RESUMO
BACKGROUND: The World Health Organization recommends a 1- or 2-dose human papillomavirus (HPV) vaccination schedule for females aged 9 to 20 years. Studies confirming the efficacy of a single dose and vaccine modifications are needed, but randomized controlled trials are costly and face logistical and ethical challenges. We propose a resource-efficient single-arm trial design that uses untargeted and unaffected HPV types as controls. METHODS: We estimated HPV vaccine efficacy (VE) from a single arm by comparing 2 ratios: the ratio of the rate of persistent incident infection with vaccine-targeted HPV 16 and 18 (HPV 16/18) and cross-protected types HPV 31, 33, and 45 (HPV 31/33/45) to vaccine-unaffected types HPV 35, 39, 51, 52, 56, 58, 59, and 66 (HPV 35/39/51/52/56/58/59/66) vs the ratio of prevalence of these types at the time of trial enrollment. We compare VE estimates using only data from the bivalent HPV 16/18 vaccine arm of the Costa Rica Vaccine Trial with published VE estimates that used both the vaccine and control arms. RESULTS: Our single-arm approach among 3727 women yielded VE estimates against persistent HPV 16/18 infections similar to published 2-arm estimates from the trial (according-to-protocol cohort: 91.0% , 95% CI = 82.9% to 95.3% [single-arm] vs 90.9% , 95% CI = 82.0% to 95.9% [2-arm]; intention-to-treat cohort: 41.7%, 95% CI = 32.4% to 49.8% [single-arm] vs 49.0% , 95% CI = 38.1% to 58.1% [2-arm]). VE estimates were also similar in analytic subgroups (number of doses received; baseline HPV serology status). CONCLUSIONS: We demonstrate that a single-arm design yields valid VE estimates with similar precision to a randomized controlled trial. Single-arm studies can reduce the sample size and costs of future HPV vaccine trials while avoiding concerns related to unvaccinated control groups. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00128661.
Assuntos
Infecções por Papillomavirus , Vacinas contra Papillomavirus , Neoplasias do Colo do Útero , Eficácia de Vacinas , Feminino , Humanos , Costa Rica/epidemiologia , Papillomavirus Humano 16 , Papillomavirus Humano 18 , Papillomavirus Humano , Papillomaviridae , Infecções por Papillomavirus/epidemiologia , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus/administração & dosagem , Vacinas contra Papillomavirus/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Neoplasias do Colo do Útero/epidemiologia , Neoplasias do Colo do Útero/prevenção & controleRESUMO
How do unpleasant post-vaccination symptoms become recognized as vaccine 'side effects'? In this paper, we argue that it is not necessarily the logical outcome of scientific verification that it is said to be. The paper draws on an ethnographic study carried out in a small town, El Carmen de Bolivar, on Colombia's Caribbean coast from February through May 2019. In 2014, hundreds of girls in the town reported a range of mysterious symptoms following mass vaccination against the Human Papilloma Virus (HPV). Denying the girls' insistence that their symptoms were due to the vaccine, the official diagnosis was Mass Psychogenic Illness. Comparing these events with studies of controversial responses to other vaccines, we suggest that the pathway from post-vaccination symptoms to 'side effects' is cognitively and socially complex. In particular, it is context-dependent. Drawing on research in medical anthropology, sociology and STS, we argue that the official diagnosis was influenced by the subjects' marginal status; by a projection of the region's violent past onto individual inhabitants; by health professionals' commitment to a restricted notion of evidence (devaluing patients' own accounts); and by an institutional inability or unwillingness to stand against 'global consensus', which deems HPV safe.
