Immunogenicity and Safety of a 9-valent Human Papillomavirus Vaccine in HIV-positive Women (9-VPH-MVIH)

February 13, 2020 updated by: Carmen Hidalgo Tenorio, University Hospital Virgen de las Nieves

Immunogenicity and Safety of a 9-valent Human Papillomavirus Vaccine in HIV-positive Women.

In adult HIV-positive patients, data on the safety and immunogenicity of the quadrivalent HPV (qHPV) vaccine have been reported with excellent results (13 14); also, the results of a clinical trial of qHPV vaccine conducted in seropositive patients older than 36 years (WLHIV and MSM) have been published.

Even now, there is not a trial about immunogenicity and safety of a 9-valent human papillomavirus vaccine in HIV-positive women; for this reason, the investigators plan to conduct this clinical trial.

HYPOTHESYS: The administration of Nonavalent HPV vaccine (HPV-9) in adult women living with HIV will produce antibodies against nine genotypes of HPV, thus preventing the acquisition of new infections by those genotypes. Besides, this will prevent the cervical and anal dysplasia in these women.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a phase IV (post-authorization study), open, single-arm trial of 9-valent human papillomavirus (9-HPV) vaccine in HIV-positive women. The recruitment and follow-up period will be 6 and 30 months, respectively.

At the initial clinical visit (V0), the conditions and objectives of the study were explained. The details were summarised in a document, which was presented to the patient who then signed the informed consent form. 2 mucosa samples were taken from the anal canal for the detection and genotyping of the HPV and for anal cytology; and high resolution anoscopy will be carried out. The patients will send to gynaecologist for exploration. Finally, full blood haemogram and blood chemistry analysis were measured, together with cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8) lymphocytes counts, HIV viral load (VL) and antibodies against 9 genotypes of the 9-HPV vaccine. 9-HPV vaccine will be administered at day 1 (V1), month 2 (V2) and month 6 (V3). Flow of subjects through the study in graphic 1.

Settings and locations: The patients who enrolled were HIV-positive women that were attending the Infectious Diseases Service of the "University Hospital Virgen de las Nieves", Granada (Spain), "Hospitalary Complex Ciudad de Jaén" (Spain) and "University hospital San Cecilio", Granada (Spain).

The purposes of the study were explained to the potential participants who then underwent screening, and enrolled if they met the inclusion criteria for the trial. They were asked to sign the fully informed consent form. The study will be conducted in compliance with ethical and moral principles stated in the Declaration of Helsinki as well as the current Spanish Laws on Biomedical Research(LEY 14/2007, de 3 de julio). Data were coded to ensure anonymity.

SAMPLE SIZE CONSIDERATIONS:

Currently, the rate of infections in unvaccinated women in the participating centers is 46.4% (12). The efficacy rate of the tetravalent vaccine in the prevention of cervical cancer is close to 100% and in the appearance of external anal lesions in men, around 85% (21). Considering that in our study population, the effectiveness is at least 75%, to achieve an accuracy of 5% in the estimation of a proportion through a normal 95% asymptotic confidence interval, assuming that the proportion is 11, 6% (25% of 46.4%), it will be necessary to include 158 women in the study. To this sample size will be added 10% in anticipation of possible losses in the follow-up or dropouts.

DATA COLLECTION:

All data were collected and coded to ensure anonymity according to the current legal requirements in Spain and European Union (EU) (GDPR Regulation (EU) 2016/679). At the initial clinical visit (V0), the conditions and objectives of the study were explained to subjects. The details were summarised in a document, which was presented to the patient who then signed the informed consent form.

Study Type

Interventional

Enrollment (Anticipated)

158

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Andalucía
      • Granada, Andalucía, Spain, 18008
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
        • Contact:
        • Principal Investigator:
          • CARMEN HIDALGO, Dr
        • Principal Investigator:
          • JUAN PASQUAU, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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/µL.
  • History of allergy to aluminium and/or yeast extract excipient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Only arm
Single arm, Receiving treatment
Biological: Human Papillomavirus 9-valent Vaccine, Recombinant
Vaccine administrated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibodies against the 9 genotypes of the qHPV vaccine
Time Frame: 30 months
immunogenicity of a 9-valent human papillomavirus vaccine in HIV-positive women older than ≥18 years
30 months
Incidence of Treatment-Emergent Adverse Events of a 9-valent human papillomavirus vaccine in HIV-positive women older than ≥18 years
Time Frame: Through study completion, up to 30 months
Number of Participants With Any Adverse Event (AE)
Through study completion, up to 30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
new HPV genotypes
Time Frame: Determined at 12th, 24th, 30th month
acquisition rate of HPV genotypes of anal and cervical mucosa.
Determined at 12th, 24th, 30th month
Data analysis of risk factors in subject who acquire HPV genotypes from data recorded at follow-up visits via survey.
Time Frame: 30 months
The survey asks about HPV risk factors.
30 months
progression to dysplastic lesions
Time Frame: Determined at 12th, 24th, 30th month
rate of progression to dysplastic lesions (LSIL, high grade squamous intraepithelial lesion (HSIL) and Cancer) anal and cervical after vaccination.
Determined at 12th, 24th, 30th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Virgen de las Nieves

Collaborators

Instituto de Salud Carlos III

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 12, 2020

Primary Completion (ANTICIPATED)

July 30, 2022

Study Completion (ANTICIPATED)

December 30, 2022

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

February 13, 2020

First Posted (ACTUAL)

February 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9-VPH-MVIH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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