Skip to main content
Journal cover image

Immunogenicity and safety of varying dosages of a fifth-wave influenza A/H7N9 inactivated vaccine given with and without AS03 adjuvant in healthy adults.

Publication ,  Journal Article
Jackson, LA; Stapleton, JT; Walter, EB; Chen, WH; Rouphael, NG; Anderson, EJ; Neuzil, KM; Winokur, PL; Smith, MJ; Schmader, KE; Swamy, GK ...
Published in: Vaccine
January 12, 2024

BACKGROUND: Human infections with the avian influenza A(H7N9) virus were first reported in China in 2013 and continued to occur in annual waves. In the 2016/2017 fifth wave, Yangtze River Delta (YRD) lineage viruses, which differed antigenically from those of earlier waves, predominated. METHODS: In this phase 2 double-blinded trial we randomized 720 adults ≥ 19 years of age to receive two injections of a YRD lineage inactivated A/Hong Kong/125/2017 fifth-wave H7N9 vaccine, given 21 days apart, at doses of 3.75, 7.5, and 15 µg of hemagglutinin (HA) with AS03A adjuvant and at doses of 15 and 45 µg of HA without adjuvant. RESULTS: Two doses of adjuvanted vaccine were required to induce HA inhibition (HI) antibody titers ≥ 40 in most participants. After two doses of the 15 µg H7N9 formulation, given with or without AS03 adjuvant, the proportion achieving a HI titer ≥ 40 against the vaccine strain at 21 days after the second vaccination was 65 % (95 % CI, 57 %-73 %) and 0 % (95 % CI, 0 %-4%), respectively. Among those who received two doses of the 15 µg adjuvanted formulation the proportion with HI titer ≥ 40 at 21 days after the second vaccination was 76 % (95 % CI, 66 %-84 %) in those 19-64 years of age and 49 % (95 % CI, 37 %-62 %) in those ≥ 65 years of age. Responses to the adjuvanted vaccine formulations did not vary by HA content. Antibody responses declined over time and responses against drifted H7N9 strains were diminished. Overall, the vaccines were well tolerated but, as expected, adjuvanted vaccines were associated with more frequent solicited systemic and local adverse events. CONCLUSIONS: AS03 adjuvant improved the immune responses to an inactivated fifth-wave H7N9 influenza vaccine, particularly in younger adults, but invoked lower responses to drifted H7N9 strains. These findings may inform future influenza pandemic preparedness strategies.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Vaccine

DOI

EISSN

1873-2518

Publication Date

January 12, 2024

Volume

42

Issue

2

Start / End Page

295 / 309

Location

Netherlands

Related Subject Headings

  • Virology
  • Vaccines, Inactivated
  • Squalene
  • Middle Aged
  • Influenza, Human
  • Influenza Vaccines
  • Influenza A Virus, H7N9 Subtype
  • Immunogenicity, Vaccine
  • Humans
  • Hemagglutination Inhibition Tests
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Jackson, L. A., Stapleton, J. T., Walter, E. B., Chen, W. H., Rouphael, N. G., Anderson, E. J., … Roberts, P. C. (2024). Immunogenicity and safety of varying dosages of a fifth-wave influenza A/H7N9 inactivated vaccine given with and without AS03 adjuvant in healthy adults. Vaccine, 42(2), 295–309. https://doi.org/10.1016/j.vaccine.2023.12.001
Jackson, Lisa A., Jack T. Stapleton, Emmanuel B. Walter, Wilbur H. Chen, Nadine G. Rouphael, Evan J. Anderson, Kathleen M. Neuzil, et al. “Immunogenicity and safety of varying dosages of a fifth-wave influenza A/H7N9 inactivated vaccine given with and without AS03 adjuvant in healthy adults.Vaccine 42, no. 2 (January 12, 2024): 295–309. https://doi.org/10.1016/j.vaccine.2023.12.001.
Jackson LA, Stapleton JT, Walter EB, Chen WH, Rouphael NG, Anderson EJ, et al. Immunogenicity and safety of varying dosages of a fifth-wave influenza A/H7N9 inactivated vaccine given with and without AS03 adjuvant in healthy adults. Vaccine. 2024 Jan 12;42(2):295–309.
Jackson, Lisa A., et al. “Immunogenicity and safety of varying dosages of a fifth-wave influenza A/H7N9 inactivated vaccine given with and without AS03 adjuvant in healthy adults.Vaccine, vol. 42, no. 2, Jan. 2024, pp. 295–309. Pubmed, doi:10.1016/j.vaccine.2023.12.001.
Jackson LA, Stapleton JT, Walter EB, Chen WH, Rouphael NG, Anderson EJ, Neuzil KM, Winokur PL, Smith MJ, Schmader KE, Swamy GK, Thompson AB, Mulligan MJ, Rostad CA, Cross K, Tsong R, Wegel A, Roberts PC. Immunogenicity and safety of varying dosages of a fifth-wave influenza A/H7N9 inactivated vaccine given with and without AS03 adjuvant in healthy adults. Vaccine. 2024 Jan 12;42(2):295–309.
Journal cover image

Published In

Vaccine

DOI

EISSN

1873-2518

Publication Date

January 12, 2024

Volume

42

Issue

2

Start / End Page

295 / 309

Location

Netherlands

Related Subject Headings

  • Virology
  • Vaccines, Inactivated
  • Squalene
  • Middle Aged
  • Influenza, Human
  • Influenza Vaccines
  • Influenza A Virus, H7N9 Subtype
  • Immunogenicity, Vaccine
  • Humans
  • Hemagglutination Inhibition Tests