Moreira Dos Santos Lívia Zignago, Rodrigues Camila Cristina Martini, Miyaji Karina Takesaki, Infante Vanessa, Picone Camila de Melo, Lara Amanda Nazareth, Eklund Carina, Kann Hanna, Dillner Joakim, Mayaud Philippe, Sartori Ana Marli Christovam
Departamento de Infectologia e Medicina Tropical, Faculdade de Medicina da Universidade de Sao Paulo (FMUSP), Sao Paulo, Brazil.
Centro de Referencia para Imunobiologicos Especiais, Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP), Sao Paulo, Brazil.
Front Cell Infect Microbiol. 2024 Dec 18;14:1451308. doi: 10.3389/fcimb.2024.1451308. eCollection 2024.
Immunocompromised persons have high risk of persistent human papillomavirus (HPV) infection and HPV-related diseases, and lower immune response to vaccines. This study evaluated the immunogenicity and safety of administering a fourth dose of quadrivalent (4v)HPV vaccine in immunosuppressed women who did not seroconvert after three doses.
An open-label, not-controlled trial included immunosuppressed women (solid organ transplant patients and women receiving treatment for SLE) who did not seroconvert to at least one of the four HPV vaccine types after three 4vHPV vaccine doses. All participants received a fourth 4vHPV vaccine dose (median 27 months after third dose). Immunogenicity was evaluated a month after the fourth dose, by measuring seroconversion rates and antibody geometric mean concentration (GMC).
Twenty-three women were included. Among women who did not seroconvert for each vaccine type after three doses, 2/10 seroconverted to HPV6, 3/10 to HPV11, 3/10 to HPV16 and 6/18 to HPV18, after the fourth 4vHPV dose. There was an increase in antibody GMC for HPV 6, 16, 18, with highest increase for HPV16 (from 6.02 to 44.63 International Units). There was no increase of anti-HPV-11. Within seven days after vaccination, only three of the 23 vaccinees reported any adverse event, none of which were classified as serious.
Although safe, the fourth 4vHPV vaccine dose led to seroconversion in only few immunosuppressed women who had not seroconverted after three doses.
免疫功能低下者持续性人乳头瘤病毒（HPV）感染及HPV相关疾病风险较高，且对疫苗的免疫反应较低。本研究评估了在接种三剂后未产生血清转化的免疫抑制女性中接种第四剂四价（4v）HPV疫苗的免疫原性和安全性。
一项开放标签、非对照试验纳入了在接种三剂4vHPV疫苗后未对四种HPV疫苗类型中的至少一种产生血清转化的免疫抑制女性（实体器官移植患者和接受系统性红斑狼疮治疗的女性）。所有参与者均接种了第四剂4vHPV疫苗（第三剂后中位时间为27个月）。在第四剂接种一个月后，通过测量血清转化率和抗体几何平均浓度（GMC）评估免疫原性。
纳入了23名女性。在三剂后未对每种疫苗类型产生血清转化的女性中，第四剂4vHPV疫苗接种后，10名中有2名对HPV6产生血清转化，10名中有3名对HPV11产生血清转化，10名中有3名对HPV16产生血清转化，18名中有6名对HPV18产生血清转化。HPV 6、16、18的抗体GMC有所增加，其中HPV16增加最多（从6.02国际单位增至44.63国际单位）。抗HPV-11没有增加。接种疫苗后七天内，23名接种者中只有3名报告了任何不良事件，均未被归类为严重不良事件。
尽管安全，但第四剂4vHPV疫苗仅使少数在接种三剂后未产生血清转化的免疫抑制女性产生了血清转化。
