tetano
Editor, Senior Moderator
Vaccine
. 2022 Apr 21;S0264-410X(22)00366-8.
doi: 10.1016/j.vaccine.2022.03.055. Online ahead of print.
Safety and immunogenicity of monovalent H7N9 influenza vaccine with AS03 adjuvant given sequentially or simultaneously with a seasonal influenza vaccine: A randomized clinical trial
Justin R Ortiz[SUP] 1 [/SUP], Paul W Spearman[SUP] 2 [/SUP], Paul A Goepfert[SUP] 3 [/SUP], Kaitlyn Cross[SUP] 4 [/SUP], C Buddy Creech[SUP] 5 [/SUP], Wilbur H Chen[SUP] 6 [/SUP], Susan Parker[SUP] 2 [/SUP], Edgar T Overton[SUP] 3 [/SUP], Michelle Dickey[SUP] 2 [/SUP], Heather L Logan[SUP] 3 [/SUP], Ashley Wegel[SUP] 4 [/SUP], Kathleen M Neuzil[SUP] 6 [/SUP]
Affiliations
Abstract
Background: Influenza A/H7N9 viruses have pandemic potential.
Methods: We conducted an open-label, randomized, controlled trial of AS03-adjuvanted 2017 inactivated influenza A/H7N9 vaccine (H7N9 IIV) in healthy adults. Group 1 received H7N9 IIV and seasonal quadrivalent influenza vaccine (IIV4) simultaneously, followed by H7N9 IIV three weeks later. Group 2 received IIV4 alone and then two doses of H7N9 IIV at three-week intervals. Group 3 received one dose of IIV4. We used hemagglutination inhibition (HAI) and microneutralization (MN) assays to measure geometric mean titers and seroprotection (≥1:40 titer) to vaccine strains and monitored for safety.
Results: Among 149 subjects, seroprotection by HAI three weeks after H7N9 IIV dose 2 was 51% (95 %CI 37%-65%) for Group 1 and 40% (95 %CI 25%-56%) for Group 2. Seroprotection by MN at the same timepoint was 84% (95 %CI 72%-93%) for Group 1 and 74% (95 %CI 60%-86%) for Group 2. By 180 days after H7N9 IIV dose 2, seroprotection by HAI or MN was low for Groups 1 and 2. Responses measured by HAI and MN against each IIV4 strain three weeks after IIV4 vaccination were similar in all groups. Solicited local and systemic reactions were similar after a single vaccination, while those receiving simultaneous H7N9 and IIV4 had slightly more reactogenicity. There were no serious adverse events or medically-attended adverse events related to study product receipt.
Conclusions: Adjuvanted H7N9 IIV was modestly immunogenic whether administered simultaneously or sequentially with IIV4, though responses declined by 180 days. IIV4 was immunogenic regardless of schedule.
Clinical trials registration: NCT03318315.
. 2022 Apr 21;S0264-410X(22)00366-8.
doi: 10.1016/j.vaccine.2022.03.055. Online ahead of print.
Safety and immunogenicity of monovalent H7N9 influenza vaccine with AS03 adjuvant given sequentially or simultaneously with a seasonal influenza vaccine: A randomized clinical trial
Justin R Ortiz[SUP] 1 [/SUP], Paul W Spearman[SUP] 2 [/SUP], Paul A Goepfert[SUP] 3 [/SUP], Kaitlyn Cross[SUP] 4 [/SUP], C Buddy Creech[SUP] 5 [/SUP], Wilbur H Chen[SUP] 6 [/SUP], Susan Parker[SUP] 2 [/SUP], Edgar T Overton[SUP] 3 [/SUP], Michelle Dickey[SUP] 2 [/SUP], Heather L Logan[SUP] 3 [/SUP], Ashley Wegel[SUP] 4 [/SUP], Kathleen M Neuzil[SUP] 6 [/SUP]
Affiliations
- PMID: 35465983
- DOI: 10.1016/j.vaccine.2022.03.055
Abstract
Background: Influenza A/H7N9 viruses have pandemic potential.
Methods: We conducted an open-label, randomized, controlled trial of AS03-adjuvanted 2017 inactivated influenza A/H7N9 vaccine (H7N9 IIV) in healthy adults. Group 1 received H7N9 IIV and seasonal quadrivalent influenza vaccine (IIV4) simultaneously, followed by H7N9 IIV three weeks later. Group 2 received IIV4 alone and then two doses of H7N9 IIV at three-week intervals. Group 3 received one dose of IIV4. We used hemagglutination inhibition (HAI) and microneutralization (MN) assays to measure geometric mean titers and seroprotection (≥1:40 titer) to vaccine strains and monitored for safety.
Results: Among 149 subjects, seroprotection by HAI three weeks after H7N9 IIV dose 2 was 51% (95 %CI 37%-65%) for Group 1 and 40% (95 %CI 25%-56%) for Group 2. Seroprotection by MN at the same timepoint was 84% (95 %CI 72%-93%) for Group 1 and 74% (95 %CI 60%-86%) for Group 2. By 180 days after H7N9 IIV dose 2, seroprotection by HAI or MN was low for Groups 1 and 2. Responses measured by HAI and MN against each IIV4 strain three weeks after IIV4 vaccination were similar in all groups. Solicited local and systemic reactions were similar after a single vaccination, while those receiving simultaneous H7N9 and IIV4 had slightly more reactogenicity. There were no serious adverse events or medically-attended adverse events related to study product receipt.
Conclusions: Adjuvanted H7N9 IIV was modestly immunogenic whether administered simultaneously or sequentially with IIV4, though responses declined by 180 days. IIV4 was immunogenic regardless of schedule.
Clinical trials registration: NCT03318315.