O180 Safety and Immunogenicity of the Hpv‐16/18 As04‐adjuvanted Vaccine in Hiv‐positive Women in South Africa Up to 12 Months After Vaccination

Denny, Lynette; Hendricks, Bronwyn; Gordon, Claire L.; Hervé, Caroline; Thomas, Florence; Hezareh, Marjan; Dobbelaere, Kurt; Durand, Christelle; Struyf, Frank

doi:10.1016/s0020-7292(12)60610-9

Cited by 7 publications

(5 citation statements)

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“…Reported vaccine efficacy was used as a proxy for effectiveness as follows: CIN1+ 50.3 % (95 % CI: 40.2–58.8 %; CIN1 health state in the model), CIN2+ 64.9 % (95 % CI: 52.7–74.2 %; CIN2/3 health state) and CIN3+ 93.2 % (95 % CI: 78.9–98.7 %; CC health state) [ 15 ]. Vaccine efficacy in HIV+ subjects is assumed to be the same as those reported for HIV- cohort in the PATRICIA trial, based on recently reported immunogenicity results from a phase I/II clinical trial in HIV+ women in South Africa showing the vaccine is immunogenic and does not impact on HIV disease progression in HIV+ women [ 16 ].…”

Section: Methodsmentioning

confidence: 99%

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Cost-effectiveness analysis of human papillomavirus vaccination in South Africa accounting for human immunodeficiency virus prevalence

Stander²,

Kriekinge

et al. 2015

BMC Infect Dis

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BackgroundThis study aims at evaluating the cost-effectiveness of a 2-dose schedule human papillomavirus (HPV) vaccination programme of HPV and human immunodeficiency virus (HIV) naïve 12-year-old girls, in addition to cervical cancer (CC) screening alone, in South Africa. The study aims to account for both the impact of the vaccine among girls who are HIV-positive (HIV+) as well as HIV-negative (HIV-) population.MethodsA previously published Markov cohort model was adapted to assess the impact and cost-effectiveness of a HPV vaccination programme in girls aged 12 years (N = 527 900) using the AS04-adjuvanted HPV-16/18 vaccine from a public payer perspective. Two subpopulations were considered: HIV- and HIV+ women. Each population followed the HPV natural history with different transition probabilities. Model input data were obtained from the literature, local databases and Delphi panel. Costs and outcomes were discounted at 5 %. Extensive sensitivity analyses were conducted to assess the robustness of the evaluation.ResultsImplementation of the AS04-adjuvanted HPV-16/18 vaccine in combination with current cytological screening in South African girls could prevent up to 8 869 CC cases and 5 436 CC deaths over the lifetime of a single cohort. Without discounting, this HPV vaccine is dominant over screening alone; with discounting, the incremental cost-effectiveness ratio is ZAR 81 978 (South African Rand) per quality-adjusted life years (QALY) gained. HPV vaccination can be considered cost-effective based on World Health Organization (WHO) recommended threshold (3 x gross domestic product/capita = ZAR 200 293). In a scenario with a hypothetical targeted vaccination in a HIV+ subpopulation alone, the modelled outcomes suggest that HPV vaccination is still cost-effective, although the incremental cost-effectiveness ratio increases to ZAR 102 479. Results were sensitive to discount rate, vaccine efficacy, HIV incidence and mortality rates, and HPV-related disease transition probabilities.ConclusionsThe AS04-adjuvanted HPV-16/18 vaccine can be considered cost-effective in a South African context although the cost-effectiveness is expected to be lower in the HIV+ subpopulation than in the overall female population. With improved access to HIV treatment, the HIV mortality and incidence rates are likely to be reduced, which could improve cost-effectiveness of the vaccination programme in South Africa.Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-015-1295-z) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 99%

“…Efficacy of these vaccines has been demonstrated in adolescents and adult women [ 11 – 15 ]. Moreover, HPV vaccines clinical trials in HIV-infected individuals have shown that these vaccines have clinically acceptable safety profiles and are immunogenic [ 16 , 17 ].…”

Section: Introductionmentioning

confidence: 99%

Cost-effectiveness analysis of human papillomavirus vaccination in South Africa accounting for human immunodeficiency virus prevalence

Stander²,

Kriekinge

et al. 2015

BMC Infect Dis

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“…Safety and immunogenicity of the bivalent vaccine have been evaluated in a Phase II interventional study in South Africa (Clinical trials registration: NCT00586339). Preliminary results were presented at AORTIC 7th International Conference, November 2011, Cairo Egypt [41]. The study showed that regardless of baseline HPV status, all HIV-positive and HIV-negative subjects had seroconverted to HPV16/18 at Month 2 and Month 7.…”

Section: Hpv Vaccination In Hiv-infected Individualsmentioning

confidence: 99%

Human Papillomavirus, Human Immunodeficiency Virus and Immunosuppression

Denny

Franceschi

Sanjosé

et al. 2012

Vaccine

215

193

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The vast majority of women infected with human immunodeficiency virus (HIV) will be co-infected with human papillomavirus (HPV). The interaction between the two sexually transmitted infections appears to be related to the alteration in cell-mediated immunity in HIV infected persons, increased susceptibility, and possibly reactivation of latent HPV infection. Linkage studies of HIV/AIDs and Cancer registries have indicated a 2- to 22-fold increase in cervical cancer in HIV-positive women compared to HIV-negative women. Data on the prevalence of HPV types in invasive cervical carcinoma (ICC) suggest that the proportion of infection with types HPV16/18 (responsible for over 70% of all cervical cancers) is similar in HIV-negative and HIV-positive women. The biological interaction between HIV and HPV needs further elucidation, although there is some evidence that the presence of HPV infection may be associated with increased HIV transmission. Adolescents perinatally infected by HIV are known to have higher rates of HPV infection and also have been shown to seroconvert in response to HPV vaccination with the quadrivalent vaccine, albeit to lower titers than HIV-negative individuals. Anal cancer incidence is greatly increased in HIV-positive individuals, particularly in HIV-positive men who have sex with men. Screening for anal cancer precursors is feasible and effective; however, the impact on reduction of anal cancer remains to be demonstrated. There are ongoing studies on the safety, immunogenicity, and efficacy of current HPV vaccines in HIV-positive individuals and mature data are awaited. Male circumcision may be another approach to prevention of HPV transmission, which also requires further study. This article forms part of a special supplement entitled "Comprehensive Control of HPV Infections and Related Diseases" Vaccine Volume 30, Supplement 5, 2012.

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“…50 Nevertheless, titers for both vaccines peaked 1 month after the third dose and declined over the next year but remained relatively stable for the duration of follow-up (4 years for Cervarix and 4.5 years for Gardasil). 51,52 Women vaccinated with Cervarix showed titers greater than the GMT observed after natural infection during the plateau stage. However, almost one-third of those vaccinated with Gardasil experienced a drop in HPV 18 titers to less than the level of detection.…”

Section: Immunogenicity Trialsmentioning

confidence: 99%

“…63 Preliminary results of a phase II trial of the bivalent vaccine performed in South Africa showed that both HIV-negative and HIV-infected women seroconverted to HPV 16 and 18 regardless of baseline HPV status. 51 However, women with HIV had significantly lower geometric mean titers compared with their HIV-negative counterparts. There are many other studies looking at adolescents, young women, and men infected with HIV.…”

Section: Immunogenicity Trialsmentioning

confidence: 99%