The Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates
NCT ID: NCT01183611
Last Updated: 2010-09-17
Study Results
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Basic Information
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COMPLETED
PHASE3
1740 participants
INTERVENTIONAL
2007-04-30
2010-09-30
Brief Summary
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* Stratified 1: There are 180 neonates born to the mother with positive for both HBsAg and HBeAg will be randomized into two groups according to the ratio of 2:1. 120 subjects will receive the 10 mcg experimental vaccine and 60 subjects will receive 10 mcg control vaccine respectively.
* Stratified 2: There are 360 neonates born to the mother with positive for HBsAg but negative for HBeAg will be randomized into two groups according to the ratio of 2:1. 240 subjects will receive the 10 mcg experimental vaccine and 120 subjects will receive 10 mcg control vaccine respectively.
* Stratified 3: There are 1200 neonates born to the mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb will be randomized into 3 groups. 600 of them will receive the 10mcg experimental vaccine. 300 subjects will receive 10mcg control vaccine. And the other 300 subjects will receive 5mcg control vaccine.
The recombinant hepatitis B vaccine will be administered at m0, 1 and 6. Following each immunization, safety will be measured by assessment of adverse events through 30 days following each vaccination, serious adverse events and new-onset chronic medical conditions through 6 months post the final vaccination (Day 180 after last vaccination). For the immunogenicity testing will apply the chemiluminescence immunoassay on serum obtained on the day 0, 210 and 360 after born.
Detailed Description
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The primary safety objective of this study is to assess the safety of 10 mcg recombinant hepatitis B vaccine in the Chinese health neonates. The primary immunogenicity objective is to assess the antibody response following 3 doses immunization of the 10 mcg experimental dose and 10 or 5 mcg control dose, Participants will include up to 1740 healthy neonates. This is a randomized, double-blinded, Phase III study. This study is designed to investigate the safety, reactogenicity, and immunogenicity of 10ug recombinant hepatitis B vaccine (yeast). Subjects will be stratified by the mother with positive for both HBsAg and HBeAg, positive for the surface antigen but negative for HBeAg, negative for the HBsAg and HBeAg and HBeAb and HBcAb.
* Stratified 1: There are 180 neonates born to the mother with positive for both HBsAg and HBeAg will be randomized into two groups according to the ratio of 2:1. 120 subjects will receive the 10 mcg experimental vaccine and 60 subjects will receive 10 mcg control vaccine respectively.
* Stratified 2: There are 360 neonates born to the mother with positive for HBsAg but negative for HBeAg will be randomized into two groups according to the ratio of 2:1. 240 subjects will receive the 10 mcg experimental vaccine and 120 subjects will receive 10 mcg control vaccine respectively.
* Stratified 3: There are 1200 neonates born to the mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb will be randomized into 3 groups. 600 of them will receive the 10mcg experimental vaccine. 300 subjects will receive 10mcg control vaccine. And the other 300 subjects will receive 5mcg control vaccine.
All these neonates will have the vaccination within 24 hours after born. The recombinant hepatitis B vaccine will be administered at m0, 1 and 6. Following each immunization, safety will be measured by assessment of adverse events through 30 days following each vaccination, serious adverse events and new-onset chronic medical conditions through 6 months post the final vaccination (Day 180 after last vaccination). For the immunogenicity testing will apply the chemiluminescence immunoassay on serum obtained on the day 0, 210 and 360 after born.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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A1
health neonates born to mother with positive for both HBsAg and e antigen
Experimental recombinant hepatitis B vaccine, HBIG
Experimental 10mcg/0.5 ml recombinant hepatitis B vaccine and 200IU HBIG
A2
health neonates born to mother with positive for both HBsAg and e antigen
Active Comparator hepatitis B vaccine
Active Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine，200IU HBIG
B1
health neonates born to a mother positive for HBsAg, negative for the hepatitis B e antigen
Experimental recombinant hepatitis B vaccine, HBIG
Experimental 10mcg/0.5 ml recombinant hepatitis B vaccine and 200IU HBIG
B2
health neonates born to a mother positive for HBsAg, negative for the hepatitis B e antigen
Active Comparator hepatitis B vaccine
Active Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine，200IU HBIG
C1
health neonates born to mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb
Experimental recombinant hepatitis B vaccine
Experimental 10mcg/0.5 ml of recombinant hepatitis B vaccine
C2
health neonates born to mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb
Active Comparator recombinant hepatitis B vaccine.
Active Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine.
C3
health neonates born to mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb
Placebo Comparator recombinant hepatitis B vaccine
Placebo Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine.
Interventions
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Experimental recombinant hepatitis B vaccine, HBIG
Experimental 10mcg/0.5 ml recombinant hepatitis B vaccine and 200IU HBIG
Active Comparator hepatitis B vaccine
Active Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine，200IU HBIG
Experimental recombinant hepatitis B vaccine
Experimental 10mcg/0.5 ml of recombinant hepatitis B vaccine
Active Comparator recombinant hepatitis B vaccine.
