Clinical trial · Interventional
Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors
Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial
NCT01492582CI-TRIAL-00054714completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Survivor | — | UNRESOLVED | — |
| Prevention of Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| medical chart review | Other | — | UNRESOLVED |
| 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 | — | UNRESOLVED |
| survey administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prevention (vaccine therapy)
- description
- 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.
- interventionNames
- Biological: 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)
- Other: laboratory biomarker analysis
- Other: survey administration
- Other: medical chart review
Primary outcomes (3)
- measure
- Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey])
- timeFrame
- At baseline
- description
- The prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 9 Years
- Maximum age
- 26 Years
Show eligibility criteria text
Inclusion Criteria: * AIM 1 (SURVEY) (AIM 1 is closed to enrollment) * Cancer survivor * Between 12 and 60 months after completion of cancer therapy (chemotherapy, radiation, hematopoietic cell transplant \[HCT\]) * Scheduled for a return clinic visit at one of the participating institutions * English or Spanish-speaking * Willing to provide informed consent/assent for study participation * AIM 2 (VACCINE EVALUATION) * Meets all inclusion criteria outlined in Aim 1 * Survey response indicated no prior history of HPV vaccination OR patient has no prior history of HPV vaccination by self - or parent/caregiver-report * English or Spanish-speaking * Medical clearance from treating clinician for study participation * Agrees to return to participating institution for 3 HPV vaccine injections * Willing to provide informed consent/assent for study participation Exclusion Criteria: * AIM 2 (VACCINE EVALUATION) * Allergy to any component of the HPV vaccine including yeast and aluminum * Thrombocytopenia (platelet count \< 50K) or coagulation disorder that would contraindicate intramuscular injection * Transfusion of blood products or intravenous immune globulin within 3 months of study entry * Female, and a) currently pregnant or lactating, or b) of childbearing potential and unwilling to avoid pregnancy during the vaccine phase of study (beginning at Day 1 and continuing until at least 4 weeks after all 3 vaccine doses have been administered)
References
Publications (4)
- DERIVEDLandier 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. PMID 34767765
- DERIVEDYork 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. PMID 32552278
- DERIVEDCherven 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. PMID 31291010
- DERIVEDKlosky 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. PMID 28837404