Therapeutic HPV-16 Vaccination for the Treatment of Anal Dysplasia (VACCAIN-T)
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|ClinicalTrials.gov Identifier: NCT01923116|
Recruitment Status : Completed
First Posted : August 15, 2013
Last Update Posted : March 15, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Anal Intraepithelial Neoplasia HIV||Drug: HPV-16 vaccine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Therapeutic Vaccination Against Human Papillomavirus Type 16 for the Treatment of Anal Intraepithelial Neoplasia in HIV+ Men|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||December 2017|
|Experimental: HPV-16 vaccine||
Drug: HPV-16 vaccine
Vaccination with SLP-HPV-01® with or without interferon-a injections.
- Safety/ toxicity of the HPV-16 vaccine in HIV+ MSM [ Time Frame: up to 18 months ]Monitoring for spontaneous adverse events and injection-site reactions will be done weekly for three weeks after each vaccination. Clinical assessments and laboratory tests (routine hematology and chemistry) will be performed before the second and third vaccination and thereafter every 3 months for a total of 18 months of follow-up. Adverse events are graded according to version 3.0 of the Common Terminology Criteria for Adverse Events (CTCAE), which grades events on a scale of 1 to 5, with higher grades indicating greater severity.
- Regression of intra-anal high grade AIN lesion [ Time Frame: Primary outcome: 3, 6, 12 months. Secondary: 18 months. ]High resolution anoscopy is performed to monitor the AIN lesions. Biopsies will be obtained of suspected lesions. Complete response is defined as histological resolution of AIN, partial response is defined as regression from high grade to low grade AIN. In case of persisting high grade AIN, a partial response is defined as a decrease in lesion size of 50% or more.
- HPV16-specific immunity in blood [ Time Frame: 3 weeks after the 1st, 2nd and 3rd vaccination ]
In order to assess the systemic changes in immunity, which are induced by vaccination we will examine venous blood samples by using peripheral blood lymphocytes that are tested by a set of complementary T-cell assays: i.e. proliferation (LST), cytokine production (IFNg, TNFa, IL-4, IL-5, IL-10, and IL-2) as well as by ELISPOT (IFNg) for ex-vivo detection of antigen-specific responses and by multiparametric intracellular cytokine/extracellular activation marker staining to determine the type (CD4+ and/or CD8+) and function of T-cells that respond.
A vaccine-induced response is defined as a 3-fold increase compared to the pre-vaccination result.
- Regression of peri-anal high grade AIN lesions [ Time Frame: 3, 6, 12 and 18 months ]High resolution anoscopy is performed to monitor the AIN lesions. Biopsies will be obtained of suspected lesions. Complete response is defined as histological resolution of AIN, partial response is defined as regression from high grade to low grade AIN. In case of persisting high grade AIN, a partial response is defined as a decrease in lesion size of 50% or more.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- Written informed consent
- Age ≥ 18 years
- HIV+ MSM, CD4 count > 350/ul (maximum 3 months before screening visit)
- Biopsy-proven intra-anal high-grade AIN caused by HPV16, resistant to, or recurring after previous treatment with cauterization (or other local treatment), 5FU or imiquimod. A patient is considered resistant to cauterization if after 2 cauterization sessions still lesions are found. A patient is considered resistant to 5FU or imiquimod if after 4 months of weekly (multiple day) application still lesions are found.
- Good performance status (a Karnofsky performance score of ≥60 [on a scale of 0 to 100, with higher scores indicating better performance status])
- Normal pretreatment laboratory blood values as described previously. This means: Leukocytes >3 x 109/L, lymfocytes >1 x 109/L, trombocytes >100 x 109/L and hematocrit >30%.
- Immunosuppressive medication or other diseases associated with immunodeficiency
- Life expectancy < 1 year
- History of anal carcinoma
- IFN-α criteria (see SmPC): severe cardiac, thyroid, hepatic or central nervous system disease, including severe depression in the past.
- Previous HPV vaccination
- Currently treated with IFN-α against hepatitis C
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923116
|Academic Medical Center|
|Amsterdam, Noord-Holland, Netherlands, 1105 AZ|
|Principal Investigator:||Jan M Prins, prof, MD, infectiologist||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Principal Investigator:||Henry JC de Vries, prof, MD, dermatologist||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Responsible Party:||Prof. Jan Prins, Prof. dr. J.M. Prins, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|
|Other Study ID Numbers:||
|First Posted:||August 15, 2013 Key Record Dates|
|Last Update Posted:||March 15, 2018|
|Last Verified:||March 2018|
Anal intraepithelial neoplasia
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type