scholarly journals 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

2020 ◽  
Author(s):  
Shuang Zhao ◽  
Shangying Hu ◽  
Xiaoqian Xu ◽  
Xun Zhang ◽  
Qinjing Pan ◽  
...  
Keyword(s):  
Vaccine Efficacy ◽  
Hpv Vaccination ◽  
Hpv Infection ◽  
Occurrence Rate ◽  
Subsequent Infection ◽  
Hpv 16 ◽  
Post Hoc Analysis ◽  
Adjuvanted Vaccine ◽  
Post Hoc ◽  
The Impact

Abstract Background: It is widely acknowledged that HPV prophylactic vaccine could prevent new infections and their associated lesions among women who were predominantly HPV-naive at vaccination. Yet there still remains uncertainty about whether HPV vaccination could benefit 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 women from subsequent infection and cervical lesions (LSIL+ and CIN2+) after excision treatment. Results: 168 (vaccine, n=87; placebo, n=81) performed excisional treatment in this clinical trial. We observed a significant effect of vaccination on acquiring 14 high-risk HPV (HR-HPV) infection after treatment (vaccine efficacy: 27.0%; 95% CI 4.9%, 44.0%). The vaccine efficacy against new infections after treatment for 14 HR-HPV infection was estimated as 32.0% (95%CI 1.8%, 52.8%), and was 41.2% (95%CI -162.7%, 86.8%) for HPV16/18 infection. The accumulative clearance rates of the vaccine group and placebo group were 88.9% and 81.6% for HPV16/18 infection (P=0.345), 63.4%, 48.7% for 14 HR-HPV infection (P=0.062), respectively. No significant difference was observed on the persistent rate of HPV16/18, 14 HR-HPV infection and occurrence rate of LSIL+ between the two groups. Conclusions: No significant evidence from this study showed that HPV-16/18 AS04-adjuvanted vaccine could lead to viral faster clearance or have any effect on the rates of persistent infection among women who had excision treatment. However, the vaccine may still benefit post-treatment women with “primary prophylactic” effect. Further research is required in clarifying the effect of using the prophylactic HPV vaccine as therapeutic agents. ClinicalTrials.gov Identifier: NCT00779766Date and status of trial registration: October 24, 2008 Completed; Has Results

scholarly journals 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

2020 ◽  
Author(s):  
Shuang Zhao ◽  
Shangying Hu ◽  
Xiaoqian Xu ◽  
Xun Zhang ◽  
Qinjing Pan ◽  
...  
Keyword(s):  
Vaccine Efficacy ◽  
Hpv Vaccination ◽  
Hpv Infection ◽  
Occurrence Rate ◽  
Subsequent Infection ◽  
Hpv 16 ◽  
Post Hoc Analysis ◽  
Adjuvanted Vaccine ◽  
Post Hoc ◽  
Oncogenic Hpv

Abstract 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.

scholarly journals 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

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Shuang Zhao ◽  
Shangying Hu ◽  
Xiaoqian Xu ◽  
Xun Zhang ◽  
Qinjing Pan ◽  
...  
Keyword(s):  
Vaccine Efficacy ◽  
Hpv Vaccination ◽  
Hpv Infection ◽  
Trial Registration ◽  
Subsequent Infection ◽  
Hpv 16 ◽  
Post Hoc Analysis ◽  
Adjuvanted Vaccine ◽  
Link Type ◽  
Post Hoc

Abstract Background It is widely acknowledged that HPV prophylactic vaccine could prevent new infections and their associated lesions among women who are predominantly HPV-naive at vaccination. Yet there still remains uncertainty about whether HPV vaccination could benefit to individuals who have 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 women from subsequent infection and cervical lesions (LSIL+ and CIN2+) after excision treatment. Results One hundred sixty-eight (vaccine, n = 87; placebo, n = 81) performed excisional treatment in this clinical trial. We observed a significant effect of vaccination on acquiring 14 high-risk HPV (HR-HPV) infection after treatment (vaccine efficacy: 27.0%; 95% CI 4.9, 44.0%). The vaccine efficacy against new infections after treatment for 14 HR-HPV infection was estimated as 32.0% (95%CI 1.8, 52.8%), and was 41.2% (95%CI -162.7, 86.8%) for HPV16/18 infection. The accumulative clearance rates of the vaccine group and placebo group were 88.9 and 81.6% for HPV16/18 infection (P = 0.345), 63.4, 48.7% for 14 HR-HPV infection (P = 0.062), respectively. No significant difference was observed on the persistent rate of HPV16/18, 14 HR-HPV infection and occurrence rate of LSIL+ between the two groups. Conclusions No significant evidence from this study showed that HPV-16/18 AS04-adjuvanted vaccine could lead to viral faster clearance or have any effect on the rates of persistent infection among women who had excision treatment. However, the vaccine may still benefit post-treatment women with “primary prophylactic” effect. Further research is required in clarifying the effect of using the prophylactic HPV vaccine as therapeutic agents. Trial registration ClinicalTrials.gov identifier: NCT00779766. Date and status of trial registration: October 24, 2008. Completed; Has Results.

