tetano
Editor, Senior Moderator
Immun Ageing
. 2023 Jul 1;20(1):30.
doi: 10.1186/s12979-023-00355-7. Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trial
Kenneth E Schmader[SUP] 1 2 [/SUP], Christine K Liu[SUP] 3 4 5 [/SUP], Brendan Flannery[SUP] 6 [/SUP], Wes Rountree[SUP] 7 [/SUP], Heidi Auerbach[SUP] 5 [/SUP], Elizabeth D Barnett[SUP] 8 [/SUP], Elizabeth P Schlaudecker[SUP] 9 [/SUP], Christopher A Todd[SUP] 7 [/SUP], Marek Poniewierski[SUP] 7 [/SUP], Mary A Staat[SUP] 9 [/SUP], Theresa Harrington[SUP] 10 [/SUP], Rongxia Li[SUP] 10 [/SUP], Karen R Broder[SUP] 10 [/SUP], Emmanuel B Walter[SUP] 7 11 [/SUP]
Affiliations
Background: Adjuvanted inactivated influenza vaccine (aIIV) and high-dose inactivated influenza vaccine (HD-IIV) are U.S.-licensed for adults aged ≥ 65 years. This study compared serum hemagglutination inhibition (HAI) antibody titers for the A(H3N2) and A(H1N1)pdm09 and B strains after trivalent aIIV3 and trivalent HD-IIV3 in an older adult population.
Results: The immunogenicity population included 342 participants who received aIIV3 and 338 participants who received HD-IIV3. The proportion of participants that seroconverted to A(H3N2) vaccine strains after allV3 (112 participants [32.8%]) was inferior to the proportion of participants that seroconverted after HD-IIV3 (130 participants [38.5%]) at day 29 after vaccination (difference, - 5.8%; 95%CI, - 12.9% to 1.4%). There were no significant differences between the vaccine groups in percent seroconversion to A(H1N1)pdm09 or B vaccine strains, in percent seropositivity for any of the strains, or in post-vaccination GMT for the A(H1N1)pdm09 strain. The GMTs for the post-vaccination A(H3N2) and B strains were higher after HD-IIV than after aIIV3.
Conclusions: Overall immune responses were similar after aIIV3 and HD-IIV3. For the primary outcome, the aIIV3 seroconversion rate for H3N2 did not meet noninferiority criteria compared with HD-IIV3, but the HD-IIV3 seroconversion rate was not statistically superior to the aIIV3 seroconversion rate.
Trial registration: ClinicalTrials.gov Identifier: NCT03183908.
Keywords: Adjuvanted influenza vaccine; Aged; High dose influenza vaccine; Immunogenicity; Influenza vaccine.
. 2023 Jul 1;20(1):30.
doi: 10.1186/s12979-023-00355-7. Immunogenicity of adjuvanted versus high-dose inactivated influenza vaccines in older adults: a randomized clinical trial
Kenneth E Schmader[SUP] 1 2 [/SUP], Christine K Liu[SUP] 3 4 5 [/SUP], Brendan Flannery[SUP] 6 [/SUP], Wes Rountree[SUP] 7 [/SUP], Heidi Auerbach[SUP] 5 [/SUP], Elizabeth D Barnett[SUP] 8 [/SUP], Elizabeth P Schlaudecker[SUP] 9 [/SUP], Christopher A Todd[SUP] 7 [/SUP], Marek Poniewierski[SUP] 7 [/SUP], Mary A Staat[SUP] 9 [/SUP], Theresa Harrington[SUP] 10 [/SUP], Rongxia Li[SUP] 10 [/SUP], Karen R Broder[SUP] 10 [/SUP], Emmanuel B Walter[SUP] 7 11 [/SUP]
Affiliations
- PMID: 37393237
- PMCID: PMC10314373
- DOI: 10.1186/s12979-023-00355-7
Background: Adjuvanted inactivated influenza vaccine (aIIV) and high-dose inactivated influenza vaccine (HD-IIV) are U.S.-licensed for adults aged ≥ 65 years. This study compared serum hemagglutination inhibition (HAI) antibody titers for the A(H3N2) and A(H1N1)pdm09 and B strains after trivalent aIIV3 and trivalent HD-IIV3 in an older adult population.
Results: The immunogenicity population included 342 participants who received aIIV3 and 338 participants who received HD-IIV3. The proportion of participants that seroconverted to A(H3N2) vaccine strains after allV3 (112 participants [32.8%]) was inferior to the proportion of participants that seroconverted after HD-IIV3 (130 participants [38.5%]) at day 29 after vaccination (difference, - 5.8%; 95%CI, - 12.9% to 1.4%). There were no significant differences between the vaccine groups in percent seroconversion to A(H1N1)pdm09 or B vaccine strains, in percent seropositivity for any of the strains, or in post-vaccination GMT for the A(H1N1)pdm09 strain. The GMTs for the post-vaccination A(H3N2) and B strains were higher after HD-IIV than after aIIV3.
Conclusions: Overall immune responses were similar after aIIV3 and HD-IIV3. For the primary outcome, the aIIV3 seroconversion rate for H3N2 did not meet noninferiority criteria compared with HD-IIV3, but the HD-IIV3 seroconversion rate was not statistically superior to the aIIV3 seroconversion rate.
Trial registration: ClinicalTrials.gov Identifier: NCT03183908.
Keywords: Adjuvanted influenza vaccine; Aged; High dose influenza vaccine; Immunogenicity; Influenza vaccine.