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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03654 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 1R01CA166559 | U.S. NIH Grant/Contract | View source | |
| Merck-IISP#40083 | Other Identifier | Merck & Co. | |
| COH-11034 | Other Identifier | City of Hope IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Merck Sharp & Dohme LLC | INDUSTRY |
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This trial will comprehensively evaluate the human papillomavirus (HPV) vaccine in cancer survivors between 9 and 26 years of age by (1) determining the prevalence of HPV vaccine initiation among young cancer survivors, and (2) determining the immune response to and safety/tolerability of the quadrivalent and nonavalent HPV vaccine in young cancer survivors.
PRIMARY OBJECTIVES:
I. Using a cross-sectional survey approach, estimate the prevalence of HPV vaccine non-initiation: a) Examine sociodemographic, behavioral, and medical determinants of HPV vaccine non-initiation.
II. Using a single-arm, phase II, open-label, prospective longitudinal trial design, to evaluate the 3-dose HPV quadrivalent (HPV4) and nonavalent (HPV9) vaccine series and measure the following endpoints: a) Determine immunogenicity following the third and final vaccine dose; b) Identify clinical/host factors influencing immunogenicity; c) Determine the safety/tolerability of the HPV vaccine in cancer survivors.
III. Evaluate the persistence of antibody response at 2 years post vaccine initiation and identify clinical/host factors influencing response persistence.
OUTLINE:
AIM 1 (SURVEY): Patients (ages 18-26 years) or their parents (for patients ages 9-17 years) complete a survey regarding the patient's HPV vaccination status, knowledge of HPV-related disease, and factors important in making decisions regarding vaccination.
AIM 2 (VACCINE EVALUATION): Patients not previously immunized against HPV receive quadrivalent human papillomavirus recombinant vaccine (HPV-6, -11, -16, -18, for patients enrolled on or before 3/1/16) or the nonavalent human papillomavirus recombinant vaccine (HPV-6, -11, -16, -18, -31, -33, -45, -52, -58, for patients enrolled after 3/1/16) intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention (vaccine therapy) | Experimental | Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58) | Biological | Given IM |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey]) | The prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years | At baseline |
| Immunogenicity of the HPV Vaccine in Cancer Survivors (Anti-HPV 16 and 18 Geometric Mean Titers) (Aim 2 [Vaccine Evaluation]) | To demonstrate the non-inferiority of the antibody responses to the HPV vaccine in cancer survivors ages 9 to 26 years when compared to antibody responses of age- and sex-matched historical healthy population. | 1 month following vaccination dose #3 |
| Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation]) | To demonstrate comparable safety/tolerability of the HPV vaccine in cancer survivors ages 9 to 26 years when compared to age- and sex-matched general population. | Dose 1 through Month 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy Landier, PhD, CRNP | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| City of Hope Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34767765 | Derived | Landier W, Bhatia S, Wong FL, York JM, Flynn JS, Henneberg HM, Singh P, Adams K, Wasilewski-Masker K, Cherven B, Jasty-Rao R, Leonard M, Connelly JA, Armenian SH, Robison LL, Giuliano AR, Hudson MM, Klosky JL. Immunogenicity and safety of the human papillomavirus vaccine in young survivors of cancer in the USA: a single-arm, open-label, phase 2, non-inferiority trial. Lancet Child Adolesc Health. 2022 Jan;6(1):38-48. doi: 10.1016/S2352-4642(21)00278-9. Epub 2021 Nov 10. | |
| 32552278 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prevention (Vaccine Therapy) | Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. laboratory biomarker analysis: Correlative studies survey administration: Ancillary studies medical chart review: Ancillary studies |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2016 |
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| laboratory biomarker analysis | Other | Correlative studies |
|
| survey administration | Other | Ancillary studies |
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| medical chart review | Other | Ancillary studies |
|
|
| Duarte |
| California |
| 91010 |
| United States |
| Emory University School Of Medicine | Atlanta | Georgia | 30308 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Saint Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| York JM, Klosky JL, Chen Y, Connelly JA, Wasilewski-Masker K, Giuliano AR, Robison LL, Wong FL, Hudson MM, Bhatia S, Landier W. Patient-Level Factors Associated With Lack of Health Care Provider Recommendation for the Human Papillomavirus Vaccine Among Young Cancer Survivors. J Clin Oncol. 2020 Sep 1;38(25):2892-2901. doi: 10.1200/JCO.19.02026. Epub 2020 Jun 18. |
| 31291010 | Derived | Cherven B, Castellino SM, Chen Y, Wong FL, York JM, Wasilewski-Masker K, Hudson MM, Bhatia S, Klosky JL, Landier W. Intent and subsequent initiation of human papillomavirus vaccine among young cancer survivors. Cancer. 2019 Nov 1;125(21):3810-3817. doi: 10.1002/cncr.32379. Epub 2019 Jul 10. |
| 28837404 | Derived | Klosky JL, Hudson MM, Chen Y, Connelly JA, Wasilewski-Masker K, Sun CL, Francisco L, Gustafson L, Russell KM, Sabbatini G, Flynn JS, York JM, Giuliano AR, Robison LL, Wong FL, Bhatia S, Landier W. Human Papillomavirus Vaccination Rates in Young Cancer Survivors. J Clin Oncol. 2017 Nov 1;35(31):3582-3590. doi: 10.1200/JCO.2017.74.1843. Epub 2017 Aug 24. |
| FG001 | Survey Arm | Patients (ages 18-26 years) or their parents (for patients ages 9-17 years) complete a survey regarding the patient's HPV vaccination status, knowledge of HPV-related disease, and factors important in making decisions regarding vaccination. |
|
| Received First Quadrivalent Vaccine Dose |
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| Received First Nonavalent Vaccine Dose |
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| COMPLETED |
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| NOT COMPLETED |