The Impact of Smoking on Cardiovascular Outcomes and Comorbidities in Statin-treated Patients with Coronary Artery Disease: A Post hoc Analysis of the GREACE Study

2013 ◽  
Vol 11 (5) ◽  
pp. 779-784 ◽  
Author(s):  
Vasilios G. Athyros ◽  
Konstantinos Tziomalos ◽  
Niki Katsiki ◽  
Thomas D. Gossios ◽  
Olga Giouleme ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Cardiovascular Outcomes ◽  
Post Hoc Analysis ◽  
Artery Disease ◽  
Post Hoc ◽  
The Impact

Outcomes of Passable and Non-passable Strictures in Clinical Trials of Crohn’s Disease: A Post-hoc Analysis

2021 ◽  
Author(s):  
Neeraj Narula ◽  
Emily C L Wong ◽  
Parambir S Dulai ◽  
John K Marshall ◽  
Jean-Frederic Colombel ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Activity Index ◽  
Disease Activity Index ◽  
Symptom Improvement ◽  
Logistic Regression Models ◽  
Post Hoc Analysis ◽  
Endoscopic Remission ◽  
Post Hoc ◽  
The Impact

Abstract Background and Aims There is paucity of evidence on the reversibility of Crohn’s disease [CD]-related strictures treated with therapies. We aimed to describe the clinical and endoscopic outcomes of CD patients with non-passable strictures. Methods This was a post-hoc analysis of three large CD clinical trial programmes examining outcomes with infliximab, ustekinumab, and azathioprine, which included data on 576 patients including 105 with non-passable strictures and 45 with passable strictures, as measured using the Simple Endoscopic Score for Crohn’s Disease [SES-CD]. The impact of non-passable strictures on achieving clinical remission [CR] and endoscopic remission [ER] was assessed using multivariate logistic regression models. CR was defined as a Crohn’s Disease Activity Index [CDAI] <150, clinical response as a CDAI reduction of ≥100 points, and ER as SES-CD score <3. Results After 1 year of treatment, patients with non-passable strictures demonstrated the ability to achieve passable or no strictures in 62.5% of cases, with 52.4% and 37.5% attaining CR and ER, respectively. However, patients with non-passable strictures at baseline were less likely to demonstrate symptom improvement compared with those with passable or no strictures, with reduced odds of 1-year CR (adjusted odds ratio [aOR] 0.17, 95% CI 0.03–0.99, p = 0.048). No significant differences were observed between patients with non-passable strictures at baseline and those with passable or no strictures in rates of ER [aOR 0.82, 95% CI 0.23–2.85, p = 0.751] at 1 year. Conclusions Patients with non-passable strictures can achieve symptomatic and endoscopic remission when receiving therapies used to treat CD, although they are less likely to obtain CR compared with patients without non-passable strictures. These findings support the importance of balancing the presence of non-passable strictures in trial arms.

Modelling the population-level impact of vaccination on the transmission of human papillomavirus type 16 in Australia

Sexual Health ◽  
2007 ◽  
Vol 4 (3) ◽  
pp. 147 ◽  
Author(s):  
David G. Regan ◽  
David J. Philp ◽  
Jane S. Hocking ◽  
Matthew G. Law
Keyword(s):  
Human Papillomavirus ◽  
Cost Effectiveness ◽  
Hpv Infection ◽  
Conclusive Evidence ◽  
Effective Vaccine ◽  
High Coverage ◽  
Hpv 16 ◽  
Highly Effective ◽  
Catch Up ◽  
The Impact

