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WHAT'S NEW THIS TUESDAY: FIVE ON HUMAN PAPILLOMAVIRUS VACCINATION

Sunday, 12th of August 2012

•  WHAT'S NEW: FIVE ON HUMAN PAPILLOMAVIRUS VACCINATION
  
•  ABSTRACTS ON GLOBAL ASPECTS OF HPV VACCINATION

 From http://www.hpv2011.org/pics/1/4/Abstract%20Book%201%20EP-PH%20WEBB%20110922.pdf

• 1) PROSPECTS FOR RAPID WORLDWIDE REDUCTION OF CERVICAL CANCER

J Peto, London School of Hygiene and Tropical Medicine, London, UNITED KINGDOM

S Franceschi, International Agency for Research on Cancer, Lyon, FRANCE

C Gilham, London School of Hygiene and Tropical Medicine, London, UNITED KINGDOM

Most HPV16/18 vaccination programmes target adolescent girls who have not yet been infected. However, restricting HPV vaccination to young women will have little effect on overall cancer rates for several decades, as most of the 10 million women who will develop cervical cancer over the next 20 years have already been infected with HPV. The majority of HPV infections disappear within a year or two, and these confer little risk of progression to cancer. A screen-and-treat policy based on a single HPV test therefore entails substantial overtreatment, and does not protect against subsequent reinfection. Polyvalent HPV vaccines that prevent the large majority of incident infections with high-risk HPV types (notably HPV L2 vaccines) and rapid HPV testing may soon be available at affordable cost, and this will have important implications for vaccination and screening policy, particularly in older women. Polyvalent HPV vaccination, followed 3 years later by a rapid HPV test and immediate ablative treatment of all persisting HR-HPV infections (irrespective of cytology or colposcopy), would greatly reduce cervical cancer incidence in women at all ages. This once in a lifetime intervention might be a cost-effective alternative to regular screening in developed countries, and in developing countries where regular cervical screening is impractical it may be the only way to produce a large and rapid reduction in cervical cancer incidence and mortality. The EUROGIN 2010 Roadmap on Cervical Cancer Prevention suggests that in developing countries this might be achieved more easily by a programme of mass vaccination followed a few years later by mass HPV testing than by attempting to follow up individual women after vaccination.

Declaration of interest

None declared.

 

• 2) PROGRAM COSTS TO INTRODUCE HPV VACCINE IN FOUR LOW-RESOURCE SETTINGS

C Levin, PATH, Seattle, UNITED STATES

H Van Minh, Department of Health Economics, Hanoi Medical University, Hanoi, Vietnam

J Odaga, Child Health and Development Centre, Makarere University, Kampala, Uganda

S Sarit Rout, Centre for Operations Research and Training, Vadodara, India

D Nguyen, PATH, Hanoi, Vietnam

L Menezes, PATH, New Delhi, India

M A Mendoza Araujo, Estrategia Sanitaria Nacional de Inmunización, Ministry of Health, Peru, Lima, Peru

Background: The advent of HPV vaccines is estimated to have a significant impact on the reduction of cervical cancer incidence and mortality. As developing countries consider whether they can afford to introduce HPV vaccine, much of the attention has focused on the vaccine price (the reported public-sector price is now around US$20 per dose). While vaccine price will remain a key driver on the cost side, national governments will also need to consider additional resources to support implementation costs associated with new delivery strategies to reach pre-adolescent girls.

Objectives: Estimate incremental program costs associated with reaching pre-adolescent girls for HPV vaccination in four low-resource settings—Peru, Uganda, India, and Vietnam.

Methods: Microcosting methods were used to guide primary data collection on resource use (staff, supplies, equipment), combined with existing expenditure reports and price data from government, project, or health center administrative records. Data were collected at multiple levels of the health system from a sub-sample of health facilities participating in HPV vaccine demonstration projects for both start-up and recurring activities. Costs exclude project-related expenses and are incremental to existing services.

