390(10098):946-958. (PMID: 28689664) Vaccine. 2013 Aug 12;31(36):3756-62. (PMID: 23623857) J Infect Dis. 2004 Jan 15;189(2):233-8. (PMID: 14722887) JAMA. 2022 Oct 25;328(16):1604-1615. (PMID: 36215063) J Virol. 2013 Jan;87(1):354-62. (PMID: 23077314) J Virol. 2017 May 12;91(11):. (PMID: 28298602) Clin Vaccine Immunol. 2015 Dec 16;23(3):189-95. (PMID: 26677198) J Infect Dis. 2020 Jun 16;222(1):82-91. (PMID: 31605113) PLoS One. 2015 Mar 24;10(3):e0120355. (PMID: 25803697) J Infect Dis. 2021 Mar 29;223(6):1062-1072. (PMID: 32726422) Am J Respir Crit Care Med. 2021 Mar 1;203(5):594-603. (PMID: 32871092) N Engl J Med. 2005 Apr 28;352(17):1749-59. (PMID: 15858184) mBio. 2020 Apr 7;11(2):. (PMID: 32265331) J Infect Dis. 2004 Jul 15;190(2):373-8. (PMID: 15216475) Vaccine. 2013 Aug 20;31(37):3987-94. (PMID: 23742994) Am J Respir Crit Care Med. 2015 May 1;191(9):1040-9. (PMID: 25730467) Front Immunol. 2019 Sep 25;10:2247. (PMID: 31608061) Vaccine. 2008 Nov 25;26(50):6373-82. (PMID: 18822334) N Engl J Med. 2023 Feb 16;388(7):595-608. (PMID: 36791160) JAMA. 2003 Jan 8;289(2):179-86. (PMID: 12517228) Curr Top Microbiol Immunol. 2013;372:391-404. (PMID: 24362701) |
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: | 20240829 |
مُعرف محوري في PubMed: | PMC10599610 |
DOI: | 10.1126/sciadv.adj7611 |
PMID: | 37878713 |
قاعدة البيانات: | MEDLINE |
تدمد: | 2375-2548 |
---|---|
DOI: | 10.1126/sciadv.adj7611 |