Background: Vaccines are now available to prevent the development of cervical cancer from genital human papillomavirus (HPV) infection. The decision to vaccinate depends on a vaccine’s cost-effectiveness. A rigorous cost-effectiveness model for vaccinated individuals is presented in a companion paper; this paper investigates the additional benefits the community might receive from herd immunity. Methods: A mathematical model was developed to estimate the impact of a prophylactic vaccine on transmission of HPV type 16 in Australia. The model was used to estimate the expected reduction in HPV incidence and prevalence as a result of vaccination, the time required to achieve these reductions, and the coverage required for elimination. The modelled population was stratified according to age, gender, level of sexual activity and HPV infection status using a differential equation formulation. Clinical trials show that the vaccine is highly effective at preventing persistent infection and pre-cancerous lesions. These trials do not, however, provide conclusive evidence that infection is prevented altogether. The possible modes of vaccine action were investigated to see how vaccination might change the conclusions. Results: The model predicts that vaccination of 80% of 12-year-old girls will eventually reduce HPV 16 prevalence by 60–100% in vaccinated and 7–31% in unvaccinated females. If 80% of boys are also vaccinated, reductions will be 74–100% in vaccinated and 86–96% in unvaccinated females. A campaign covering only 12-year-old girls would require 5–7 years to achieve 50% of the eventual reduction. With a catch-up campaign covering 13–26-year-olds, this delay would be reduced to only 2 years. Unrealistically high coverage in both sexes would be required to eliminate HPV 16 from the population. Under pessimistic assumptions about the duration of vaccine-conferred immunity, HPV 16 incidence is predicted to rise in some older age groups. Conclusions: Mass vaccination with a highly effective vaccine against HPV 16 has the potential to substantially reduce the incidence and prevalence of infection. Catch-up vaccination offers the potential to substantially reduce the delay before the benefits of vaccination are observed. A booster vaccination might be required to prevent an increase in incidence of infection in women over 25 years of age.

scholarly journals Four-Factor Prothrombin Complex Concentrate Reduces Time to Procedure in Vitamin K Antagonist-Treated Patients Experiencing Gastrointestinal Bleeding: A Post Hoc Analysis of Two Randomized Controlled Trials

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Majed A. Refaai ◽  
Truptesh H. Kothari ◽  
Shana Straub ◽  
Jacob Falcon ◽  
Ravi Sarode ◽  
...  
Keyword(s):  
Gastrointestinal Bleeding ◽  
Vitamin K ◽  
Prothrombin Complex Concentrate ◽  
Invasive Procedure ◽  
Vitamin K Antagonist ◽  
Phase Iii ◽  
Two Phase ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
The Impact

Introduction. To investigate the impact of a 4-factor prothrombin complex concentrate (4F-PCC [Beriplex®/Kcentra®]) versus plasma on “time to procedure” in patients with acute/severe gastrointestinal bleeding requiring rapid vitamin K antagonist (VKA) reversal prior to invasive procedure. Methods. A post hoc analysis of two phase III trials of 4F-PCC versus plasma in patients with acute/severe gastrointestinal bleeding. The treatment arms were compared for study treatment volume, infusion times, and time from start of study treatment to procedure. Results. Analysis included 42 patients (plasma, n=20; 4F-PCC, n=22). Median (interquartile range) infusion time was significantly shorter for the 4F-PCC group than for the plasma group (16 [13, 26] min versus 210 [149, 393] min; P<0.0001). Median infusion volumes were significantly smaller (103 [80, 130] mL versus 870 [748, 1001] mL; P<0.0001) and median time from study treatment initiation to first procedure was significantly shorter in the 4F-PCC group than in the plasma group (17.5 [12.8, 22.8] versus 23.9 [18.5, 62.0] h; P=0.037). Conclusions. In this analysis of patients with acute/severe gastrointestinal bleeding requiring urgent VKA reversal prior to an invasive procedure, 4F-PCC (compared with plasma) was associated with smaller infusion volumes, shorter infusion times, and reduced time to procedure.

Tu1726 – The Impact of Early Disease Control with Vedolizumab on Surgery Rates Among Patients with Crohn's Disease: A Post Hoc Analysis of the Gemini Trials

2019 ◽  
Vol 156 (6) ◽  
pp. S-1100
Author(s):  
Parambir S. Dulai ◽  
Laurent Peyrin-Biroulet ◽  
Kristen Hahn ◽  
Natasha Khalife ◽  
Dirk Lindner ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Disease Control ◽  
Early Disease ◽  
Post Hoc Analysis ◽  
Surgery Rates ◽  
Post Hoc ◽  
The Impact
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