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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004991-23 | EudraCT Number | ||
| GRS1360/A/16 | Other Grant/Funding Number | G.R.Salud de Castilla y León, Junta CyL | |
| 17/1311 | Other Identifier | IBSAL (INSTITUTO DE INVESTIGACION BIOMEDICA DE SALAMANCA) |
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| Name | Class |
|---|---|
| Instituto de Investigación Biomédica de Salamanca | OTHER |
| Spanish Clinical Research Network - SCReN | NETWORK |
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Health workers with biological risk in their tasks, who have been vaccinated as non-responders to conventional vaccination against Hepatitis B. To provide Health workers-staff with an additional protection tool against hepatitis B infection. To evaluate the efficacy of the adjuvanted vaccine in healthy nonresponders to conventional hepatitis B vaccine.
An interventional, phase 4, single group assignment, without masking (open label), preventive clinical trial was carried out in health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B.
Methods: 67 health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B, were enrolled in the Clinical Trial. All participants were from 18 years up to 64 years old. The criteria defining them as non-responders to the conventional hepatitis B vaccine is anti HBsAb titers < 10 mUI/ml following the application of six doses of conventional vaccine at 20 lg doses (two complete guidelines). The objective of this study was to provide Health workersstaff with an additional protection tool against hepatitis B infection, and to evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fendrix | Experimental | The primary immunisation consists of 4 separate 0.5 ml doses of FENDRIX administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed). | Biological | The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Protective Levels of Antibodies After Treatment | Measurement of antibody antiHBs: before the first dose and a month after the administration of each dose. | Between 40 and 60 days after the last dose given |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose L. Bravo-Grande, MD PhD | IBSAL-Instituto de Investigación Biomédica de Salamanca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain | ||
| Complejo Asistencial Universitario de León |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33334613 | Derived | Bravo-Grande JL, Asuncion Blanco-Gonzalez M, de la Torre-Robles JM, Asmat-Inostrosa MP, Fernandez-Escribano M, Villalobos IM, Covadonga Caso-Pita M, Hervella-Ordonez M, Canibano Cimas LM, de la Fuente-Martin JM, Luisa Rodriguez de la Pinta M, Olivas JRB, Munoz-Ruiperez C, Alonso Lopez MA, Del Campo MT, Antonieta Ramirez Perez M, Sanchez-Arcilla I, Marzola-Payares M, Rescalvo-Santiago F, Paula-Ortiz M, Sanchez-Santos JM, Lopez-Perez R. Vaccination adjuvated against hepatitis B in Spanish National Healthcare System (SNS) workers typed as non-responders to conventional vaccines. Vaccine. 2021 Jan 15;39(3):554-563. doi: 10.1016/j.vaccine.2020.12.006. Epub 2020 Dec 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fendrix | The primary immunisation consists of 4 separate 0.5 ml doses of FENDRIX administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).: The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2018 |
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non-responders to conventional treatment of hepatitis B vaccination and consent to participate
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|
| León |
| 24080 |
| Spain |
| Hospital Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Complejo Asistencial Universitario de Palencia | Palencia | 34005 | Spain |
| Complejo Asistencial Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Clinico Universitario de Valladolid | Valladolid | 47003 | Spain |
| Complejo Asistencial de Zamora | Zamora | 49022 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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Subjects had to work in the SNS -including university students undertaking work placements in SNS health centres (subject to and limited by the specific regulations on health and safety in each autonomous region)- and be of working age.
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| ID | Title | Description |
|---|---|---|
| BG000 | Fendrix | The primary immunisation consists of 4 separate 0.5 ml doses of FENDRIX administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).: The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Protective Levels of Antibodies After Treatment | Measurement of antibody antiHBs: before the first dose and a month after the administration of each dose. | Posted | Count of Participants | Participants | Between 40 and 60 days after the last dose given |
|
|
|
1 year, 6 months
AE 32 SAE 0 Total 32
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fendrix | The primary immunisation consists of 4 separate 0.5 ml doses of FENDRIX administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).: The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule: 1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine | 0 | 67 | 0 | 67 | 29 | 67 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Puncture Zone Pain | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Diarrhea | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Paresthesia in the puncture area | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cramp | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Diverticulitis | General disorders | MedDRA 10.0 | Non-systematic Assessment |
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Number of possible participants from all hospitals were small. This resulted in the need to extend recruitment to additional centres in order to obtain an optimal study sample.
We also encountered a lack of information concerning staff who do not respond to vaccination.
We also encountered some isolated difficulties as regards organizing all trial visits and their dates for various reasons, including vacations and sick leave. It was resolved through study coordination.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ricardo López-Pérez, PhD. Study Coordinator and Manager of Clinical Trial | UICEC, Complejo Asistencial Universitario de Salamanca - Instituto de Investigación Biomédica de Salamanca (IBSAL), Plataforma SCReN, Salamanca, Spain | 923 291100 | 55779 | ricardo.lopez@scren.es |
| May 6, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2018 | Mar 25, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D006505 | Hepatitis |
| D006525 | Hepatitis, Viral, Human |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004275 | DNA, Ribosomal |
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D004247 | DNA |
| D009696 | Nucleic Acids |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|