Clinical trial NCT03023631: Gardasil 9 Vaccine in Preventing HPV Infection in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant
Official title: Human Papillomavirus Antibody Response After GARDASIL 9 Vaccination in Patients After Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Allogeneic Hematopoietic Stem Cell Transplant Recipient
Hematopoietic and Lymphoid Cell Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-01-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Eligibility 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

Primary outcomes:
measure: Antibody response defined as numerically elevated antibody titer of any type at 1 month post-dose 3 (month 7)
timeFrame: At 1 month post-dose 3
Secondary outcomes:
measure: Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
timeFrame: Up to 3 days post-intervention
measure: Antibody persistence at 6 months post-dose 3
timeFrame: At 6 months post-dose 3
measure: Human papillomavirus (HPV) vaccination completion rate
timeFrame: Up to 3 days post-intervention
measure: Estimation of antibody titers
timeFrame: At 6-12 months post-transplant, and at 1 and 6 months post-dose 3
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jessica P Hwang
role: PRINCIPAL_INVESTIGATOR
References: