Immunogenicity and Safety of the Hepatitis B Vaccine Hepavax-Gene TF and a Comparator Hepatitis B Vaccine in Newborns

Study Overview
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Brief Summary
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The primary purpose of this study is to determine whether HepavaxGene TF is non-inferior to the comparator vaccine both at impeding hepatitis B transmission from mothers positive for chronic hepatitis B (Stratum 1) to their children and also in terms of seroconversion rate in children of mothers negative for chronic hepatitis B (Stratum 2) one month after completion of the immunization schedule.

Official Title
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A Prospective, Randomized, Double-blind, Parallel-group, Controlled Study of the Immunogenicity and Safety of the Recombinant Hepatitis B Vaccine (Hepavax-Gene TF) and a Comparator Univalent Hepatitis B Vaccine in Neonates

Conditions
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Hepatitis B

Intervention / Treatment
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* Biological: HepavaxGene (thiomersal free)
* Biological: Engerix B


Participation Criteria
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Eligibility Criteria
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Three types of subject: Neonates whose mothers are positive for both HBsAg and HBeAg Neonates whose mothers are positive for only HBsAg Neonates whose mothers are negative for both HBsAg and HBeAg INCLUSION CRITERIA: Full-term neonates with gestational age from 37 weeks to 42 weeks; Apgar scores are no less than 7 at birth; Neonates with standard body temperature (auxiliary temperature < 37.1°); Neonates weighing ≥ 2,500 grams at birth; Neonates with icteric index within the normal range (physiologic jaundice is permitted); Informed consent form signed by parent/guardian; The requirements of the clinical trial protocol can be observed on the basis of the opinion of the investigator. EXCLUSION CRITERIA: Subject's parent has a history of family diseases such as convulsion and brain diseases; Mothers have low immunologic function or a history of organ transplantation or hemodialysis; Subject's parent is allergic to any composition of Hepatitis B vaccine; A family history of thrombocytopenia, or other disturbance of blood coagulation, which may result in a contraindication for intramuscular injection; Known immunologic function damage; Mothers had received gamma globulin or immunoglobulin injection during pregnancy; Any congenital malformation Known or suspected to suffer from diseases such as active infection and cardiovascular disease; Any condition believed by the investigator to have possible impact on trial evaluation.

Ages Eligible for Study
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Maximum Age: 1 Day

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HepavaxGene Stratum 1a<br>Subjects of mothers with chronic hepatitis B (positive for both HBsAg and hepatitis B envelope antigen - HBeAg) | Biological: HepavaxGene (thiomersal free)<br>* 10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6<br>|
| Active Comparator: Comparator vaccine Stratum 1a<br>Subjects of mothers with chronic hepatitis B (positive for both HBsAg and HBeAg) | Biological: Engerix B<br>* 10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6<br>|
| Experimental: HepavaxGene Stratum 1b<br>Subjects of mothers with chronic hepatitis B (positive for HBsAg only) | Biological: HepavaxGene (thiomersal free)<br>* 10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6<br>|
| Active Comparator: Comparator vaccine Stratum 1b<br>Subjects of mothers with chronic hepatitis B (positive for HBsAg only) | Biological: Engerix B<br>* 10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6<br>|
| Experimental: HepavaxGene Stratum 2<br>Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg) | Biological: HepavaxGene (thiomersal free)<br>* 10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6<br>|
| Active Comparator: Comparator vaccine Stratum 2<br>Subjects of mothers without chronic hepatitis B (negative for both HBsAg and HBeAg) | Biological: Engerix B<br>* 10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate for subjects in Stratum 2 | Hepatitis B surface antibody (HBsAb) concentrations are measured from blood samples by standard enzyme linked immuno sorbent assay (ELISA) for subjects whose mothers are negative for chronic hepatitis B. Seroconversion rate is defined as HBsAb ≥10 mIU/mL. | Month 7 | 
| Positivity for HBsAg for subjects in Stratum 1 | The presence of hepatitis B surface antigen (HBsAg), as determined by ELISA, for subjects whose mothers are positive for chronic hepatitis B | Month 2, Month 7 and Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate for subjects in Stratum 1 | Seroconversion rate is defined as HBsAb concentrations from ELISA ≥10 mIU/mL | Month 7 | 
| Solicited adverse events | Local adverse events: pain, erythema, swelling at the injection site Systemic adverse events: irritability, sleepiness, change in eating/breast feeding habits, crying, fever [body temperature ≥38°C] | Days 1 to 4 | 
| Seroconversion rate for subjects in Stratum 1 | Seroconversion rate is defined as HBsAb concentrations from ELISA ≥10 mIU/mL | Month 12 | 
| Positivity for HBsAg for subjects in Stratum 2 |  | Months 2, 7 and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B Vaccine, Hepatitis B Virus, Antigen, Antibody, Vaccination