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Participants who consented to the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prevention (Vaccine Therapy) | Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. |
| BG001 | Survey | Patients (ages 18-26 years) or their parents (for patients ages 9-17 years) complete a survey regarding the patient's HPV vaccination status, knowledge of HPV-related disease, and factors important in making decisions regarding vaccination. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey]) | The prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years | Participants who returned an evaluable survey | Posted | Count of Participants | Participants | At baseline |
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| ||||||||||||||||||||||||||
| Primary | Immunogenicity of the HPV Vaccine in Cancer Survivors (Anti-HPV 16 and 18 Geometric Mean Titers) (Aim 2 [Vaccine Evaluation]) | To demonstrate the non-inferiority of the antibody responses to the HPV vaccine in cancer survivors ages 9 to 26 years when compared to antibody responses of age- and sex-matched historical healthy population. | Posted | Geometric Mean | Standard Deviation | mMu/mL | 1 month following vaccination dose #3 |
| ||||||||||||||||||||||||||||
| Primary | Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation]) | To demonstrate comparable safety/tolerability of the HPV vaccine in cancer survivors ages 9 to 26 years when compared to age- and sex-matched general population. | Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group. | Posted | Number | participants | Dose 1 through Month 7 |
|
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Other (Not Including Serious) Adverse Events: Nonavalent: 7 days after each vaccine dose Quadrivalent: 14 days after each vaccine dose Serious Adverse Events were reported up to Month 7 (no SAEs occurred within 7-14 days of each vaccine dose).
No adverse events are reported for the survey arm participants as adverse events were not monitored/assessed for participants in this arm.
Note: 254 participants received the first dose of the quadrivalent vaccine. However, one participant never returned to clinic or returned phone calls after receiving the first vaccine. No follow-up information is available for this participant so only 253 participants are reported in this group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prevention (Vaccine Therapy)- Quadrivalent | Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. | 0 | 253 | 11 | 253 | 129 | 253 |
| EG001 | Prevention (Vaccine Therapy)- Nonavalent Vaccine | Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. | 0 | 182 | 7 | 182 | 108 | 182 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
| ||
| Relapse of primary cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Subsequent malignant neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Erythema nodosum | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hospitalization for musculoskeletal issue | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Hospitalization for endocrine disorder | Endocrine disorders | Non-systematic Assessment |
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| Hospitalization for fluid-electrolyte disorder | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hospitalization for neurologic disorder | Nervous system disorders | Non-systematic Assessment |
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| Hospitalization for psychiatric disorder | Psychiatric disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain or Tenderness, any | General disorders | Systematic Assessment |
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| Injection Site Swelling, any | General disorders | Systematic Assessment |
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| Injection Site Erythema, any | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Fever (≥100.0⁰F) | General disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wendy Landier, Deputy Director, Institute for Cancer Outcomes and Survivorship | University of Alabama at Birmingham | (205) 638-2120 | wlandier@peds.uab.edu |
| Jan 27, 2020 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 4, 2019 | Feb 28, 2020 | ICF_001.pdf |
| ID | Term |
|---|---|
| D014614 | Vaccines, Synthetic |
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| C000634046 | Human Papillomavirus Recombinant Vaccine nonavalent |
| ID | Term |
|---|---|
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D017778 | Vaccines, Combined |
| D053918 | Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
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| Title | Measurements |
|---|---|
|
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | Quadrivalent Anti-HPV 16, Female, Age 16-26 Years | Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. |
| OG004 | Nonavalent Anti-HPV 16, Male, Age 9-15 Years | Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. |
| OG005 | Nonavalent Anti-HPV 16, Female, Age 9-15 Years | Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. |
| OG006 | Nonavalent Anti-HPV 16, Male, Age 16-26 Years | Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. |
| OG007 | Nonavalent Anti-HPV 16, Female, Age 16-26 Years | Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. |
| OG008 | Quadrivalent Anti-HPV 18, Male, Age 9-15 Years | Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. |
| OG009 | Quadrivalent Anti-HPV 18, Female, Age 9-15 Years | Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. |
| OG010 | Quadrivalent Anti-HPV 18, Male, Age 16-26 Years | Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. |
| OG011 | Quadrivalent Anti-HPV 18, Female, Age 16-26 Years | Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. |
| OG012 | Nonavalent Anti-HPV 18, Male, Age 9-15 Years | Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. |
| OG013 | Nonavalent Anti-HPV 18, Female, Age 9-15 Years | Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. |
| OG014 | Nonavalent Anti-HPV 18, Male, Age 16-26 Years | Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. |
| OG015 | Nonavalent Anti-HPV 18, Female, Age 16-26 Years | Patients receive nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. |
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