Monday HPV Gardasil 9 vaccine seminar 2018 by Professor Alison J Sinclair https://padlet.com/a_j_sinclair/xao879s36gf3 resources, questions and responses en-us 2017-12-14 12:13:20 UTC 2025-10-09 04:50:44 UTC hello@padlet.com 0 Please can each group upload a response to your question in the appropriate column (note there are 2 groups per question). You can add text directly or an audio recording e.g. via vocaroo (https://vocaroo.com) or add a photo of a hand written response or diagram or annotated figure ... each upload is linked to the device used - you should be able to edit in real time. a_j_sinclair https://padlet.com/a_j_sinclair/xao879s36gf3/wish/216119474 2017-12-14 12:24:40 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/216119474 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/223000993 Cervical cancer world-wide incidence
http://gco.iarc.fr/today/home]]> 2018-01-20 11:14:39 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/223000993 Human papillomavirus (HPV) and cervical cancer Fact sheet Updated June 2016 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/223001185 2018-01-20 11:17:49 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/223001185 case study "Final efficacy, immunogenicity, and safety analyses of a nine-valent human papillomavirus vaccine in women aged 16–26 years: a randomised, double-blind trial" https://padlet.com/a_j_sinclair/xao879s36gf3/wish/223001737 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31821-4/abstract]]> 2018-01-20 11:24:20 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/223001737 Question 4 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240834432 Intention to treat involves all the patients allocated after a randomisation, which was 14215 as mentioned in the article. Per-protocol includes only those patients who completed the treatment which was originally allocated.
The outcome for the intention to treat group was worse because they did not complete the full cours of treatment. Only 26% of the patients completed the treatment

]]> 2018-03-12 13:12:46 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240834432 A quadrivalent vaccine was used as the control, meaning it contains the vaccines for HPV 6, 11, 16 and 18. It was important to use this as a control because a placebo was deemed unethical- not fair to deny half of the sample a vaccine. It also allows better comparison. https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240836439 2018-03-12 13:15:55 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240836439 There is already a quadrivalent vaccine for HPV covering HPV 6, 11, 16 and 18 (qHPV). Since most people will be infected with HPV in their life, some of which are oncogenic (HPV 16 and 18), it is highly unethical to give a placebo and not a vaccine. https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240836878 2018-03-12 13:16:28 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240836878 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240838115 A quadrivalent vaccine was used as the control in this study.It still provides coverage for the four most common cancer causing HPV variants (6,11,16 and 18). It was unethical to use a placebo and expose people to the potential risk of cancer by providing no vaccine coverage of HPV.]]> 2018-03-12 13:18:18 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240838115 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240838255 It is also a valid control cause the 9vHPV showed non inferiority to the qHPV vaccine ]]> 2018-03-12 13:18:29 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240838255 Question 1 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240841143 2018-03-12 13:22:53 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240841143 It was important to use a quadrivalent vaccine that covered HPV 6, 11, 16 and 18, as these are the four main pathogenic species of HPV. Also a placebo was deemed as unethical- not fair to deny half of the sample a vaccine. It also allows better comparison between groups. https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240841197 2018-03-12 13:22:58 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240841197 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240841687 The main justification for use is the 97.4% efficacy amongst all groups vaccinated. the 11 deaths in the study were not vaccine related, with only one minimal allergic reaction proving its disadvantages are minimal. The actual administration of the vaccine is intramuscular making it advantageous to use.


]]> 2018-03-12 13:23:47 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240841687 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240841771  
The data shows that prophylactic administration of the 9vHPV vaccine is highly efficacious in preventing infection, cervical cytological abnormalities, histologically detected high-grade lesions and medical procedures associated with vaccine HPV types (97.4% efficacy). mITT analysis showed vaccination post exposure is ineffective. Vaccine efficacy is sustained after 6 years of vaccination. 
]]> 2018-03-12 13:23:55 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240841771 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240842980 The justification for the use of prophylactic vaccines against HPV to prevent cervical cancer is that a prevention method is better than trying to treat cancer at a later stage. The cost of a vaccine is cheaper than cancer treatments and is far less stressful on the patient and the health care system. ]]> 2018-03-12 13:25:46 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240842980 Question 5 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240845553 Cervical cancer is not only caused by HPV but by other agents too, which the vaccine is not targeting and therefore the efficacy is not applicable to the vaccine. More clinical symptoms indicate the vaccine has worked less effectively. ]]> 2018-03-12 13:29:24 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240845553 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240846549 It is easier to not get cancer in the first place than trying to treat it when you have HPV. ]]> 2018-03-12 13:30:55 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240846549 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240846870  Vaccines are preventative- prophylactic use is more ethical (as well as economically favourable) because it helps prevent multiple cancers. It is more effective to prevent as cancers are variable and often hard and expensive to treat. It also means people do not have to go through the side effects of the treatment. 

