A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Adults
A Randomized, Opened, Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy Young Adults
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
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Beijing, Kina, 100191
- Peking University
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Healthy subjects aged between 16 and 25 as established by medical history and clinical examination
- Written informed consent will be obtained from each subject before the serum screening of HBV markers
- Seronegative for HBsAg, anti-HBs antibody, anti-HBc antibody
- Have never been immunized with HBV vaccine before
Exclusion Criteria:
- Subject has a medical history of allergic to any ingredient of vaccine
- Family history of seizures or progressive neurological disease
- Autoimmune disease or immunodeficiency
- Women with pregnant
- Bleeding disorder diagnosed by a doctor
- Chronic diseases: hepatitis, tumor, tuberculosis,et.al
- Any prior administration of immunoglobulins or blood products in the last 3 mon before recruitment
- Subjects had a medical history of serious adverse reactions to vaccines
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: 20μg, 0-1-6
117 young adults were administered with 20μg of hepatitis B vaccine according to the 0-1-6 mon schedule.
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Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.
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Experimentell: 60μg, 0-1
112 young adults were administered with 60μg of hepatitis B vaccine according to the 0-1 mon schedule.
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Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.
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Experimentell: 60μg, 0-2
125 young adults were administered with 60μg of hepatitis B vaccine according to the 0-2 mon schedule.
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Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
Tidsram: one month after a series vaccination of the regimen
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The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs antibody will be compared among the three vaccine groups. |
one month after a series vaccination of the regimen
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
Tidsram: 1-year after the first dose of the regimens
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The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs will be compared among the three vaccine groups. |
1-year after the first dose of the regimens
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Immunogenicity of Hepatitis B Vaccine With Different Doses and Schedules in Healthy Young Adults
Tidsram: 2-year after the first dose of the regimens
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The measurements of anti-HBs antibodies were determined quantitatively by CMIA using the Architect i2000SR analyzer (Abbott, Chicago, IL, USA). The accepted protective serum anti-HBs level was ≥10 mIU/ml. Anti-HBs≥10 and < 100 mIU/ml were considered low response, and anti-HBs concentrations ≥100 but < 1000 mIU/ml were middle or moderate response, and hyper or high response was associated with an anti-HBs level ≥1000 mIU/ml. The GMCs of anti-HBs antibody will be compared among the three vaccine groups. The dynamic changes of seroprotection rates and GMCs of anti-HBs antibody will also be analyzed over the 2 years. |
2-year after the first dose of the regimens
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Safety of HBV Vaccine Determined by Number of Participants With Adverse Events
Tidsram: 0-3 day after the first dose of immunization
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Participants were monitored for any adverse events occurring within 30 min after each injection for immediate reactions and instructed to measure axillary temperature and record selected injection-site reactions (pain, erythema, induration, swelling, pruritus, cutaneous rash) and systemic reactions (headache, vomiting, asthenia, allergic reaction, fatigue, diarrhea, myalgia, general malaise, etc.) on the day of vaccination and the subsequent 3 days.
Adverse reactions were graded or categorized according to the standard guideline for adverse reactions grading in vaccine clinical trials as Grade 1-3.
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0-3 day after the first dose of immunization
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studierektor: Zhongliao Fang, Dr., Guangxi provincial center for desease control and prevention
- Studierektor: Hui Zhuang, Dr., Peking University Health Science Center
Publikationer och användbara länkar
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Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
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Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HepB-2014
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