Clinical trial of qHPV vaccine in HIV positive Men who have sex with me

Not Applicable

Completed

• Conditions: Anal cancer related with HPV and HIV positive MSM; Cancer

• Registration Number: ISRCTN14732216
• Lead Sponsor: Fundacion Progreso Y Salud, Consejeria De Salud Y Bienestar Social (Progress and Health Foundation, Ministry of Health and Social Welfare)

Brief Summary

2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28720147 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28729879 results 2021 Results article in https://doi.org/10.3390/v13020144 (added 12/09/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-02
• Study Completion: 2017-05-12
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

1. HIV-positive MSM patients
2. >18 years of age
3. Those who, at the time of inclusion into the study, had not been infected simultaneously by the 4 genotypes of HPV that the quadrivalent vaccine addresses
4. Patients who had high-resolution anoscopy (HRA) screening for inclusion are normal or had only condylomas and/or low squamous intraepithelial lesion (LSIL) in anal biopsy

Exclusion Criteria

1. HIV positive MSM (Men Who Have Sex with Men)
2. Simultaneous anal infection caused by the 4 genotypes addressed by the vaccine, or at least HPV16
3. Aged 18 years and over
4. Active opportunist infection at the time of recruitment into the study
5. Patients who, in screening anoscopy had HSIL, or ASCC or having received treatment for these lesions
6. History of allergy to aluminium and/or yeast extract excipient

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of the qHPV vaccine is assessed through the development of HSIL or anal cancer in anal mucosa using high resolution anoscopy at baseline and 48 months.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Clearance of HPV genotypes in anal canal mucosa after vaccination is measured using PCR at baseline, 12, 24, 36 and 48 months<br> 2. Prevalence of high squamous intraepithelial lesion (HSIL) and HR-HPV in the anal mucosa is measured using high resolution anoscopy at baseline, 12, 24, 36 and 48 months<br> 3. The seroconversion to the four serotypes of HPV used after vaccination is measured using PCR at baseline, 12, 24, 36 and 48 months<br> 4. Adverse effects after vaccination are measured using a purpose build questionnaire (including questions about pain, nausea, diarrhoea, rash, abdominal pain, pain at injection site) and blood testing (to determine if there are any kidney, liver, or muscle effects) at baseline, 2 and 6 months after each vaccination<br>