Active Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine.
Placebo Comparator recombinant hepatitis B vaccine
Placebo Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine.
Eligibility Criteria
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Inclusion Criteria
• Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 1 day of age)
• Subjects with a 5-minute Apgar score ≥ 7.
• Subjects with temperature \<37.1°C on axillary setting
• Subjects with a birth weight ≥ 2.5 kg.
• Normal neonatal jaundice.
* Written informed consent obtained from the parent(s) of the subject.
* Subjects who the investigator believes that their parent(s) can and will comply with the requirements of the protocol.
2. B group(B1-B2) Subjects born to a mother positive for HBsAg, but negative for the hepatitis B e antigen.
• Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 1 day of age)
• Subjects with a 5-minute Apgar score ≥ 7.
• Subjects with temperature \<37.1°C on axillary setting
• Subjects with a birth weight ≥2.5 kg.
• Normal neonatal jaundice.
• Written informed consent obtained from the parent(s) of the subject.
• Subjects who the investigator believes that their parent(s) can and will comply with the requirements of the protocol
3. C group（C1-C3）Subjects born to a mother negative for HBsAg, hepatitis Be Antigen, antibody to hepatitis B core antigen, antibody to hepatitis B e-antigen.
* Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 1 day of age)
* Subjects with a 5-minute Apgar score ≥ 7.
* Subjects with temperature \<37.1°C on axillary setting
* Subjects with a birth weight ≥ 2.5 kg.
* Normal neonatal jaundice.
* Written informed consent obtained from the parent(s) of the subject.
* Subjects who the investigator believes that their parent(s) can and will comply with the requirements of the protocol.
Exclusion Criteria
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Subjects born to a mother had administrated of immunoglobulins and/or any blood products during the pregnancy.
• Use of any investigational or non-registered product other than the study vaccines since birth, or planned use during the study period.
• Born to a mother known or suspected to be positive for HIV.
* Family history of congenital or hereditary immunodeficiency.
* Children in care.
* Neonatal jaundice requiring systemic treatment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Major congenital defects or serious chronic illness, including perinatal brain damage.
* Dysgenopathy
* Any reaction or hypersensitivity to the hepatitis B vaccines.
* Acute infections
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
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1. B group (B1-B2) Subjects born to a mother positive for HBsAg, but negative for the hepatitis B e antigen.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Subjects born to a mother had administrated of immunoglobulins and/or any blood products during the pregnancy.
• Use of any investigational or non-registered product other than the study vaccines since birth, or planned use during the study period.
• Born to a mother known or suspected to be positive for HIV.
• Family history of congenital or hereditary immunodeficiency.
• Children in care.
• Neonatal jaundice requiring systemic treatment.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Major congenital defects or serious chronic illness, including perinatal brain damage.
• Dysgenopathy
• Any reaction or hypersensitivity to the hepatitis B vaccines.
• Acute infections
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
3 C group (C1-C3) Subjects born to a mother negative for HBsAg, hepatitis Be Antigen, antibody to hepatitis B core antigen, antibody to hepatitis B e-antigen.
• Subjects born to a mother positive for antibody to HBsAg, or e antigen, or antibody to B core antigen or antibody to hepatitis B e-antigen.
• Family history of seizures or progressive neurological disease.
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Subjects born to a mother had administrated of immunoglobulins and/or any blood products during the pregnancy.
• Use of any investigational or non-registered product other than the study vaccines since birth, or planned use during the study period.
• Born to a mother known or suspected to be positive for HIV.
• Family history of congenital or hereditary immunodeficiency.
• Children in care.
* Neonatal jaundice requiring systemic treatment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Major congenital defects or serious chronic illness, including perinatal brain damage.
* Dysgenopathy
* Any reaction or hypersensitivity to the hepatitis B vaccines.
* Acute infections
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
24 Hours
ALL
No
Sponsors
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Jiangsu Province Centers for Disease Control and Prevention
NETWORK
Responsible Party
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Jiangsu Provincial Center for Diseases Control and Prevention
Locations
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Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
Countries
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References
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Zhu FC, Liang ZL, Meng FY, Zeng Y, Mao QY, Chu K, Song XF, Yao X, Li JX, Ji H, Zhang YJ, Li L, Pan HX, Xu K, Dai WM, Zhang WW, Deng F, Wang H, Wang JZ. Retrospective study of the incidence of HFMD and seroepidemiology of antibodies against EV71 and CoxA16 in prenatal women and their infants. PLoS One. 2012;7(5):e37206. doi: 10.1371/journal.pone.0037206. Epub 2012 May 25.
Other Identifiers
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JSVCT008
Identifier Type: -
Identifier Source: org_study_id