Assuntos
Infecções por Papillomavirus , Vacinas contra Papillomavirus , Região do Caribe , Colômbia/epidemiologia , Feminino , Humanos , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus/efeitos adversos , VacinaçãoRESUMO
Dengue is endemic in several regions, and the global incidence is increasing. The recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV) is recommended for dengue seropositive individuals ≥ 9 years. Human papillomavirus (HPV) vaccination is recommended for girls aged 9-14 years to prevent HPV infection-related cancers. This study assessed the immunogenicity and safety of a bivalent HPV (types 16 and 18) vaccine and CYD-TDV when co-administered concomitantly or sequentially. This was a Phase IIIb, randomized, open-label, multicenter study in girls aged 9-14 years in Mexico (NCT02979535). Participants were randomized 1:1 to receive three doses of CYD-TDV 6 months apart and two doses of bivalent HPV vaccine either concomitantly with, or 1 month before (sequentially), the first 2 CYD-TDV doses. Antibody levels were measured at baseline and 28-days after each vaccine dose for all participants, using an enzyme-linked immunosorbent assay for HPV-16 and HPV-18 antibodies, and a plaque reduction neutralization test for the four dengue serotypes; results are reported only for participants who were seropositive at baseline. Safety was assessed for all randomized participants throughout the study. Of the randomized participants, 305/478 (63.8%) were seropositive for dengue at baseline: 154 in the concomitant group and 151 in the sequential group. After the last HPV vaccine dose, the antibody titers for HPV were comparable in seropositive participants between treatment groups, with between group titer ratios of 0.966 for HPV-16 and 0.999 for HPV-18. After dose 3 of CYD-TDV, antibody titers were comparable for the concomitant and sequential groups across all serotypes, with between-group ratios close to 1 (serotype 1: 0.977; serotype 2: 0.911; serotype 3: 0.921; serotype 4: 0.931). CYD-TDV and a bivalent HPV vaccine administered concomitantly or sequentially in dengue seropositive girls aged 9-14 years elicited comparable immune responses with similar safety profiles.
Assuntos
Vacinas contra Dengue , Dengue , Vacinas contra Papillomavirus , Anticorpos Antivirais , Dengue/prevenção & controle , Vacinas contra Dengue/efeitos adversos , Feminino , Humanos , Imunogenicidade da Vacina , México , Vacinas contra Papillomavirus/efeitos adversos , Vacinas CombinadasRESUMO
OBJECTIVE: We conducted a systematic review and meta-analysis to access HPV vaccines' safety and immunogenicity in Systemic Lupus Erythematosus (SLE) women. METHODS: The search was conducted in the most relevant databases. Meta-analyses to evaluate seroconversion rates for each HPV vaccine type and SLE flare rates after vaccination were performed. RESULTS: We identified 3,467 articles; six papers referring to SLE population were included. Five articles that evaluated vaccine immunogenicity at 7th month after enrollment were included in the meta-analysis. Overall seroconversion rates among SLE participants were 89.3% (95%CI, 0.76-1.00) for HPV6; 92.4% (95%CI, 0.82-1.00) for HPV11; 96.4% (95%CI, 0.93-1.00) for HPV16; and 91.8% (95%CI, 0.85-1.00) for HPV18. Five studies were included in the qualitative analysis of vaccines safety. Pain at the injection site was the most common adverse event (AE). Just one study reported serious AE not related to the vaccine. Flare rate after HPV vaccination was 12,6% (95% CI, 0.04-0.21). CONCLUSION: Few studies, small sample size, evaluated HPV vaccines in SLE women. Seroconversion rates in SLE women were like healthy women, but anti-HPV geometric mean titers (GMT) were slightly lower in SLE women. HPV vaccines were safe in this population.
