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

Efecctiveness of of the quadrivalent human papillomavirus (qHPV) vaccine in HIV-positive Spanish men having sex with men (MSM): a double-blind randomised clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14732216

Enrollment

120

Registered

2016-08-02

Start date

2012-05-15

Completion date

Unknown

Last updated

2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal cancer related with HPV and HIV positive MSM Cancer Anal cancer related with HPV and HIV positive MSM

Interventions

Participants are randomised to one of two groups using Epidat 3.1 software: Vaccine group: Participants receive injections of 0.5ml Quadrivalent (HPVs 6/11/16/18) vaccine into the delt

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1. Clearance of HPV genotypes in anal canal mucosa after vaccination is measured using PCR at baseline, 12, 24, 36 and 48 months 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 3. The seroconversion to the four serotypes of HPV used after vaccination is measured using PCR at baseline, 12, 24, 36 and 48 months 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	—

Measure

Time frame

1. Clearance of HPV genotypes in anal canal mucosa after vaccination is measured using PCR at baseline, 12, 24, 36 and 48 months 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 3. The seroconversion to the four serotypes of HPV used after vaccination is measured using PCR at baseline, 12, 24, 36 and 48 months 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

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 26, 2026