Clinical Trial Heberbiovac HB vaccine Material Reference Batch

A randomised, open and controlled clinical study to evaluate the reactogenicity, tolerance and immunogenicity profile of 7C671/1 Heberbiovac HB standard vaccine batch candidate in healthy adult volunteers.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000109

Enrollment

246

Registered

2011-05-16

Start date

2009-10-20

Completion date

Unknown

Last updated

2026-08-10

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

Conditions

Hepatitis B prophylaxis

Interventions

Group I: The Heberbiovac HB vaccine experimental lot (7C671/1) by the intramuscular route, schedule 0-1-2 months and 20µg/mL HBsAg per dose Group II: The Heberbiovac HB vaccine control batch (7C141/0)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Apparently healthy subjects, both sexes. 2) Age from 18 up to 65 years old. 3) Current contraceptive device use for women on reproductive age or not planning a pregnancy in the forthcoming six month after enrollment in the trial. 4) Signing of the written inform consent act.

Exclusion criteria

Exclusion criteria: 1) History of viral hepatitis type B or previous vaccination against Hepatitis B. 2) Seropositivity for HBsAg (HBsAg+) 3) Underlying immunosuppressive disease, current intake of immunosuppressor drugs (including steroids) in the six month period prior to study entry. 4) Non-controlled Chronic diseases (eg. Arterial hypertension, Diabetes mellitus, renal failure, heart failure, hyper-thiroidism, malignant neoplasia, epilepsy, etc), autoimmune disease (Systemic lupus erithematosus, rheumatoid arthritis, Multiple sclerosis, Type 1 Diabetes Mellitus, etc.) 5) Feverish states (>37.5°C) at the moment of each vaccination visit 6) History of severe allergy (Asthma Grade III or IV, urtycaria, Dermatitis, Bronchitis, etc.). 7) History of thiomersal allergy or allergy to any component of the vaccine. 8) Pregnancy or breastfeeding.

Design outcomes

Primary

Measure	Time frame
Seroprotection percentage (+ de 10 UI of AntiHBs antibodies). Measuring time: 90 days after the administration of the first vaccine dose. Hyper-responder rate (+ de 1000 UI, Yes/No). Measuring time: 90 days after the administration of the first vaccine dose. antiHBs GMT. Measuring time: 90 days after the administration of the first vaccine dose.	—

Secondary

Measure	Time frame
Local and systemic adverse events, within 72 hours, and at 7 and 30 days after vaccination in each dose.	—

Countries

Cuba

Contacts

Public ContactDr. Arístides Aguilar Betancourt

Center for Genetic Engineering and Biotechnology (CIGB).

aristides.aguilar@cigb.edu.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026