Assuntos
Imunogenicidade da Vacina , Lúpus Eritematoso Sistêmico/imunologia , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus/efeitos adversos , Vacinas contra Papillomavirus/imunologia , Vacinação/efeitos adversos , Feminino , Humanos , Infecções por Papillomavirus/imunologiaRESUMO
RESUMO: Objetivo: Estimar a cobertura da primeira e da segunda dose da vacina papilomavírus humano (HPV) no Brasil, conforme a microrregião, comparando-se as coortes de meninas com 14, 15 e 16 anos em 2017, e investigar a associação da heterogeneidade espacial na cobertura vacinal com variáveis sociodemográficas. Métodos: A informação sobre doses aplicadas nos anos de 2013 a 2017 por idade foi obtida do Programa Nacional de Imunizações. O número de meninas residentes com sete, oito e nove anos em 2010, em cada microrregião, é oriundo do censo brasileiro de 2010. Para a análise, a cobertura vacinal acumulada por microrregião (n = 558) foi categorizada em baixa (< 80%) e adequada (≥ 80%), e um modelo logístico com intercepto aleatório foi ajustado, tendo cobertura vacinal adequada como desfecho. O efeito aleatório (unidade da federação) foi incluído para captar a correlação entre microrregiões que pertencem ao mesmo estado. Resultados: O percentual de microrregiões que alcançou a cobertura vacinal adequada foi significativamente maior para a primeira dose (entre 91,8 e 159,2%), independentemente da coorte. Observou-se menor cobertura da segunda dose (entre 7 e 79,9%), com heterogeneidade associada ao grau de urbanização e à presença de domicílios com banheiro de uso próprio no município. O efeito aleatório mostrou forte poder explicativo, sugerindo importantes diferenças entre os estados brasileiros no alcance da cobertura vacinal. Conclusão: Apesar de a vacina HPV estar disponível no Programa de Imunização, os achados do presente estudo apontam para uma dificuldade do alcance da cobertura vacinal adequada.
ABSTRACT: Objective: To estimate the coverage of the first and second dose of the human papillomavirus (HPV) vaccine in Brazil according to microregion, comparing cohorts of girls aged 14, 15, and 16 years in 2017, and investigate the association between spatial heterogeneity in vaccination coverage and sociodemographic variables. Methods: Information about the doses administered from 2013 to 2017 by age was gathered from the National Immunization Program. The number of girls aged seven, eight, and nine years living in each microregion in 2010 was obtained from the 2010 Brazilian Census. For the analysis, the cumulated vaccination coverage per microregion (n = 558) was categorized as low (< 80%) and adequate (≥ 80%), and a random intercept logistic model was adjusted, with adequate vaccination coverage as the outcome. The random effect (federative unit) was included to identify the correlation between microregions that belong to the same state. Results: The percentage of microregions with adequate vaccination coverage was significantly higher in the first dose (between 91.8 and 159.2%), regardless of the cohort. The coverage of the second dose was lower (between 7 and 79.9%), with heterogeneity associated with the degree of urbanization and households with private bathrooms in the municipality. The random effect showed a strong explanatory power, suggesting important differences among Brazilian states as to the outreach of vaccination coverage. Conclusion: Although the HPV vaccine is available through the Immunization Program, the findings of the present study point to a difficulty in achieving adequate vaccination coverage.
Assuntos
Humanos , Feminino , Criança , Adolescente , Vacinação/estatística & dados numéricos , Infecções por Papillomavirus/prevenção & controle , Cobertura Vacinal/estatística & dados numéricos , Alphapapillomavirus , Vacinas contra Papillomavirus/administração & dosagem , Brasil , Imunização , Vacinas contra Papillomavirus/efeitos adversosRESUMO
OBJECTIVE: To estimate the coverage of the first and second dose of the human papillomavirus (HPV) vaccine in Brazil according to microregion, comparing cohorts of girls aged 14, 15, and 16 years in 2017, and investigate the association between spatial heterogeneity in vaccination coverage and sociodemographic variables. METHODS: Information about the doses administered from 2013 to 2017 by age was gathered from the National Immunization Program. The number of girls aged seven, eight, and nine years living in each microregion in 2010 was obtained from the 2010 Brazilian Census. For the analysis, the cumulated vaccination coverage per microregion (n = 558) was categorized as low (< 80%) and adequate (≥ 80%), and a random intercept logistic model was adjusted, with adequate vaccination coverage as the outcome. The random effect (federative unit) was included to identify the correlation between microregions that belong to the same state. RESULTS: The percentage of microregions with adequate vaccination coverage was significantly higher in the first dose (between 91.8 and 159.2%), regardless of the cohort. The coverage of the second dose was lower (between 7 and 79.9%), with heterogeneity associated with the degree of urbanization and households with private bathrooms in the municipality. The random effect showed a strong explanatory power, suggesting important differences among Brazilian states as to the outreach of vaccination coverage. CONCLUSION: Although the HPV vaccine is available through the Immunization Program, the findings of the present study point to a difficulty in achieving adequate vaccination coverage.
