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Peer-reviewedCC BY 4.0Frontiers in Immunology

Immunogenicity and safety of trivalent inactivated influenza vaccine in adults living with HIV compared with HIV-uninfected adults: a study from China

  • Jinfeng Su1,2
  • Kai Gao3
  • Shasha Han4
  • Xuewen Tang3
  • Xue Guo5,6
  • Hui Liang3
  • Xiaoqin Liu4
  • Xiaoteng Xu5
  • Jun Yan7
  • Ye Qiu5
  • Ye Yao8
  • Dingyan Yan9
6 more authors
  • Baiqing Zhao10
  • Kexing Zhou10
  • Chenlu Xu11
  • Xiaohua Qi3,12
  • Yehong Wu13,6
  • Jianhua Yu14
14 affiliations
  1. 1Peking University
  2. 2Department of Marketing and Product Planning, China National Biotec Group Company Limited
  3. 3Department of Immunization Program, Zhejiang Provincial Center for Disease Control and Prevention
  4. 4Medical Affairs Department, China National Biotec Group Company Limited
  5. 5Medical Affairs Department, Changchun Institute of Biological Products Co., Ltd
  6. 6State Key Laboratory of Novel Vaccines for Emerging Infectious Diseases
  7. 7Second Department of Infectious Diseases, Hangzhou Xixi Hospital of Hangzhou Medical College
  8. 8School of Public Health, Fudan University
  9. 9Second Department of Hepatology, Hangzhou Xixi Hospital of Hangzhou Medical College
  10. 10Emergency Department, Hangzhou Xixi Hospital of Hangzhou Medical College
  11. 11Department of Infection Prevention and Control, Hangzhou Xixi Hospital of Hangzhou Medical College
  12. 12Zhejiang Key Lab of Vaccine, Infectious Disease Prevention and Control
  13. 13Research and Development Department, Changchun Institute of Biological Products Co., Ltd
  14. 14Department of Infectious Diseases, Hangzhou Xixi Hospital of Hangzhou Medical College
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Abstract

Objective: To evaluate the immunogenicity and safety of trivalent inactivated influenza vaccine (IIV3) in adults aged ≥18 years living with HIV and to provide evidence supporting influenza vaccination in this population in China.

Methods: This single-center, open-label comparative analysis was derived from a larger three-arm clinical study. For the present comparative analysis, 472 vaccinated participants were planned, including 236 adults living with HIV (Group 1) and 236 age- and sex-comparable HIV-uninfected adults (Group 2). Participants in both groups received one dose of IIV3 (0.5 mL) on Day 0. Blood samples were collected before and 28 days after vaccination for hemagglutination inhibition (HI) antibody testing against A(H1N1), A(H3N2), and B/Victoria strains. Immunogenicity endpoints included seroconversion rate, seroprotection rate, geometric mean titer (GMT), and geometric mean increase (GMI). Safety was assessed by monitoring solicited and unsolicited adverse events (AEs) and serious adverse events (SAEs) during 6 months of follow-up. An unvaccinated cohort of adults living with HIV from the original trial was included only for an exploratory, descriptive analysis of influenza-like illness (ILI), without assessment of vaccine efficacy.

Results: A total of 489 participants were enrolled, including 237 in Group 1 and 252 in Group 2. At 28 days post-vaccination, seroconversion rates did not differ significantly between Group 1 and Group 2 for A(H1N1) (91.00% vs. 86.69%, P > 0.05), but significantly lower for A(H3N2) (49.50% vs. 89.52%) and B/Victoria (40.00% vs. 64.52%) (both P < 0.001). Seroprotection rates were also lower in Group 1 than in Group 2 for A(H1N1), A(H3N2), and B/Victoria (94.00% vs. 97.98%, 63.50% vs. 97.18%, and 40.50% vs. 68.55%, respectively). Post-vaccination GMTs were significantly lower in Group 1 for all three strains (all P < 0.001). GMI was higher for A(H1N1) but lower for A(H3N2) and B/Victoria in Group 1 than in Group 2 (all P < 0.001). Multivariable analyses showed that HIV infection remained independently associated with several measures of vaccine-induced immune responses after adjustment for demographic and clinical factors, particularly for A(H3N2). IIV3 was generally safe and well tolerated. Most AEs were mild in severity, and no Grade 4 adverse reactions or vaccine-related SAEs were reported. During the period from 29 days to 6 months after vaccination, few influenza-like illness events were reported among vaccinated and unvaccinated participants living with HIV; these findings were descriptive and were not used to assess vaccine efficacy against influenza.

Conclusion: Adults living with HIV developed substantial antibody responses following IIV3 vaccination, although the magnitude of response varied across influenza strains. A(H1N1) seroconversion was high in adults living with HIV, whereas responses to A(H3N2) and B/Victoria were generally lower than those in HIV-uninfected adults. HIV infection remained associated with reduced vaccine-induced immune responses for several strain-specific outcomes after multivariable adjustment, with associations particularly evident for A(H3N2). IIV3 was safe and well tolerated, supporting current recommendations for influenza vaccination in adults living with HIV.

