Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
730
Countries
1
Sites
1
HPV infection
To assess the direct effectiveness of vaccination with the bivalent HPV vaccine (Cervarix ®) against anal HPV-16/18 infections among men who have sex with men (MSM) aged 19-26 years who visit the Sexual Health Clinic (SHC) of Amsterdam.
Key facts
- Sponsor
- Geneeskundige En Gezondheidsdienst Amsterdam
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 6 Feb 2023 → ongoing
- Decision date (initial)
- 2023-01-27
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- GSK (GLAXOSMITHKLINE BIOLOGICALS SA)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess the direct effectiveness of vaccination with the bivalent HPV vaccine (Cervarix ®) against anal HPV-16/18 infections among men who have sex with men (MSM) aged 19-26 years who visit the Sexual Health Clinic (SHC) of Amsterdam.
Secondary objectives 5
- To assess the anal DNA prevalence and the seroprevalence of HPV-16/18 among MSM aged 19-26 years visiting the SHC and determinants of HPV-16/18 infection
- To assess the serologic response after vaccination, and factors affecting serological response
- To assess how VE is affected by age and number of lifetime sex partners
- To assess how HPV-16/18 anal positivity 24 months after start of vaccination is affected by HPV DNA status & HPV antibody status at the moment of vaccination
- To collect samples and data allowing to later estimate VE against type-specific penile and oral HPV infections among MSM aged 19-26 years
Conditions and MedDRA coding
HPV infection
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 14
- (Group 1, recruited at baseline) Being male and reporting sex with other men in preceding 6 months
- (Group 1, recruited at baseline) Age 19-26 years
- (Group 1, recruited at baseline) Attending the SHC in Amsterdam
- (Group 1, recruited at baseline) Accepting prophylactic HPV vaccination
- (Group 1, recruited at baseline) Planning to stay in or around Amsterdam over the next two years
- (Group 1, recruited at baseline) Willing and able to return for 1 subsequent visit for vaccination
- (Group 1, recruited at baseline) Willing and able to complete an online questionnaire at month 15
- (Group 1, recruited at baseline) Willing and able to return for a month 24 final study visit
- (Group 1, recruited at baseline) Providing informed consent
- (Group 2, recruited month 24) Being male and reporting sex with other men in the preceding 6 months
- (Group 2, recruited month 24) Age 21-28 years
- (Group 2, recruited month 24) Attending the Sexual Health Clinic in Amsterdam
- (Group 2, recruited month 24) Accepting hypothetically prophylactic HPV vaccination
- (Group 2, recruited month 24) Providing informed consent
Exclusion criteria 6
- (Group 1 & 2) Having been vaccinated with one or more doses of any of the HPV vaccines
- (Group 1 & 2) Not able to read/understand Dutch or English
- (Group 1 & 2) Previous enrolment in the study
- (Group 1 & 2) History of anal cancer or anal intraepithelial neoplasia (AIN)
- (Group 1 & 2) Unlikely to adhere to the study protocol
- (Group 1 & 2) Allergy to one or more components of the vaccine
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- We will conduct an observational study and compare anal HPV-16/18 prevalence between vaccinated and unvaccinated MSM attending the sexual health center (SHC). We will primarily measure HPV-16 and HPV-18 DNA positivity.
Secondary endpoints 2
- DNA HPV16/18 DNA positivity and HPV16/18 seropositivity
- HPV16/18 seropositivity 24 months post HPV vaccination
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD330183 · Product
- Active substance
- Human Papillomavirus Type 16 L1 Protein Adjuvanted by AS04 Adsorbed on Aluminium Hydroxide, Hydrated Produced on Baculovirus HI-5 RIX4446 Cells, Trichoplusia Ni. Derived
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1.5 ml millilitre(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- J07BM02 — -
- Marketing authorisation
- EU/1/07/419/012
- MA holder
- GLAXOSMITHKLINE BIOLOGICALS S.A.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Geneeskundige En Gezondheidsdienst Amsterdam
- Sponsor organisation
- Geneeskundige En Gezondheidsdienst Amsterdam
- Address
- Nieuwe Achtergracht 100
- City
- Amsterdam
- Postcode
- 1018 WT
- Country
- Netherlands
Scientific contact point
- Organisation
- Geneeskundige En Gezondheidsdienst Amsterdam
- Contact name
- Prof. dr. M.F. Schim van der Loeff
Public contact point
- Organisation
- Geneeskundige En Gezondheidsdienst Amsterdam
- Contact name
- Prof. dr. M.F. Schim van der Loeff
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 730 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Geneeskundige En Gezondheidsdienst Amsterdam
Infectious Diseases, Team Research, Nieuwe Achtergracht 100, 1018 WT, Amsterdam
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2023-02-06 | 2023-02-07 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-04 | Netherlands | Acceptable 2023-01-27
|
2023-01-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-05-17 | Netherlands | Acceptable 2023-01-27
|
2023-05-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-12-08 | Netherlands | Acceptable 2023-01-27
|
2023-12-08 |