Human Papilloma Virus InfectionHPV-VACPLUSNCT04391647
Developing Methods to Investigate Additional Opportunities of HPV Vaccination by Using First-void Urine Samples
An observational study of Human Papilloma Virus Infection, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
The main objective of this study is to develop protocols using FV urine that investigate in vitro whether infectious virions can be neutralized by HPV vaccination. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus Infection
- What is being tested?
- First-void urine collection and Blood draw
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 11 May 2020to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: In total 50 women will be included in this trial. During their study visit, participants are asked to collect a first-void urine sample with the Colli-PeeTM device. Hereafter, a blood sample of 5-10 cc is collected. Following sample collection, women are asked to fill in a questionnaire. HPV positive women who gave their consent to be contacted with the results will later be again contacted and asked to provide additional FV urine samples every day during 2 weeks. Since this is a unique pilot study, no specific data exist for sample size calculation. However, the sample size is estimated based on HPV prevalence results from a surveillance study in Belgium. From the 50 participating women (age 18-25), we expect 20% to be HPV DNA positive.Taking possible dropouts into account, this will lead to approximately 5 HPV infected women to provide samples during 14 days. Ultimately, we will obtain 120 samples to be used to develop the intended protocols.
Who may be able to join
- Female
- 18-25 years of age
- Sexually active or has been sexually active in the past
- Cases (n=25): fully vaccinated women, i.e. receiving all necessary doses of the HPV vaccine (according to the KCE recommendations) able to prove their vaccination (brand and schedule) with an official document.
- Control group (n=25): women self-reported to be not previously vaccinated with a single dose of any prophylactic HPV vaccine available.
- Willing to give informed consent to the CEV research team.
- Giving consent to the research team (CEV) to contact his/her general practioner and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy (included in ICF)
Who cannot join
- Women participating in another clinical study at the same time of this study.
- Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the previous six months prior to study enrolment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing Methods to Investigate Additional Opportunities of HPV Vaccination, Including Control of Infection and Transmission, by Using a Cervicovaginal Human Sample, Collected by Urination (HPV-VACPLUS)
The main objective of this study is to develop protocols using FV urine that investigate in vitro whether infectious virions can be neutralized by HPV vaccination.
Read the detailed description
In total 50 women will be included in this trial whereof 25 fully vaccinated with a prophylactic HPV vaccine and 25 not vaccinated with a prophylactic HPV vaccine. These women will be asked to collect a first-void urine sample with the Colli-PeeTM device (Novosanis). Hereafter, a blood sample of 5-10 cc will be collected. HPV DNA positive women who gave their consent to be contacted with the results, will later be contacted again and asked to provide additional FV urine samples every day during 2 weeks. For this, urine collection devices (Colli-PeeTM, Novosanis) will be provided by postal mail. The collected urine samples (and blood sample as control for HPV antibodies) will be used for the development of protocols within this project.
- Conditions
- Human Papilloma Virus Infection
- Being tested
- First-void urine collection, Blood draw
- Keywords
- First-void urine, Self-sampling, Vaccination, Infectious virions, Neutralizing antibodies, HPV
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First-void urine collectionOther
Also called FV urine
- One time collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) during visit at the Centre for the Evaluation of Vaccination.
- IF HPV positive and the woman gave consent to be contacted again: Collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) each day during 14 days (n = 14)
Blood drawOther
- One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination.
| Study group | Role | What they receive |
|---|---|---|
| HPV vaccinated group | Women (18-25 years old) whom are previously fully vaccinated with the bivalent (Cervarix), quadrivalent (Gardasil) or nonavalent (Gardasil) prophylactic HPV vaccine.
No intervention/drug to be administered. Receives: Other: First-void urine collection; Other: Blood draw | |
| HPV unvaccinated group | Women (18-25 years old) whom are not previously vaccinated with the bivalent (Cervarix), quadrivalent (Gardasil) or nonavalent (Gardasil) prophylactic HPV vaccine.
No intervention/drug to be administered. Receives: Other: First-void urine collection; Other: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocols to investigate the neutralizing ability of HPV vaccine-induced antibodies
To develop protocols that investigate whether infectious HPV virions may be neutralized by HPV vaccine-induced antibodies, preventing autoinoculation and transmission to sexual partners.
