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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 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

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 more

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.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,168 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,441 Total Patients Enrolled
Jessica P HwangPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
3,210 Total Patients Enrolled

Media Library

Recombinant Human Papillomavirus Nonavalent Vaccine Clinical Trial Eligibility Overview. Trial Name: NCT03023631 — Phase 4
Hematopoietic Stem Cell Transplant Recipient Research Study Groups: Prevention (Gardasil 9 vaccine)
Hematopoietic Stem Cell Transplant Recipient Clinical Trial 2023: Recombinant Human Papillomavirus Nonavalent Vaccine Highlights & Side Effects. Trial Name: NCT03023631 — Phase 4
Recombinant Human Papillomavirus Nonavalent Vaccine 2023 Treatment Timeline for Medical Study. Trial Name: NCT03023631 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for potential study participants in this clinical trial?

"It appears that this trial, first posted on April 23rd 2017 and last edited June 29th 2022 is not currently accepting candidates. However, 384 other trials are presently open to prospective participants."

Answered by AI

What is the numerical capacity of this medical experiment?

"Unfortunately, no more patients are being recruited for this medical trial which was first posted on April 23rd 2017 and last updated June 29th 2022. If you're still looking to participate in related studies, there are currently 352 trials actively enrolling allogeneic hematopoietic stem cell transplant recipients as well as 32 trials recruiting participants for the recombinant human papillomavirus nonavalent vaccine."

Answered by AI

Could you please outline the research that has been carried out regarding Recombinant Human Papillomavirus Nonavalent Vaccine?

"At present, 32 clinical studies are being operated to assess the efficacy of Recombinant Human Papillomavirus Nonavalent Vaccine. Of those live trials, 16 have reached Phase 3 status. Bangkok and Chang Wat Nonthaburi serve as primary locations for these experiments; however, there are an additional 244 sites globally that are conducting research for this vaccine."

Answered by AI

What medical benefits has the Recombinant Human Papillomavirus Nonavalent Vaccine been associated with?

"Recombinant Human Papillomavirus Nonavalent Vaccine is a viable option for treating the following viral infections: infection caused by human papillomavirus type 58, affliction stemming from human papillomavirus type 31, and general human papillomavirus (HPV) contamination."

Answered by AI

Is this the inaugural experiment of its type?

"Investigated since 2002, recombinant human papillomavirus nonavalent vaccine was first trialled in the same year by Merck Sharp & Dohme Corp. After confirming its efficacy through a 12167-person phase 3 trial, 32 current studies are being conducted across 129 cities and 32 countries to further explore this promising therapeutic intervention."

Answered by AI

Is Recombinant Human Papillomavirus Nonavalent Vaccine safe for human consumption?

"Due to this being a Phase 4 trial and the vaccine having already been approved, our team at Power rated Recombinant Human Papillomavirus Nonavalent Vaccine's safety as 3 on a scale of 1-3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Gardasil 9 Vaccine in Preventing HPV Infection in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant
2017. "Gardasil 9 Vaccine in Preventing HPV Infection in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03023631.
~1 spots leftby May 2024
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