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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-23

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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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

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Allogeneic Hematopoietic Stem Cell Transplant Recipient Hematopoietic and Lymphoid Cell Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prevention (Gardasil 9 vaccine)

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.

Group Type EXPERIMENTAL

Recombinant Human Papillomavirus Nonavalent Vaccine

Intervention Type BIOLOGICAL

Given IM

Interventions

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Recombinant Human Papillomavirus Nonavalent Vaccine

Given IM

Intervention Type BIOLOGICAL

Other Intervention Names

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Gardasil 9 Nonavalent HPV VLP Vaccine Recombinant HPV Nonavalent Vaccine Recombinant Human Papillomavirus 9-valent Vaccine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No