Measured: Within 2 years after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start11 May 2020
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma Virus InfectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Van Damme, Universiteit Antwerpen
- Investigators
- Pierre Van Damme, Prof, MD, PhD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391647
- Sponsor's protocol ID
- B3002020000025
- Acronym
- HPV-VACPLUS
- Status last verified
- Sep 2021
- First submitted
- 12 May 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Methods to Investigate Additional Opportunities of HPV Vaccination, Including Control of Infection and Transmission, by Using a Cervicovaginal Human Sample, Collected by Urination (HPV-VACPLUS)
- ClinicalTrials.gov ID
- NCT04391647
- Acronym / sponsor ID
- HPV-VACPLUS / B3002020000025
- Conditions
- Human Papilloma Virus Infection
- Keywords
- First-void urine, Self-sampling, Vaccination, Infectious virions, Neutralizing antibodies, HPV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to develop protocols using FV urine that investigate in vitro whether infectious virions can be neutralized by HPV vaccination.
Detailed description
In total 50 women will be included in this trial whereof 25 fully vaccinated with a prophylactic HPV vaccine and 25 not vaccinated with a prophylactic HPV vaccine. These women will be asked to collect a first-void urine sample with the Colli-PeeTM device (Novosanis). Hereafter, a blood sample of 5-10 cc will be collected. HPV DNA positive women who gave their consent to be contacted with the results, will later be contacted again and asked to provide additional FV urine samples every day during 2 weeks. For this, urine collection devices (Colli-PeeTM, Novosanis) will be provided by postal mail. The collected urine samples (and blood sample as control for HPV antibodies) will be used for the development of protocols within this project.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPV vaccinated group | – | Other: First-void urine collection, Other: Blood drawWomen (18-25 years old) whom are previously fully vaccinated with the bivalent (Cervarix), quadrivalent (Gardasil) or nonavalent (Gardasil) prophylactic HPV vaccine. No intervention/drug to be administered. |
| HPV unvaccinated group | – | Other: First-void urine collection, Other: Blood drawWomen (18-25 years old) whom are not previously vaccinated with the bivalent (Cervarix), quadrivalent (Gardasil) or nonavalent (Gardasil) prophylactic HPV vaccine. No intervention/drug to be administered. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- In total 50 women will be included in this trial. During their study visit, participants are asked to collect a first-void urine sample with the Colli-PeeTM device. Hereafter, a blood sample of 5-10 cc is collected. Following sample collection, women are asked to fill in a questionnaire. HPV positive women who gave their consent to be contacted with the results will later be again contacted and asked to provide additional FV urine samples every day during 2 weeks. Since this is a unique pilot study, no specific data exist for sample size calculation. However, the sample size is estimated based on HPV prevalence results from a surveillance study in Belgium. From the 50 participating women (age 18-25), we expect 20% to be HPV DNA positive.Taking possible dropouts into account, this will lead to approximately 5 HPV infected women to provide samples during 14 days. Ultimately, we will obtain 120 samples to be used to develop the intended protocols.
Key inclusion criteria (7 listed)
- Female
- 18-25 years of age
- Sexually active or has been sexually active in the past
- Cases (n=25): fully vaccinated women, i.e. receiving all necessary doses of the HPV vaccine (according to the KCE recommendations) able to prove their vaccination (brand and schedule) with an official document.
- Control group (n=25): women self-reported to be not previously vaccinated with a single dose of any prophylactic HPV vaccine available.
Key exclusion criteria (2 listed)
- Women participating in another clinical study at the same time of this study.
- Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the previous six months prior to study enrolment.
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 |
|---|---|---|
| First-void urine collectionAlso: FV urine* One time collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) during visit at the Centre for the Evaluation of Vaccination. * IF HPV positive and the woman gave consent to be contacted again: Collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) each day during 14 days (n = 14) | Other | HPV unvaccinated group, HPV vaccinated group |
| Blood draw- One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination. | Other | HPV unvaccinated group, HPV vaccinated group |
Primary outcome
Protocols to investigate the neutralizing ability of HPV vaccine-induced antibodies
Time frame: Within 2 years after study completion
To develop protocols that investigate whether infectious HPV virions may be neutralized by HPV vaccine-induced antibodies, preventing autoinoculation and transmission to sexual partners.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Pierre Van Damme, Prof, MD, PhD principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papilloma Virus Infection, run by Universiteit Antwerpen at 1 site in Belgium.
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 7 inclusion and 2 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 29 Sep 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 Belgium. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Protocols to investigate the neutralizing ability of HPV vaccine-induced antibodies (time frame: Within 2 years after study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2021.