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Gardasil Vaccination in Post Stem Cell Transplant Patients
Phase 1 trial testing Gardasil in Gardasil Vaccine in 64 participants. Completed in 19 July 2016.
| Lead sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 64 |
| Start date | 2 June 2010 |
| Primary completion | 19 July 2016 |
| Estimated completion | 19 July 2016 |
| Sites | 1 location across United States |
National Heart, Lung, and Blood Institute (NHLBI)
Adults 18 to 50, female only, with Gardasil Vaccine or Stem Cell Transplant. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The percentage of subjects who developed antibody response to the quadrivalent HPV (qHPV) vaccine (HPV - 6/ - 11/ - 16/ - 18). Anti-HPV-6/11/16/18-specific antibody responses using L1 Virus Like Particle (VLP) ELISA were measured in serum.
| Group | Value | 95% CI |
|---|---|---|
| Transplant With Immunosuppression | 18 | |
| Transplant With no Immunosuppression | 20 | |
| Healthy Volunteer | 20 |
Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Transplant With Immunosupp… | Transplant With no Immunos… | Healthy Volunteer |
|---|---|---|---|---|
| Pain | General disorders | — | — | — |
| Fatigue | General disorders | — | — | — |
| Swelling | General disorders | — | — | — |
| Erythema | General disorders | — | — | — |
| Headache | General disorders | — | — | — |
| Pruritus | General disorders | — | — | — |
| Rash | General disorders | — | — | — |
| Pyrexia | General disorders | — | — | — |
| Edema | General disorders | — | — | — |
Data from ClinicalTrials.gov NCT01092195 adverse events section.
Background: * Gardasil , a recently approved vaccine for the sexually transmitted human papillomavirus (HPV), provides immunity to four types of HPV that are associated with genital warts and cervical, vaginal, and vulvar precancer and cancer. The vaccine has been shown to be highly effective in preventing infection with these HPV types and was approved for use by the Food and Drug Administration. * More research is needed about the vaccine s ability to induce immunity in individuals with suppressed immune systems, such as those who have had other kinds of cancer treatment such as stem cell transplant. Genital warts, precancer, and cancer have been reported as a late complication after stem cell transplant. Researchers are interested in determining whether the HPV vaccine is safe to give and able to induce immunity in female stem cell transplant recipients, their female donors, and healthy female volunteers. Objectives: \- To assess the safety and immune response of the HPV vaccine in female recipients of stem cell transplants who are either off or on stable doses of immunosuppression. Eligibility: * Females between 18 and 50 years of age who have had allogenic stem cell transplants. * Healthy female volunteers, including stem cell donors, are also eligible for this study. Design: * Participants will be screened with a physical examination, blood and urine tests, and saliva samples, and will be asked to complete a sexual quality of life questionnaire. * Sexually active participants will also have a routine gynecologic evaluation. * Participants will receive three HPV vaccinations according to the standard vaccination schedule (with the second and third following 2 and 6 months after the first). Participants will record their daily temperature and any reactions to the vaccine on a vaccine report card for 1 week after each vaccination. * Participants will have clinic visits for further testing 2, 6, 7, and 12 months after receiving the first HPV vaccine.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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