Results: Delivery cost per dose ranged from US$1.44 per dose in Uganda’s outreach-based strategy to US$4.67 per dose in Vietnam’s school-based strategy, and averaged around US$2.70 per dose in pulsed campaigns in Peru and India. Start-up costs account for as much as 50% of the total cost in some country settings.

Conclusions: HPV vaccine implementation costs per dose are likely to be higher compared to Expanded Programme on Immunization vaccines, but may decline as they become better integrated into immunization and school-based health services. These findings can inform the budgetary requirements of donors and national governments, providing useful information about actual resource needs to introduce and eventually scale up HPV vaccinations.

Declaration of interest

None declared

• 3) HPV VACCINE ACCEPTABILITY ACROSS THE GLOBE

T Weiss, Merck/MSD, West Point, PA, UNITED STATES, C Nwankwo, Merck/MSD, West Point, PA, UNITED STATES, M Wagner, BioMedCom, Montreal, CANADA, P Singhal, Merck/MSD, West Point, PA, UNITED STATES, S Rosenthal, Columbia Univ. and NY Presbyterian Children's Hospital, New York, NY, UNITED STATES, G Zimet, Indiana Univ., Indianapolis, IN, UNITED STATES

Background: HPV vaccine acceptability research can aid in understanding factors that can lead to successful implementation of HPV vaccination programs.

Objective: Determine factors that drive acceptance of HPV vaccination internationally, including knowledge, attitudes, and beliefs.

Methods: Search of recent, English-language scientific literature to determine acceptability of HPV vaccination across countries around the globe. Initial search identified research primarily conducted in 2007 and 2008. This search is being expanded to include more recent research, as well as research conducted before the adoption of HPV vaccines.

Results: Willingness to receive the vaccine for oneself or one’s child is high in many populations, sometimes despite significant knowledge gaps. Nevertheless, more knowledge about HPV and associated diseases is often linked to higher willingness to receive the vaccine. Not having sufficient information is sometimes cited as a reason for refusing vaccination. Others include affordability of the vaccine, concerns about safety and efficacy, and the belief that oneself or one’s child is not at risk.

Awareness of HPV and knowledge of its relationship to cervical cancer and genital warts varies globally, even within the same country. There is evidence that acceptance of HPV vaccination improves once individuals are informed about HPV infection, its repercussions, and the characteristics of the vaccine. For many individuals, acceptance of the vaccine depends upon recommendation by trusted healthcare providers, such as nurses or doctors.

Conclusions: Knowledge and provider recommendations are some key factors of HPV vaccine acceptability. Willingness to receive the vaccine for oneself or one’s child is high in many populations, but barriers related to knowledge and provider recommendations continue to exist. Public education, training of healthcare providers and development of vaccine recommendations by national bodies are important steps towards integrating HPV vaccination into national vaccination programs and ensuring appropriate uptake.

Declaration of interest

Lead author is full-time employee of Merck.

PS is full-time employee of Merck.

CN is research fellow at Merck.

MW is full-time employee of BioMedCom. BioMedCom received funding as part of this project.

Research is funded by Merck.

SR and GZ have received investigator grants from Merck.

HUMAN PAPILLOMAVIRUS VACCINATION IN TANZANIAN SCHOOLGIRLS: CLUSTER-RANDOMIZED TRIAL COMPARING 2 VACCINE-DELIVERY STRATEGIES

1. 1.   Deborah Watson-Jones1,2, Kathy Baisley1, Riziki Ponsiano2, Francesca Lemme1,2,

Pieter Remes2,3, David Ross1, Saidi Kapiga1,2, Philippe Mayaud1, Silvia de Sanjosé4,5,

Daniel Wight3, John Changalucha6 and Richard Hayes1

Journal of Infectious Diseasesjid.oxfordjournals.org

1. J Infect Dis. (2012) 206 (5): 678-686. First published online: June 18, 2012

+ Author Affiliations

1. 1.    ¹London School of Hygiene and Tropical Medicine, London 
2. 2.    ³Medical Research Council Social & Public Health Sciences Unit, Glasgow, United Kingdom
3. 3.    ²Mwanza Intervention Trials Unit
4. 4.    ⁶National Institute for Medical Research, Mwanza, Tanzania
5. 5.    ⁴Unit of Infections and Cancer, Cancer Epidemiology Research Programme, IDIBELL, Institut Català d'Oncologia
6. 6.    ⁵CIBER Epidemiologia y Salud Publica, Barcelona, Spain
7. Correspondence: Deborah Watson-Jones, MD, PhD, Faculty of Infectious and Tropical Diseases, Keppel St, London WC1E 7HT, United Kingdom (deborah.watson-jones@lshtm.ac.uk).