Clinical trial registration: https://www.chictr.org.cn/showprojEN.html?proj=255613 , identifier ChiCTR2500112191.

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Cite

BibTeXRIS
BibTeX
@article{su2026immunogenicity,
  title = {{Immunogenicity and safety of trivalent inactivated influenza vaccine in adults living with HIV compared with HIV-uninfected adults: a study from China}},
  author = {Jinfeng Su and Kai Gao and Shasha Han and Xuewen Tang and Xue Guo and Hui Liang and Xiaoqin Liu and Xiaoteng Xu and Jun Yan and Ye Qiu and Ye Yao and Dingyan Yan and Baiqing Zhao and Kexing Zhou and Chenlu Xu and Xiaohua Qi and Yehong Wu and Jianhua Yu},
  journal = {Frontiers in Immunology},
  year = {2026},
  month = oct,
  doi = {10.3389/fimmu.2026.1945123},
  url = {https://www.frontiersin.org/articles/10.3389/fimmu.2026.1945123/full},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Immunogenicity and safety of trivalent inactivated influenza vaccine in adults living with HIV compared with HIV-uninfected adults: a study from China
AU  - Jinfeng Su
AU  - Kai Gao
AU  - Shasha Han
AU  - Xuewen Tang
AU  - Xue Guo
AU  - Hui Liang
AU  - Xiaoqin Liu
AU  - Xiaoteng Xu
AU  - Jun Yan
AU  - Ye Qiu
AU  - Ye Yao
AU  - Dingyan Yan
AU  - Baiqing Zhao
AU  - Kexing Zhou
AU  - Chenlu Xu
AU  - Xiaohua Qi
AU  - Yehong Wu
AU  - Jianhua Yu
PY  - 2026
DA  - 2026/10/16
JO  - Frontiers in Immunology
DO  - 10.3389/fimmu.2026.1945123
UR  - https://www.frontiersin.org/articles/10.3389/fimmu.2026.1945123/full
AB  - Objective: To evaluate the immunogenicity and safety of trivalent inactivated influenza vaccine (IIV3) in adults aged ≥18 years living with HIV and to provide evidence supporting influenza vaccination in this population in China.  Methods: This single-center, open-label comparative analysis was derived from a larger three-arm clinical study. For the present comparative analysis, 472 vaccinated participants were planned, including 236 adults living with HIV (Group 1) and 236 age- and sex-comparable HIV-uninfected adults (Group 2). Participants in both groups received one dose of IIV3 (0.5 mL) on Day 0. Blood samples were collected before and 28 days after vaccination for hemagglutination inhibition (HI) antibody testing against A(H1N1), A(H3N2), and B/Victoria strains. Immunogenicity endpoints included seroconversion rate, seroprotection rate, geometric mean titer (GMT), and geometric mean increase (GMI). Safety was assessed by monitoring solicited and unsolicited adverse events (AEs) and serious adverse events (SAEs) during 6 months of follow-up. An unvaccinated cohort of adults living with HIV from the original trial was included only for an exploratory, descriptive analysis of influenza-like illness (ILI), without assessment of vaccine efficacy.  Results: A total of 489 participants were enrolled, including 237 in Group 1 and 252 in Group 2. At 28 days post-vaccination, seroconversion rates did not differ significantly between Group 1 and Group 2 for A(H1N1) (91.00% vs. 86.69%, P > 0.05), but significantly lower for A(H3N2) (49.50% vs. 89.52%) and B/Victoria (40.00% vs. 64.52%) (both P < 0.001). Seroprotection rates were also lower in Group 1 than in Group 2 for A(H1N1), A(H3N2), and B/Victoria (94.00% vs. 97.98%, 63.50% vs. 97.18%, and 40.50% vs. 68.55%, respectively). Post-vaccination GMTs were significantly lower in Group 1 for all three strains (all P < 0.001). GMI was higher for A(H1N1) but lower for A(H3N2) and B/Victoria in Group 1 than in Group 2 (all P < 0.001). Multivariable analyses showed that HIV infection remained independently associated with several measures of vaccine-induced immune responses after adjustment for demographic and clinical factors, particularly for A(H3N2). IIV3 was generally safe and well tolerated. Most AEs were mild in severity, and no Grade 4 adverse reactions or vaccine-related SAEs were reported. During the period from 29 days to 6 months after vaccination, few influenza-like illness events were reported among vaccinated and unvaccinated participants living with HIV; these findings were descriptive and were not used to assess vaccine efficacy against influenza.  Conclusion: Adults living with HIV developed substantial antibody responses following IIV3 vaccination, although the magnitude of response varied across influenza strains. A(H1N1) seroconversion was high in adults living with HIV, whereas responses to A(H3N2) and B/Victoria were generally lower than those in HIV-uninfected adults. HIV infection remained associated with reduced vaccine-induced immune responses for several strain-specific outcomes after multivariable adjustment, with associations particularly evident for A(H3N2). IIV3 was safe and well tolerated, supporting current recommendations for influenza vaccination in adults living with HIV.  Clinical trial registration: https://www.chictr.org.cn/showprojEN.html?proj=255613 , identifier ChiCTR2500112191.
SN  - 1664-3224
ER  -