Clinical trial NCT02968420: Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine
Official title: Long Term Immune Memory Responses to Human Papillomavirus (HPV) Vaccination Following 2 Verses 3 Doses of Quadrivalent HPV Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Human Papillomavirus
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Merck Canada Inc.
First posted: 2016-11-18
Enrollment: 18
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 1.
* 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 1.
* 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

Primary outcomes:
measure: B Memory Cell Response (% of Memory B Cells That Are Antigen-specific)
timeFrame: At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine
measure: Plasmablast Response (% of All B Cells That Are Plasmablasts)
timeFrame: At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine
Secondary outcomes:
measure: Variable Gene Usage (Comparison of the Nucleotide Sequences of Antigen-specific Antibody Heavy and Light Chain Variable Region Sequences)
timeFrame: At Day 7 and Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine
measure: Serum Antibody Response (cLIA) - Geometric Mean Titer
timeFrame: At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine
measure: Serum Antibody Response (cLIA) - Geometric Mean Titer
timeFrame: At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine
measure: Serum Antibody Response (Total IgG) - Geometric Mean Titer
timeFrame: At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine
measure: Serum Antibody Response (Total IgG) - Geometric Mean Titer
timeFrame: At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vaccine Evaluation Center, BC Children's Hospital Research Institute
state: British Columbia
Study officials:
affiliation: Vaccine Evaluation Center, University of British Columbia
name: Tobi Kollmann, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vaccine Evaluation Center, University of British Columbia
name: Manish Sadarangani, BM BCh DPhil
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olsson SE, Villa LL, Costa RL, Petta CA, Andrade RP, Malm C, Iversen OE, Hoye J, Steinwall M, Riis-Johannessen G, Andersson-Ellstrom A, Elfgren K, von Krogh G, Lehtinen M, Paavonen J, Tamms GM, Giacoletti K, Lupinacci L, Esser MT, Vuocolo SC, Saah AJ, Barr E. Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine. Vaccine. 2007 Jun 21;25(26):4931-9. doi: 10.1016/j.vaccine.2007.03.049. Epub 2007 Apr 20.