HeberNasvac in chronic hepatitis B viral infection in adult patients. Routine clinical practice study

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Evaluation of adherence, effectiveness, quality of life, and safety in patients with chronic HBV infection treated with HeberNasvac®. Routine clinical practice study

Secondary indentifying numbers:

MRN-01-25

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

National Science, Technology and Innovation Program PNCT-2026 / BioCubaFarma

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Trials notification

Regulatory instance:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Yusimik

Last name:

Roman Martinez

Medical Specialty :

First-Degree Specialist in Gastroenterology and Comprehensive General Medicine

Affiliation:

Institute of Gastroenterology (IGE)

Postal address:

Calle 25 entre H e I. Vedado, Plaza de la Revolucion

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78315600

+53-78325594 ext. 145

+53-78325595 ext. 145

+53-78325596 ext. 145

Email address:

yrmtnez@gmail.com [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, “Dr. Salvador Allende” Teaching Clinical-Surgical Hospital, Daniel Bejottes Ramirez, MD., First-Degree Specialist in Gastroenterology and Comprehensive General Medicine

Pinar del Río, “Abel Santamaría Cuadrado” Teaching General Hospital, Jessica Madera Delgado, MD., First-Degree Specialist in Gastroenterology

Artemisa, “Ivan Portuondo” Teaching General Hospital, Harlim Rodriguez Rodriguez, MD., Specialist in Gastroenterology

Matanzas, “Comandante Faustino Perez Hernandez” Clinical and Surgical University Hospital, Maria Amelia Breckford Caraballo, MD., First-Degree Specialist in Comprehensive General Medicine and Gastroenterology

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

12/01/2026

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Chronic Hepatitis B virus infection

Intervention(s):

HeberNasVac Group (experimental): Two treatment cycles will be administered according to the therapeutic vaccine’s product leaflet. In the first cycle, a 1.0 mL dose of HeberNasvac® intranasal per dispersible syringe will be administered every two weeks until completing 5 doses (weeks 0, 2, 4, 6, and 8). In the second cycle, which will be administered four weeks after the first cycle, a 1.0 mL dose of HeberNasvac® intranasal per dispersible syringe will be administered simultaneously with a 1.0 mL dose of HeberNasvac® subcutaneously. In this cycle, five doses of the combination will be administered every two weeks (weeks 12, 14, 16, 18, and 20) until completing week 20. Delays of up to 1 month between each administration are permitted. It allows the recovery of missed doses and continue of the scheme´s defined time intervals.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1. Treatment adherence (Good adherence: 80% or more of administrations, Fair adherence: Between 60% and 70% of administrations, Poor adherence: 50% or less administrations). Measurement time: At the end of treatment. 2. Percentage of HBsAg loss or reduction (Percentage of patients with HBsAg loss or reduction. Values will be recorded according to the established unit (IU/ml)). Measurement time: At baseline, at six months, at one year, and annually for up to 5 years.

Key secondary outcomes:

1. Quality of Life (Chronic Liver Disease Questionnaire, CLDQ). Measurement time: At baseline and, one year after. 2. Percentage of patients with HBV DNA below the limit of detection (Values will be recorded according to the established unit (IU/mL)). Measurement time points: At baseline, at six months, at one year, and annually up to five years. 3. Percentage of HBeAg and/or HBsAg loss and/or seroconversion (HBeAg: Positive or negative (dichotomous response); anti-HBeAg: Positive or negative (dichotomous response); anti-HBs: Positive or negative (dichotomous response)). Measurement time: At baseline, at six months, at one year, and annually up to five years. 4. Mean Logarithmic Reduction of HBV DNA (Values will be recorded according to the established unit (IU/mL)). Measurement time: At baseline, at six months, at one year, and annually up to five years. 5. Biochemical response defined by sustained normalization of ALT (Values will be recorded using the established unit (U/L), categorized as: normal, abnormal not clinically significant, abnormal clinically significant, and not performed, according to the defined normal reference ranges). Measurement time: At baseline, at six months, at one year, and annually up to five years. 6. Response to liver fibrosis (APRI (Relationship between ASAT levels and platelet count) and FIB-4 (Calculated from age, platelet count and ASAT and ALAT levels) indices; Transient elastography (Fibroscan). Results are reported in kPa. The degree of fibrosis will be determined from F0 to F4, taking into account the results obtained by each of the methods evaluated. F4 being the exclusion criterion for the inclusion of the patient in the study). Measurement time: At baseline, at six months, at one year, and annually up to five years. 7. Adverse Events –AE (Adverse events occurring during the study will be recorded, including those related to findings from the physical examination. It will measure: Occurrence of any AE(yes/no); Description of the AE (Name of the adverse event); Duration of the AE (Difference in dates between onset and resolution); Intensity of the AE (Mild, Moderate, Severe); Severity of the AE (Serious, Not serious); Action taken regarding the investigational treatment (No change, Dose modification, Temporary interruption, Permanent discontinuation); Outcome of the AE (Recovered, Improved, Ongoing, With squeals); Causality relationship (Very likely; Likely Possible; Unlikely; Not related; Not assessable)). Measurement time: From the treatment started until 30 days after the last immunization.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

