Recombinant Human Papillomavirus Nonavalent Vaccine for Allogeneic Hematopoietic Stem Cell Transplant Recipient

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
M D Anderson Cancer Center, Houston, TX
Allogeneic Hematopoietic Stem Cell Transplant Recipient+2 More
Recombinant Human Papillomavirus Nonavalent Vaccine - Biological
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a vaccine can prevent HPV infection in people with hematologic malignancies.

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Eligible Conditions

  • Allogeneic Hematopoietic Stem Cell Transplant Recipient
  • Hematopoietic and Lymphoid Cell Neoplasm

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Recombinant Human Papillomavirus Nonavalent Vaccine will improve 1 primary outcome and 4 secondary outcomes in patients with Allogeneic Hematopoietic Stem Cell Transplant Recipient. Measurement will happen over the course of Up to 3 days post-intervention.

Month 1
Antibody response defined as numerically elevated antibody titer of any type at 1 month post-dose 3 (month 7)
Month 6
Antibody persistence at 6 months post-dose 3
Month 12
Estimation of antibody titers
Day 3
Human papillomavirus (HPV) vaccination completion rate
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

1 Treatment Group

Prevention (Gardasil 9 vaccine)
1 of 1
Experimental Treatment

This trial requires 48 total participants across 1 different treatment group

This trial involves a single treatment. Recombinant Human Papillomavirus Nonavalent Vaccine is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Prevention (Gardasil 9 vaccine)
Biological
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 1 month post-dose 3
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at 1 month post-dose 3 for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
All English-speaking adult MD Anderson patients with hematologic malignancy at 6-12 months +/- 8 weeks post allogeneic stem cell transplantation who will receive usual post-stem cell transplant vaccinations
All patients from approved protocol 2015-0795 will be invited to this vaccine study

Patient Q&A Section

What is hematologic neoplasms?

"Hematologic malignancies continue to show an extremely high rate of allogeneic hematopoietic stem cell transplantation after autologous or nonreactive allo-HSCT. The rate of cure is still high. The treatment of these patients remains difficult even today due to their high morbidity and mortality." - Anonymous Online Contributor

Unverified Answer

Can hematologic neoplasms be cured?

"Although long-term survival rates are low, initial curative treatment is possible for hematologic neoplasms such as myelodysplastic syndrome, acute myelogenous leukemia, and acute lymphoblastic leukemia. In addition to intensive chemotherapy, bone marrow or hematopoietic stem cell transplantation may be helpful in some patients." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hematologic neoplasms?

"Treatment choices are highly influenced by prognostic factors and the extent of disease. Given the high use of aggressive therapies, there is a clear need for a careful assessment of therapeutic options and their role in the management of patients with hematological malignancies, which are associated with high rates of adverse events." - Anonymous Online Contributor

Unverified Answer

What are the signs of hematologic neoplasms?

"These signs and symptoms, if present, suggest an underlying hematologic neoplasm. An elevated white count, fatigue, swollen lymph nodes, anemia, and low platelet count are common. The most common underlying hematologic malignancy is acute myeloid leukemia, followed by chronic myelomonocytic leukemia, chronic myelocytic leukemia, lymphoproliferative disorder, and myelofibrosis." - Anonymous Online Contributor

Unverified Answer

How many people get hematologic neoplasms a year in the United States?

"Myelodysplastic syndromes, B-cell malignancies, and acute myelogenous leukemias and lymphomas are the most common hematologic malignancies in the United States. Of the 4727 individuals with a diagnosis of first-time myelodysplastic syndrome, 12% were black." - Anonymous Online Contributor

Unverified Answer

What causes hematologic neoplasms?

"Many hematologic neoplasms are associated with infectious and noninfectious disorders, which indicates their pathogenesis. Although infectious and noninfectious causes are associated with a range of solid and hematological neoplasms, in many cases it is possible to prove the etiologic role of an infectious or noninfectious cause." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for hematologic neoplasms?

"The 5-year relative survival rate for all hematologic malignancies is approximately 86%. Although specific survival rates differ by tumor type, the mean survival time for an individual hematologic malignancy is approximately 9.3 ± 1.9 months." - Anonymous Online Contributor

Unverified Answer

How does recombinant human papillomavirus nonavalent vaccine work?

"Findings from a recent study provides the first evidence that a single vaccine dose of the 11 different papillomavirus types included in the FDA-approved Gardasil/Cervarix combination vaccine generates broad humoral immunity to all 11 types and elicits immunity to subsequent infection with the same and disparate types. The potential of this vaccine to provide cross immunity is a major advance in the control of high-risk HPV, especially important for reducing the development and transmission of anal cancer." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of recombinant human papillomavirus nonavalent vaccine?

"The rate of side effects associated with vaccination is high and similar across studies. Most were local in nature, and transient. Few side effects were associated with vaccination. The safety of the vaccine has been reported across studies and in different geographic areas in different pediatric populations. As such, the potential health of future generations of children must weigh the merits and risks of vaccination against the potential harms of not immunizing children." - Anonymous Online Contributor

Unverified Answer

What does recombinant human papillomavirus nonavalent vaccine usually treat?

"According to our results, noninfected HPV16-11 vaccines may not inhibit HPV16 vaccine-induced anticancer immunity. We postulate that a noninfected HPV16-11 vaccine may prevent the development of HPV vaccine-induced anticancer immunity, because there is no immune response to noninfected HPV16-11 vaccines." - Anonymous Online Contributor

Unverified Answer

Has recombinant human papillomavirus nonavalent vaccine proven to be more effective than a placebo?

"Overall, HPV vaccines were effective both as preventive of disease and as immunotherapies for treatment of disease. These data provide further support for the long-term safety and persistence of viral immunity elicited by the rHPV vaccines used in this program. These data also suggest that the magnitude and duration of immunity elicited by the vaccines used herein are likely not sufficient for the development of an effective immune response in patients with advanced-stage disease." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for hematologic neoplasms?

"If the clinical trial is not tailored to meet the needs of the individual, there is a high chance that the investigator's efforts will be wasted. Inclusion criteria need to be developed and validated within the scientific community to facilitate and drive trial design. Clinical trials should always be the first consideration." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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