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This study will enroll 9-13 year old children living with HIV from Lima, Peru and Rio de Janeiro, Brazil as well as HIV-uninfected children of the same age group from the same areas. Baseline data collection includes: age, sexual activity status, pregnancy status and HPV antibody serology for all children, as well as HIV viral load, % CD4 or CD4 counts for children living with HIV (CLWH). Eligible CLWH will be block randomized to three interventions arms and HIV uninfected children will be directly enrolled into a fourth control arm. HPV vaccination (Gardasil 9) will be administered as single doses at study visits as follows:
- Arm 1 (HIV+) receives 3 doses at 0, 2, 6 months
- Arm 2 (HIV+) receives 2 doses at 0 and 6 months
- Arm 3 (HIV+) receives 1 dose at 0 month
- Arm 4 (HIV -) receives 2 doses 0, 6 months All arms receive an anamnestic booster dose 24 months after the last specific regimen vaccine dose to elicit B memory and antibody responses. Arm 3 receives one additional dose at month 30 to complete the 3-dose recommended schedule for CLWH.
A generation of children living with HIV (CLWH) in Latin America and the Caribbean (LAC) are approaching the age of sexual debut and are, therefore, at risk of infection by oncogenic human papilloma viruses (HPVs). Three virus-like-particle based vaccines are highly efficacious in preventing HPV infections and disease: Cervarix, including types 16 and 18 (2vHPV), Gardasil containing types 6, 11, 16 and 18 (4vHPV), and Gardasil 9 containing types 6, 11, 16, 18, 31, 33, 45, 52 and 58 (9vHPV). Best practice HPV vaccination schedules for HIV-infected children are not known, and alternative dosing schedules may improve immunogenicity and provide better long-term protection. Duration of vaccine response will correlate with elevated anamnestic response measured 24 months after last dose of a given regimen. Importantly, this vaccine trial will take place among CLWH in resource-poor settings, and may have global implications for vulnerable children, who may have low nutritional status, etc., who would most benefit from highly immunogenic and efficient vaccine schedules.
In vaccinating CLWH one of the critical questions is whether the vaccine will provide long term protection from HPV infections. Our studies will focus on the generation of long-lived B cell memory immunity. The investigators will test responses to the following: the standard three-dose regimen recommended by the CDC for CLWH (arm 1: CLWH), the two-dose regimen recommended for immunocompetent adolescents by CDC, Peruvian and Brazilian guidelines (arm 2: CLWH and arm 4: HIV-uninfected youth), and a one-dose regimen (arm 3: CLWH). It is well known that both antibody titers and B cell memory (Bmem) responses peak around one month after the last dose of vaccine then gradually fall and reach a plateau by 18 months post vaccination. Therefore, Bmem responses will be studied at one month after the last vaccine dose and again during the plateau at 24 months past the last vaccine dose. In order to stimulate an anamnestic response a booster dose will be given 24 months after the last dose of each regimen in each arm. Characteristic of an anamnestic response is a very rapid rise in antibody titer accompanied by a burst of plasmablasts. To measure these responses, blood will be collected at 1 and 4 weeks after the booster dose. Comparison of responses in arms 1, 2, and 3 will explore the need for a 3-dose regimen in CLWH. An innovation of this trial is to test, for the first time, the immune response to a reduced number of doses of HPV vaccine in CLWH. The purpose of this study is to find the optimum number of doses of 9vHPV to elicit a robust B cell memory and antibody responses in CLWH. Responses in CLWH will be compared against HIV-uninfected youth who receive the standard 2-dose regimens per CDC Peruvian and Brazilian guidelines.
HPV 9-valent vaccine
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro
Not yet recruiting
Fred Hutchinson Cancer Research Center
Published on BioPortfolio: 2020-02-16T17:40:48-0500
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