Vaccination against human papillomavirus (HPV) after allogeneic stem cell transplantation, a randomized study between early and late vaccination.

Phase 1

Conditions: Recipients of allogeneic stem cell transplantation
Therapeutic area: Diseases [C] - Neoplasms [C04]
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: CTIS2022-502912-35-00

Lead Sponsor: Vastra Gotalandsregionen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

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 thromobocytopenia (under 50 x 10^9) not allowing intramuscular injektion, Severe acute GvHD grade III-IV., Extensive chronic GvHD requiring treatment with prednisonedoses above 0.7 mg/kg/day plus at least two other systemic treatments against GvHD (for example ruxolitinib or photoferesis)., Prednisonedoses above 1mg/kg/dag at studystart., 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 blodthinning medication contraindicating intramuscular injection, Allergy against Gardasil 9

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare vaccine responses to Gardasil 9® at early start post-transplant vaccination (start at 9 months) compared to late (15 months) after stem cell transplant.;Secondary Objective: Antibody level against all nine HPV-types in the vaccine 1 month after completion of vaccination, early vs late, Antibody level against all nine HPV-types in the vaccine 12 months after completion of vaccination, early vs late, Proportion seronegative/seropositive against the nine HPV-types in the vaccine at 1 and 12 months after completion of vaccination, early vs late, Seroconversion against the nine HPV-types in the vaccine, prevaccination compared to 1 month after completion of vaccination, early vs late, Proportion of seropositive against 7/9 serotypes in the vaccine at 1 and 12 months after completion of vaccination, early vs late;Primary end point(s): Antibody level (GMT) against HPV 16 measured 1 months after the third vaccine dose, early vs late

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Antibody level (GMT) against all 9 HPV-serotypes included in vaccine (-6, -11, -16, -18, -31, -33, -45, -52, -58) measured 1 month after the third vaccinedose. Early vs late.;Secondary end point(s):Antibody level (GMT) against all 9 HPV-serotypes included in vaccine (-6, -11, -16, -18, -31, -33, -45, -52, -58) measured at 12 months after the third vaccine dose. Early vs late.;Secondary end point(s):Proportion seropositive/negative against 9 HPV-serotypes included in vaccine measured 1 and 12 months after third dose. Early vs late.;Secondary end point(s):Seroconversion against 9 HPV-serotypes included in vaccine, prevaccination compared to 1 month after third dose, early vs late.;Secondary end point(s):Proportion seropositive against 7/9 HPV-types included in the vaccine at 1 and 12 months after completion of vaccination. Early vs late.