NCT05439083

Immunogenicity of 9-valent HPV Vaccine

Status unknown Phase 4 Last updated 8 March 2024

What this trial tests

Phase 4 trial testing 9-valent HPV vaccine in Human Papilloma Virus Infection in 120 participants. Status unknown.

Timeline

7 March 2023

Primary endpoint
1 September 2024

1 March 2025

Quick facts

Lead sponsor	Talia Sainz Costa
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	120
Start date	7 March 2023
Primary completion	1 September 2024
Estimated completion	1 March 2025
Sites	1 location across Spain

Drugs / interventions tested

• 9-valent HPV vaccine — full drug profile →

Conditions studied

• Human Papilloma Virus Infection — all drugs for Human Papilloma Virus Infection →

Sponsor

Talia Sainz Costa

Who can join

Adults 9 to 18, any sex, with Human Papilloma Virus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Human papillomavirus (HPV) causes the most prevalent sexually transmitted infections in the world. The nonavalent HPV vaccine (9vHPV) provides protection against 9 high-risk HPV serotypes, responsible for causing approximately 90% of cervical and other HPV-related anogenital cancers, as well as 90% of genital warts. The risk of cancer is substantially increased among immunocompromised patients.

Although studies have demonstrated seroprotection among children and adolescents, boys and girls, with the 9vHPV vaccine, the immunogenicity of this vaccine has been poorly explored in immunocompromised children and adolescents (including transplant patients, and those infected with human immunodeficiency virus (HIV)). Several factors, including the immunological consequences of vertically acquired infection, immunosuppressive therapies and age, could lead to an increased risk of infection in children and adolescents who are immunocompromised. Lower immunogenicity in these populations. These children may have a poor response to vaccines and therefore require additional doses. Markers such as CD4/CD8 or torque teno virus (TTV) replication could be linked to immunogenicity and thus serve as predictors of efficacy for routine clinical practice.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Current status and future directions for the development of human papillomavirus vaccines.
   Wang R, Huang H, Yu C, Li X, et al · · 2024 · cited 36× · PMID 38983849 · DOI 10.3389/fimmu.2024.1362770