Abstract below; full text is at http://jid.oxfordjournals.org/content/206/5/678.full

Background.We compared vaccine coverage achieved by 2 different delivery strategies for the quadrivalent human papillomavirus (HPV) vaccine in Tanzanian schoolgirls.

Methods.In a cluster-randomized trial of HPV vaccination conducted in Tanzania, 134 primary schools were randomly assigned to class-based (girls enrolled in primary school grade [class] 6) or age-based (girls born in 1998; 67 schools per arm) vaccine delivery. The primary outcome was coverage by dose.

Results.There were 3352 and 2180 eligible girls in schools randomized to class-based and age-based delivery, respectively. HPV vaccine coverage was 84.7% for dose 1, 81.4% for dose 2, and 76.1% for dose 3. For each dose, coverage was higher in class-based schools than in age-based schools (dose 1: 86.4% vs 82.0% [P = .30]; dose 2: 83.8% vs 77.8% [P = .05]; and dose 3: 78.7% vs 72.1% [P = .04]). Vaccine-related adverse events were rare. Reasons for not vaccinating included absenteeism (6.3%) and parent refusal (6.7%). School absenteeism rates prior to vaccination ranged from 8.1% to 23.5%.

Conclusions.HPV vaccine can be delivered with high coverage in schools in sub-Saharan Africa. Compared with age-based vaccination, class-based vaccination located more eligible pupils and achieved higher coverage. HPV vaccination did not increase absenteeism rates in selected schools. Innovative strategies will be needed to reach out-of-school girls.

Clinical Trials Registration. NCT01173900.

• MALE VACCINATION AGAINST HUMAN PAPILLOMAVIRUS

J Infectious Diseases, Volume 12, Issue 8, Pages 582 - 583, August 2012

Editorial below; see also article from Australia at on the same subject at

http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(12)70031-2/fulltext

Original Text

David M Salisbury a

If high enough coverage for vaccination against human papillomavirus (HPV) can be achieved in girls and women, boys and men should be protected from infection. Hence, routine vaccination of male adolescents might not be cost effective. At present, only Austria and the USA have recommended routine vaccination against HPV in boys and men as well as in girls and women. No reports of the coverage among male recipients seem to be available for Austria, and the US recommendation is only newly made. The consequences of such programmes, therefore, cannot be assessed.

In The Lancet Infectious Diseases, Georgousakis and colleagues1 provide an excellent summary of currently available information on many aspects of HPV vaccination, set against the present circumstances in Australia. Some features that define the Australian programme might or might not be transferable to other countries. Vaccination of girls aged 12—13 years with a quadrivalent vaccine is provided in schools, which achieves coverage of 73%. At that level of coverage, a 59% reduction in the prevalence of genital warts was seen in girls and women aged 12—26 years and of 39% in that among heterosexual boys and men in the same age group, although prevalence did not decline in non-vaccinated women or in men who have sex with men.2 These outcomes are very encouraging, as they suggest that a degree of population protection has been achieved, and they are hopefully early indicators of prevention of cervical infection and subsequent cancer.

