Clinical Trials

MainTitle

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

This study is currently recruiting participants. (see Contacts and Locations)

Verified February 2020 by Carmen Hidalgo Tenorio, University Hospital Virgen de las Nieves

Sponsor
University Hospital Virgen de las Nieves

Collaborator
Instituto de Salud Carlos III

Information provided by (Responsible Party)
Carmen Hidalgo Tenorio, University Hospital Virgen de las Nieves

ClinicalTrials.gov Identifier
NCT04270773

First received: January 13, 2020
Last updated: February 13, 2020
Last Verified: February 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections
HPV Infection

Biological : Human Papillomavirus 9-valent Vaccine, Recombinant
Phase 4

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a phase IV (post-authorization study), open, single-arm trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunogenicity and Safety of a 9-valent Human Papillomavirus Vaccine in HIV-positive Women.

Further study details as provided by Carmen Hidalgo Tenorio, University Hospital Virgen de las Nieves:

Primary Outcome Measures

  • 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
  • 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)
Secondary Outcome Measures:
  • new HPV genotypes [ Time Frame: Determined at 12th, 24th, 30th month ]
    acquisition rate of HPV genotypes of anal and cervical mucosa.
  • 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.
  • 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.

Estimated Enrollment: 158
Study Start Date: February 12, 2020
Estimated Study Completion Date: December 30, 2022
Estimated Primary Completion Date: July 30, 2022 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Other: Only arm
Single arm, Receiving treatment
Biological: Human Papillomavirus 9-valent Vaccine, Recombinant

Vaccine administrated

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: No  

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.


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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04270773

Contacts

Contact:   CARMEN HIDALGO +34 958 895 414 CHIDALGO72@GMAIL.COM
Contact:   SERGIO SEQUERA, PH +34 958 895 414 SERGIOSEQUERA15@GMAIL.COM

Locations

Spain
Hospital Universitario Virgen de Las Nieves Recruiting
Granada, Andalucía, Spain, 18008
Contact: SERGIO SEQUERA, Ph    +34 958 895 414    SERGIOSEQUERA15@GMAIL.COM
Principal Investigator: CARMEN HIDALGO, Dr
Principal Investigator: JUAN PASQUAU, Dr

Sponsors and Collaborators

University Hospital Virgen de las Nieves
Instituto de Salud Carlos III
More Information

More Information


Responsible Party: Carmen Hidalgo Tenorio, Principal Investigator, University Hospital Virgen de las Nieves  
ClinicalTrials.gov Identifier: NCT04270773   History of Changes  
Other Study ID Numbers: 9-VPH-MVIH  
Study First Received: January 13, 2020  
Last Updated: February 13, 2020  
Individual Participant Data    
Plan to Share IPD: Undecided  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Infection
Communicable Diseases
Papillomavirus Infections

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.