Immunogenicity of Hepatitis B Vaccination Among Drug Users

Hepatitis B Vaccination Clinical Trial

Official title:

Immunogenicity and Safety of High-dose Hepatitis B Vaccine Among Drug Users: a Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02959775
• Other study ID #: 2012ZX10002001003004002
• Status: Completed
• Phase: Phase 4
• Start date: August 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2021
• Source: Shanxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Uptake, adherence, and completion of vaccination among drug users were low, and their immune function and immune response to hepatitis B vaccination were also suboptimal, indicating that the current practice of hepatitis B vaccination can't protect drug users from HBV infection.

This is a randomized, open-label, blank-controlled trial, conducted among drug users with drug rehabilitation. This study will compare the immunogenicity and safety of three intramuscular 20µg and 60µg recombinant hepatitis B vaccines at months 0, 1, and 6 among drug users

Description:

Comparison of 2 vaccination strategy against Hepatitis B in Drug Users

Intervention:

Arm 1 : Receive three intramuscular injections of 60 µg recombinant hepatitis B vaccine at months 0, 1 and 6;

Arm 2 : Receive three intramuscular injections of 20 µg recombinant hepatitis B vaccine at months 0, 1 and 6;

Arm 3 : Receive no vaccination during the study period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: October 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Aged between 18 and 70 years at the enrolment

• current illicit drug users before drug rehabilitation

• negative for hepatitis B surface antigen (HBsAg) and hepatitis B surface antibody (anti-HBs) at enrollment

• having spent acute physiological detoxification phase

Exclusion Criteria:

• any intolerance or allergy to any component of the vaccine

• ongoing opportunistic infection

• liver disease

• hemopathy

• cancer

• unexplained fever in the last week before the recruiting

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Vaccination

Intervention

Biological:
• 60 µg dose hepatitis B vaccine
three-dose, 60 µg per dose
• 20 µg dose hepatitis B vaccine
three-dose, 20 µg per dose

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanxi Medical University	Centers for Disease Control and Prevention, China

References & Publications (1)

Feng Y, Shi J, Gao L, Yao T, Feng D, Luo D, Li Z, Zhang Y, Wang F, Cui F, Li L, Liang X, Wang S. Immunogenicity and safety of high-dose hepatitis B vaccine among drug users: A randomized, open-labeled, blank-controlled trial. Hum Vaccin Immunother. 2017 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number and Rate of Participants With Anti-HBs High-level Response at Month 7	The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations =100 mIU/ml were high-level response.	Month 7
Other	Number and Rate of Participants With Anti-HBs High-level Response at Month 12	The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations =100 mIU/ml were high-level response.	Month 12
Other	Anti-HBs Concentration at Month 6 Before the Third Injection	Anti-HBs concentration at month 6 before the third injection by CMIA	Month 6 before the third injection
Other	Number and Rate of Participants With Anti-HBs Seroconversion at Month 6 Before the Third Injection	The measurements of anti-HBs antibodies were determined quantitatively by CMIA. The accepted protective serum anti-HBs level was =10 mIU/ml.	Month 6 before the third injection
Other	Number and Rate of Participants With Anti-HBs High-level Response at Month 6 Before the Third Injection	The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations =100 mIU/ml were high-level response.	Month 6 before the third injection
Primary	Number and Rate of Participants With Anti-HBs Seroconversion at Month 7	The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay). The accepted protective serum anti-HBs level was =10 mIU/ml.	Month 7
Secondary	Anti-HBs Concentration at Month 7	The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay).	Month 7
Secondary	Anti-HBs Concentration at Month 12	The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay).	Month 12
Secondary	Number and Rate of Participants With Anti-HBs Seroconversion at Month 12	The measurements of anti-HBs antibodies were determined quantitatively by CMIA(Chemiluminescent Microparticle Immunoassay).; The accepted protective serum anti-HBs level was =10 mIU/ml.	Month 12
Secondary	Occurrence of Adverse Events After Vaccination	Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B	Within 7 days after the vaccination, at Month 0, 1, and 6
Secondary	Occurrence of Adverse Events After Vaccination	Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B	Within 28 days after the vaccination, at Month 0, 1, and 6
Secondary	Serious Adverse Events (SAE) Occurred During Month 12		Month 0-12