The Immunogenicity and Safety of 60mcg/30mcg Recombinant Hepatitis B Vaccines in People Who Failed to Respond to Routine Administration of Hepatitis B Vaccines
1 other identifier
interventional
1,091
0 countries
N/A
Brief Summary
This study is an expanded Phase 2/Phase 3 clinical trial base on the safety data obtained from the phase 1 clinical trial. The purpose of this study is to further evaluate the immunogenicity and safety of 60mcg/30mcg recombinant hepatitis B vaccines in people aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines and to explore the optimizing immunizing dose and immune procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2006
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 15, 2010
CompletedFirst Posted
Study publicly available on registry
September 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
April 23, 2012
CompletedApril 27, 2012
April 1, 2012
4.1 years
September 15, 2010
March 29, 2012
April 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders
Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after second vaccination
one month after the second vaccination
Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders
Quantitative detection of anti-HBs using ratio-immunity method on serum obtained one month after third vaccination
one month after the third vaccination
Secondary Outcomes (4)
Immunogenicity of Recombinant Hepatitis B Vaccines in Nonresponders
one month after the first vaccination
the Safety of Recombinant Hepatitis B Vaccines in Nonresponders
within the first 30 days after first vaccination
the Safety of Recombinant Hepatitis B Vaccines in Nonresponders
within the first 30 days after second vaccination
the Safety of Recombinant Hepatitis B Vaccines in Nonresponders
within the first 30 days after third vaccination
Study Arms (3)
60mcg/1.0ml recombinant hepatitis B vaccine
EXPERIMENTAL600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
30mcg/1.0ml recombinant hepatitis B vaccine
EXPERIMENTAL600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
10mcg/1.0ml recombinant hepatitis B vaccine
PLACEBO COMPARATOR300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
Interventions
to receive 60mcg/1.0ml recombinant HBV vaccines on day 0, 30 and 60
to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60
Eligibility Criteria
You may qualify if:
- Filter period: The subjects to receive first 10mcg recombinant hepatitis B vaccines:
- Healthy subjects aged 16 and older as established by medical history and clinical examination
- The subjects or their guardians are able to understand and sign the informed consent
- Had never received the hepatitis B vaccines
- Subjects who can and will comply with the requirements of the protocol
- Revaccination period: The nonresponders to receive first 60mcg recombinant hepatitis B vaccines:
- Healthy subjects aged 16 and older as established by medical history and clinical examination
- The subjects or their guardians are able to understand and sign the informed consent
- After the routine administration of 10mcg hepatitis B vaccines, the peak period levels of anti-HBs is lower than 10mIU/ml
- Subjects with temperature \<37.1°C on axillary setting
- Subjects who can and will comply with the requirements of the protocol
You may not qualify if:
- Filter period: The subjects to receive first 10mcg recombinant hepatitis B vaccines:
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- Family history of seizures or progressive neurological disease
- Family history of congenital or hereditary immunodeficiency
- Women of pregnancy, lactation or about to be pregnant in 60 days
- Autoimmune disease or immunodeficiency
- Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
- Any prior administration of administration of immunoglobulins
- Filter period: The subjects to receive second or/and third 10mcg recombinant hepatitis B vaccines:
- Any reaction or hypersensitivity to the recombinant hepatitis B vaccines after the vaccinations
- Serious adverse reactions to vaccines
- Active infections
- Subjects who want to quit the study
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
- Revaccination period: The nonresponders to receive first 60mcg recombinant hepatitis B vaccines:
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Pan HX, Zeng Y, Song XF, Zhang YJ, Xu K, Liang ZL, Zhu FC. Immune response to hepatitis B vaccine with high antigen content in non-responders after standard primary vaccination in Chinese adults. Vaccine. 2014 Jun 17;32(29):3706-12. doi: 10.1016/j.vaccine.2014.02.094. Epub 2014 Mar 27.
PMID: 24681228DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Fengcai Zhu
- Organization
- Jiangsu Provincial Center for Disease Control and Prevention
Study Officials
- PRINCIPAL INVESTIGATOR
Feng-Cai Zhu, Master
Jiangsu Provincial Center for Diseases Control and Prevention
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2010
First Posted
September 16, 2010
Study Start
November 1, 2006
Primary Completion
December 1, 2010
Study Completion
March 1, 2011
Last Updated
April 27, 2012
Results First Posted
April 23, 2012
Record last verified: 2012-04