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

PRIMARY OBJECTIVES:

I. To determine the immunogenicity of recombinant human papillomavirus nonavalent vaccine
(GARDASIL 9) administered after allogeneic stem cell transplant (SCT) in patients with
hematologic malignancy by comparing HPV 9-plex competitive Luminex immunoassay (9-plex cLIA)
titers before and after GARDASIL 9 administration.

II. To evaluate the safety and tolerability of GARDASIL 9 administered after allogeneic SCT
in patients with hematologic malignancy.

OUTLINE:

Patients undergo standard of care allogeneic stem cell transplant. 6-12 months following
transplant, patients receive recombinant human papillomavirus nonavalent vaccine
intramuscularly (IM) on day 0 and at 2 and 6 months in the absence of disease progression or
unacceptable toxicity.

After completion of study intervention, patients are followed up within 3 days.

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