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

NCT04270773 | Active Not Recruiting Phase 4

• 1 other identifier: 9-VPH-MVIH
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections; HPV Infection

Outcome Measures

Primary Outcomes (2)

• Antibodies against the 9 genotypes of the qHPV vaccine

  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

  Number of Participants With Any Adverse Event (AE)

  Through study completion, up to 30 months

Secondary Outcomes (3)

• new HPV genotypes

  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.

  30 months

• progression to dysplastic lesions

  Determined at 12th, 24th, 30th month

Study Arms (1)

Only arm

OTHER

Single arm, Receiving treatment

Biological: Human Papillomavirus 9-valent Vaccine, Recombinant

Interventions

Human Papillomavirus 9-valent Vaccine, Recombinant BIOLOGICAL

Vaccine administrated

Only arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Virgen de las Nieves: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Universitario Virgen de Las Nieves

Granada, Andalusia, 18008, Spain

Location

Related Publications (12)

• Palefsky JM. Human papillomavirus-associated anal and cervical cancers in HIV-infected individuals: incidence and prevention in the antiretroviral therapy era. Curr Opin HIV AIDS. 2017 Jan;12(1):26-30. doi: 10.1097/COH.0000000000000336.

  PMID: 27828801 BACKGROUND

• Stier EA, Sebring MC, Mendez AE, Ba FS, Trimble DD, Chiao EY. Prevalence of anal human papillomavirus infection and anal HPV-related disorders in women: a systematic review. Am J Obstet Gynecol. 2015 Sep;213(3):278-309. doi: 10.1016/j.ajog.2015.03.034. Epub 2015 Mar 19.

  PMID: 25797230 BACKGROUND

• Jemal A, Simard EP, Dorell C, Noone AM, Markowitz LE, Kohler B, Eheman C, Saraiya M, Bandi P, Saslow D, Cronin KA, Watson M, Schiffman M, Henley SJ, Schymura MJ, Anderson RN, Yankey D, Edwards BK. Annual Report to the Nation on the Status of Cancer, 1975-2009, featuring the burden and trends in human papillomavirus(HPV)-associated cancers and HPV vaccination coverage levels. J Natl Cancer Inst. 2013 Feb 6;105(3):175-201. doi: 10.1093/jnci/djs491. Epub 2013 Jan 7.

  PMID: 23297039 BACKGROUND

• Firnhaber C, Westreich D, Schulze D, Williams S, Siminya M, Michelow P, Levin S, Faesen M, Smith JS. Highly active antiretroviral therapy and cervical dysplasia in HIV-positive women in South Africa. J Int AIDS Soc. 2012 Jun 7;15(2):17382. doi: 10.7448/IAS.15.2.17382.

  PMID: 22713259 BACKGROUND

• Piketty C, Selinger-Leneman H, Grabar S, Duvivier C, Bonmarchand M, Abramowitz L, Costagliola D, Mary-Krause M; FHDH-ANRS CO 4. Marked increase in the incidence of invasive anal cancer among HIV-infected patients despite treatment with combination antiretroviral therapy. AIDS. 2008 Jun 19;22(10):1203-11. doi: 10.1097/QAD.0b013e3283023f78.

  PMID: 18525266 BACKGROUND

• Franceschi S, Lise M, Clifford GM, Rickenbach M, Levi F, Maspoli M, Bouchardy C, Dehler S, Jundt G, Ess S, Bordoni A, Konzelmann I, Frick H, Dal Maso L, Elzi L, Furrer H, Calmy A, Cavassini M, Ledergerber B, Keiser O; Swiss HIV Cohort Study. Changing patterns of cancer incidence in the early- and late-HAART periods: the Swiss HIV Cohort Study. Br J Cancer. 2010 Jul 27;103(3):416-22. doi: 10.1038/sj.bjc.6605756. Epub 2010 Jun 29.

  PMID: 20588274 BACKGROUND

• Hidalgo-Tenorio C, de Jesus SE, Esquivias J, Pasquau J. High prevalence and incidence of HPV-related anal cancer precursor lesions in HIV-positive women in the late HAART era. Enferm Infecc Microbiol Clin (Engl Ed). 2018 Nov;36(9):555-562. doi: 10.1016/j.eimc.2017.10.014. Epub 2017 Dec 6. English, Spanish.

  PMID: 29208455 BACKGROUND

• Hidalgo-Tenorio C, Rivero-Rodriguez M, Gil-Anguita C, Esquivias J, Lopez-Castro R, Ramirez-Taboada J, de Hierro ML, Lopez-Ruiz MA, Martinez RJ, Llano JP. The role of polymerase chain reaction of high-risk human papilloma virus in the screening of high-grade squamous intraepithelial lesions in the anal mucosa of human immunodeficiency virus-positive males having sex with males. PLoS One. 2015 Apr 7;10(4):e0123590. doi: 10.1371/journal.pone.0123590. eCollection 2015.

  PMID: 25849412 BACKGROUND

• Park IU, Palefsky JM. Evaluation and Management of Anal Intraepithelial Neoplasia in HIV-Negative and HIV-Positive Men Who Have Sex with Men. Curr Infect Dis Rep. 2010 Mar;12(2):126-33. doi: 10.1007/s11908-010-0090-7. Epub 2010 Feb 24.

  PMID: 20461117 BACKGROUND

• Wilkin T, Lee JY, Lensing SY, Stier EA, Goldstone SE, Berry JM, Jay N, Aboulafia D, Cohn DL, Einstein MH, Saah A, Mitsuyasu RT, Palefsky JM. Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-1-infected men. J Infect Dis. 2010 Oct 15;202(8):1246-53. doi: 10.1086/656320.

  PMID: 20812850 BACKGROUND

• Wilkin TJ, Chen H, Cespedes MS, Leon-Cruz JT, Godfrey C, Chiao EY, Bastow B, Webster-Cyriaque J, Feng Q, Dragavon J, Coombs RW, Presti RM, Saah A, Cranston RD. A Randomized, Placebo-Controlled Trial of the Quadrivalent Human Papillomavirus Vaccine in Human Immunodeficiency Virus-Infected Adults Aged 27 Years or Older: AIDS Clinical Trials Group Protocol A5298. Clin Infect Dis. 2018 Oct 15;67(9):1339-1346. doi: 10.1093/cid/ciy274.

  PMID: 29659751 BACKGROUND

• Hidalgo-Tenorio C, Ramirez-Taboada J, Gil-Anguita C, Esquivias J, Omar-Mohamed-Balgahata M, SamPedro A, Lopez-Ruz M, Pasquau J. Safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccine in HIV-positive Spanish men who have sex with men (MSM). AIDS Res Ther. 2017 Jul 18;14(1):34. doi: 10.1186/s12981-017-0160-0.

  PMID: 28720147 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Papillomavirus Infections

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; DNA Virus Infections; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a phase IV (post-authorization study), open, single-arm trial

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: February 17, 2020
• Study Start: February 12, 2020
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

ES (1)