Inclusion criteria:

1. Patients with chronic hepatitis B (defined as being HBsAg seropositive for a minimum of 6 months), of either sex, and aged ≥19 years. 2. Patients who express their willingness to participate in the research by signing an informed consent form.

Exclusion criteria:

1. Patients with clinical evidence or suspicion of hepatocellular carcinoma and/or liver cirrhosis based on ultrasound and elastography (≥18kPa). 2. Patients with a history of decompensated liver or kidney transplants, or who are receiving hemodialysis treatment. 3. Patients with chronic autoimmune and oncohematological diseases. 4. Patients with fever, acute illnesses, or decompensated chronic illnesses. 5. Patients with ALAT or ASAT enzyme levels above 500 IU/L. 6. Patients being treated with another investigational product. 7. Patients with acute allergic conditions or a history of severe allergic reactions, or with a known hypersensitivity to any component of the vaccine. 8. Pregnant patients. 9. Patients with mental and/or psychiatric disorders that make it difficult to collect information, their treatment, or follow up their progress.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

Target sample size:

500

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Maria

Middle Name:

Acelia

Last Name:

Marrero Miragaya

Specialty:

Second-degree specialist in general surgery. Doctor of Medical Sciences

Affiliation:

National Coordinating Center for Clinical Trials (Cencec)

Postal Address:

5ta A e/ 60 y 62, Miramar, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72164221

Email :

acelia@cencec.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Maria

Middle Name:

Acelia

Last Name:

Marrero Miragaya

Specialty:

Second-degree specialist in general surgery. Doctor of Medical Sciences.

Affiliation:

National Coordinating Center for Clinical Trials (Cencec)

Postal Address:

5ta A e/ 60 y 62, Miramar, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72164221

Email :

acelia@cencec.sld.cu [2]

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Institute of Gastroenterology

Dr. Salvador Allende Teaching Clinical-Surgical Hospital

Abel Santamaria Cuadrado Teaching General Hospital

Ivan Portuondo Teaching General Hospital

Comandante Faustino Perez Hernandez Clinical and Surgical University Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

11/11/2025

09/10/2025

24/10/2025

11/11/2025

27/10/2025

Postal address of Ethic Committee :

Calle 25 entre H e I. Vedado, Plaza de la Revolucion, ZC: 10400. Havana, Cuba

Calzada del Cerro 1551 esq. Domínguez. Cerro. ZC:12000. Havana, Cuba

Km 89 Carretera Central. ZC:20200. Pinar del Rio, Cuba

Calle 78 s/n, entre 33 y 37, San Antonio de los Baños. Artemisa, Cuba

Carretera Central Km. 101. Matanzas, Cuba

Telephone:

+53-78325067

+53- 78776354

+53-48762006

+53-52546410

+53-45247016

Email:

lissetglezf@infomed.sld.cu

raisa.baguer@info med.sld.cu

mpglez@infomed.sld.cu

alexeiperez94@gmail.com

claralaucirica.mtz@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

29/12/2031

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000469

Date of Registration in Primary Registry:

23/12/2025

Record Verification Date:

2025/12/23

Next update date:

2026/12/23

Link to the spanish version:

Click here [3]