B977 Papillomavirus as the cause of diseases classified to other chapters Papillomavirus as the cause of diseases classified to other chapters
Conditions
Interventions
This is a randomized, open-Iabel study of a licensed HPV vaccine given in three different dosing Regimens among CLWH and HIV-uninfected children from the same communities. Twenty-five CLWH will be en
participants in Arms 2 & 4 will receive vaccine doses at 0,6, and 30 months
and participants in Arm 3 will receive vaccine doses at 0, 24, and 30 months. Duration of participation will be 30 months for participants in Arm 3, and 31 months for participants in Arms 1, 2, and 4
Sponsors
Fred Hutchinson Cancer Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 4.1.1 Arms 1 - 3: Children must be living with HIV. Hl V infection must be confirmed by local algorithm (positive NAAT test before 18 months of age with positive serologic test thereafter). Ann 4: Children must be healthy (without autoimmune disease or cancer) and not living with HIV. 4.1.2 Children in Anns 1 - 3 must be on a consistent, clinically appropriate combination ART regimen for >6 months prior to study enrollment. 4.1.3Children must be 9- 13-years-old (at or after 9lh birthday, prior to 14th birthday). This will allow us to vaccinate participants within the recommended age range for receipt of HPV vaccination in Peru and Brazil. Only children ages 9-11 (at or after 9th birthday, prior to 12u1birthday) will be enrolled into arm 3 and 4. 4.1.4 The most recent clinical laboratory values for children in Arms 1, 2, & 3 (CLWH) must be as described below: CD4 % > 15% or CD4 counts >200 cells/ mm3. VL (<400 copies/mL) 4.1.5 All female participants must not be pregnant (all females will receive pregnancy tests at all vaccine visits prior to receipt of study vaccine). The effects of Gardasil® 9 on the developing human fetus at the recommended therapeutic dose are unknown. If pregnancy is confirmed during the screening process, enrollment will not occur. If pregnancy occurs after the first vaccine dose, additional vaccine doses will not be administered, but the child will continue in follow-up. 4.1.6 We anticipate that all children will enter the study prior to sexual debut, although this will not be investigated clinically. Potential participants who report sexual activity will not be enrolled. 4.1.7 Children in all arms must have the ability to understand and the willingness to assent to the study. Parents or guardians must be able to understand and be willing to sign a written infomed consent document.
Exclusion criteria
Exclusion criteria: 4.2.1Children who ha ve a serious illness requiring treatment with systemic medications other than ART (excluding short course oral steroids or inhaled steroid treatment for asthma), are currently under immunomodulatory therapy, received immunosuppressive therapy (> IOmglday of prednisone or equivalent for > 1 week) in the 6 months prior to enrollment date. 4.2.2 Children who received any vaccine within 3 weeks prior to enrollment date (these children will be encouraged to enroll after 3 weeks have passed. 4.2.3 Children who received blood-derived products within 6 months prior to enrollment or planned use during the study period. 4.2.4 Children who weigh less than 18 kilograms. 4.2.5 Children with cancer being treated with thermotherapy or radiation. 4.2.6 Potential participants receiving any other investigational agents may be excluded in the opinion of the supervising physician. 4.2.7 Children in all anns with contraindications to vaccination, including pregnancy or breastfeeding 4.2.8 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 4.2.9 Children who are enrolled and later found to be seropositive for HPY at study entry (by Luminex assay performed by the Central Laboratory Core in Seattle) wil1 be discontinued from specimen collection. 4.2.10 History of allergic reactions attributed to compounds of similar chemical or biologic composition to HPY vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HPV 16 neutralizing antibody GMTs at 24 months after the last dose of each vaccine regimen Pseudovirion (PsV)-based neutralization assays will be used to establish HPV16 neutralizing antibody GMT as the primary endpoint. NAME OF THE RESULT: Comparison of three - dose vs. two dose schedule in CLWH (Arm1 vs Arm2) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: At 24 monts after the lasta dose of each vaccine regimen. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.1 HPV 18 neutralizing antibody GMTs at 24 months after the last dose of each vaccine regimen 1.2 Change in HPV 16 and HPV 18 binding antibody median Fluorescence intensity-MFI (slope) between 1 month after the last dose and 18 months after the last dose, and between 18 months and 24 months after the last dose of each vaccine regimen NAME OF THE RESULT: Comparisons of three-dose vs. two-dose schedule in CLWH (Arm 1 vs Arm 2) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 1.1 At 24 monts after the lasta dose of each vaccine regimen. 1.2 Between 1 month afther the last dose and 18 months after the last dose, and between 18 months and 24 months after the lasts dose of each vaccine regimen. ;HPV 16 neutralizing antibody GMTs at 24 months after the last dose of each vaccine regimen Pseudovirion (PsV)-based neutralization assays will be used to establish HPV16 neutralizing antibody GMT as the primary endpoint. NAME OF THE RESULT: Comparison of three - dose vs. two dose schedule in CLWH (Arm1 vs Arm2) PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: At 24 monts after the lasta dose of each vaccine regimen. | — |
Countries
Brazil, Peru
Contacts
Public ContactROSEMARIE AYARZA
VIA LIBRE
Outcome results
None listed