A Phase 4 interventional study of Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed). in Hepatitis B, Hepatitis and Hepatitis, Viral, Human, sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León. Completed at 11 sites in Spain. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-08.
Sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · Phase 4, Interventional, and Prevention
Among 47 studies in Hepatitis B with a site in Spain — 2 open to participants now, 6 under way, none of them phase 3. Hepatitis B · Spain.
Among the 47 studies in Hepatitis B with a site in Spain, this one is the 30th largest by enrollment of the 35 interventional ones that give a count, is one of 2 that started in 2018, is one of 5 in phase 4, and was the 31st registered.
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's enrollment of 67 is below the median of 147 across 756 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →2 of the 47 studies in Hepatitis B with a site in Spain are open now.
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 79 Hepatitis B studies recruiting now, 40 (51%) set no upper age limit and 34 (43%) stop at 75 or younger; 13 take children under 18; 19 take healthy volunteers.
This study: 18 Years to 64 Years · all sexes · healthy volunteers too.
The full table on the hub →47 studies; the count open now beside each. This study's row is marked.
First in 1994; this study’s year is marked. 2 started in 2018.
Median enrollment 200 across the 35 interventional studies, 1,001 across the 9 observational. Of the 40 that completed or were terminated, 15 (38%) have results posted.
32 of 47 have an industry lead sponsor. The 10 most frequent:
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León has 1 study filed under Hepatitis B — fewer than ten, so there is no comparison to draw.
4 of the studies in Hepatitis B with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06963710Aligos TherapeuticsA Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME) | 2027-03 |
| NCT06497504GlaxoSmithKlineStudy of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus) | 2027-04-22 |
| NCT07654283AusperBio Therapeutics Inc.Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions | 2027-05-11 |
| NCT06537414GlaxoSmithKlineA Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB) | 2027-05-31 |
Among the 47 studies in Hepatitis B with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Biological: 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
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.
Time frame: Between 40 and 60 days after the last dose given
| Milestone | Fendrix |
|---|---|
| Started | 67 |
| Completed | 67 |
| Not completed | 0 |
Measurement of antibody antiHBs: before the first dose and a month after the administration of each dose.
| Participants | Fendrix |
|---|---|
| Positive | 63 |
| Negative | 4 |
Collected over 1 year, 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fendrix | 0/67 (0%) | 0/67 (0%) | 29/67 (43.3%) |
| Event | Fendrix |
|---|---|
| Puncture Zone PainSkin and subcutaneous tissue disorders | 19/67 |
| DiscomfortGeneral disorders | 4/67 |
| FatigueGeneral disorders | 3/67 |
| DiarrheaGeneral disorders | 2/67 |
| Paresthesia in the puncture areaGeneral disorders | 2/67 |
| CrampGeneral disorders | 1/67 |
| DiverticulitisGeneral disorders | 1/67 |
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.
| Age, Categorical(Participants) | Fendrix |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 67 |
| >=65 years | 0 |
| Age, Continuous(years) | Fendrix |
|---|---|
| Mean | 49.46 ± 11.77 |
| Sex: Female, Male(Participants) | Fendrix |
|---|---|
| Female | 47 |
| Male | 20 |
| Race (NIH/OMB)(Participants) | Fendrix |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 67 |
| Region of Enrollment(participants) | Fendrix |
|---|---|
| Spain | 67 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2018 to primary completion in Oct 2019, 18 months.
Results were first posted in Jul 2021, 1 year 8 months after primary completion.
Of 47 non-industry phase 4 interventional studies under Hepatitis B, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 66. This study's 18 months is below that.
Counting every sponsor, half of 63 studies reached it within 35 months; a quarter within 12 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León