Phase 2
N=1,499
Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors
Cancer Survivor · Prevention of Human Papillomavirus Infection
Bottom Line
View on ClinicalTrials.gov: NCT01492582 ↗Enrolled (actual)
1,499
Serious AEs
4.1%
Results posted
Apr 2020
Primary outcome: Primary: Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey]) — 179 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 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); laboratory biomarker analysis (Other); survey administration (Other); medical chart review (Other)
- Age
- Pediatric, Adult · 9+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey]) |
179 | — |
| PRIMARY Immunogenicity of the HPV Vaccine in Cancer Survivors (Anti-HPV 16 and 18 Geometric Mean Titers) (Aim 2 [Vaccine Evaluation]) |
16134.57; 15209.73; 8740.02; 6107.32; 16419.64; 11763.60 | — |
| PRIMARY Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation]) |
90; 84; 15; 15; 15; 17 | <0.001 sig |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01492582). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.