Long Term Immune Memory Responses to Human Papillomavirus (HPV) Vaccination Following 2 Verses 3 Doses of Quadrivalent HPV Vaccine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Plasmablast Response (% of All B Cells That Are Plasmablasts)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Written informed consent provided by the participant.
- •Participant whom the investigator believes can and will comply with the requirements of the protocol.
- •General good health.
- •Immunized with Q-HPV vaccine between the ages of 9-13 or 16 to 26 years on the BCGov01 study or the BC provincial program.
- •Participant who is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study. Examples of effective methods of birth control include:
- •Abstinence (no sexual activity)
- •Hormonal contraceptives including oral, injectable, implants & skin patches
- •Intrauterine device (IUD)
- •Male partner sterilization
- •Male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository)
- •Male condom combined with a female diaphragm, whether with or without a vaginal spermicide (foam, gel, cream, or suppository)
- •Adequate contraception does not apply to participants with same sex partners, when this is their preferred and usual lifestyle
排除标准
- •Received more than 3 doses of Q-HPV vaccine
- •Received any doses of HPV9 vaccine
- •Systemic hypersensitivity to Q-HPV vaccine or HPV9 vaccine or severe reaction to any previous dose of Q-HPV vaccine.
- •Receipt of blood or blood product within 3 months prior to Visit
- •Receipt of a live vaccine within 28 days or an inactive vaccine within 14 days of Visit 1
- •Immune compromise resulting from disease or immunosuppressive systemic medication use within 3 months prior to Visit
- •Inadequate participant fluency in English to provide fully informed consent.
- •Participant who is currently pregnant or planning a pregnancy during the course of the trial
结局指标
主要结局
Plasmablast Response (% of All B Cells That Are Plasmablasts)
时间窗: 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
B Memory Cell Response (% of Memory B Cells That Are Antigen-specific)
时间窗: 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
次要结局
- Variable Gene Usage (Comparison of the Nucleotide Sequences of Antigen-specific Antibody Heavy and Light Chain Variable Region Sequences)(At Day 7 and Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine)
- Serum Antibody Response (Total IgG) - Geometric Mean Titer(At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine)
- Serum Antibody Response (cLIA) - Geometric Mean Titer(At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine)
研究者
Manish Sadarangani
Principal Investigator
University of British Columbia