The overall aim of this study is to further understand the memory response to HPV vaccination in subjects who have received 2 versus 3 doses of quadrivalent HPV vaccine. Although memory responses can be detected shortly after immunization, the best approach to measure the long-lasting anamnestic response is to challenge with a booster dose years (\> 5) after the original exposure.
This is a single center, interventional study to evaluate long term memory response to Q-HPV vaccination and to natural infection. Memory response will be assessed by measuring seroprotection 8-10 years post Q-HPV vaccination and to challenge with a booster dose years after the original exposure to measure the long-lasting anamnestic response.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
Vaccine Evaluation Center, BC Children's Hospital Research Institute
Vancouver, British Columbia, Canada
B Memory Cell Response (% of Memory B Cells That Are Antigen-specific)
To compare the B memory cell populations between girls that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose after 120 months
Time frame: At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine
Plasmablast Response (% of All B Cells That Are Plasmablasts)
To compare the plasmablast populations between girls that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose after 120 months
Time frame: At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine
Variable Gene Usage (Comparison of the Nucleotide Sequences of Antigen-specific Antibody Heavy and Light Chain Variable Region Sequences)
To compare the extent of somatic hypermutation and the variable gene usage between girls that received either a primary 2 or 3 dose series
Time frame: At Day 7 and Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine
Serum Antibody Response (cLIA) - Geometric Mean Titer
To compare the serum antibody responses (cLIA) to HPV 6, 11, 16 \& 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose
Time frame: At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine
Serum Antibody Response (cLIA) - Geometric Mean Titer
To compare the serum antibody responses (cLIA) to HPV 6, 11, 16 \& 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose
Time frame: At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine
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Serum Antibody Response (Total IgG) - Geometric Mean Titer
To compare the serum antibody responses (total IgG) to HPV 6, 11, 16 \& 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose
Time frame: At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine
Serum Antibody Response (Total IgG) - Geometric Mean Titer
To compare the serum antibody responses (total IgG) to HPV 6, 11, 16 \& 18 at month 120 in females that received either a primary 2 or 3 dose series, who are then challenged with a subsequent dose
Time frame: At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine