Active — Not RecruitingPhase 4

Gardasil 9 Vaccine in Preventing HPV Infection in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant

United States48 participantsStarted 2017-04-23

Plain-language summary

This phase IV trial studies how well Gardasil 9 vaccine works in preventing human papillomavirus (HPV) infection in patients with hematologic malignancies who are undergoing donor stem cell transplant. Vaccines, such as Gardasil 9, may help the body build an effective immune response to kill cancer cells.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All English-speaking adult MD Anderson patients with hematologic malignancy at 6-12 months +/- 8 weeks post allogeneic stem cell transplantation who will receive usual post-stem cell transplant vaccinations * All patients from approved protocol 2015-0795 will be invited to this vaccine study Exclusion Criteria: * Prior allogeneic SCT * Platelet count less than or equal to 25,000 K/uL * Absolute neutrophil count less than or equal to 500/uL * Patients who have ever received HPV vaccination (at least one dose of HPV vaccine) * Patients with a prior history of HPV-related malignancy * Female patients who tested positive for pregnancy during pre-SCT evaluation

What they're measuring

Antibody response defined as numerically elevated antibody titer of any type at 1 month post-dose 3 (month 7)

Timeframe: At 1 month post-dose 3

Trial details

NCT IDNCT03023631

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-31

View on ClinicalTrials.gov More Allogeneic Hematopoietic Stem Cell Transplant Recipient trials