Immunogenicity and Safety of the Human Papillomavirus 6, 11, 16, 18 Vaccine in HIV-Infected Young Women

Cincinnati Children's Hospital Medical Center and the University of Cincinnati College of Medicine, Cincinnati, OH, U.S.
Clinical Infectious Diseases (Impact Factor: 8.89). 05/2013; 57(5). DOI: 10.1093/cid/cit319
Source: PubMed


The objective of this study was to determine whether the 3-dose quadrivalent human papillomavirus (HPV) vaccine series (HPV-6, -11, -16, -18) is immunogenic and safe in young women infected with human immunodeficiency virus (HIV).Methods
We enrolled 99 women aged 16-23 years in a phase 2, open-label, multicenter trial, conducted from 2008 to 2011 by the Adolescent Medicine Trials Network for HIV/AIDS Interventions. Outcome measures were immunogenicity 4 weeks after dose 3, measured by (1) geometric mean titers (GMTs) and (2) seroconversion rates for HPV-6, -11, -16, and -18, among those seronegative and HPV DNA negative for each type. Immune responses were compared to those of a historical comparison group of HIV-negative women (n = 267) using univariate methods. Clinical and laboratory adverse events were assessed after each dose.ResultsThe mean age of subjects was 21.4 years; 80% were non-Hispanic black, 69 were not taking antiretroviral therapy (ART), and 30 were taking ART. No differences in GMTs were noted among participants taking ART vs the comparison group, but GMTs were lower in participants not taking ART vs the comparison group for HPV-16 (2393 vs 3892 milli-Merck units per milliliter [mMU/mL], P =. 012) and HPV-18 (463 vs 801 mMU/mL, P =. 003). Seroconversion rates were 100% for HPV-6, -11, -16, and -18 among participants taking ART. Rates ranged from 92.3% (for HPV-18) to 100.0% (for HPV-6) among participants not taking ART. One severe adverse event (fatigue) was noted.Conclusions
In a sample of HIV-infected women who were HPV DNA and HPV seronegative, immune responses to HPV vaccination were generally robust and the vaccine was well tolerated.Clinical Trials RegistrationNCT00710593. © The Author 2013. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved.

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    • "Levin et al. [15] showed that QHPV was safe, immunogenic and did not alter CD4+ % or plasma HIV-RNA in a cohort of HIV-infected children and adolescents aged 7–12 years. Results from a multicenter trial performed by the Adolescent Medicine Trials Network for HIV/AIDS Interventions, in young women aged 16–23 years (n = 99), indicated that immune responses to QHPV were robust and the vaccine well tolerated [16]. "
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    ABSTRACT: The ability of a quadrivalent human papilloma virus (HPV)-16/18/6/11 VLP vaccine (Gardasil) to elicit HPV-specific cell-mediated immune responses was evaluated in antiretroviral therapy (ART)-treated HIV-infected young adults. Results showed that, after three doses of vaccine, central memory and effector memory CD4+ and CD8+ T lymphocytes, as well as HPV-specific interleukin (IL)2+/CD4+, interferon-gamma (IFN-[gamma]+)/CD4+, IFN-[gamma]+/CD8+ and tumour necrosis factor-alpha (TNF-[alpha])+/CD8+ T lymphocytes and Perforin and Granzyme B secreting CD8+ T lymphocytes were significantly increased. Notably, results obtained in HIV-infected patients were comparable to those seen in HIV-uninfected age-matched healthy controls.
    Full-text · Article · Mar 2015 · AIDS
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    • "Quadrivalent HPV vaccine was immunogenic and well tolerated in HIV-infected young women in a recent study (29). HPV vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP) for HIV-infected individuals through age 26 yr for those who did not get any or all doses when they were younger (30). "
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    ABSTRACT: The epidemiology on human papillomavirus (HPV) among human immunodeficiency virus (HIV)-infected women in Korea is not well established. A retrospective study was conducted to determine the prevalence and genotype distribution of HPV infection among HIV-infected women in Korea. HPV DNA genotype and cervical cytology were examined in 60 HIV-positive women and 1,938 HIV-negative women. HPV genotypes were analyzed by using a HPV DNA chip. HIV-infected women had higher prevalence of high-risk HPV (hr-HPV) infection (30% vs 4.9%, adjusted odds ratio [AOR], 6.96; 95% confidence interval [CI], 3.63-13.34, P<0.001) and abnormal cervical cytology (18.3% vs 1.8%, AOR, 10.94; 95% CI, 5.18-23.1, P<0.001) compared with controls. The most common hr-HPV genotype detected in HIV-infected women was HPV 16 (10%), followed by 18 (6.7%) and 52 (5%). Prevalence of quadrivalent vaccine-preventable types (HPV 6, 11, 16, and 18) was 21.7% and 2.3% in HIV-positive women and HIV-negative women, respectively. Age was a significant risk factor for hr-HPV infection in HIV-infected women (P=0.039). The presence of hr-HPV was significantly associated with abnormal cervical cytology (P<0.001). These findings suggest that HPV testing for cervical cancer screening in HIV-infected women would be necessary, particularly among young age group.
    Full-text · Article · Jan 2014 · Journal of Korean medical science
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    ABSTRACT: Background: We compared the immunogenicity and reactogenicity of Cervarix or Gardasil human papillomavirus (HPV) vaccines in adults infected with the human immunodeficiency virus (HIV). Methods: This was a double-blind, controlled trial randomizing HIV-positive adults to receive 3 doses of Cervarix or Gardasil at 0, 1.5, and 6 months. Immunogenicity was evaluated for up to 12 months. Neutralizing anti-HPV-16/18 antibodies were measured by pseudovirion-based neutralization assay. Laboratory tests and diary cards were used for safety assessment. The HPV-DNA status of the participants was determined before and after immunization. Results: Ninety-two participants were included in the study. Anti-HPV-18 antibody titers were higher in the Cervarix group compared with the Gardasil group at 7 and 12 months. No significant differences in anti-HPV-16 antibody titers were found among vaccine groups. Among Cervarix vaccinees, women had higher anti-HPV-16/18 antibody titers compared to men. No sex-specific differences in antibody titers were found in the Gardasil group. Mild injection site reactions were more common in the Cervarix group than in the Gardasil group (91.1% vs 69.6%; P = .02). No serious adverse events occurred. Conclusions: Both vaccines were immunogenic and well tolerated. Compared with Gardasil, Cervarix induced superior vaccine responses among HIV-infected women, whereas in HIV-infected men the difference in immunogenicity was less pronounced.
    Full-text · Article · Nov 2013 · The Journal of Infectious Diseases
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