Safety and immunogenicity of commercial Hepatitis B vaccines.

“Comparative immunogenicity and reactogenicity of Heberbiovac-HB and three commercial recombinant hepatitis B vaccines in healthy adults”.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000031

Enrollment

400

Registered

2009-02-27

Start date

2004-03-31

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Hepatitis B (Prevention).

Interventions

Volunteers were assigned (ratio 1:1:1:1) to one of the four treatment groups (recombinant hepatitis B vaccines): one cuban (Heberbiovac HB, CIGB, Havana), two Korean vaccines (Euvax-B, LG Chemical Ltd

Hepatitis B Vaccines

Vaccines, Synthetic

Injections, Intramuscular

Heberbiovac-HB, Engerix-B, Euvax-B, Hepavax-Gene

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1.Healthy adults from both sexes. 2.Age range: 18 until 45 years old. 3.Current use of contraceptive method for women of fertile age. 4.Written informed consent obtained.

Exclusion criteria

Exclusion criteria: 1.Known history of infection with hepatitis B or present antibodies surface antigen (antiHBs) prior to the inclusion (including pre-vaccination anti-hepatitis B). 2.Positive for surface antigen of hepatitis B (HBsAg +). 3.Underlying immunosuppressive disease, ingestion of current immunosuppressive drugs (including steroids) or in the six months prior to study. 4.People who are decompensated chronic diseases (hypertension, diabetes mellitus, renal failure, heart failure, hyperthyroidism, malignancy, epilepsy, etc.). Or suffer from any autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, diabetes mellitus type 1 , etc). 5.Persons with a severe allergy (asthma grade III or IV, hives, dermatitis, bronchitis, etc). 6.Thiomersal allergy or any of the components of the vaccine. 7.Pregnancy and lactancy.

Design outcomes

Primary

Measure	Time frame
Immunogenicity (seroprotection percentage [antiHBs=10 UI/L], hyper-responders [antiHBs=1000UI/L] and geometric mean titers of anti-HBs [antiHBs GMT] at 60 and 90-days postvaccination).	—

Secondary

Measure	Time frame
Reactogenicity, adverse events rate in each dose (first 72 hours), 7 and 30 days post-vaccination.	—

Countries

Cuba

Contacts

Public ContactAristides Aguilar Betancourt

Center for Genetic Engineering and Biothecnology (CIGB)

aristides.aguilar@cigb.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026