← Back to Search

Gardasil 9 Vaccine for Blood Cancers

Phase 4

Waitlist Available

Led By Jessica P Hwang

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Patients with a prior history of HPV-related malignancy

Female patients who tested positive for pregnancy during pre-SCT evaluation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 month post-dose 3

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial looks at whether the Gardasil 9 vaccine can prevent HPV infection in people with blood cancers who are getting a stem cell transplant from a donor.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, vaccines like Gardasil 9 can cause reactions at the injection site, fever, headache, fatigue and sometimes allergic responses.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had cancer linked to HPV before.

Select...

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

Select...

I have had a stem cell transplant from a donor.

Select...

I have received at least one dose of the HPV vaccine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 month post-dose 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 month post-dose 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 month post-dose 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Antibody response defined as numerically elevated antibody titer of any type at 1 month post-dose 3 (month 7)

Secondary study objectives

Antibody persistence at 6 months post-dose 3

Estimation of antibody titers

Human papillomavirus (HPV) vaccination completion rate

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prevention (Gardasil 9 vaccine)Experimental Treatment1 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.

0 / 4Eligibility criteria met