OBJETIVO: Estimar a cobertura da primeira e da segunda dose da vacina papilomavírus humano (HPV) no Brasil, conforme a microrregião, comparando-se as coortes de meninas com 14, 15 e 16 anos em 2017, e investigar a associação da heterogeneidade espacial na cobertura vacinal com variáveis sociodemográficas. MÉTODOS: A informação sobre doses aplicadas nos anos de 2013 a 2017 por idade foi obtida do Programa Nacional de Imunizações. O número de meninas residentes com sete, oito e nove anos em 2010, em cada microrregião, é oriundo do censo brasileiro de 2010. Para a análise, a cobertura vacinal acumulada por microrregião (n = 558) foi categorizada em baixa (< 80%) e adequada (≥ 80%), e um modelo logístico com intercepto aleatório foi ajustado, tendo cobertura vacinal adequada como desfecho. O efeito aleatório (unidade da federação) foi incluído para captar a correlação entre microrregiões que pertencem ao mesmo estado. RESULTADOS: O percentual de microrregiões que alcançou a cobertura vacinal adequada foi significativamente maior para a primeira dose (entre 91,8 e 159,2%), independentemente da coorte. Observou-se menor cobertura da segunda dose (entre 7 e 79,9%), com heterogeneidade associada ao grau de urbanização e à presença de domicílios com banheiro de uso próprio no município. O efeito aleatório mostrou forte poder explicativo, sugerindo importantes diferenças entre os estados brasileiros no alcance da cobertura vacinal. CONCLUSÃO: Apesar de a vacina HPV estar disponível no Programa de Imunização, os achados do presente estudo apontam para uma dificuldade do alcance da cobertura vacinal adequada.
Assuntos
Alphapapillomavirus , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus/administração & dosagem , Cobertura Vacinal/estatística & dados numéricos , Vacinação/estatística & dados numéricos , Adolescente , Brasil , Criança , Feminino , Humanos , Imunização , Vacinas contra Papillomavirus/efeitos adversosRESUMO
BACKGROUND: Oncogenic human papillomavirus (HPV) infections cause most cases of cervical cancer. Here, we report long-term follow-up results for the Costa Rica Vaccine Trial (publicly funded and initiated before licensure of the HPV vaccines), with the aim of assessing the efficacy of the bivalent HPV vaccine for preventing HPV 16/18-associated cervical intraepithelial neoplasia grade 2 or worse (CIN2+). METHODS: Women aged 18-25 years were enrolled in a randomised, double-blind, controlled trial in Costa Rica, between June 28, 2004, and Dec 21, 2005, designed to assess the efficacy of a bivalent vaccine for the prevention of infection with HPV 16/18 and associated precancerous lesions at the cervix. Participants were randomly assigned (1:1) to receive an HPV 16/18 AS04-adjuvanted vaccine or control hepatitis A vaccine. Vaccines were administered intramuscularly in three 0·5 mL doses at 0, 1, and 6 months and participants were followed up annually for 4 years. After the blinded phase, women in the HPV vaccine group were invited to enrol in the long-term follow-up study, which extended follow-up for 7 additional years. The control group received HPV vaccine and was replaced with a new unvaccinated control group. Women were followed up every 2 years until year 11. Investigators and patients were aware of treatment allocation for the follow-up phase. At each visit, clinicians collected cervical cells from sexually active women for cytology and HPV testing. Women with abnormal cytology were referred to colposcopy, biopsy, and treatment as needed. Women with negative results at the last screening visit (year 11) exited the long-term follow-up study. The analytical cohort for vaccine efficacy included women who were HPV 16/18 DNA-negative at vaccination. The primary outcome of this analysis was defined as histopathologically confirmed CIN2+ or cervical intraepithelial neoplasia grade 3 or worse associated with HPV 16/18 cervical infection detected at colposcopy referral. We calculated vaccine efficacy by year and cumulatively. This long-term follow-up study is registered with ClinicalTrials.gov, NCT00867464. FINDINGS: 7466 women were enrolled in the Costa Rica Vaccine Trial; 3727 received the HPV vaccine and 3739 received the control vaccine. Between March 30, 2009, and July 5, 2012, 2635 women in the HPV vaccine group and 2836 women in the new unvaccinated control group were enrolled in the long-term follow-up study. 