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| Name | Class |
|---|---|
| Merck Canada Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study. |
|
| Group 2 | Active Comparator | Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study. |
|
| Group 3 | Active Comparator | Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Papillomavirus 9-valent Vaccine, Recombinant | Biological | All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At Day 7 and Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobi Kollmann, MD PhD | Vaccine Evaluation Center, University of British Columbia | Principal Investigator |
| Manish Sadarangani, BM BCh DPhil | Vaccine Evaluation Center, University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vaccine Evaluation Center, BC Children's Hospital Research Institute | Vancouver | British Columbia | V5Z 4H4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17499406 | Background | 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. | |
| 39914257 |
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If IPD is required, please contact the study team for further discussions- any sharing will be dependent on alignment with original informed consent obtained from study participants and in agreement with the study team.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study. Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study. |
| FG001 | Group 2 | Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study. Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study. |
| FG002 | Group 3 | Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study. Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study. Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | % of memory B cells that are Ag-specific | At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine |
|
Adverse events were collected at Day 7 (+/-1) and Day 30 (+/-3) following booster dose.
Provincially reportable and serious adverse events only were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Group 1: girls who received 2 doses of Q-HPV vaccine at 0, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study. Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Manish Sadarangani | Vaccine Evaluation Center | 604-875-2422 | msadarangani@bcchr.ubc.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 19, 2017 | Jan 6, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 15, 2019 | Jun 23, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000634046 | Human Papillomavirus Recombinant Vaccine nonavalent |
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|
| 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 | 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 | At Day 30 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 | 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 | At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine |
| Derived |
| Carter JJ, Smith RA, Scherer EM, Skibinski DAG, Sankaranarayanan S, Luxembourg A, Kollmann T, Marty KD, Sadarangani M, Dobson S, Galloway DA. Term immune memory responses to human papillomavirus (HPV) vaccination following 2 versus 3 doses of HPV vaccine. Vaccine. 2025 Mar 19;50:126817. doi: 10.1016/j.vaccine.2025.126817. Epub 2025 Feb 5. |
| BG001 | Group 2 | Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study. Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study. |
| BG002 | Group 3 | Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study. Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | Kg/m^2 |
|
| OG001 |
| Group 2 |
Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study. Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study. |
| OG002 | Group 3 | Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study. Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study. |
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | % of all B cells that are plasmablasts | At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine |
|
|
|
| Secondary | 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 | The extent of somatic hypermutation was planned by comparing the nucleotide sequences of the heavy and light chain variable region sequences of each antibody cloned in this study to germ line sequences of these genes in public databases. This was not possible due to insufficient quality of DNA for sequencing. | Posted | At Day 7 and Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine |
|
|
| Secondary | 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 | Posted | Geometric Mean | 95% Confidence Interval | antibody titer | At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine |
|
|
|
| Secondary | 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 | Posted | Geometric Mean | 95% Confidence Interval | antibody titer | At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine |
|
|
|
| Secondary | 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 | Posted | Geometric Mean | 95% Confidence Interval | antibody titer | At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine |
|
|
|
| Secondary | 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 | Posted | Geometric Mean | 95% Confidence Interval | antibody titer | At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine |
|
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|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Group 2 | Group 2: girls who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 9-13 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study. Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Group 3 | Group 3: young women who received 3 doses of Q-HPV vaccine at 0, 2, 6 month schedule 8-10 years ago when they were between 16-26 years of age at the time of the first dose. The intervention of a single dose of licensed Gardasil 9 vaccine (Human Papillomavirus 9-valent Vaccine, Recombinant) will be administered at Day 0 of the study. Human Papillomavirus 9-valent Vaccine, Recombinant: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study. | 0 | 6 | 0 | 6 | 0 | 6 |
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| HPV16 |
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| HPV18 |
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| HPV16 |
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| HPV18 |
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| HPV16 |
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| HPV18 |
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| HPV16 |
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| HPV18 |
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