<< Back To Home

NEW THIS TUESDAY: IMPLEMENTATION OF THE QUADRIVALENT VACCINE AGAINST HPV, BRAZIL

Wednesday, 2nd of October 2013 Print
  • IMPLEMENTATION OF THE QUADRIVALENT VACCINE AGAINST HPV IN THE MUNICIPALITY OF CAMPOS DOS GOYTACAZES, BRAZIL – A COMBINATION OF STRATEGIES TO INCREASE IMMUNIZATION COVERAGE AND EARLY REDUCTION OF GENITAL WARTS 

Trials in Vaccinology

Received 28 July 2013

Accepted 13 August 2013

Available online 23 September 2013


Abstract

Introduction

Among the more than 100 types of human papillomavirus (HPV), about 90% of genital warts are caused by HPV types 6 and 11; types 16 and 18 cause 70% of cases of cervical cancer. Tracking through Pap associated with condom use are strategies in preventing this condition. Vaccination against HPV has been added to the portfolio of protection. In September 13, 2010, the quadrivalent vaccine against HPV was made available for resident girls between 11 and 15 years of age in the municipality of Campos dos Goytacazes, Rio de Janeiro, Brazil using a hybrid strategy of vaccination.

Objectives

Assess vaccination coverage in that municipality after adopting several strategies for active search and missed opportunities for vaccination against HPV. Evaluate acceptance for the vaccine and reasons for refusal the HPV vaccine. Evaluate the frequency and occurrence of adverse events to that vaccine. A survey of reduction of genital warts was also conducted.

Methods

A survey of vaccination coverage for the chosen age group was carried out. By previous appointment, schools received vaccination on site; two “D-Days” for municipal vaccination were set along side with the creation of the project “Holidays HPV-free”. The vaccine was also offered in two public permanent sites on a daily basis; Vaccine adverse events were assessed in 1000 adolescents after 96 h of vaccine administration A survey on reduction of genital warts was studied 3 years before and 2 years after introduction of vaccine.

Results

The 1st vaccine dose reached about 53%, 90.1% and 87.9% of coverage, respectively in 2010, 2011 and 2012. By using the same model, the complete scheme with 3rd dose reached 0%, 65.1% and 66.2% of coverage status. There were observed a total of 430 local and systemic events in 360 subjects (36% of 1000 girls), stratified by each dose received. No serious adverse events or any hospitalization were reported; We also observed a reduction of about 55% in the incidence of genital warts in women under 21 years old.

Conclusion

A hybrid strategy for HPV proved to be effective in vaccinating adolescents in this municipality. HPV vaccine was safe and effective in reducing genital warts, as demonstrated by international studies.


Introduction

The human papillomavirus (HPV) is a sexually transmitted virus with a high outcome of morbidity and mortality of cervical cancer [1], accounting for about 275,000 deaths annually in women worldwide [1].

In Brazil, a high percentage of the population is infected with HPV, with an estimate of about 9–10 million of individuals infected, producing an annual incidence of 17,540 new cases of cervical cancer, responsible for 4000 deaths per year in the country [2].

HPV belongs to a heterogeneous family of more than 100 different genotypes. Among these genotypes, 40 of them can infect the anogenital region [3]. They are classified in high-risk and low-risk HPV. The high-risk HPV offers a high oncogenic potential and is associated with cancer of the cervix. HPV can produce neoplastic changes known as intraepithelial cervical neoplasia (CIN) grade I, II and III, related to the degree of dysplasia. They are configured by lesions that lead to both cervical and uterine carcinoma. Although HPV infection are of high incidence in young women at early sexual activity, its worst outcome, in the form of cervical cancer, is more common in women aged 40–60 years old, given the long period of viral latency and evolution [4].

The main related HPV types of epidemiological importance are types 16 and 18 (high risk), responsible for 70% of cases of cervical cancer, and types 6 and 11 (low risk), which account for 90% of cases of genital warts [5], [6] and [7]. This virus can also be associated with other types of cancer in addition to affecting the anogenital tract, such as the cancer on the laryngeal, respiratory and digestive tracts [8] and [9].

According to the portfolio of protection against HPV, the early tracking with Pap screening associated with the use of condom and also HPV vaccination are the current state of the art of prevention. Quadrivalent (types 6, 11, 16, 18) and bivalent (types 16 and 18) vaccines against HPV are licensed nationally. Internationally they are known as Gardasil® (MSD) and Cervarix® (GSK), respectively [10]. As the highest incidence of infection occurs soon after the onset of sexual activity, vaccination is recommended before this period, which varies around 11 and 12 years of age. Printed recommendations indicate vaccination from 9 years of age onwards [10]. According to the World Health Organization (WHO) [11], the combination of strategies to increase coverage against HPV associated with the most appropriate monitoring tools, will set the base to reach the endpoint of reducing the incidence of HPV related diseases.

