HEBERBIOVAC HB vaccine to reference material.

Evaluation in adults of the immunogenicity and reactogenicity of lot 5C0701/0 of the HEBERBIOVAC HB vaccine candidate for reference material.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000244

Enrollment

190

Registered

2017-04-30

Start date

2017-07-01

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

Prophylaxis of Hepatitis B virus infection.

Interventions

Group I (Experimental): Recombinant Hepatitis B vaccine, Heberbiovac HB. A single batch of the vaccine (Batch number 5C0701/0, CIGB, La Habana) containing 20µg HBsAg will be used: 1mL by intramuscular

Hepatitis B Vaccines

Viral Hepatitis Vaccines

Vaccines, Synthetic

HEBERBIOVAC HB Recombinant hepatitis B vaccine

Eligibility

Sex/Gender

All

Age

35 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Voluntariness of the subject through the signing of informed consent. 2. Age between 35 and 55 years. 3. Subjects of both sexes. 4. Do not present evidence of decompensated organic or psychiatric disease according to questioning and physical examination. 5. Women of childbearing age who use a contraceptive method and continue their use throughout the study. 6. Post-menopausal woman (with at least 2 years of amenorrhea) or documented history of hysterectomy and / or double annexectomy.

Exclusion criteria

Exclusion criteria: 1. History of Hepatitis B virus infection. 2. Positivity for Hepatitis B surface antigen (HBsAg +) or presence of antibodies against surface antigen (Anti-HBs). 3. Pregnancy, puerperium or breastfeeding. 4. Acute infection of any type requiring specific treatment. 5. Decompensated chronic diseases (High blood pressure, Diabetes mellitus, Chronic renal failure, Heart failure, Ischemic heart disease). 6. Severe allergic history (Urticaria, Atopic dermatitis, Severe bronchitis, Grade III or IV bronchial asthma). 7. Immunosuppressive treatment in the 6 months prior to inclusion in the study. 8. Allergy to Thiomersal or any component of the vaccine.

Design outcomes

Primary

Measure	Time frame
Seroprotection (defined as titers of anti-Hbs=10 IU / L). Measurement time: 30 days after the third dose (day 90).	—

Secondary

Measure	Time frame
Immunogenicity (seroprotection = 10 IU / L at day 60 of the immunization schedule and = 100 IU / L after the second and third doses administered). Measurement time: at 60 and 90 days after the start of the immunization schedule. Adverse clinical events-AE (Occurrence of AE (Yes, No) Description of AE (name of event) Intensity of AE (mild, moderate, severe). Measurement time: first 72 hours and at 30, 60 and 90 days of initiation of the immunization schedule.	—

Measure

Time frame

Immunogenicity (seroprotection = 10 IU / L at day 60 of the immunization schedule and = 100 IU / L after the second and third doses administered). Measurement time: at 60 and 90 days after the start of the immunization schedule. Adverse clinical events-AE (Occurrence of AE (Yes, No) Description of AE (name of event) Intensity of AE (mild, moderate, severe). Measurement time: first 72 hours and at 30, 60 and 90 days of initiation of the immunization schedule.

—

Countries

Cuba

Contacts

Public ContactNelvis Figueroa Baile

Center for Genetic Engineering and Biotechnology (CIGB).

nelvis.figueroa@cigb.edu.cu

Outcome results

None listed

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