Trial | NCT03023631  Report issue

Title

Gardasil 9 Vaccine in Preventing HPV Infection in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant
Human Papillomavirus Antibody Response After GARDASIL 9 Vaccination in Patients After Allogeneic Stem Cell Transplantation

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    48
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.
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.
Study Started
Apr 23
2017
Primary Completion
May 31
2024
Anticipated
Study Completion
May 31
2024
Anticipated
Last Update
Dec 08
2023

Biological Recombinant Human Papillomavirus Nonavalent Vaccine

Given IM

  • Other names: Gardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent Vaccine

Prevention (Gardasil 9 vaccine) Experimental

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

Criteria 

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
No Results Posted