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Gardasil 9 Vaccine in Preventing HPV Infection in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant

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ClinicalTrials.gov Identifier: NCT03023631
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This phase IV trial studies how well Gardasil 9 vaccine works in preventing human papillomavirus (HPV) infection in patients with hematologic malignancies who are undergoing donor stem cell transplant. Vaccines, such as Gardasil 9, may help the body build an effective immune response to kill cancer cells.

Condition or disease Intervention/treatment Phase
Allogeneic Hematopoietic Stem Cell Transplant Recipient Hematopoietic and Lymphoid Cell Neoplasm Biological: Recombinant Human Papillomavirus Nonavalent Vaccine Phase 4

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the immunogenicity of recombinant human papillomavirus nonavalent vaccine (GARDASIL 9) administered after allogeneic stem cell transplant (SCT) in patients with hematologic malignancy by comparing HPV 9-plex competitive Luminex immunoassay (9-plex cLIA) titers before and after GARDASIL 9 administration.

II. To evaluate the safety and tolerability of GARDASIL 9 administered after allogeneic SCT in patients with hematologic malignancy.

OUTLINE:

Patients undergo standard of care allogeneic stem cell transplant. 6-12 months following transplant, patients receive recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) on day 0 and at 2 and 6 months in the absence of disease progression or unacceptable toxicity.

After completion of study intervention, patients are followed up within 3 days.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Human Papillomavirus Antibody Response After GARDASIL 9 Vaccination in Patients After Allogeneic Stem Cell Transplantation
Actual Study Start Date : April 23, 2017
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prevention (Gardasil 9 vaccine)
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.
Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
Given IM
Other Names:
  • Gardasil 9
  • Nonavalent HPV VLP Vaccine
  • Recombinant HPV Nonavalent Vaccine
  • Recombinant Human Papillomavirus 9-valent Vaccine




Primary Outcome Measures :
  1. Antibody response defined as numerically elevated antibody titer of any type at 1 month post-dose 3 (month 7) [ Time Frame: At 1 month post-dose 3 ]
    Antibody response at 1 month post-dose 3 (month 7) will be compared with baseline antibody level. The study will use results from the 9-plex competitive Luminex immunoassay (9-plex cLIA) test to estimate the antibody response rate at dose 3 with 95% confidence interval (CI). Will apply Student t-test/Wilcoxon test to compare continuous variables between patients who obtained antibody response as defined in the primary endpoint (responders) and those who did not respond (non-responders), and the chi-square test or the Fisher's exact test to assess the association between response status and patients' demographic and clinical characteristics. Logistic regression analysis will be used to assess the multivariate relationship between patient demographic and clinical characteristics on the probability of antibody response.


Secondary Outcome Measures :
  1. Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [ Time Frame: Up to 3 days post-intervention ]
    Safety and tolerability of recombinant human papillomavirus nonavalent vaccine measured by occurrence of grade >= 3 adverse events (AEs) that are possibly, probably, or definitely related to recombinant human papillomavirus nonavalent vaccine for all 3 vaccine administrations. The study will report the AE rate with a corresponding upper bound of a 1-sided 95% CI.

  2. Antibody persistence at 6 months post-dose 3 [ Time Frame: At 6 months post-dose 3 ]
    Antibody persistence at 6 months post-dose 3 will be compared with 1 month post-dose 3. The study will apply a paired t-test with noninferiority hypotheses.

  3. Human papillomavirus (HPV) vaccination completion rate [ Time Frame: Up to 3 days post-intervention ]
    The study will calculate the proportion of patients who are able to complete the 3 shot series of HPV vaccination. Will describe them in terms of demographics, and clinical characteristics.

  4. Estimation of antibody titers [ Time Frame: At 6-12 months post-transplant, and at 1 and 6 months post-dose 3 ]
    Antibody titer will be measured repeatedly by the 9-plex cLIA test. Appropriate transformation (e.g. log transformation) of antibody titer will be used in the analyses to satisfy the normality assumption of linear or linear mixed effect model. Geometric mean titers will be used to summarize antibody titer at each time point. Linear mixed effect models for repeated measures analysis will be employed to assess change in antibody titer over time and to compare antibody titer change over time between different patient groups adjusting for other important covariates including disease characteristics (tumor stage, site, pathology), and other patient prognostic factors. Interaction between time and patients' characteristics on the change of antibody titer will be also investigated.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Prior allogeneic SCT
  • Platelet count less than or equal to 25,000 K/uL
  • Absolute neutrophil count less than or equal to 500/uL
  • Patients who have ever received HPV vaccination (at least one dose of HPV vaccine)
  • Patients with a prior history of HPV-related malignancy
  • Female patients who tested positive for pregnancy during pre-SCT evaluation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023631


Contacts
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Contact: Jessica Hwang 713-745-4516 jphwang@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jessica P. Hwang    713-745-4516      
Principal Investigator: Jessica P. Hwang         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jessica P Hwang M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03023631     History of Changes
Other Study ID Numbers: 2016-0714
NCI-2018-02606 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0714 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs