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

M.D. Anderson Cancer Center

Status and phase: Active, not recruiting; Phase 4

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Allogeneic Hematopoietic Stem Cell Transplant Recipient

Treatments: Biological: Recombinant Human Papillomavirus Nonavalent Vaccine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03023631

2016-0714 (Other Identifier)

NCI-2018-02606 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Prevention (Gardasil 9 vaccine)

Experimental group

Description:

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.

Treatment:

Biological: Recombinant Human Papillomavirus Nonavalent Vaccine