Human Papilloma Virus InfectionABSOP-FollowUpNCT03542227
Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine
An observational study of Human Papilloma Virus Infection, run by Universiteit Antwerpen at 1 site in Belgium.
Trial summary
The aim of the study is to develop and implement robust analytical protocols for first-void urine sample preparation and antibody assays to monitor vaccine induced immunity against HPV (Human Papillomavirus). Read more about this study
- Who is it for?
- Ages 16 to 55 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
- 63 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Dec 2017to 23 Jun 2022
- 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 16 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: In total 63 women are included in this trial. During their first two study visits, at day 0 and 7m post-vaccination, participants are asked to collect a first-void urine sample with the Colli-PeeTM device (n=63). During their third visit, the included women are asked to collect a third first-void urine sample with the Colli-PeeTM device (n = 58). Hereafter, a blood sample of 5-10 cc is collected. Following sample collection, women are asked to fill in a questionnaire (n=58).
Who may be able to join
- Participant of the HPV V503-004 study at UA/UZA
- Willing to give informed consent (ICF) to the CEV research team
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
university of Antwerp - centre for the evaluation of vaccination
Wilrijk, Antwerp, 2610
About this study
Official title: Study for the Development of Standard Operating Procedures for Anti-HPV Antibody Detection in First-void Urine: the AB-SOP Follow-up Study
The aim of the study is to develop and implement robust analytical protocols for first-void urine sample preparation and antibody assays to monitor vaccine induced immunity against HPV (Human Papillomavirus).
Read the detailed description
Participants of the HPV V503-004 study (Phase III Clinical trial vaccinating (young) adult women in Antwerp, EudraCT NUMBER: 2015-005093-38) will be asked if they are willing to provide two additional urine samples at day 1 and month 7 for biomedical research. Furthermore, they will be contacted again at approximately 3.5 years and asked if they are willing to provide an additional urine sample and a serum sample. At 3.5 years, they will also be asked to fill in a brief questionnaire. The collected urine will be used for the development and optimization of robust analytical protocols for sample preparation and antibody assays.
- Conditions
- Human Papilloma Virus Infection
- Being tested
- First-void urine collection, Blood draw
- Keywords
- Antibodies, Vaccination, Self-sampling, First-void urine, 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
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.
Blood drawOther
Also called Serum sample
Blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination.
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of HPV specific IgG (Immunoglobulin G) in FV urine.
To detect HPV specific IgG concentrations (ratio HPV specific IgG/total human IgG), in first-void urine from 63 women to monitor the immune response before and after vaccination with a prophylactic HPV vaccine (Gardasil9).
Measured: Within 6 months 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 posted31 May 2018
- Study start11 Dec 2017
- Primary completion11 Jan 2022
- Study completion23 Jun 2022
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 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 AntwerpenIlse De Coster, MD, Principal investigator, Universiteit AntwerpenWiebren A. A. Tjalma, Prof, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542227
- Sponsor's protocol ID
- B300201734258
- Acronym
- ABSOP-FollowUp
- Status last verified
- Nov 2022
- First submitted
- 18 May 2018
- Last updated
- 8 Nov 2022
- 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 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for the Development of Standard Operating Procedures for Anti-HPV Antibody Detection in First-void Urine: the AB-SOP Follow-up Study
- ClinicalTrials.gov ID
- NCT03542227
- Acronym / sponsor ID
- ABSOP-FollowUp / B300201734258
- Conditions
- Human Papilloma Virus Infection
- Keywords
- Antibodies, Vaccination, Self-sampling, First-void urine, HPV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 31 May 2018 (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 aim of the study is to develop and implement robust analytical protocols for first-void urine sample preparation and antibody assays to monitor vaccine induced immunity against HPV (Human Papillomavirus).
Detailed description
Participants of the HPV V503-004 study (Phase III Clinical trial vaccinating (young) adult women in Antwerp, EudraCT NUMBER: 2015-005093-38) will be asked if they are willing to provide two additional urine samples at day 1 and month 7 for biomedical research. Furthermore, they will be contacted again at approximately 3.5 years and asked if they are willing to provide an additional urine sample and a serum sample. At 3.5 years, they will also be asked to fill in a brief questionnaire. The collected urine will be used for the development and optimization of robust analytical protocols for sample preparation and antibody assays.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- In total 63 women are included in this trial. During their first two study visits, at day 0 and 7m post-vaccination, participants are asked to collect a first-void urine sample with the Colli-PeeTM device (n=63). During their third visit, the included women are asked to collect a third first-void urine sample with the Colli-PeeTM device (n = 58). Hereafter, a blood sample of 5-10 cc is collected. Following sample collection, women are asked to fill in a questionnaire (n=58).
Key inclusion criteria (2 listed)
- Participant of the HPV V503-004 study at UA/UZA
- Willing to give informed consent (ICF) to the CEV research team
Key exclusion criteria (0 listed)
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 urineCollection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) during visit at the Centre for the Evaluation of Vaccination. | Other | – |
| Blood drawAlso: Serum sampleBlood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination. | Other | – |
Primary outcome
Concentration of HPV specific IgG (Immunoglobulin G) in FV urine.
Time frame: Within 6 months after study completion
To detect HPV specific IgG concentrations (ratio HPV specific IgG/total human IgG), in first-void urine from 63 women to monitor the immune response before and after vaccination with a prophylactic HPV vaccine (Gardasil9).
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 8 Nov 2022.
- 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
Ilse De Coster, MD principal investigator
Universiteit Antwerpen
Wiebren A. A. Tjalma, Prof, MD, PhD principal investigator
University Hospital, Antwerp
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 2 inclusion and 0 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 8 Nov 2022. 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?
Concentration of HPV specific IgG (Immunoglobulin G) in FV urine. (time frame: Within 6 months 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 8 Nov 2022.