"H5N8 vaccine"

Safety and Immunogenicity of Influenza A/H5N8 Virus Vaccine in Healthy Adults: Durability and Cross-reactivity of Antibody Responses. Influenza A/H5N8 viruses infect poultry and wild birds in many countries. In 2021, the first human A/H5N8 cases were reported. We conducted a phase I, cohort-randomized, double-blind, controlled trial of inactivated influenza A/H5N8 vaccine (clade 2.3.4.4c , followed by the one-dose AS03 group, the MF59 groups, and the non-adjuvanted groups. Antibody levels returned to baseline 12 months after the second vaccination in all groups except the 15 μg AS03-adjuvanted group. Cross-reactive antibodies to clade 2.3.4.4b strains isolated from recent human cases were demonstrated in a subset of both 15 μg adjuvanted groups. Two doses of influenza A/H5N8 vaccine were

Intervention/treatment Experimental: a VN with AS03 Adjuvant, then gf/WA with AS03 AdjuvantSingle dose of Vietnam (VN) (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/Washington (WA) (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22 Biological: AS03 adjuvant0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose Experimental: b IN with AS03 Adjuvant, then gf/WA with AS03 AdjuvantSingle dose of IN (H5N1) vaccine with AS03 Adjuvant (Dose 1 = Day 1), followed by single dose of gf/WA (H5N8) vaccine with AS03 Adjuvant (Dose 2 = Day 22

: AS03 Drug: MF59 adjuvant Biological: Monovalent Influenza A/H5N8 vaccine Phase 1 Detailed Description: This is a Phase I cohort-randomized, double-blind, controlled trial designed to assess the safety, reactogenicity, and immunogenicity of a monovalent inactivated influenza A/H5N8 virus vaccine manufactured by bioCSL administered at different dosages (3.75 and 15 mcg of HA per dose) given participation duration is approximately 13 months. Subjects will be enrolled in one of two cohorts, and within each cohort subjects will be randomized in a 2:2:1 ratio. Subjects in Cohort 1 will be randomly assigned to 1 of 3 treatment arms to receive two doses of the A/H5N8 vaccine at varying antigen dosages (3.75 or 15 mcg HA) with AS03 (30-76 subjects per treatment arm), or to a comparator arm receiving

Phase Avian Influenza Influenza Drug: AS03 Drug: MF59 adjuvant Biological: Monovalent Influenza A/H5N8 vaccine Phase 1 Detailed Description: This is a Phase I randomized, double-blind, controlled trial in 275 males and non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all eligibility criteria which include screening hematology, chemistry