Human Papilloma Virus InfectionPhase 4NCT05439083
Immunogenicity of 9-valent HPV Vaccine
A Phase 4 study testing 9-valent HPV vaccine in people with Human Papilloma Virus Infection, run by Talia Sainz Costa at 1 site in Spain.
Trial summary
Human papillomavirus (HPV) causes the most prevalent sexually transmitted infections in the world. The nonavalent HPV vaccine (9vHPV) provides protection against 9 high-risk HPV serotypes, responsible for causing approximately 90% of cervical and other HPV-related anogenital cancers, as well as 90% of genital warts. Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus Infection
- What is being tested?
- 9-valent HPV vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 7 Mar 2023to 1 Mar 2025
- Phase
- Phase 4
- 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 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La paz
Madrid, 28046
Talía Sainz Acosta, MD
About this study
Official title: Immunogenicity of 9-valent HPV Vaccine in Immunocompromised Children and Adolescents
Human papillomavirus (HPV) causes the most prevalent sexually transmitted infections in the world. The nonavalent HPV vaccine (9vHPV) provides protection against 9 high-risk HPV serotypes, responsible for causing approximately 90% of cervical and other HPV-related anogenital cancers, as well as 90% of genital warts. The risk of cancer is substantially increased among immunocompromised patients.
Although studies have demonstrated seroprotection among children and adolescents, boys and girls, with the 9vHPV vaccine, the immunogenicity of this vaccine has been poorly explored in immunocompromised children and adolescents (including transplant patients, and those infected with human immunodeficiency virus (HIV)). Several factors, including the immunological consequences of vertically acquired infection, immunosuppressive therapies and age, could lead to an increased risk of infection in children and adolescents who are immunocompromised. Lower immunogenicity in these populations. These children may have a poor response to vaccines and therefore require additional doses. Markers such as CD4/CD8 or torque teno virus (TTV) replication could be linked to immunogenicity and thus serve as predictors of efficacy for routine clinical practice.
- Conditions
- Human Papilloma Virus Infection
- Being tested
- 9-valent HPV vaccine
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9-valent HPV vaccineBiological
All participants will receive the immunization schedule according to guidelines: immunosuppressed patients will receive a three-dose schedule: 0.5 mL intramuscular injection of 9vHPV at entry plus an additional dose at month 2 and month 6. Healthy controls aged 9-14 years will receive a two-dose schedule: 0 and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Immunosuppressed Group | Experimental | 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.
9-valent HPV vaccine: three-dose schedule: Months 0-2-6. Receives: Biological: 9-valent HPV vaccine |
| Control Group | Other | N=30 Healthy controls aged 9-14 9-valent HPV vaccine: two-dose schedule: Months 0-6. Receives: Biological: 9-valent HPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion of subjects from baseline to month 7 (determined by serum anti-HPV antibody titers)
Percentage of subjects seroconverting from baseline to month 7
Measured: From baseline to month 7
Seroconversion of subjects from baseline to month 12 (determined by serum anti-HPV antibody titers)
Percentage of subjects maintaining antibody titers 12 months after immunization.
Measured: From baseline to month 12
Seroconversion of subjects from baseline to month 18 (determined by serum anti-HPV antibody titers)
Percentage of subjects maintaining antibody titers 18 months after immunization.
Measured: From baseline to month 18
Secondary outcomes (3)
Ratio of geometric mean serum antibody titers (GMTs)
GMTs from baseline to month 7
Measured: From baseline to month 7
Delta of geometric mean serum antibody titers
Delta of geometric mean serum antibody titers from 1 to 12 months after immunization.
Measured: From 1 to 12 months
Percentage of subjects seroconverting from baseline to month 7
Percentage of subjects seroconverting from baseline to month 7 in each of the study populations.
Measured: From baseline to month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start7 Mar 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of patients: 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: N=30 Healthy controls aged 9-14. Both groups receive the 9-valent HPV vaccine.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Talia Sainz Costa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Talia Sainz Costa, Instituto de Investigación Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439083
- Sponsor's protocol ID
- 19042021/22
- Status last verified
- Mar 2024
- First submitted
- 27 Jun 2022
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of 9-valent HPV Vaccine in Immunocompromised Children and Adolescents
- ClinicalTrials.gov ID
- NCT05439083
- Acronym / sponsor ID
- 19042021/22
- Conditions
- Human Papilloma Virus Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Talia Sainz CostaUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 30 Jun 2022 (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.
Human papillomavirus (HPV) causes the most prevalent sexually transmitted infections in the world. The nonavalent HPV vaccine (9vHPV) provides protection against 9 high-risk HPV serotypes, responsible for causing approximately 90% of cervical and other HPV-related anogenital cancers, as well as 90% of genital warts. The risk of cancer is substantially increased among immunocompromised patients.
Although studies have demonstrated seroprotection among children and adolescents, boys and girls, with the 9vHPV vaccine, the immunogenicity of this vaccine has been poorly explored in immunocompromised children and adolescents (including transplant patients, and those infected with human immunodeficiency virus (HIV)). Several factors, including the immunological consequences of vertically acquired infection, immunosuppressive therapies and age, could lead to an increased risk of infection in children and adolescents who are immunocompromised. Lower immunogenicity in these populations. These children may have a poor response to vaccines and therefore require additional doses. Markers such as CD4/CD8 or torque teno virus (TTV) replication could be linked to immunogenicity and thus serve as predictors of efficacy for routine clinical practice.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups of patients: 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: N=30 Healthy controls aged 9-14. Both groups receive the 9-valent HPV vaccine.
| Arm | Type | Receives |
|---|---|---|
| Immunosuppressed Group | Experimental | Biological: 9-valent HPV vaccineN=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. 9-valent HPV vaccine: three-dose schedule: Months 0-2-6. |
| Control Group | Other | Biological: 9-valent HPV vaccineN=30 Healthy controls aged 9-14 9-valent HPV vaccine: two-dose schedule: Months 0-6. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| 9-valent HPV vaccineAll participants will receive the immunization schedule according to guidelines: immunosuppressed patients will receive a three-dose schedule: 0.5 mL intramuscular injection of 9vHPV at entry plus an additional dose at month 2 and month 6. Healthy controls aged 9-14 years will receive a two-dose schedule: 0 and 6 months. | Biological | Control Group, Immunosuppressed Group |
Primary outcome
Seroconversion of subjects from baseline to month 7 (determined by serum anti-HPV antibody titers)
Time frame: From baseline to month 7
Percentage of subjects seroconverting from baseline to month 7
Seroconversion of subjects from baseline to month 12 (determined by serum anti-HPV antibody titers)
Time frame: From baseline to month 12
Percentage of subjects maintaining antibody titers 12 months after immunization.
Seroconversion of subjects from baseline to month 18 (determined by serum anti-HPV antibody titers)
Time frame: From baseline to month 18
Percentage of subjects maintaining antibody titers 18 months after immunization.
3 secondary outcomes
Ratio of geometric mean serum antibody titers (GMTs)
Time frame: From baseline to month 7
Delta of geometric mean serum antibody titers
Time frame: From 1 to 12 months
Percentage of subjects seroconverting from baseline to month 7
Time frame: From baseline to month 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
Related trials for Human Papilloma Virus Infection
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
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.
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 9-valent HPV vaccine in people with Human Papilloma Virus Infection, run by Talia Sainz Costa at 1 site in Spain.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Talia Saínz Costa (+ 34 91 727 74 43, talia.sainz@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion of subjects from baseline to month 7 (determined by serum anti-HPV antibody titers) (time frame: From baseline to month 7). The study lists 3 primary outcomes in all. 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 Mar 2024.