High titre neutralising antibodies to influenza after oral tablet immunisation: a phase 1, randomised, placebo-controlled trial

The Lancet Infectious Diseases
David LiebowitzSean N Tucker

Abstract

Most influenza vaccines are manufactured in eggs, and the inactivated virus is purified for injection. For a seasonal influenza product, manufacturing, distribution, and perhaps even vaccine coverage, would be greatly improved with an oral tablet alternative made in cell culture. We aimed to assess the safety and immunogenicity of an oral tablet vaccine against influenza A H1N1 in healthy adults. At a single site, we did a randomised, double-blind, placebo-controlled trial of a monovalent influenza A H1N1 vaccine to establish the safety and immunogenicity of a recombinant, non-replicating, adenovirus vector expressing haemagglutinin and double-stranded RNA adjuvant delivered orally by tablets. Participants had to have an initial haemagglutination inhibition titre of at most 1/20, be aged between 18 and 49 years, and be in good health. We randomly assigned (1:1) participants to receive either a single oral dose of vaccine or placebo. Randomisation was done by computer-generated assignment, and study drug was distributed with concealed identity to the masked staff by an unmasked pharmacist. Investigative site staff, people directly involved with immunological assays or the assessment of clinical safety, and participants were mask...Continue Reading

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Citations

Oct 19, 2016·Human Vaccines & Immunotherapeutics·Sarah MarshallAnne C Moore
Sep 4, 2015·The Lancet Infectious Diseases·Patricia E Fast, Josephine H Cox
Apr 14, 2016·Infectious Diseases and Therapy·Ciaran D ScallanSean N Tucker
Apr 23, 2016·Human Vaccines & Immunotherapeutics·Chao Zhang, Dongming Zhou
Jul 1, 2016·Current Opinion in Infectious Diseases·Philippe VanhemsElodie Munier-Marion
Jul 28, 2016·Human Vaccines & Immunotherapeutics·Rory D de Vries, Guus F Rimmelzwaan
Apr 7, 2018·Human Vaccines & Immunotherapeutics·Zhichao ZhengMingtao Zeng
Apr 27, 2018·Expert Review of Vaccines·Amandine Gagneux-BrunonElisabeth Botelho-Nevers
Aug 11, 2018·Expert Review of Vaccines·Claire P MattisonAron J Hall
Jun 6, 2020·Expert Review of Vaccines·Jordan E CatesAron J Hall
Feb 16, 2020·Nature Reviews. Drug Discovery·Chih-Jen WeiGary J Nabel
May 26, 2018·Vaccines·Sarah Sebastian, Teresa Lambe
May 30, 2020·Annual Review of Pharmacology and Toxicology·Jacob William CoffeyGiovanni Traverso
Nov 12, 2020·Microorganisms·Steven RockmanIan G Barr
Jan 11, 2021·Advanced Drug Delivery Reviews·Deborah PushparajahRoderick A Slavcev
Jan 10, 2021·Advanced Drug Delivery Reviews·Jeroen PolletUlrich Strych
Mar 6, 2021·Expert Review of Vaccines·Kristina Jonsson-SchmunkMaria A Croyle
Aug 2, 2017·Clinical Therapeutics·Nicolas W Cortes-PenfieldRobert L Atmar
Apr 30, 2021·Biotechnology and Bioengineering·Sofia B CarvalhoRicardo J S Silva
Jan 25, 2020·The Lancet Infectious Diseases·Larisa Rudenko, Irina Isakova-Sivak
Jul 28, 2021·Nature Reviews. Immunology·Ed C Lavelle, Ross W Ward
Aug 21, 2021·The Journal of Allergy and Clinical Immunology. in Practice·Richard B KennedyGregory A Poland
Oct 7, 2021·Expert Review of Vaccines·Badriyah Shadid AlotaibiGhulam Murtaza

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