Immunogenicity and safety of a 9-valent human papillomavirus vaccine in HIV-positive women

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003486-17-ES

Enrollment

173

Registered

2020-01-23

Start date

2020-02-11

Completion date

Unknown

Last updated

2025-01-13

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

Conditions

New infection and lesions of papillomavirus in HIV-infected women

Interventions

Trade Name: Gardasil 9 suspensión inyectable en jeringa precargada Pharmaceutical Form: Suspension for injection INN or Proposed INN: Human Papillomavirus Type 16 L1 protein Other descriptive name: HU

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: HIV-positive women patients of =18 years of age who, at the time of study inclusion were not infected simultaneously by the 16, 18 genotypes of HPV in vagina and/or anus. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 173 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - WLHIV patients who had simultaneous anal infection with the 16, 18, 31, 33, 45, 52 y 58 genotypes. - WLHIV diagnosed in V0 of ASCC or anal HSIL. - Active opportunist infection at the time of recruitment into the study. - Cd4 count < 200 cel/uL. - History of allergy to aluminium and/or yeast extract excipient.

Design outcomes

Primary

Measure	Time frame
Main Objective: To analyze the immunogenicity and safety of a 9-valent human papillomavirus vaccine in HIV-positive women older than =18 years.;Secondary Objective: 1. Analyze after vaccination, the acquisition rate of HPV genotypes of anal and cervical mucosa. 2.Investigate the risk factors related to acquisition of HPV genotypes (such as HAART, comorbidities, age, smoking, condom use, CD4 cell count, viral load, etc) in anal and cervical mucosa. 3.To evaluate, in women with normal anal and cervical mucosa, the rate of progression to dysplastic lesions (LSIL, HSIL and Cancer) anal and cervical after vaccination in the follow-up period.;Primary end point(s): Proportion of subjects with new infections from genotypes included in de 9-valent vaccine and aparition of cervical and anal dysplasia in these women .;Timepoint(s) of evaluation of this end point: 30th month, when data from follow up visits are collected.	—

Measure

Time frame

Main Objective: To analyze the immunogenicity and safety of a 9-valent human papillomavirus vaccine in HIV-positive women older than =18 years.;Secondary Objective: 1. Analyze after vaccination, the acquisition rate of HPV genotypes of anal and cervical mucosa. 2.Investigate the risk factors related to acquisition of HPV genotypes (such as HAART, comorbidities, age, smoking, condom use, CD4 cell count, viral load, etc) in anal and cervical mucosa. 3.To evaluate, in women with normal anal and cervical mucosa, the rate of progression to dysplastic lesions (LSIL, HSIL and Cancer) anal and cervical after vaccination in the follow-up period.;Primary end point(s): Proportion of subjects with new infections from genotypes included in de 9-valent vaccine and aparition of cervical and anal dysplasia in these women .;Timepoint(s) of evaluation of this end point: 30th month, when data from follow up visits are collected.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Proportion of acquisition of HPV genotypes of anal and cervical mucosa. 2. Prevalence of risk factors related to acquisition of HPV genotypes (such as HAART, comorbidities, age, smoking, condom use, CD4 cell count, viral load, etc) in anal and cervical mucosa. 3. Proportion of women with normal anal and cervical mucosa, with progression to dysplastic lesions (LSIL, HSIL and Cancer) anal and cervical after vaccination in the follow-up period.;Timepoint(s) of evaluation of this end point: 30th month, when data from follow up visits are collected.	—

Measure

Time frame

Secondary end point(s): 1. Proportion of acquisition of HPV genotypes of anal and cervical mucosa. 2. Prevalence of risk factors related to acquisition of HPV genotypes (such as HAART, comorbidities, age, smoking, condom use, CD4 cell count, viral load, etc) in anal and cervical mucosa. 3. Proportion of women with normal anal and cervical mucosa, with progression to dysplastic lesions (LSIL, HSIL and Cancer) anal and cervical after vaccination in the follow-up period.;Timepoint(s) of evaluation of this end point: 30th month, when data from follow up visits are collected.

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Countries

Spain

Contacts

Public Contactclinical trials information

FIBAO

958895414

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026