Gardasil 9 Vaccine for Blood Cancers

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Prior SCT, Low platelets, Low neutrophils, Prior HPV vaccine, HPV malignancy, Pregnancy, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Gardasil 9 vaccine to evaluate its effectiveness in preventing HPV infections in individuals with blood cancers who have undergone a stem cell transplant. The goal is to enhance the immune system's ability to combat HPV, potentially reducing the risk of further complications or cancer development. Participants should have received a stem cell transplant 6-12 months prior and be receiving routine post-transplant vaccines. This study may suit those who have not received any previous HPV vaccine doses. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for the Gardasil 9 vaccine?

Research has shown that Gardasil 9 is generally safe and well-tolerated. This vaccine protects against nine types of HPV, which are linked to several cancers. Most side effects are mild, including pain, swelling, and redness at the injection site, while serious side effects remain rare. The FDA has already approved Gardasil 9 for preventing HPV-related cancers, and it boasts a strong safety record. Millions have received the vaccine, and its safety is closely monitored. This trial tests the vaccine in people with blood cancers, but its safety is well-documented from other uses. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard treatments for blood cancers, which often involve chemotherapy and radiation, the Gardasil 9 vaccine takes a novel approach by using a nonavalent human papillomavirus (HPV) vaccine. This vaccine is unique because it targets HPV strains, which may play a role in some blood cancers, especially in patients post stem cell transplant. Researchers are excited about this treatment because it provides a new strategy to help prevent cancer recurrence by potentially boosting the immune response in these patients. Additionally, as a vaccine, it offers a non-invasive option compared to the traditional treatments, which can be harsh and have significant side effects.

What evidence suggests that the Gardasil 9 vaccine is effective for preventing HPV infection in patients with blood cancers?

Studies have shown that the Gardasil 9 vaccine effectively prevents HPV infections, with success rates between 83% and 96.1%. Research over 15 years confirms it provides safe and long-lasting protection against HPV. The vaccine reduces HPV infections, early signs of disease, and related cancers most effectively when administered at a younger age. Gardasil 9 is already approved and used to prevent HPV, which is linked to various cancers, including cervical cancer. In this trial, participants will receive the Gardasil 9 vaccine to explore its potential to protect patients with blood cancers undergoing stem cell transplants. ^{2 6 7 8 9}

Who Is on the Research Team?

Jessica P. Hwang

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8706722/

Human Papillomavirus Vaccine Efficacy and Effectiveness ... The estimated vaccine effectiveness with one dose or more of the HPV vaccine was 83–96.1% [39,40]. 3.1. Efficacy and Effectiveness of the HPV Vaccine in Young ...

2. cdc.gov cdc.gov/hpv/hcp/vaccination-considerations/safety-and-effectiveness-data.html

HPV Vaccine Safety and Effectiveness Data More than 15 years of monitoring and research have accumulated reassuring evidence that HPV vaccination provides safe, effective, and long-lasting protection.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03023631

Gardasil 9 Vaccine in Preventing HPV Infection in Patients ... This phase IV trial studies how well Gardasil 9 vaccine works in preventing human papillomavirus (HPV) infection in patients with hematologic malignancies

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12153211/

Impact of human papillomavirus vaccines in the reduction ... Individuals vaccinated at a younger age had a greater reduction in HPV infection, precursor lesions, and cervical cancer than those vaccinated ...

5. fda.gov fda.gov/media/90064/download

Package Insert - GARDASIL 9 An interim analysis of the per-protocol effectiveness population included 1,902 subjects who completed the. GARDASIL vaccination series within one year, were ...

6. gardasil9.com gardasil9.com/patient-pd/what-is-gardasil-9/safety-and-side-effects/

GARDASIL 9 safety and side effects GARDASIL 9 does not prevent all types of cervical, vulvar, vaginal, anal, or head and neck cancers. Vaccination does not remove the need for recommended cancer ...

7. cdc.gov cdc.gov/vaccine-safety/vaccines/hpv.html

Human Papillomavirus (HPV) Vaccine Safety Gardasil 9 protects against 9 types of cancer-causing HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. For HPV vaccine to be most effective, the series ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12269663/

Adverse events following 9-valent human papillomavirus ... GARDASIL 9, a 9-valent HPV vaccine approved in 2014, is widely administered for the prevention of HPV-related malignancies.

9. merckvaccines.com merckvaccines.com/gardasil9/

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, ... The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease ...