Trial Outcomes & Findings for Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines (NCT NCT03410953)

NCT ID: NCT03410953

Last Updated: 2021-07-08

Results Overview

Measurement of antibody antiHBs: before the first dose and a month after the administration of each dose.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 67 participants
• Primary outcome timeframe: Between 40 and 60 days after the last dose given
• Results posted on: 2021-07-08

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	67
Overall Study COMPLETED	67
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines

Baseline characteristics by cohort

Measure	Fendrix n=67 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	67 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	49.46 years STANDARD_DEVIATION 11.77 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	67 Participants n=5 Participants
Region of Enrollment Spain	67 participants n=5 Participants

PRIMARY outcome

Timeframe: Between 40 and 60 days after the last dose given

Measurement of antibody antiHBs: before the first dose and a month after the administration of each dose.

Outcome measures

Measure	Fendrix n=67 Participants 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
Number of Participants With Protective Levels of Antibodies After Treatment Positive	63 Participants
Number of Participants With Protective Levels of Antibodies After Treatment Negative	4 Participants

Adverse Events

Fendrix

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fendrix n=67 participants at risk 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
Skin and subcutaneous tissue disorders Puncture Zone Pain	28.4% 19/67 • 1 year, 6 months AE 32 SAE 0 Total 32
General disorders Discomfort	6.0% 4/67 • 1 year, 6 months AE 32 SAE 0 Total 32
General disorders Fatigue	4.5% 3/67 • 1 year, 6 months AE 32 SAE 0 Total 32
General disorders Diarrhea	3.0% 2/67 • 1 year, 6 months AE 32 SAE 0 Total 32
General disorders Paresthesia in the puncture area	3.0% 2/67 • 1 year, 6 months AE 32 SAE 0 Total 32
General disorders Cramp	1.5% 1/67 • 1 year, 6 months AE 32 SAE 0 Total 32
General disorders Diverticulitis	1.5% 1/67 • 1 year, 6 months AE 32 SAE 0 Total 32

Additional Information

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

Phone: 923 291100

Email: ricardo.lopez@scren.es

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place