It should be noted that HPV vaccines are not included in the Brazilian National Immunization Program (NIP) and is only available in private clinics. Exceptionally, the city of Campos dos Goytacazes, by using its own funds, included the quadrivalent vaccine against HPV in the municipal vaccination calendar on September 13th, 2010, making it available for residents aged 11–15 years old.

This study aims to assess the effectiveness of the “hybrid” strategy of HPV vaccination in Campos dos Goytacazes, using vaccination strategies in schools, at two fixed sites as well as other additional vaccination strategies. “Holidays HPV-free” was a pioneering initiative targeted to girls, aiming to increase their attendance to nearest Public Permanent Vaccination sites. Thus, the objective was to assess through a survey, the vaccination coverage against HPV, linked to a web-based tool for monitoring the vaccination process. It is known that many successful programs for HPV vaccination were implemented in developed countries, but there is little literature available to demonstrate the effectiveness of strategies in a city of a developing country like Brazil thus demonstrating reduction of genital warts in young women.

Methods

Characteristics of the city

The municipality of Campos dos Goytacazes is the largest city in the state of Rio de Janeiro, Brazil, covering 4032 km2 of both urban and rural areas. The population is estimated of 463,545 inhabitants (240,000 of women) and is considered the largest metropolitan area outside the state. Its economy is based on oil extraction, which represents about 80% of the national production [12]. According to data from the Brazilian Institute of Geography and Statistics (IBGE), the population of girls of 11–15 years of age to be vaccinated is of 20.286, 20.479 and 20.661 of adolescents, respectively in 2010, 2011 and 2012.

Epidemiological data from the municipality considered the annual incidence of 30 cases of cervical cancer per 100.000 women. There is an annual average of 15 deaths (7.5 per 100,000 women). The Ministry of Health of Brazil consider the average incidence of 17 cases/100,000 women and 5 deaths/100,000 women.

Design of pre vaccination strategy

The decision to offer the quadrivalent vaccine against HPV in the municipality of Campos dos Goytacazes was made based on: (i) realization of a “hybrid” strategy, (ii) refusal to vaccinate and (iii) a cost-effectiveness survey, which was conducted prior to this study.

Firstly, a “hybrid” strategy to combine mobile vaccination in local schools and also in public permanent vaccination sites, from Mondays to Fridays was carried out. This city houses 262 schools, including public and private, distributed in all districts and rural areas, bearing about 68 Public Clinics equipped with vaccination rooms. The reason for choosing such strategy was based on the size of the municipality and the number of schools.

This “hybrid” strategy was made possible thanks to the School Health Program (PSE), a municipal strategy that brings together a series of actions along with health services in schools in Campos dos Goytacazes. Such initiative contributed with the municipal vaccination strategy, which also included a series of lectures given in public and private schools on HPV. Such lectures were rather useful in elucidating issues of parents and adolescents.

Aiming to find out the low attendance of girls to HPV vaccination, 300 parents were interviewed after the lectures. Results of interviews helped in achieving vaccination events such as “D-day” and “Holidays HPV-free”.

A technical committee constituted by doctors and specialists as well as public health experts designed a cost effectiveness model in order to ensure that the cost of the vaccine would be lower when compared to the treatment of genital warts and consequently the risk of developing cervix cancer and other HPV-related diseases.

Vaccination at school

Initially, with PSEs collaboration, the professionals of the County Immunization Coordination sent official letters to all schools requesting the nominal list of girls aged 11–15 years old. From 2011, when reaching the age of 11, the girls were referred to vaccination. Vaccination routes involving schools from the same district were scheduled. An informed consent term was sent to each parent or guardian informing the benefits of vaccination, potential risks and an authorization term for carrying out vaccination at schools.

Note to users: Corrected proofs are Articles in Press that contain the authors corrections. Final citation details, e.g., volume/issue number, publication year and page numbers, still need to be added and the text might change before final publication.

Although corrected proofs do not have all bibliographic details available yet, they can already be cited using the year of online publication and the DOI , as follows: author(s), article title, journal (year), DOI. Please consult the journals reference style for the exact appearance of these elements, abbreviation of journal names and use of punctuation.

When the final article is assigned to an issue of the journal, the Article in Press version will be removed and the final version will appear in the associated published issue of the journal. The date the article was first made available online will be carried over.

41257527