Safety, Reactogenicity, and Immunogenicity of Inactivated Monovalent Influenza A(H5N1) Virus Vaccine Administered With or Without AS03 Adjuvant

Open Forum Infectious Diseases
Wilbur H ChenKaren L Kotloff

Abstract

The national stockpile for influenza pandemic preparedness includes vaccines against an array of strains and adjuvants that could be utilized to induce immunologic priming as a pandemic wave emerges. We assessed the feasibility of a strategy that allows the flexibility of postmanufacture mixture of vaccine and adjuvant at the point of care. We conducted a randomized, double-blind, multicenter trial among healthy adults aged 18-49 years who received 2 doses of inactivated influenza A/Indonesia/05/2005 (H5N1 clade 2.2.3) virus vaccine containing either 3.75, 7.5, or 15 µg of hemagglutinin (HA) with or without AS03 adjuvant, administered 21 days apart. Subjects were observed for local (injection site) and systemic reactogenicity and adverse events. Sera were tested for hemagglutination inhibition (HAI) and microneutralization (MN) antibody levels against the homologous strain and 4 heterologous avian strains. Vaccine containing ASO3 adjuvant was associated with significantly more local reactions compared with nonadjuvanted vaccine, but these were short-lived and resolved spontaneously. Although the immune response to nonadjuvanted vaccine was poor, 2 doses of AS03-adjuvanted vaccine containing as little as 3.75 µg of HA elicited r...Continue Reading

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Citations

Apr 27, 2016·Nanomedicine : Nanotechnology, Biology, and Medicine·Weiping CaoSuryaprakash Sambhara
Nov 13, 2015·Clinical and Vaccine Immunology : CVI·Wilbur H ChenKaren L Kotloff
Jul 22, 2020·Human Vaccines & Immunotherapeutics·Ke ZhangJunqiong Huang
Mar 8, 2019·The Journal of Clinical Investigation·Eléna GonçalvesBehazine Combadière

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Clinical Trials Mentioned

NCT01317758

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