Статья

H7N9 live attenuated influenza vaccine in healthy adults: A randomised, double-blind, placebo-controlled, phase 1 trial

L. Rudenko, I. Isakova-Sivak, A. Naykhin, I. Kiseleva, M. Stukova, M. Erofeeva, D. Korenkov, V. Matyushenko, E. Sparrow, M. Kieny,
2021

Background: H7N9 avian influenza viruses characterised by high virulence and presence of mammalian adaptation markers have pandemic potential. Specific influenza vaccines remain the main defence. We assessed the safety and immunogenicity of an H7N9 live attenuated influenza vaccine (LAIV) candidate in healthy adult volunteers. Methods: We did a phase 1, double-blind, randomised, placebo-controlled trial in Saint Petersburg, Russia. Eligible participants were healthy adults aged 18-49 years. The participants were randomised 3:1 to receive live vaccine or placebo, according to a computer-generated randomisation scheme. Two doses of vaccine or placebo were administered intranasally 28 days apart, each followed by 7 day stays in hospital. Immune responses were assessed in nasal swabs, saliva, and serum specimens collected before and 28 days after each vaccine dose. The primary outcome was the safety profile. This trial is registered with ClinicalTrials.gov, number NCT02480101. Findings: Between Oct 21, 2014, and Oct 31, 2014, 40 adults were randomised, of whom 39 (98%) were included in the per-protocol analysis (29 in the vaccine group and ten in the placebo group). The frequency of adverse events did not differ between the vaccine and placebo groups. Seroconversion of neutralising antibodies was seen in 14 participants after the first vaccine dose (48%, 95% CI 29·4-67·5) and 21 after the second vaccine dose (72%, 52·8-87·3). Immune responses were seen in 27 of 29 recipients (93%, 95% CI 77·2-99·2). Adverse effects were seen in 19 (63%) vaccine recipients and nine (90%) placebo recipients after the first dose and in nine (31%) and four (40%), respectively, after the second dose. These effects were mainly local and all were mild. Interpretation: The H7N9 LAIV was well tolerated and safe and showed good immunogenicity. Funding: WHO. © 2016 World Health Organization.

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

Метаданные

Об авторах
  • L. Rudenko
    Department of Virology, Institute of Experimental Medicine, Saint Petersburg, Russian Federation
  • I. Isakova-Sivak
    Department of Molecular Virology, Research Institute of Influenza, Saint Petersburg, Russian Federation
  • A. Naykhin
    Department of Epidemiology and Prophylaxis, Research Institute of Influenza, Saint Petersburg, Russian Federation
  • I. Kiseleva
    Department of Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland
  • M. Stukova
    Department of Health Systems and Innovation, World Health Organization, Geneva, Switzerland
  • M. Erofeeva
  • D. Korenkov
  • V. Matyushenko
  • E. Sparrow
  • M. Kieny
Название журнала
  • The Lancet Infectious Diseases
Том
  • 16
Выпуск
  • 3
Страницы
  • 303-310
Ключевые слова
  • influenza vaccine; neutralizing antibody; placebo; influenza vaccine; live vaccine; virus antibody; adult; Article; blood sampling; controlled study; coughing; dizziness; epistaxis; female; headache; hospitalization; human; immune response; immunogenicity; influenza A; Influenza A virus (H7N9); male; normal human; nose disease; nose obstruction; nose smear; outcome assessment; pharynx disease; phase 1 clinical trial; priority journal; randomized controlled trial; rhinorrhea; Russian Federation; saliva; seroconversion; side effect; sore throat; biosynthesis; blood; clinical trial; double blind procedure; immunization; immunology; Influenza A virus (H7N9); Influenza, Human; middle aged; virology; young adult; Adult; Antibodies, Viral; Double-Blind Method; Female; Humans; Immunization Schedule; Influenza A Virus, H7N9 Subtype; Influenza Vaccines; Influenza, Human; Male; Middle Aged; Vaccines, Attenuated; Young Adult
Издатель
  • Lancet Publishing Group
Тип документа
  • journal article
Тип лицензии Creative Commons
  • CC
Правовой статус документа
  • Свободная лицензия
Источник
  • scopus