This phase IV trial compares 3 different dosing schedules to find the optimal number of doses for HPV vaccination in children and adolescents living with HIV. Comparing 3 different dosing schedules may help researchers determine whether a single dose of HPV vaccine could be effective in preventing HPV in children and adolescents living with HIV.
OUTLINE: Participants living with HIV are randomized to one of three arms. HIV-negative participants are assigned to a fourth arm. ARM 1: Participants living with HIV receive recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) at enrollment, and at 2 and 6 months. Participants also receive recombinant human papillomavirus nonavalent vaccine booster dose IM at 30 months. ARM 2: Participants living with HIV receive recombinant human papillomavirus nonavalent vaccine IM at enrollment and at 6 months. Participants also receive recombinant human papillomavirus nonavalent vaccine booster dose IM at 30 months. ARM 3: Participants living with HIV receive recombinant human papillomavirus nonavalent vaccine IM at enrollment. Participants also receive recombinant human papillomavirus nonavalent vaccine booster dose IM at 24 months and recombinant human papillomavirus nonavalent vaccine completion dose IM at 30 months. ARM 4: Participants without HIV receive recombinant human papillomavirus nonavalent vaccine IM at enrollment. Participants also receive recombinant human papillomavirus nonavalent vaccine booster dose IM at 24 months and recombinant human papillomavirus nonavalent vaccine completion dose IM at 30 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
97
Given IM
Evandro Chagas National Institute of Infectious Diseases (INI), Oswaldo Cruz Foundation (FIOCRUZ) STD and AIDS Clinical Research Laboratory
Rio de Janeiro, Rio de Janeiro, Brazil
GHESKIO Center
Port-au-Prince, Haiti
Via Libre
Lima, Peru
Human papillomavirus type 16 (HPV16) neutralizing antibody geometric mean titers (GMTs) (Arm 1 versus [vs.] Arm 2)
Pseudovirion (PsV)-based neutralization assays will be used to establish HPV 16 neutralizing antibody GMT.
Time frame: At 24 months after the last dose of each vaccine regimen
Human papillomavirus type 18 (HPV18) neutralizing antibody GMTs (Arm 1 vs. Arm 2)
Pseudovirion (PsV)-based neutralization assays will be used to establish HPV 18 neutralizing antibody GMT.
Time frame: At 24 months after the last dose of each vaccine regimen
Change in HPV16 and HPV18 binding antibody median fluorescence intensity-MFI (slope) (Arm 1 vs. Arm 2)
The Luminex immunoassay-based assay will be used to measure HPV 16 and HPV 18 binding antibody MFI.
Time frame: 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
HPV16 and HPV18 neutralizing antibody GMTs (Arm 2 vs. Arm 3)
Pseudovirion (PsV)-based neutralization assays will be used to establish HPV 16 and HPV 18 neutralizing antibody GMT.
Time frame: At 24 months after the last vaccine dose
Change in HPV16 and HPV18 binding antibody MFI (slope) (Arm 2 vs. Arm 3)
The Luminex immunoassay-based assay will be used to measure HPV 16 and HPV 18 binding antibody MFI.
Time frame: Between 1 month and 18 months after the last vaccine dose, and between 18 months and 24 months after the last vaccine dose
Binding antibody MFI to all 9 vaccine HPV types (Arm 2 vs. Arm 3)
Compare the response to a 0, 6- months two-dose schedule vs. a 0, 24-months two-dose schedule in children living with HIV (CLWH). The Luminex immunoassay-based assay will be used to measure HPV 16 and HPV 18 binding antibody MFI, as well as the binding antibody MFI for other HPV types.
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Time frame: At month 7 in Arm 2 and month 25 in Arm 3
HPV16 and HPV18 neutralizing antibody GMTs (Arm 3 vs. Arm 4)
Pseudovirion (PsV)-based neutralization assays will be used to establish HPV 16 and HPV 18 neutralizing antibody GMT.
Time frame: At 24 months after the first (single) vaccine dose
Change in HPV16 and HPV18 binding antibody MFI (slope) (Arm 3 vs. Arm 4)
The Luminex immunoassay-based assay will be used to measure HPV 16 and HPV 18 binding antibody MFI.
Time frame: Between 1 month and 18 months after the single vaccine dose, and between 18 months and 24 months after the first (single) vaccine dose