The Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates

NCT01183611 | Completed Phase 3 DMC

• 1 other identifier: JSVCT008
• Study Type: interventional
• Target: 1,740
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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

Virus Disease; DNA Virus Infections; Hepadnaviridae Infections

Keywords

safety; immunogenicity; HBV vaccine; perinatal transmission

Outcome Measures

Primary Outcomes (2)

• The immunogenicity of experimental recombinant HBV vaccines in healthy neonates on day 210

  Immunogenicity testing will be chemiluminescence immunoassay on serum obtained on day 210 after first dose

  on day 210 after the first dose

• The immunogenicity of experimental recombinant HBV vaccines in healthy neonates on day 360

  Immunogenicity testing will be chemiluminescence immunoassay on serum obtained on day 360 after first dose

  on day 360 after the first dose

Secondary Outcomes (3)

• To evaluate the safety of recombinant HBV vaccines in the health neonates after first dose

  within the first 30 days after first dose

• To evaluate the safety of recombinant HBV vaccines in the health neonates after second dose

  within the first 30 days after second dose

• To evaluate the safety of recombinant HBV vaccines in the health neonates after third dose

  within the first 30 days after third dose

Study Arms (7)

A1

EXPERIMENTAL

health neonates born to mother with positive for both HBsAg and e antigen

Biological: Experimental recombinant hepatitis B vaccine, HBIG

A2

ACTIVE COMPARATOR

health neonates born to mother with positive for both HBsAg and e antigen

Biological: Active Comparator hepatitis B vaccine

B1

EXPERIMENTAL

health neonates born to a mother positive for HBsAg, negative for the hepatitis B e antigen

Biological: Experimental recombinant hepatitis B vaccine, HBIG

B2

ACTIVE COMPARATOR

health neonates born to a mother positive for HBsAg, negative for the hepatitis B e antigen

Biological: Active Comparator hepatitis B vaccine

C1

EXPERIMENTAL

health neonates born to mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb

Biological: Experimental recombinant hepatitis B vaccine

C2

ACTIVE COMPARATOR

health neonates born to mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb

Biological: Active Comparator recombinant hepatitis B vaccine.

C3

PLACEBO COMPARATOR

health neonates born to mother with negative for the HBsAg and HBeAg and HBeAb and HBcAb

Biological: Placebo Comparator recombinant hepatitis B vaccine

Interventions

Experimental recombinant hepatitis B vaccine, HBIG BIOLOGICAL

Experimental 10mcg/0.5 ml recombinant hepatitis B vaccine and 200IU HBIG

A1; B1

Active Comparator hepatitis B vaccine BIOLOGICAL

Active Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine，200IU HBIG

A2; B2

Experimental recombinant hepatitis B vaccine BIOLOGICAL

Experimental 10mcg/0.5 ml of recombinant hepatitis B vaccine

C1

Active Comparator recombinant hepatitis B vaccine. BIOLOGICAL

Active Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine.

C2

Placebo Comparator recombinant hepatitis B vaccine BIOLOGICAL

Placebo Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine.

C3

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A group (A1-A2)Subjects born to a mother positive for both HBsAg and 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.
• 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.

You may not qualify if:

• A group (A1-A2) Subjects born to a mother positive for both HBsAg and e Antigen.
• 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

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead

Study Sites (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

• 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.

  PMID: 22662137 DERIVED

MeSH Terms

Conditions

Virus Diseases; DNA Virus Infections; Hepadnaviridae Infections

Interventions

hepatitis B hyperimmune globulin

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: August 17, 2010
• Study Start: April 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 17, 2010

Record last verified: 2010-09

Locations

CN (1)