2635 women in the HPV vaccine group and 2677 women in the control group were included in the analysis cohort for years 0-4, and 2073 women from the HPV vaccine group and 2530 women from the new unvaccinated control group were included in the analysis cohort for years 7-11. Median follow-up time for the HPV group was 11·1 years (IQR 9·1-11·7), 4·6 years (4·3-5·3) for the original control group, and 6·2 years (5·5-6·9) for the new unvaccinated control group. At year 11, vaccine efficacy against incident HPV 16/18-associated CIN2+ was 100% (95% CI 89·2-100·0); 34 (1·5%) of 2233 unvaccinated women had a CIN2+ outcome compared with none of 1913 women in the HPV group. Cumulative vaccine efficacy against HPV 16/18-associated CIN2+ over the 11-year period was 97·4% (95% CI 88·0-99·6). Similar protection was observed against HPV 16/18-associated CIN3-specifically at year 11, vaccine efficacy was 100% (95% CI 78·8-100·0) and cumulative vaccine efficacy was 94·9% (73·7-99·4). During the long-term follow-up, no serious adverse events occurred that were deemed related to the HPV vaccine. The most common grade 3 or worse serious adverse events were pregnancy, puerperium, and perinatal conditions (in 255 [10%] of 2530 women in the unvaccinated control group and 201 [10%] of 2073 women in the HPV vaccine group). Four women in the unvaccinated control group and three in the HPV vaccine group died; no deaths were deemed to be related to the HPV vaccine. INTERPRETATION: The bivalent HPV vaccine has high efficacy against HPV 16/18-associated precancer for more than a decade after initial vaccination, supporting the notion that invasive cervical cancer is preventable. FUNDING: US National Cancer Institute.
Assuntos
Papillomavirus Humano 16/imunologia , Papillomavirus Humano 18/imunologia , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus/administração & dosagem , Displasia do Colo do Útero/prevenção & controle , Neoplasias do Colo do Útero/prevenção & controle , Vacinas Combinadas/administração & dosagem , Adolescente , Adulto , Costa Rica , Método Duplo-Cego , Feminino , Humanos , Imunização , Gradação de Tumores , Infecções por Papillomavirus/diagnóstico , Infecções por Papillomavirus/virologia , Vacinas contra Papillomavirus/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Neoplasias do Colo do Útero/patologia , Neoplasias do Colo do Útero/virologia , Vacinas Combinadas/efeitos adversos , Adulto Jovem , Displasia do Colo do Útero/patologia , Displasia do Colo do Útero/virologiaRESUMO
BACKGROUND: Concerns about the safety and efficacy of vaccines in patients with autoimmune diseases (AID) have led to contradictions and low vaccination coverage in this population, who are at a higher risk of infections, including by human papillomavirus (HPV). Although HPV vaccines have been recommended for immunocompromised patients, there is still a lack of data to support its use for AID patients, such as juvenile dermatomyositis (JDM) patients. The aim of this study was to assess the safety and immunogenicity of the quadrivalent HPV (qHPV) vaccine in a cohort of JDM patients. METHODS: JDM patients aged from 9 to 20 years and healthy controls (HC) were enrolled to receive a 3-dose schedule of qHPV vaccine from March/2014 to March/2016. Study visits were performed before the first dose, 1 month after the second and third doses, and 6 months after the third dose. Participants completed a diary of