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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 month post-dose 3
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Antibody response defined as numerically elevated antibody titer of any type at 1 month post-dose 3 (month 7)
Secondary outcome measures
Antibody persistence at 6 months post-dose 3
Estimation of antibody titers
Human papillomavirus (HPV) vaccination completion rate
+1 moreTrial 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.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,466 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,316 Total Patients Enrolled
Jessica P HwangPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
3,210 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am an English-speaking adult, 6-12 months post stem cell transplant for blood cancer at MD Anderson, getting standard vaccines.I have received at least one dose of the HPV vaccine.
Research Study Groups:
This trial has the following groups:- Group 1: Prevention (Gardasil 9 vaccine)
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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