Safety and immunogenicity of Multimeric-001 (M-001) followed by seasonal quadrivalent inactivated influenza vaccine in young adults – A randomized clinical trial

Atmar R.L.; Bernstein D.I.; Winokur P.Frey S.E.Angelo L.S.Bryant C.Ben-Yedidia T.Roberts P.C.El Sahly H.M.Keitel W.A.

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Safety and immunogenicity of Multimeric-001 (M-001) followed by seasonal quadrivalent inactivated influenza vaccine in young adults – A randomized clinical trial

机译：Safety and immunogenicity of Multimeric-001 (M-001) followed by seasonal quadrivalent inactivated influenza vaccine in young adults – A randomized clinical trial

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© 2023 Elsevier LtdBackground: The continuing evolution of influenza viruses poses a challenge to vaccine prevention, highlighting the need for a universal influenza vaccine. We evaluated the safety and immunogenicity of one such candidate, Multimeric-001 (M-001), when used as a priming vaccine prior to administration of quadrivalent inactivated influenza vaccine (IIV4). Methods: Healthy adults 18 to 49 years of age were enrolled in a phase 2 randomized, double-blind placebo-controlled trial. Participants received two doses of either 1.0-mg M-001 or saline placebo (60 per study arm) on Days 1 and 22 followed by a single dose of IIV4 on about Day 172. Safety, reactogenicity, cellular immune responses and influenza hemagglutination inhibition (HAI) and microneutralization (MN) were assessed. Results: The M-001 vaccine was safe and had an acceptable reactogenicity profile. Injection site tenderness (39% post-dose 1, 29% post-dose 2) was the most common reaction after M-001 administration. Polyfunctional CD4+ T cell responses (perforin-negative, CD107α-negative, TNF-α+, IFN-γ+, with or without IL-2) to the pool of M-001 peptides increased significantly from baseline to two weeks after the second dose of M-001, and this increase persisted through Day 172. However, there was no enhancement of HAI or MN antibody responses among M-001 recipients following IIV4 administration. Conclusions: M-001 administration induced a subset of polyfunctional CD4+ T cells that persisted through 6 months of follow-up, but it did not improve HAI or MN antibody responses to IIV4. (clinicaltrials.gov NCT03058692).

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《Vaccine》 |2023年第16期|2716-2722|共7页
作者
Atmar R.L.; Bernstein D.I.; Winokur P.Frey S.E.Angelo L.S.Bryant C.Ben-Yedidia T.Roberts P.C.El Sahly H.M.Keitel W.A.;
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Saint Louis University School of Medicine;

Emmes Corporation;

BiondVax Pharmaceuticals Ltd.Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases National Institutes of HealthDepartment of Medicine Baylor College of MedicineDepartment of Molecular Virology & Microbiology Baylor College of MedicineCincinnati Children's Hospital Medical Center University of Cincinnati College of MedicineUniversity of Iowa College of Medicine;

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正文语种英语
中图分类医学免疫学;
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Influenza vaccine; M-001; Polyfunctional CD4+ T cells; Randomized clinical trial; Serology;

Safety and immunogenicity of Multimeric-001 (M-001) followed by seasonal quadrivalent inactivated influenza vaccine in young adults – A randomized clinical trial

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