HPV (Human Papilloma Virus) Vaccination After Treatment of Anal Intraepithelial Neoplasia (AIN) (VACCAIN-P)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02087384|
Recruitment Status : Completed
First Posted : March 14, 2014
Last Update Posted : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|AIN HIV||Biological: Gardasil Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Quadrivalent HPV Vaccination After Effective Treatment of Anal Intraepithelial Neoplasia in HIV+ Men|
|Actual Study Start Date :||March 2014|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||February 2019|
Intramuscular Gardasil vaccination at 0, 2 and 6 months.
Placebo Comparator: Placebo
Intramuscular Saline 0.9% vaccination at 0, 2 and 6 months
injection of 0.9% saline
Other Name: intramuscular Saline 0.9%
- Cumulative recurrence of intra-anal or peri-anal HG AIN at 12 months after the last vaccination (18 months after inclusion), as assessed by HRA, with biopsies taken of suspect lesions. [ Time Frame: 18 months ]
- Toxicity/ safety of the Gardasil vaccine in HIV+ MSM. [ Time Frame: 18 months ]One week after each vaccination and during all follow up visits the most common adverse events of Gardasil and other eventually occuring complaints will be evaluated by history taking. Adverse events will be graded according to the CTCAE v4 (Common Terminology Criteria for Adverse Events), which grades events on a scale of 1 to 5, with higher grades indicating greater severity.
- Recurrence of intra-anal or peri-anal HG AIN at the moment of last vaccination and 6 months afterwards. [ Time Frame: 6 and 12 months ]
- Cumulative occurrence of intra-anal or peri-anal LG AIN at 12 months after the last vaccination. [ Time Frame: 18 months ]The patients with LG AIN at inclusion are excluded from this analysis.
- Cumulative occurrence of anogenital warts at 12 months after the last vaccination. [ Time Frame: 18 months ]Evaluated by physical examination and history taking.
- Causative HPV type in recurrent AIN lesions, as assessed by LCM/ PCR. [ Time Frame: 18 months ]
- HPV type-specific antibody response. [ Time Frame: 9 months (3 months after last vaccination) ]
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): NCT02087384
|DC Klinieken Oud Zuid|
|Amsterdam, Noord-Holland, Netherlands, 1071 NX|
|Onze Lieve Vrouwe Gasthuis|
|Amsterdam, Noord-Holland, Netherlands, 1090 HM|
|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)|