A Randomized, Placebo-Controlled, Dose-Escalation Study to Determine the Safety, Tolerability, and Immunogenicity of an HPV-16 Therapeutic Vaccine in HIV-Positive Participants With Oncogenic HPV Infection of the Anus

Anderson, J.; Hoy, Jennifer; Hillman, Richard J.; Barnden, Megan; Eu, Beng; McKenzie, Andrew; Gittleson, Charmaine

doi:10.1097/qai.0b013e3181b7354c

Cited by 35 publications

(20 citation statements)

References 37 publications

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“…However, despite effective HAART, responses remain suboptimal relative to HIV-negative individuals, although they improve with larger and more frequent vaccine doses [76]. On this subject, data reported by Anderson et al [77] appear intriguing but not conclusive. Thirty-five HIV-positive men who have sex with men, with AIN and mild to moderate immune-suppression (CD4 cell count >300 cells/mL) were treated with a novel therapeutic HPV-16 E6E7 ISCOMATRIX vaccine.…”

Section: F) Perspectives On Preventative and Therapeutic Vaccinementioning

confidence: 98%

Anal Cancer: Focus on HIV-Positive Patients in the HAART Era

Zanet

Berretta

Martellotta

et al. 2011

CHR

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Anal cancer represents an increasing health problem, especially in immune-compromised patients, as HIV-positive patients. Notably, a significant higher incidence rate is reported among HIV infected patients with the advent of highly active antiretroviral therapy (HAART). To date, no randomised trial supports the correlation between existing screening strategies and reduced progression of anal intraepithelial neoplasia (AIN) to anal cancer or improved survival. Nevertheless, screening and treatment of AIN by topical agents should be implemented in high risk population. Data on invasive anal cancer treatment show that combined modality treatment (CMT) is the treatment of choice. Early reports on HIV-positive patients describe higher treatment toxicity and a relation with lower CD4 count and higher HIV viral load. More recently, reported outcomes seem to be similar in HIV-positive population and general population. Reports on a rise in local recurrence rates and in acute side effects along with a correlation with pre-treatment CD4 counts in HIV-positive patients, are not confirmed by all authors. The development of the first approved vaccine is a milestone in the field of anogenital cancers. However, many questions are still unresolved especially as concerns immunization in the setting of HIV infection.

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Section: F) Perspectives On Preventative and Therapeutic Vaccinementioning

confidence: 98%

Anal Cancer: Focus on HIV-Positive Patients in the HAART Era

Zanet

Berretta

Martellotta

et al. 2011

CHR

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“…Vaccination of patients with recombinant HPV 16 early gene proteins E6 and E7 (HPV-16E6/E7) formulated with ISCOMATRIX adjuvant consistently elicited both high titre Ab and specific cytotoxic T-cells in healthy and HIV-infected individuals (Anderson et al, 2009;Frazer et al, 2004). Similarly, T-cell responses were detected in the majority of individuals receiving an HCVcore/ISCOMATRIX vaccine (Drane et al, 2009).…”

Section: Iscomatrix Adjuvant Consistently Stimulates Robust and Readimentioning

confidence: 99%

ISCOMATRIX: a novel adjuvant for use in prophylactic and therapeutic vaccines against infectious diseases

Morelli

Becher

Koernig

et al. 2012

Journal of Medical Microbiology

114

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The ISCOMATRIX adjuvant has antigen delivery and presentation properties as well as immunomodulatory capabilities, which combine to provide enhanced and accelerated immune responses. The responses are broad, including a range of subclasses of antibodies as well as CD4+ and CD8 + T-cells. A range of ISCOMATRIX vaccines (ISCOMATRIX adjuvant combined with antigen) have now been tested in clinical trials and have been shown to be generally safe and well tolerated as well as immunogenic, generating both antibody (Ab) and T-cell responses. The mechanisms by which ISCOMATRIX adjuvant facilitates its immune effects are the scope of significant study and indicate that ISCOMATRIX adjuvant (i) rapidly traffics antigen into the cytosol of multiple dendritic cell subsets, (ii) induces the induction of an array of cytokines and chemokines and (iii) links the innate and adaptive immune responses in vivo in a Toll-likereceptor-independent but MyD88-dependent manner. These data highlight the clinical utility of ISCOMATRIX adjuvant in the development of prophylactic and therapeutic vaccines for infectious disease.

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“…The immune responses generated after vaccination with ISCOMATRIX TM vaccines have been reviewed or published previously and will not be discussed in this review. 2,[11][12][13] The studies completed by CSL with the optimized ISCOMATRIX TM adjuvant form the basis of the safety profile reported in this review. method to assign the missing values.…”

Section: Overview Of Iscomatrix Tm Adjuvantmentioning

confidence: 99%