Joura, E., Giuliano, A., Iversen, O., Bouchard, C., Mao, C., Mehlsen, J., … Luxembourg, A. (2015). A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. The New England Journal of Medicine. doi: 10.1056/NEJMoa1405044.
This article is a fundamental investigation concerning a 9-valent virus-like particle vaccine against the infectious disease caused by human papillomavirus (HPV). This vaccine includes several types of this oncogenic virus. The research design was a randomized international control study, which included vaccination of women in double blind phase by 9vHPV. The participants were vaccinated in three stages by means of intramuscular injections. Then, laboratory testing, which included analysis of swabs from internal and external female organs, was performed. It was taken for further DNA investigations. Analysis of response to vaccine was conducted by detection of human antibodies in the serum taken from vaccinated women. The women had to perform regularly cytological testing in the laboratories. With the help of biopsy, the participants were tested for the papillomavirus. The participants were aged from 16 to 26 years, and thus, fall within the interest group to address the PICO question. The obtained results were evaluated with the help of several statistical methods. The authors concluded that vaccination contributed to development of effective immune response against HPV, which allowed for prevention of infection. conclusions out of the testing results. In spite of being conducted on a large sample, the study is partially relevant to address the research question. Its major limitation was absence of control placebo group, and thus, comparison between persons receiving the vaccine and the ones, who avoid it, could not be performed. Still, the preventive and immunogenic properties of the studied formulation were shown.
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Huh, W., Joura, E., Giuliano, A., Iversen, O., de Andrade, R., Ault, K., … Luxembourg, A. (2017). Final efficacy, immunogenicity, and safety analyses of a nine-valent human papillomavirus vaccine in women aged 16–26 years: A randomized, double-blind trial. The Lancet, 390(10108), 2143-2159. doi: 10.1016/S0140-6736(17)31821-4.
This article is the final part of investigation described in the previous one. It was conducted with the use of additional vaccine against HPV, thus 9 valent HPV and quadrivalent HPV were examined. It was a randomized double blind study, during which immunogenicity, efficiency, and safety of vaccines was tested in in 105 places in 18 countries of the world. The instigated women were examined for abnormal cervical issues and their heath histories were checked. The participants were aged between 16 and 26 years, had no current or past abnormal cytological results, and no more than four sexual partners during their life. A variety of investigations and tests were performed before vaccination and after the process. The authors provided sufficient description and deep explanation of all the laboratory tests conducted before, during, and after the experiment. Antibody responses were tested for both HPV vaccines. It was shown that sufficient immune response lasted for up to six years. The authors concluded that the efficiency of vaccine for prevention of papillomavirus in women aged 26 years and lower is the highest. Unfortunately, several women died during the experiment, but all the cases were not related to application of vaccine. The results of the final stage of the investigation show that the 9vHPV vaccine is the most effective and prevents infection with papillomavirus (PV), cytological abnormalities, and any related cervical changes. Both studied vaccines showed had 90% protection form the diseases and cervical cancer. Although immunogenic profile was similar for the two vaccines, 9vHPV appeared much stronger for infection prevention and had broader coverage. Again, the issue with lack in control group is the major limitation of the analyzed study. Thus, the stated PICO question is only partially answered by this research.
Giuliano, A., Palefsky, J., Goldstone, S., Moreira, E., Penny, M., Aranda, C., … Guris, D. (2011). Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males. New England Journal of Medicine, 364(5), 401-411. doi: 10.1056/nejmoa0909537.
This article investigates the issue of papillomavirus infection, which is common for boys and men. The authors tested safety of the quadrivalent vaccine, which is quite efficient and effective in preventing genital lesions and anogenital PV infections among male patients. More than 4000 healthy male patients aged 16-26 years were enrolled from 18 states of the world. The study had a design of placebo controlled randomized and double blind trial. The first stated objective was test for efficiency of vaccine and its ability to reduce the incidence of external genital lesions and disorders caused by PV infection (type 6,11,16,18). The aspect of the efficiency was addressed by testing the per-protocol population, which attained all tree vaccinations and had negative results concerning the papillomavirus infection. The other group of the participants received the vaccine regardless of their current PV status. The results confirmed the effectiveness of the studied vaccine, as it was able to prevent HP infection and diseases caused by this virus among male patients aged 16-26 years. The investigation can be further developed, as it addresses the issue of PV spread in male population, while females are more commonly used as subjects in similar studies. The conducted research has a significant contribution to vaccine development, since it confirms not only the efficiency and safety of the vaccine, but also its necessity for male subjects, as well as female. This article completely addresses the research PICO questions, because the research design included comparison between persons receiving the vaccine and the ones, who did not. The age of participants was within the range suggested by the PICO question.
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Romanowski, B., de Borba, P.C., Naud, P.S., Roteli-Martins, C.M., de Carvalho, N.S., Teixeira, J.C., … Sgriobhadair, A. (2009). Sustained efficacy and immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine: Analysis of a randomized placebo-controlled trial up to 6.4 years. The Lancet, 374(9706), 1975-1985. doi: 10.1016/S0140-6736(09)61567-1.
This article is focused on the problem of human papillomavirus prevention with the help of vaccination. The study was aimed to confirm a fundamental importance of AS04-adjuvanted vaccine because of its ability to protect from PV-induced diseases for 4 to 6 years. The study has a randomized, placebo controlled, double blind design. It was conducted with the participation of 1113 patients in 27 sites in three countries. Women aged 15-25 years, who were negative for 14 types of HPV and did not have signs of infection were included. During the follow up, which lasted for 6.4 years, tests were conducted over the cervical samples for identification HPV DNA. The first objective was to identify the efficiency of vaccine for protection from PV in the long term perspective. The results confirmed sufficient efficiency and strong disease resistance during the short period (12 months), and much weaker during the next six years. The results confirmed that protection form HPV and its related disorders is 100% effective by the end of the first year, it drops to about 95% by the fifth and the sixth years. The obtained results also confirmed that application of the vaccine is safe and does not lead to development of complications. During the research, the participants did not experience any unexpended consequences, and there were no eath cases. The study was properly performed and did not have any serious issues, which would reduce the level of evidence it provides. Therefore, it can be used to fully address the suggested PICO question.
