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

NCT03023631 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: 2016-0714NCI-2018-02606
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Antibody response defined as numerically elevated antibody titer of any type at 1 month post-dose 3 (month 7)

  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.

  At 1 month post-dose 3

Secondary Outcomes (4)

• Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

  Up to 3 days post-intervention

• Antibody persistence at 6 months post-dose 3

  At 6 months post-dose 3

• Human papillomavirus (HPV) vaccination completion rate

  Up to 3 days post-intervention

• Estimation of antibody titers

  At 6-12 months post-transplant, and at 1 and 6 months post-dose 3

Study Arms (1)

Prevention (Gardasil 9 vaccine)

EXPERIMENTAL

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

Interventions

Recombinant Human Papillomavirus Nonavalent Vaccine BIOLOGICAL

Given IM

Also known as: Gardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent Vaccine

Prevention (Gardasil 9 vaccine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jessica P Hwang

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 18, 2017
• Study Start: April 23, 2017
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

US (1)