Vaccination Against Human Papillomavirus (HPV) After Allogeneic Stem Cell Transplantation

Launched by VASTRA GOTALAND REGION · Jan 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well the 9-valent HPV vaccine (Gardasil 9®) works in adults who have received an allogeneic stem cell transplant. After this type of transplant, patients often lose their immunity, which puts them at a higher risk for infections and certain cancers, including those linked to HPV. The trial will compare the immune response of participants who receive the vaccine starting 9 months after their transplant to those who receive it starting 15 months after their transplant.

To be eligible for this trial, participants must be adults aged 18 to 45 who have received a stem cell transplant from a related or unrelated donor. They can join the study regardless of whether they were vaccinated against HPV before their transplant. However, those with certain health issues, such as severe complications from their transplant or certain medications, will not be able to participate. If chosen for the trial, participants can expect to receive the vaccine and have their immune response monitored to see how effectively their body responds to it. This study is important because it may help improve vaccination strategies for people at risk of HPV-related cancers after a stem cell transplant.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Recipient of AlloSCT from related or unrelated donor.
• • Adults (men and women) ≥18 years up to and including 45 years of age for vaccination.
• • Patients can be included regardless of prior HPV vaccination prior to transplantation
• Exclusion Criteria:
• • Severe thrombocytopenia (under 50 x 10\^9) not allowing intramuscular injection
• • Severe acute GvHD grade III-IV.
• • Extensive chronic GvHD requiring treatment with prednisone doses above 0.7 mg/kg/day plus at least two other systemic treatments against GvHD (for example ruxolitinib or photopheresis).
• • Prednisone doses above 1mg/kg/day at study start.
• • Treatment with rituximab 6 months before start of vaccination. Doses given later (unusual) do not require exclusion.
• • Treatment within 3 months before start of vaccination with iv or sc immunoglobulin.
• • Pregnancy, pregnancy desire or active pregnancy planning during time vaccine is given and up to three months after last vaccine dose.
• • Treatment with blood thinning medication contraindicating intramuscular injection
• • Allergy against Gardasil 9