Basu, P., Bhattacharya, C., Biswas, J., Singh, P., & Banerjee, D. (2013). Efficacy and safety of human papillomavirus vaccine for primary prevention of cervical cancer: A review of evidence from phase III trials and national programs. South Asian Journal of Cancer, 2(4), 187-192. doi: 10.4103/2278-330X.119877.
The conducted research addressed the efficiency and safety of vaccination, confirming the necessity to perform it. It was aimed to improve the national immunization system and to make people trust vaccination against HPV. Implementation of this approach can protect population from a number of cancer cases. It was a literature review conducted with the use of clinical trials. The national immunization programs work around the world in the countries with high and medium income, and thus, data from international studies were gathered and systematized by the authors. It was concluded that vaccine against HPV is quite specific and unique, and thus, fears related to vaccine use are unreasonable. The authors make an interesting conclusion that this vaccine is the first in the world vaccine targeted to prevent cancer. Actually, vaccination against HPV is a method to omit the cancer. However, this statement is applicable to women only, as this disease develops due to HPV infection only in females, while males can still suffer from skin lesions and other manifestations. As the previous articles, this one tries to convince the majority to perform vaccination. Furthermore, the authors demand that vaccination should be compulsory for protection of new generations form cancer. Actually, the purpose of the source is justification of the necessity for vaccination, as positive effects overweight the possible challenges and consequences.
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Wheeler, C., Castellsagu?, X., Garland, S., Szarewski, A., Paavonen, J., Naud, P., … Lehtinen, M. (2012). Cross-protective efficacy of HPV-16/18 AS04-adjuvanted vaccine against cervical infection and precancer caused by non-vaccine oncogenic HPV types: 4-year end-of-study analysis of the randomised, double-blind PATRICIA trial. The Lancet Oncology, 13(1), 100-110. doi: 10.1016/s1470-2045(11)70287-x.
This article evaluates the HPV-16/18 AS04-adjuvanted vaccine efficiency in the target population regarding only oncogenic types of HPV. It was a fundamental scientific research conducted during 4 years. The objective was to define the efficiency of this type of vaccine and it possibility to prevent cancer. The study design was a randomized controlled and double blind. Healthy women aged between 15 and 25 years, who had less than six sexual partners during their life, were included. They were tested for oncological HPV types DNA and examined. The control group received the vaccine against oncogenic PV, while the control one was injected with placebo. The authors performed deep and fundamental analysis of the results with the application of appropriate statistics tests. It allowed them conclude that vaccine efficiency was quite high and could contribute to prevention of oncological diseases in women. During the six months of investigation, the researches confirmed that non-vaccinated females were subjected to higher risks to have oncological diseases, as some of them developed cervical cancer. Meanwhile, such outcome was not identified for the experimental group. The major limitation of this study is its conduction with the use of vaccine against oncogenic types of PV only. Thus, its findings only partially address the stated PICO question, which addressed all possible health issues, not only cancer cases. Still, the research is useful, as it was properly organized and thus, provides high level of evidence.
Harper, D., Franco, E., Wheeler, C., Ferris, D., Jenkins, D., Schuind, A., … Dubin. G. (2004). Efficacy of a bivalent L1 virus-like particle vaccine in prevention of infection with human papillomavirus types 16 and 18 in young women: A randomised controlled trial. The Lancet, 364(9447), 1757-1765. doi: 10.1016/s0140-6736(04)17398-4.
The study was aimed at identification of vaccination efficiency for prevention of infection with the most oncogenic type of papillomavirus (16,18). More than 1000 women aged between 15 and 25 years, who did not have current infection with PV were included into the study. It had a randomized controlled, double blind design, where the control group received placebo and the experimental one was injected with vaccine on a 0 month, 1 month, and 6-month schedule. For 27 months, women were assessed for the signs of infection by means of cervical cytological examination. Comparison between the two groups was performed with the use of appropriate statistical tests. It was identified that the studied vaccine had 91.6% efficiency for prevention of incident and 100% efficacy in case of persistent infection. The researchers concluded that vaccination can prevent more than 70% of cervical cancer cases around the world. Thus, it is the most effective way to protect human form the most aggressive types of HPV associated with cancer development. This study partially addresses the PICO question, as protection against oncological types of PV was studied only. However, it can be used as a high-quality source, as research design was carefully planned and implemented.
Palefsky, J., Giuliano, A., Goldstone, S., Moreira, E., Aranda, C., Jessen, H., Garner, E.I. (2011). HPV Vaccine against anal HPV infection and anal intraepithelial neoplasia. New England Journal of Medicine, 365(17), 1576-1585. doi: 10.1056/nejmoa1010971.
The article is focused on the problem of anal cancer caused by HPV. The rates of anal cancer became one of the most dangerous type of oncology, affecting equally female and male patients. Men who have single sex intimate relations are the most vulnerable population.
Safety and efficiency of the quadrivalent HPV vaccine were investigated with the help of the randomised controlled methodology. The researched randomly assigned more than 600 men, who had intimate relations with men, to control and experimental groups that received placebo and vaccine respectively. High efficiency of the studied vaccine was confirmed, as well as its safety. This study partially addresses the PICO question, as protection against types of PV causing anal cancer only was studied. However, it can be used as a high-quality source, as research design was carefully planned and implemented