Effect of Tetanus-diphtheria vaccine in promotion of immune response against hepatitis B vaccine

Comparison of immune response to hepatitis B vaccine in simultaneous injections of Tetanus-diphtheria and B hepatitis vaccines with hepatitis B vaccine alone in Azahra staff having anti-HBs Ab lower than 100 IU/ml

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014051015999N2

Enrollment

280

Registered

2014-08-06

Start date

2013-02-14

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Hepatitis B. Chronic viral hepatitis

Interventions

Intervention 1: Intervention 1: This intervention was implemented by 40 microgram of rHBsAg produced by CUBA-SIA Company, while Tetanous-diphteria vaccine (Td [0.5ml of toxoid produced at Pasteur Ins

Prevention

Intervention 1: This intervention was implemented by 40 microgram of rHBsAg produced by CUBA-SIA Company, while Tetanous-diphteria vaccine (Td [0.5ml of toxoid produced at Pasteur Institute]) was si

Intervention 2: 40 microgram of recombinant HBsAg (rHBsAg) produced by CUBA-SIA company in months of 0, 1 and 6

Eligibility

Sex/Gender

All

Age

20 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Individuals being Hepatitis B Antigen (HBsAg) negative whilst they were vaccinated against B hepatitis and their antibody titers would be lower than 100 IU/ml. Lack of primary or acquired immune deficiency Exclusion criteria: Individuals will be excluded from the study and they will be treated if their status of hypersensitivity is recognized.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Hepatitis B Antibody titer. Timepoint: 1 and 6 months after vaccination. Method of measurement: By ELISA method.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoya Taleban

Isfahan University of Medical Sciences

r.taleban@med.mui.ac.ir+98 31 3792 2542

Outcome results

None listed

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