SPERANZA project: HPV vaccination after treatment for CIN2+

Ghelardi, Alessandro; Parazzini, Fabio; Martella, Francesca; Pieralli, Annalisa; Bay, Paola; Tonetti, A.; Svelato, Alessandro; Bertacca, Gloria; Lombardi, Stefania; Joura, Elmar A.

doi:10.1016/j.ygyno.2018.08.033

Cited by 148 publications

(167 citation statements)

References 17 publications

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“…The first evidence that HPV vaccination also reduces posttreatment relapse is becoming available. As well as the previous clinical observations of Kang et al, Ghelardi et al showed that posttreatment vaccination of women resulted in an 81.2% (95% confidence interval 34.3-95.7%) risk reduction of clinical disease relapse (Ghelardi et al, 2018;Kang et al, 2013). These observations are an additional argument for vaccination of HPV-positive women, as they show an additional individual benefit in the case of disease progression.…”

Section: Vaccination Reduces the Risk Of Clinical Disease Relapse Aftmentioning

confidence: 68%

HPV vaccination: Are we overlooking additional opportunities to control HPV infection and transmission?

Vorsters

Damme

Bosch

2019

International Journal of Infectious Diseases

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Human papillomavirus virus-like particles (HPV VLPs) have distinctive immunogenic properties that generate a durable antibody response, producing high-quality neutralizing antibodies. By vaccination, i.e., intramuscular injection of these HPV VLPs, the viral survival strategy of avoiding exposure to the systemic immune system is completely overruled, and large amounts of vaccine-induced systemic antibodies are generated. These systemic circulating antibodies are easily transuded to the genital mucosa and are detectable in female genital secretions. It is well accepted that these antibodies interact with the virions presented by an infected partner and inhibit infection. However, much less attention has been paid to the role of anti-HPV vaccine-induced antibodies in an HPV-infected individual where infectious virions are encountered by neutralizing antibodies in mucosal secretions. There is a clear need to further investigate and document this role. Indeed, if HPV vaccination of HPV-infected women has an effect on HPV transmission, auto-inoculation, and relapse after treatment, this may influence how we model, assess, and implement HPV vaccination programmes.

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Section: Vaccination Reduces the Risk Of Clinical Disease Relapse Aftmentioning

confidence: 68%

HPV vaccination: Are we overlooking additional opportunities to control HPV infection and transmission?

Vorsters

Damme

Bosch

2019

International Journal of Infectious Diseases

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“…Although encouraging, these data indicate that the prophylactic HPV vaccine had weak activity against such HPV16/18-related high-grade lesions. Recently, a prospective clinical project, the SPERANZA study, was carried out to determine the effectiveness of the tetravalent vaccine for reduction of the risk of clinical relapse in women treated for CIN2 (126). Overall, 344 women were included in the study, and 6.4% of the nonvaccinated women showed clinical disease recurrence, while for the vaccinated women, there was only 1.2% recurrence.…”

Section: Hpv Prophylactic Vaccines Used As Therapeutic Vaccinesmentioning

confidence: 99%

The Use of Both Therapeutic and Prophylactic Vaccines in the Therapy of Papillomavirus Disease

et al. 2020

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“…Vaccination was associated with a reduced relapse of any subsequent high grade cervical disease by 64.9% [9]. A prospective study, evaluating the clinical effectiveness of HPV vaccine in reducing CIN2 + recurrent disease in women who underwent cervical conization for cervical HSIL and FIGO stage Ia1 cervical cancer, suggested that quadrivalent HPV-vaccination injected 30 days after conization for CIN2 + lesion reduced the risk of subsequent HSIL recurrence by 81.2% [12].…”

Section: Introductionmentioning

confidence: 99%

Impact of HPV-16/18 AS04-adjuvanted vaccine on preventing subsequent infection and disease after excision treatment: Post-hoc analysis from a randomized controlled trial

Zhao

et al. 2020

Preprint

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Background It is widely acknowledged that HPV prophylactic vaccine could prevent new infections and their associated lesions among women who were predominantly HPV-naïve at vaccination. Yet there still remains uncertainty about whether HPV vaccination benefits to individuals who had undergone surgery for cervical disease. Methods This post-hoc analysis intends to focus on intent-to-treat participants who underwent excision treatment at baseline and the follow-up period in a phase II/III, double-blind, randomized trial (ClinicalTrials.gov, number NCT00779766) conducted in Jiangsu province, China. We evaluate the impact of HPV vaccination on preventing subsequent infection and cervical lesions (LSIL + and CIN2+) after excision treatment. Results 168 (vaccine, n = 87; control, n = 81) performed excisional treatment in this clinical trial. We observed a significant effect of vaccination on rates of 14 types oncogenic HPV infection after treatment (vaccine efficacy: 27.0%; 95% CI 4.9%, 44.0%). Vaccine efficacy estimates against new infections after treatment for 14 types oncogenic HPV infection were 32.0% (95%CI 1.8%, 52.8%), for HPV16/18 infection were 41.2% (95%CI -162.7%, 86.8%).The accumulative clearance rate of the vaccine group and placebo group were respectively 88.9%, 81.6% for HPV16/18 infection (P = 0.345), 63.4%, 48.7% for 14 types oncogenic HPV infection (P = 0.062). There was no significant difference for the persistent rate of HPV16/18, 14 types oncogenic HPV infection and occurrence rate of LSIL + between the two groups. Conclusions There is no evidence that HPV-16/18 AS04-adjuvanted vaccine could lead to viral faster clearance or had effect on the persistent infection rate of the women after excision treatment. The women after treatment may get beneficial from the “primary prophylactic” effect of vaccine, while prophylactic HPV vaccine’ use as therapeutic agents deserves further researched.

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SPERANZA project: HPV vaccination after treatment for CIN2+

Cited by 148 publications

References 17 publications

HPV vaccination: Are we overlooking additional opportunities to control HPV infection and transmission?

HPV vaccination: Are we overlooking additional opportunities to control HPV infection and transmission?

The Use of Both Therapeutic and Prophylactic Vaccines in the Therapy of Papillomavirus Disease

Impact of HPV-16/18 AS04-adjuvanted vaccine on preventing subsequent infection and disease after excision treatment: Post-hoc analysis from a randomized controlled trial

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