H7N9 live attenuated influenza vaccine in healthy adults: a randomised, double-blind, placebo-controlled, phase 1 trial
| Autor: | Irina Isakova-Sivak, Daniil Korenkov, Irina Kiseleva, Larisa Rudenko, Victoria Matyushenko, Marina Stukova, Marie-Paule Kieny, Mariana Erofeeva, Anatoly Naykhin, Erin Sparrow |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Adult
Male 0301 basic medicine medicine.medical_specialty Antibodies Viral Influenza A Virus H7N9 Subtype Vaccines Attenuated medicine.disease_cause Placebo Young Adult 03 medical and health sciences 0302 clinical medicine Double-Blind Method Internal medicine Influenza Human medicine Humans Live attenuated influenza vaccine 030212 general & internal medicine Seroconversion Adverse effect Immunization Schedule Attenuated vaccine business.industry Immunogenicity Middle Aged Influenza A virus subtype H5N1 030104 developmental biology Infectious Diseases Influenza Vaccines Immunology Female Nasal administration business |
| Zdroj: | The Lancet Infectious Diseases. 16:303-310 |
| ISSN: | 1473-3099 |
| DOI: | 10.1016/s1473-3099(15)00378-3 |
| Popis: | Summary 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. |
| Databáze: | OpenAIRE |
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