possible adverse events for 14 days following each dose of vaccination (AEFV). Disease activity and current therapy were analyzed at each visit for JDM patients. In addition, serum samples from all participants were collected to test antibody concentrations against HPV16 and 18 at each visit. Participant recruitment was conducted in ten Brazilian centres. From 47 eligible JDM patients and 41 HC, 42 and 35, respectively, completed the 3-dose schedule of the vaccine, given that five JDM patients and two HC had received doses prior to their inclusion in the study. RESULTS: The AEFVs presented by the participants were mild and in general did not differ between JDM and HC groups. No severe AEFVs were related to the vaccination. Disease activity was stable, or even improved during the follow-up. One month after the third dose of the vaccine the JDM group presented seropositivity of 100% for HPV16 and 97% for HPV18, similarly to the HC group, who presented 100% for both serotypes (p = 1.000). Six months after the third dose the seropositivity for the patient group was 94% for both HPV types. CONCLUSIONS: The HPV vaccination in this cohort of JDM patients was safe and immunogenic. Since the seropositivity against HPV16 and 18 was very high after the 3-dose schedule, this regimen should be recommended for JDM patients. TRIAL REGISTRATION: Brazilian Clinical Trials Registry, number: RBR-9ypbtf . Registered 20 March 2018 - Retrospectively registered.
Assuntos
Corticosteroides/uso terapêutico , Dermatomiosite , Imunogenicidade da Vacina/imunologia , Infecções por Papillomavirus , Vacinas contra Papillomavirus , Alphapapillomavirus/imunologia , Brasil/epidemiologia , Criança , Dermatomiosite/epidemiologia , Dermatomiosite/imunologia , Dermatomiosite/terapia , Feminino , Humanos , Hospedeiro Imunocomprometido/efeitos dos fármacos , Avaliação de Processos e Resultados em Cuidados de Saúde , Infecções por Papillomavirus/epidemiologia , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus/administração & dosagem , Vacinas contra Papillomavirus/efeitos adversos , Adulto JovemRESUMO
OBJECTIVE: To identify social factors influencing the acceptance of human papilloma virus (HPV) vaccination in the Colombian population before and after the unexpected and poorly defined event of unknown etiology which occurred in 2014. METHODS: A systematic review of the literature was conducted in the following databases: Scopus, Web of Science, Medline via PubMed, Embase, Online Health Library (Biblioteca Virtual en Salud) and Ovid, and also in Google Scholar, academic repositories and in Colombian health institutions, using the terms "recombinant tetravalent vaccine against Human Papilloma Virus types 6, 11, 16, 18", "Colombia", "Papilloma" in order to primarily identify systematic reviews, quantitative and qualitative studies, narrative reviews, focusing on social aspects such as education, access, relationship with healthcare staff and role of the media which may have acted as barriers or facilitators for the acceptance of HPV vaccination in Colombia between 2006-2018. A narrative synthesis of the data was made. RESULTS: Twenty-four documents were included. The importance attached by parents, adolescents, providers and the media to having greater knowledge about HPV and its association with cervical cancer was identified. The relevance of good communication among healthcare professions and the community to enable adequate sharing of information regarding the risks and benefits of the vaccines was recognized. The inclusion of the vaccine in health insurance plans made access easier. The media must be involved as facilitators in vaccination programs. CONCLUSIONS: Education regarding HPV, patient-centered healthcare and adequate media coverage influence the acceptance of HPV vaccination in the Colombian population. Close follow-up of any vaccine-related adverse events is required.
