VACCINATION ADJUVED AGAINST HEPATITIS B IN SACYL WORKERS TYPED AS NO RESPONDERS TO CONVENTIONAL VACCINES

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004991-23-ES

Enrollment

Registered

2017-05-29

Start date

2017-10-16

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health workers with biological risk in their tasks, who have been vaccinated as non-responders to conventional vaccination against Hepatitis B

Interventions

Pharmaceutical Form: Suspension for injection INN or Proposed INN: Antígeno de superficie del virus de la Hepatitis B Other descriptive name: HEPATITIS B SURFACE ANTIGE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Health workers in the Health Area of ??Salamanca, Zamora, Leon, Valladolid and Palencia Criteria defining them as NO responders to the conventional hepatitis B vaccine: anti HBsAb titers =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Known allergy to the active substance or any of the other ingredients of the medicinal product (included in section 6 of the product data sheet). If you have ever had an allergic reaction to any vaccine against hepatitis B If you have a serious infection with fever. Subjects for whom informed consent is not obtained Subjects that have not revoked the consent initially signed.

Design outcomes

Primary

Measure	Time frame
Main Objective: To benefit and equip SACYL staff with an additional protection tool against hepatitis B infection. To evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine ; Secondary Objective: To benefit and equip SACYL staff with an additional protection tool against hepatitis B infection. To evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine ;Primary end point(s): SACYL health workers with biological risk in their tasks who have been classified as non-responders to vaccination against Hepatitis B;Timepoint(s) of evaluation of this end point: Between 40 and 60 days after the last dose given	—

Measure

Time frame

Main Objective: To benefit and equip SACYL staff with an additional protection tool against hepatitis B infection. To evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine ; Secondary Objective: To benefit and equip SACYL staff with an additional protection tool against hepatitis B infection. To evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine ;Primary end point(s): SACYL health workers with biological risk in their tasks who have been classified as non-responders to vaccination against Hepatitis B;Timepoint(s) of evaluation of this end point: Between 40 and 60 days after the last dose given

—

Secondary

Measure	Time frame
Secondary end point(s): Analyze results of anti-HBs antibody titers to see the immune response to the adjuvanted vaccine. To evaluate safety results and clinical tolerance of the adjuvanted vaccine ; Timepoint(s) of evaluation of this end point: Al mes de la adminsitracion En el momento de la administración de la vacuna y durante el mes posterior	—

Countries

Spain

Contacts

Public Contactunidad de ensayos clinicos

IBSAL (INSTITUTO DE INVESTIGACION BIOMEDICA)

ensayosclinicos@ibsal.es0034923210960

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026