Статья

Safety and immunogenicity of live attenuated influenza reassortant H5 vaccine (phase I-II clinical trials)

L. Rudenko, J. Desheva, S. Korovkin, A. Mironov, A. Rekstin, E. Grigorieva, S. Donina, A. Gambaryan, A. Katlinsky,
2021

Objective: Our studies aimed to evaluate in clinical trials the safety and immunogenicity of an H5 live influenza vaccine candidate obtained using classical reassortment techniques from a low pathogenicity avian influenza (LPAI) A/Duck/Potsdam/1402-6/86(H5N2) virus and the cold-adapted (ca) donor strain A/Leningrad/134/17/57(H2N2). Methods: During Phase I-II clinical trials, volunteers received intranasally two doses of reassortant influenza vaccine strain A/17/Duck/Potsdam/86/92 (H5N2) 21 days apart. Clinical examination of all vaccinees was conducted 7 days post-vaccination. Serum antibody responses were measured by hemagglutination-inhibition and microneutralization and local antibodies were estimated using an enzyme-linked immunosorbent assay test. Results: The vaccine was safe and of low reactogenicity with no febrile reactions. After revaccination 47·1-54·85 of subjects showed ≥fourfold seroconversions of Hamagglutination inhibition (HAI) antibodies to the hemagglutinin (HA) antigen of the A/17/Duck/Potsdam/86/ 92 (H5N2) virus and 29·4-30·8% were seroconverted to the HA antigen of the reverse genetics reassortant A/Indonesia/05/2005 × PR8 IBCDC-RG (H5N1). Virus-neutralizing antibody levels in sera of volunteers were similar to those shown in HAI test. The virus-specific nasal IgA antibody response after two vaccine doses demonstrated significant increases of ≥fourfold rise SIgA antibodies (65%) geometrical mean titers (16·0) and a rise in SIgA antibodies (2·8) compared with one dose. Conclusion: The live attenuated influenza vaccine candidate prepared using the LPAI A(H5N2) strain was well tolerated and elicited serum and local immune responses. There was evident cross-reactivity to the A(H5N1) strain in the HAI test. © 2008 Blackwell Publishing Ltd.

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  • 1. Version of Record от 2021-04-27

Метаданные

Об авторах
  • L. Rudenko
    Institute of Experimental Medicine, Russian Academy of Medical Sciences, Saint Petersburg, Russian Federation
  • J. Desheva
    Microgen, Moscow, Russian Federation
  • S. Korovkin
    M.P.Chumakov Institute of Poliomyelitis and Viral Encephalitides, Russian Academy of Medical Sciences, Moscow, Russian Federation
  • A. Mironov
    Virology Department, Institute of Experimental Medicine, Russian Academy of Medical Sciences, Acad. Pavlov's Street, Saint Petersburg 197376, Russian Federation
  • A. Rekstin
  • E. Grigorieva
  • S. Donina
  • A. Gambaryan
  • A. Katlinsky
Название журнала
  • Influenza and other Respiratory Viruses
Том
  • 2
Выпуск
  • 6
Страницы
  • 203-209
Ключевые слова
  • influenza vaccine; live vaccine; placebo; adult; antibody blood level; antibody response; antibody titer; article; binding affinity; cellular immunity; clinical trial; controlled clinical trial; controlled study; cross reaction; double blind procedure; drug dose comparison; drug efficacy; drug safety; drug tolerability; enzyme linked immunosorbent assay; erythrocyte; female; fever; hemagglutination inhibition test; human; human experiment; immunogenicity; influenza; Influenza virus A H5N2; male; nausea; nonhuman; normal human; phase 1 clinical trial; phase 2 clinical trial; phenotype; priority journal; revaccination; seroconversion; single drug dose; T lymphocyte; throat irritation; virus strain
Издатель
  • Blackwell Publishing
Тип документа
  • journal article
Источник
  • scopus