Generating epidemiological, economic and attitudinal evidence to inform policy-making about HPV vaccine introduction in India and Ethiopia

人类乳头瘤病毒（HPV）是一种遍布世界各地的病毒。该病毒主要通过性接触在人与人之间传播。在世界大部分地区，子宫颈癌是第二大最常见的癌症原因。几乎所有的病例都是由HPV引起的。HPV还会在男性和女性中引起罕见的生殖器和口腔癌。HPV有多种类型，但两种类型（16型和18型）导致了世界上大多数（约70%）的癌症病例。自2006年以来，已有两种疫苗可以预防16型和18型感染。在英国，其中一种疫苗于2008年被引入国家计划，给12-13岁的女孩接种。大多数工业化国家现在为女孩接种疫苗，一些国家也为男孩接种疫苗。有三种类型的疫苗可用于覆盖2、4和9种HPV。宫颈癌的负担在发展中国家是最高的，部分原因是社会原因，部分原因是很少有发展中国家有宫颈癌筛查（巴氏涂片）项目来检测和治疗早期癌症，从而减少了发展为临床癌症的病例数量。接种疫苗可以预防大多数这些病例，但到目前为止，由于疫苗价格高昂，HPV疫苗在发展中国家的使用非常有限。此外，由于接种疫苗的是处于青春期早期的女孩，有些人对疫苗的安全性和有效性表示担忧。在印度和埃塞俄比亚之间，估计40%的宫颈癌发生在这两个国家。在印度，根据地方当局的决定，已在有限范围内使用了这种疫苗。印度的一些地区宫颈癌风险很高，而其他地区风险较低。通过测量感染高危型人乳头瘤病毒的年轻妇女的比例，以及测量性行为模式，我们将开发一种简单的方法，使印度当局能够估计其社区的风险水平，从而优先采用人乳头瘤病毒疫苗。我们还将研究其他类型的HPV传播，以帮助政府决定使用哪种疫苗。为了帮助疫苗决策，我们还将从金钱和人力两方面衡量宫颈癌的成本。我们将通过采访新诊断的病例以及与死者家属进行访谈来调查这些问题。为了证明这种疫苗在印度确实有效，我们将跟踪旁遮普邦一群接种了HPV疫苗的年轻妇女。我们希望未来的研究人员能够证明这些女孩的感染数量大大减少。在埃塞俄比亚，宫颈癌很常见，但由于没有癌症登记，因此不可能说有多普遍。政府已在该国南部的吉马和北部的迈克勒两个地区开展了一项试点疫苗接种计划。我们将测量HPV感染在这些地区的常见程度。然后，我们将每年跟踪2000名接种疫苗的女孩和类似数量的未接种疫苗的女孩，记录性行为并衡量有多少人被感染。这将为政府和社区提供疫苗有效性的证据，使他们能够加快疫苗的引进并保持疫苗覆盖率。为了支持这一研究，将按照与印度研究类似的路线进行宫颈癌真实成本的研究。在本研究过程中，我们将评估印度Vellore的HPV实验室。该实验室将用于所有印度和许多埃塞俄比亚的样品。在研究期间，还将向两名埃塞俄比亚科学家传授实验室技术，之后他们将在埃塞俄比亚建立一个HPV实验室。

Human Papilloma Virus (HPV) is a virus found throughout the world. The virus is transmitted between humans, mainly by sexual contact. Cancer of the cervix is the second most common cause of cancer in most parts of the world. Almost all cases are caused by HPV. HPV also causes rarer genital and oral cancers in males and females. There are many types of HPV, but two types (16 and 18) are responsible for most (about 70%) of cancer cases throughout the world. Since 2006 two vaccines have been available that can prevent infection by types 16 and 18. In UK one of the vaccines was introduced into the national program in 2008, given to girls 12-13 years of age. Most industrialised countries now use the vaccine for girls, some also vaccinate boys. There are 3 types of vaccine available covering 2, 4 and 9 types of HPV. The burden of cervical cancer is highest in developing countries, partly for sociological reasons, and partly because few developing countries have cervical screening (Pap smear) programs that detect and treat early stages of cancer, reducing the number of cases that progress to clinical cancer. Vaccination could prevent most of these cases, but up to now HPV vaccine use in developing countries has been very limited because of the high price of the vaccine. In addition, because the vaccine is given to girls in early adolescence, fears have been expressed in some quarters about the safety and the effectiveness of the vaccines. Between India and Ethiopia it is estimated that 40% of all cervical cancers occur in these two countries. In India the vaccine has been used on a limited scale, based on decisions taken by local authorities. Some areas of India have high cervical cancer risk, while others have lower risk. By measuring the proportions of young women who are infected with high risk HPV types, and also measuring the patterns of sexual behaviour, we will develop a simple way by which Indian authorities can estimate the risk level in their communities, and therefore prioritise HPV vaccine introduction. We will also study the other types of HPV circulating to help the government decide on which vaccine to use. To help with vaccine decision making we will also measure the cost of cervical cancer, both in monetary and in human terms. We will investigate these issues by interviewing newly diagnosed cases, as well as conducting interviews with the families of deceased cases. To demonstrate that the vaccine actually works in India we will follow a group of young vaccinated women in the Punjab state where the HPV vaccine is being used. We expect that in future researchers will be able to show a greatly reduced number of infections in these girls. In Ethiopia, cervical cancer is common, but as there are no cancer registries it is not possible to say how common. The government has undertaken a pilot vaccination program in 2 areas of the country, Jimma in the south, and Mekelle in the north. We will measure how common HPV infection is in these areas. Then we will follow 2000 girls who have been vaccinated, and a similar number of unvaccinated girls, yearly to record sexual behaviour and to measure how many have been infected. This will provide the government and the community with proof of the effectiveness of the vaccine, enabling them to accelerate the introduction of the vaccine and to maintain vaccine coverage. To support this studies of the true cost of cervical cancer will be conducted along similar lines to the studies in India. During the course of this study we will evaluate the HPV laboratory in Vellore, India. That laboratory will be used for all Indian and many Ethiopian samples. During the study the laboratory techniques will also be taught to two Ethiopian scientists, after which they will establish a HPV laboratory in Ethiopia.