Human PapillomavirusPhase 4Merck08NCT02968420
Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine
A Phase 4 study testing Human Papillomavirus 9-valent Vaccine, Recombinant in people with Human Papillomavirus, run by University of British Columbia at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus
- What is being tested?
- Human Papillomavirus 9-valent Vaccine, Recombinant
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 11 Sep 2017to 15 May 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vaccine Evaluation Center, BC Children's Hospital Research Institute
Vancouver, British Columbia, V5Z 4H4
About this study
Official title: Long Term Immune Memory Responses to Human Papillomavirus (HPV) Vaccination Following 2 Verses 3 Doses of Quadrivalent HPV Vaccine
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.
Read the 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.
- Conditions
- Human Papillomavirus
- Being tested
- Human Papillomavirus 9-valent Vaccine, Recombinant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Papillomavirus 9-valent Vaccine, RecombinantBiological
Also called Gardasil9
All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Human Papillomavirus 9-valent Vaccine, Recombinant |
| 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. Receives: Biological: Human Papillomavirus 9-valent Vaccine, Recombinant |
| 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. Receives: Biological: Human Papillomavirus 9-valent Vaccine, Recombinant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start11 Sep 2017
- Primary completion15 May 2019
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human PapillomavirusStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Canada Inc.
- Responsible party
- Principal investigator, Manish Sadarangani, University of British Columbia
- Investigators
- Tobi Kollmann, MD PhD, Principal investigator, Vaccine Evaluation Center, University of British ColumbiaManish Sadarangani, BM BCh DPhil, Principal investigator, Vaccine Evaluation Center, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968420
- Sponsor's protocol ID
- H16-00700
- Acronym
- Merck08
- Status last verified
- Jun 2021
- First submitted
- 19 Aug 2016
- Last updated
- 25 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 17499406Carter 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.
PubMed 39914257
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Immune Memory Responses to Human Papillomavirus (HPV) Vaccination Following 2 Verses 3 Doses of Quadrivalent HPV Vaccine
- ClinicalTrials.gov ID
- NCT02968420
- Acronym / sponsor ID
- Merck08 / H16-00700
- Conditions
- Human Papillomavirus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Merck Canada Inc.
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Posted 25 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Biological: Human Papillomavirus 9-valent Vaccine, RecombinantGroup 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 | Biological: Human Papillomavirus 9-valent Vaccine, RecombinantGroup 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 | Biological: Human Papillomavirus 9-valent Vaccine, RecombinantGroup 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. |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Papillomavirus 9-valent Vaccine, RecombinantAlso: Gardasil9All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study. | Biological | Group 1, Group 2, Group 3 |
Primary outcome
B Memory Cell Response (% of Memory B Cells That Are Antigen-specific)
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
Plasmablast Response (% of All B Cells That Are Plasmablasts)
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
5 secondary outcomes
Variable Gene Usage (Comparison of the Nucleotide Sequences of Antigen-specific Antibody Heavy and Light Chain Variable Region Sequences)
Time frame: At Day 7 and Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine
Serum Antibody Response (cLIA) - Geometric Mean Titer
Time frame: At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine
Serum Antibody Response (cLIA) - Geometric Mean Titer
Time frame: At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine
Serum Antibody Response (Total IgG) - Geometric Mean Titer
Time frame: At Day 7 post challenge dose of Human Papillomavirus 9-Valent vaccine
Serum Antibody Response (Total IgG) - Geometric Mean Titer
Time frame: At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17499406Olsson 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.
- Derived from this study: PubMed 39914257Carter 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobi Kollmann, MD PhD principal investigator
Vaccine Evaluation Center, University of British Columbia
Manish Sadarangani, BM BCh DPhil principal investigator
Vaccine Evaluation Center, University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Human Papillomavirus 9-valent Vaccine, Recombinant in people with Human Papillomavirus, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
B Memory Cell Response (% of Memory B Cells That Are Antigen-specific) (time frame: At Day 30 post challenge dose of Human Papillomavirus 9-Valent vaccine). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02968420, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.