TITULO: ASPECTOS SOCIALES QUE HAN AFECTADO LA ACEPTACIÓN DE LA VACUNACIÓN CONTRA EL VIRUS DEL PAPILOMA HUMANO EN COLOMBIA. UNA REVISIÓN SISTEMÁTICA. OBJETIVO: Establecer los aspectos sociales que afectaron la aceptación de la vacuna del virus del papi- loma humano (VPH) en la población colombiana antes y después del evento mal definido e inusitado de etiología desconocida sucedido en 2014. METODOS: Se realizó una búsqueda sistemática de literatura en las bases de datos: Scopus, Web of Science, Medline vía PubMed, Embase, Biblioteca Virtual en Salud y Ovid; además, en Google Académico y en repositorios de universidades y en instituciones de salud en Colombia, con los términos: "Vacuna Tetravalente Recombinante contra el Virus del Papiloma Humano Tipos 6, 11, 16, 18", "Colombia", "Papiloma" y sus correspondientes términos en inglés, para identificar principalmente revisiones sistemáticas, estudios cuantitativos y cualitativos, y revisiones narrativas que se enfocaran en aspectos sociales como: educación, acceso, relación con el personal de salud, papel de los medios de comunicación, que pudieran haber actuado como barreras o facilitadores para la aceptación de vacunación para VPH en Colombia en el periodo 2006-2018. Se hace una síntesis narrativa de la información. RESULTADOS: Se incluyeron 24 documentos. Se identificó la importancia, para los padres, adolescentes, proveedores y los medios, de tener un mejor conocimiento del VPH y su relación con el cáncer de cuello uterino (CCU). Se reconoce la relevancia de una buena comunicación entre las profesiones de la salud y la comunidad para informar adecuadamente tanto los beneficios como los riesgos de la vacuna. La inclusión en los planes de aseguramiento facilitó el acceso a esta por parte de la población. Los medios de comunicación deben ser considerados para que actúen como facilitadores de los programas de vacunación. CONCLUSIONES: Educar en el conocimiento del VPH, una atención en salud centrada en el paciente y una adecuada cobertura de los medios de comunicación influencian la aceptación del programa de vacuna- ción contra VPH en la población colombiana. Se requiere seguir haciendo seguimiento estricto de los efectos adversos asociados a la vacuna.
Assuntos
Vacinas contra Papillomavirus , Aceitação pelo Paciente de Cuidados de Saúde , Vacinação/psicologia , Adolescente , Adulto , Criança , Colômbia , Escolaridade , Feminino , Educação em Saúde , Conhecimentos, Atitudes e Prática em Saúde , Acessibilidade aos Serviços de Saúde , Humanos , Meios de Comunicação de Massa , Motivação , Vacinas contra Papillomavirus/efeitos adversos , Pais/psicologia , Relações Profissional-Paciente , Vacinas Sintéticas , Adulto JovemRESUMO
BACKGROUND: The burden of human papillomavirus (HPV) diseases is high in Latin America. HPV vaccines licensed from 2006 onwards offer protection against most HPV-related cancers, especially when introduced into national immunization programs. Barriers to optimal vaccine uptake are, however, lowering the impact of adolescent HPV vaccination programs. Immunization of children might overcome these barriers and be a strategy of choice for some countries. METHODS: This multicenter phase III randomized, controlled, single-blind study (NCT01627561) was conducted in Colombia, Mexico and Panama to assess safety and immunogenicity of 2-dose vaccination with AS04-adjuvanted HPV-16/18 vaccine in girls 4-6 years of age. We report safety outcomes and anti-HPV-16/18 antibody titers measured by enzyme-linked immunosorbent assay in HPV-vaccinated girls that were followed over a 36-month period. RESULTS: Over 36 months (ie, 30 months after the second vaccine dose), among 74 girls included in the HPV group, 1 serious adverse event unrelated to vaccination has been reported. No withdrawal because of (serious) adverse events has been reported. At month 36, all girls in the per-protocol-cohort were still seropositive for anti-HPV-16 and anti-HPV-18 with geometric mean concentrations of 1680.6 and 536.4 enzyme-linked immunosorbent assay units/mL, respectively. CONCLUSIONS: The AS04-adjuvanted HPV-16/18 vaccine administered according to a 2-dose schedule to girls 4-6 years of age induced a high and sustained immunologic response with an acceptable safety profile during the 30 months following vaccination.