]]> 2018-03-12 13:31:30 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240846870 q. 5 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240849432 The clinical trial lasted 6yrs and cancer can take 10yrs from infection to present. Furthermore, testing for someone to get cancer is not ethical. HPV is not the singular cause of cancer and other clinical features.  

]]> 2018-03-12 13:35:17 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240849432 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240850117 The use of invasive cancer (cervical, vulvar and vaginal) as an efficacy endpoint is not acceptable for ethical reasons; also, the time from infection with HPV to development of cancer usually exceeds 10 years. Thus, HPV vaccine efficacy trials used measures such as: high-grade pre-cancerous lesions (CIN). ]]> 2018-03-12 13:36:13 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240850117 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240850620 The 'intention to treat' pts were already infected with HPV before given the vaccine. This could be why they had worse outcomes. ]]> 2018-03-12 13:36:58 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240850620 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240850708 Intention-to-treat is everyone who was recruited to the study and the per-protocol efficacy group are the ‘ideal’ candidates for the study- this means that they stay in the same group, don’t drop out, have severe side effects etc… Figure 1 shows that about 20% of each group withdrew from the study 

]]> 2018-03-12 13:37:06 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240850708 It takes 10 years to develop which takes too much time as it allows for external factors to interfere with the study so instead screening for pre-cancerous regions were measured to determine the vaccines success. Antibody response to the HPV was measured every few months this also helps relate with the efficacy. https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240852449 2018-03-12 13:39:12 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240852449 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240852570 The use of invasive cancer is not ethical to use in the study and the time to develop cancer is on average greater than 10 years.


]]> 2018-03-12 13:39:23 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/240852570 The control Vaccine was used qHPV as it contained a combination of HPV 6,11, 16 and 18 which are still highly efficacious in preventing disease. It would have been unethical to withhold the vaccine and use a placebo when vaccines have shown to be efficacious. https://padlet.com/a_j_sinclair/xao879s36gf3/wish/244471941 2018-03-21 12:14:18 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/244471941 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/244486614 Giving no vaccine to a control group when there is a vaccine with known efficacy is deemed unethical. The study did not aim to investigate the efficacy of the qHPV vaccine, it wanted to uncover by how much the 9vHpV vaccine was more efficient than qHpv. Thus theuse of qHPV for the control group was appropriate. Furthermore it would be unethical to deny treatment when the qhpv vaccine is routinely administered in parts of the world.


]]> 2018-03-21 12:48:36 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/244486614 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/244486733  

Prophylactic vaccines have a high efficacy at preventing cervical cancer and other pathologies such as infection and cervical abnormalities. This reduces cost and pressure on health services in the future due to fewer cases of cancer and other problems that are prevented by this vaccine. For example, the cost of a vaccine for one person is much lower than the cost of various rounds of cancer treatment. The use of the vaccine is also more ethical, as it can prevent the great deal of suffering that comes with cancer. 


]]> 2018-03-21 12:48:51 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/244486733 ish_ishy96 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/244487785  
Modified intention to treat mITT-Are patients who are going to receive the HPV treatment. Per-protocol groups are those who have received all 3 treatments within the year. Outcomes are worse for the former: patients would not have received the whole treatment. xo

]]> 2018-03-21 12:51:07 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/244487785 https://padlet.com/a_j_sinclair/xao879s36gf3/wish/265018617 2018-06-01 12:53:38 UTC https://padlet.com/a_j_sinclair/xao879s36gf3/wish/265018617