Gardasil 9 Vaccine for Blood Cancers

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: M.D. Anderson Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

48 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jessica P. Hwang

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for English-speaking adults with blood cancers, who are 6-12 months post donor stem cell transplant and will receive usual vaccinations. It's not for those who've had prior transplants, pregnant women, have very low blood counts, a history of HPV-related cancer or previous HPV vaccination.

Inclusion Criteria

I am an English-speaking adult, 6-12 months post stem cell transplant for blood cancer at MD Anderson, getting standard vaccines.

Patients from approved protocol 2015-0795 will be invited to this vaccine study

Exclusion Criteria

I have had cancer linked to HPV before.

I tested positive for pregnancy before my stem cell transplant evaluation.

I have had a stem cell transplant from a donor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stem Cell Transplant

Patients undergo standard of care allogeneic stem cell transplant

6-12 months

Vaccination

Patients receive recombinant human papillomavirus nonavalent vaccine intramuscularly on day 0 and at 2 and 6 months

6 months

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 days post-intervention

Treatment Details

Interventions

• Recombinant Human Papillomavirus Nonavalent Vaccine

Trial Overview The study tests the effectiveness of Gardasil 9 vaccine in preventing HPV infection among patients with hematologic malignancies after undergoing a donor stem cell transplant.

Participant Groups

Group I: Prevention (Gardasil 9 vaccine) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+