Vaccine Evaluation Center, BC Children's Hospital Research Institute
Vancouver, British Columbia, V5Z 4H4, Canada
NCT Number: NCT02968420
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.
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Notify Me17 year–35 year
Female
Interventional
Phase 4
Vancouver, British Columbia, V5Z 4H4, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
Other names: Gardasil9
Time frame: At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine
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 7 post challenge dose of Human Papillomavirus 9-Valent vaccine
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 and Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine
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 post challenge dose of Human Papillomavirus 9-Valent vaccine
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
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
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
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
University of British Columbia
Other
Long Term Immune Memory Responses to Human Papillomavirus (HPV) Vaccination Following 2 Verses 3 Doses of Quadrivalent HPV Vaccine
Acronym: Merck08
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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