Overview
Sponsor-declared trial summary
Immunosuppressed patients
To evaluate the immunogenicity of 9vHPV vaccine in immunocompromised children and adolescents. Seroconversion from baseline to month 7 following the three doses schedule recommended for children and adolescents (over 9 years of age) will be evaluated among vertically HIV-infected children and adolescents, SOT/HSCT reci…
Key facts
- Sponsor
- Hospital Universitario La Paz
- Participant type
- Pediatric, Healthy volunteers, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 7 Mar 2023 → ongoing
- Decision date (initial)
- 2022-09-29
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To evaluate the immunogenicity of 9vHPV vaccine in immunocompromised children and adolescents. Seroconversion from baseline to month 7 following the three doses schedule recommended for children and adolescents (over 9 years of age) will be evaluated among vertically HIV-infected children and adolescents, SOT/HSCT recipients and post-chemotherapy patients (PCT) and compared to healthy controls
Secondary objectives 2
- To identify markers of immune response (including age, CD4/CD8 ratio, TTV viral load), potential predictors to 9vHPV vaccine-immunogenicity.
- To generate a cohort of immunized immunosuppressed children and adolescents, candidates for future follow-up (extension phase) addressing duration of vaccine protection in this unique population.
Conditions and MedDRA coding
Immunosuppressed patients
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase 4, unicenter, open label study This is an open label, non-randomized study, addressing the efficacy of 9vHPV vaccine in immunocompromised children and adolescents above 9 years of age. All participants will be immunized according to the guidelines. The control group will be used as a reference for interpretation of antibody titers. Consecutive long-term follow up for up to 5 years will be offered, to address the duration of protection (extension phase).
|
2 | None | Immunosuppressed Group. Cohort 1: Immunosuppressed Group: N=90 Immunosuppressed patients, consisting of HIV-infected children and adolescents, hematopoietic stem cell transplant (HSCT) recipients, solid organ transplant (SOT) recipients and post-chemotherapy patients (PCT) under follow up at Hospital La Paz in Madrid Spain. Control Group. Cohort 2: Control Group: N=30 Healthy controls aged 9-14. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Children or adolescents 9 to <18 years of age
- Willing to sign consent/assent form
- If HIV positive, under ART and undetectable viral load and CD4 cell count >200/mm3 (at least 6 months)
- If the patient has received chemotherapy or is a SOT/HSCT recipient, referred for immunizations after adequate immune reconstitution according to routine clinical practice
Exclusion criteria 4
- Previous history of warts and/or anal cancer.
- Previous immunization with any HPV vaccine.
- Age below 9.
- Patients who for any reason should not be included in the study according to the evaluation of the research team.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Seroconversion of subjects from baseline to month 7 and 12 (anti HPV titers at baseline, month 7 and month 12).
Secondary endpoints 1
- Age, immunosuppression category (HIV, SOT, HSCT, PCT), CD4/CD8 ratio, specific T cell response, TTV viral load
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD7273288 · Product
- Active substance
- Human Papillomavirus Type 31 L1 Protein - Adsorbed - in the Form of Virus-Like Particles Produced in Yeast Cells (Saccharomyces Cerevisiae Canade 3C-5 (Strain 1895)) by Rdna
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 1.5 ml millilitre(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BM03 — -
- Marketing authorisation
- EU/1/15/1007/004
- MA holder
- MERCK SHARP & DOHME BV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Universitario La Paz
- Sponsor organisation
- Hospital Universitario La Paz
- Address
- Paseo Castellana 261
- City
- Madrid
- Postcode
- 28046
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Universitario La Paz
- Contact name
- Talía Sainz Costa
Public contact point
- Organisation
- Hospital Universitario La Paz
- Contact name
- Talía Sainz Costa
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Alcura Health Espana S.A. ORG-100020590
|
Viladecans, Spain | Other |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 126 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Spain | 2023-03-07 | 2023-04-18 | 2025-11-11 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-07-18 | Spain | Acceptable 2022-09-29
|
2022-09-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-01-31 | Spain | Acceptable 2022-09-29
|
2023-01-31 |