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  • EP097/#28  Immunogenicity of AS04-adjuvanted vaccine in females with existing high-risk HPV infection at first vaccination: pooled analysis of individual data from four large clinical trials worldwide

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AS03. Cervical cancer
EP097/#28  Immunogenicity of AS04-adjuvanted vaccine in females with existing high-risk HPV infection at first vaccination: pooled analysis of individual data from four large clinical trials worldwide
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  1. Tianmeng Wen1,
  2. Chenghao Pan1,
  3. Xiaoqian Xu2,
  4. Yushu Feng1,
  5. Shangying Hu1 and
  6. Fanghui Zhao1
  1. 1National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Department of Epidemiology, Beijing, China
  2. 2National Clinical Research Center for Digestive Diseases, Beijing Friendship Hospital, Capital Medical University, Department of Clinical Epidemiology and Ebm Unit, Beijing, China

Abstract

Introduction HPV vaccine protection has been proved in HPV naïve females, whereas there is a deficiency in the evidence of benefit in females with ongoing HR-HPV infection.

Methods We pooled data from four large-scale RCTs (HPV-008 NCT00122681, HPV-039 NCT00779766, VIVIANE NCT00294047, and HPV-032/063 NCT00316693) to evaluate the immune response in females with HPV-16/18 infection at first vaccination (determined by DNA status). Seropositivity was defined as an antibody titer greater than or equal to assay cut-off: 7 ELISA units (EU)/mL for HPV-18 and 8 EU/mL for HPV-16.

Results At Month 7 after the first dose, the HPV-16/18 IgG GMTs reached peaks in both HPV-16/18 positive and negative females, and then slowly declined in a similar dynamic pattern. For antibodies in females DNA-positive for the considered HPV type at baseline, lower HPV16 GMTs were observed at Month 7 (GMT ratio 0.71 [95% CI: 0.60,0.83]) and Month 12 (0.78 [0.66,0.93]) in females HPV-16 positive, compared with those negative. Lower HPV-18 GMTs were also observed in HPV-18 positive females compared with those negative at Month 7 (0.74 [0.58,0.94]) and Month 12 (0.76 [0.59,0.99]). For antibodies in those HPV DNA-positive for one vaccine type but negative for the considered HPV type, no statistically significant differences in HPV-16/18 GMTs were observed between DNA-positive and negative females. However, until Month 48, the GMTs remained at much higher levels than those before vaccination, and the seropositive rates maintained at approximately 100%.

View this table:
Abstract EP097/#28 Table 1

HPV-16/18 IgG GMT ratio grouped by baseline HPV-DNA status

Abstract EP097/#28 Figure 1
Abstract EP097/#28 Figure 1

HPV-16/18 IgG GMTs grouped by baseline HPV-DNA status. A, HPV-16 IgG GMT grouped by baseline HPV-16 DNA status; B, HPV-18 IgG GMT grouped by baseline HPV-18 DNA status; C, HPV-16 IgG GMT grouped by baseline HPV-18 DNA status; D, HPV-18 IgG GMT grouped by baseline HPV-16 DNA status

Conclusion/Implications HPV vaccine induced high and sustained immunity in women with existing HR-HPV infection. The results of our study would support vaccination recommendations and policy-making.

https://doi.org/10.1136/ijgc-2023-IGCS.201

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