NCT03023631

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Allogeneic Hematopoietic Stem Cell Transplant Recipient
• Hematopoietic and Lymphoid Cell Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Human Papillomavirus Nonavalent Vaccine	Given IM

Timeline

• Start date: 2017-04-23
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2017-01-18
• Last updated: 2025-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study