The UK currently uses a bivalent vaccine for girls aged 12—13 years, with which no effect on the prevalence of genital warts could have been expected. From September, 2012, a three-dose course of the quadrivalent vaccine Gardasil (Merck, Whitehouse Station, NJ, USA) will be used. At present, the coverage with all three doses is 84%, which is higher than 73% reported in Australia and, therefore, the same or better population protection against cervical and other cancers can be anticipated. Mathematical models suggest that a UK programme with this coverage will be highly cost effective.3 In the USA, where coverage seems to be static at around 35% for teenage girls,4 little population benefit is expected. Studies suggest that in this situation the addition of vaccination in boys and young men would be cost effective5 and helps to explain the different approaches in the UK and the USA.6

Despite the summary of Georgousakis and colleagues,1 many issues around HPV vaccination remain unresolved. For instance, some oropharyngeal cancers are associated with infection, especially with HPV 16, and prevalence seems to be increasing.7 Better data on the absolute numbers of oropharyngeal cancers and estimates of the proportion that might be prevented by HPV vaccination are needed. Whether HPV vaccination prevents oropharyngeal infection also needs to be established. If so, it would be reasonable to expect reductions in oropharyngeal cancers associated with HPV vaccine strains over time. Vaccination of boys and men contributes little to the cost-effectiveness of prevention of cervical cancer when there is high coverage among girls and women. Vaccination for the prevention of oropharyngeal cancer might also not be cost effective, except for in men who have sex with men.

Georgousakis and colleagues1 note the unknown outcome of offering vaccination to boys aged 12—13 years. While those who are vaccinated will benefit at an individual level, the degree of cost-effectiveness if they later choose vaccinated women as sexual partners is unclear; high vaccine coverage among men who have sex with unvaccinated women, or vice versa, would be most cost-effective. In both Australia and the UK, the promotion of HPV vaccination has been built on messages about the prevention of cervical cancer. Such messages are unlikely to persuade boys to be vaccinated, but changes to the messages could lower acceptance amongst girls and women.

The Australian Pharmaceutical Benefits Advisory Committee has received a an economic analysis from a vaccine manufacturer for the vaccination of boys aged 12—13 years, with a 2-year catch-up programme for boys aged 14—15 years. A positive recommendation for male vaccination has been issued on the basis of acceptable cost-effectiveness compared with female-only vaccination. In view of the notable uncertainties about so many of the possible outcomes, this change seems a conundrum, especially after female-only vaccination has shown a positive effect through herd immunity, and male vaccination was previously not cost effective. This situation might be difficult for policy makers in other developed countries to understand. Better value for money seems likely to come from efforts to raise the coverage among girls and younger women and, therefore, this approach should be tried before introduction of a male vaccination programme is attempted.

I declare that I have no conflicts of interest. The views are those of the author and do not necessarily represent those of the Department of Health.

1 Georgousakis M, Jayasinghe S, Brotherton J, Gilroy N, Chiu C, Macartney K. Population-wide vaccination against human papillomavirus in adolescent boys: Australia as a case study. Lancet Infect Dis 2012; 12: 627-634. Summary | Full Text | PDF(97KB) | CrossRef | PubMed

2 Donovan B, Franklin N, Guy R, et al. Quadrivalent human papillomavirus vaccination and trends in genital warts in Australia: analysis of national sentinel surveillance data. Lancet Infect Dis 2010; 11: 39-44. Summary | Full Text | PDF(196KB) | CrossRef | PubMed

3 Jit M, Choi YH, Edmonds WJ. Economic evaluation of human papillomavirus vaccination in the United Kingdom. BMJ 2008; 337: a769. CrossRef | PubMed

4 Centers for Disease Control and Prevention. National and state vaccination coverage among adolescents aged 13 through 17 years—United States, 2010. MMWR Morb Mortal Wkly Rep 2011; 60: 1117-1123. PubMed

5 Chesson H. HPV vaccine cost-effectiveness: updates and review. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-jun11/07-5-hpv-cost-effect.pdf. (accessed April 5, 2012).

6 Centers for Disease Control. Recommendations on the use of quadrivalent human papillomavirus vaccine in males—Advisory Committee on Immunization Practices (ACIP), 2011. MMWR Morb Mortal Wkly Rep 2011; 60: 1705-1708. PubMed

7 Simard EP, Ward EM, Siegel R, Jemal A. Cancers with increasing incidence trends in the United States: 1999 through 2008. CA Cancer J Clin 201210.3322/caac.20141. published online Jan 4. PubMed

a Department of Health, London, UK