Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection

HIV Infections Clinical Trial

Official title:

Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection: an Open-label Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03854630
• Other study ID #: 201608051MIPC
• Status: Recruiting
• Phase: Phase 4
• Start date: September 6, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2020
• Source: National Taiwan University Hospital
• Contact: Chien-Ching Hung, MD, PhD
• Phone: +886-2-23123456
• Email: hcc0401[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary aim of this open-label, randomized control trial is to compare the immunogenicity at week 28 after 20µg HBV vaccine (at week 0, 4, 24) versus 40µg HBV vaccine (40-µg at week 0, 4, 24 week) among HIV-positive patients or HIV-negative MSM who were born in Taiwan after July 1986 and tested negative for all HBV serological markers. The secondary aims are to assess the safety of double-dose HBV vaccination, the proportions of high-level responders (anti-HBs antibody >100 mIU/ml) at weeks 28 and 48, the serological responses at week 48, and incident HBV infection (indicated by appearance of anti-HBc and/or HBsAg) at week 48.

Description:

I. Study procedures:

1. Well explain, complete inform and consent documents

2. A blood test for hepatitis B surface antigen (HBsAg), anti-hepatitis B surface antibody (anti-HBs antibody), anti-hepatitis B core antibody (anti-HBc antibody), anti-HCV and RPR will be performed first.

3. The patients with all negative seromarkers (within 1 month) will be allocated to two groups (random blank=4), a standard-dose booster of 20µg and a double-dose booster of 40µg. For patients receiving 40µg, two 20µg of vaccines are injected at both sides of deltoid muscles. The schedules of booster vaccination are the same in two groups, which is at 0, 1, 6 months.

4. To detect and manage possible immediate and severe allergic reaction, patients who received vaccination will be observed for 30 minutes after injection.

5. The solicited adverse effect will be recorded on the diary card if occurred in 7 days after each dose of vaccination.

6. The titer of hepatitis B surface antibody will be examined before booster vaccination, at the 4th week, the 24th week, 28th week, 48th week. By comparing the responses in the two groups, the effect of different doses of booster vaccination can be evaluated. For those HIV-negative individuals at baseline, HIV screening test will be evaluated every 6 months during the study, at the 24th week, the 48th.

7. To screen the acquisition of hepatitis B, the anti-HBc antibody and HBsAg will be examined at the 48th week

8. To screen the acquisition of hepatitis C and syphilis, anti-HCV and RPR will be examined at the 24th week, the 48th week

9. The results of the study will be informed by phone or the physician during the follow-up care.

10. The serum/blood samples will be preserved in the research lab of the department of internal medicine and kept for 20 years. During this period, the sample will be applied or used in other studies after the patients and the Research Ethics Committee both agreed.

11. During the follow-up care, the treatment or record of hospitalization will be recorded or reviewed.

12. The participants will drop out of clinical trial when protocol violation occurred or the participant is not willing to continue.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 575
• Est. completion date: December 31, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Men who have sex with men (MSM)

• Birth date after 1986/7/1 and aged 20 years or older

• Seronegative for HBsAg, anti-HBs (<10 mIU/ml), and anti-HBc at screening (within 1 month of the first dose)

• Regularly receiving HIV care for HIV-positive patients over the past 6 months

• Seeking VCT for at least once for HIV-negative patients over the past 12 months

Exclusion Criteria:

• Active infection or malignancy within 12 months of screening

• Receiving chemotherapy, immunosuppressant, or IVIG within 12 months of screening

• Received higher than 5 mg of prednisolone, including IV, oral, or topical form, per day for more than 1 weeks within 6 months of screening

• Receiving HBV vaccination within 1 months of screening, or being allergic to HBV vaccine

• Receiving other vaccination within 1 months of screening, such as influenza, pneumococcus, HPV, HAV, varicella vaccine.

• Stage 4 and 5 of chronic kidney disease (GFR<30 mL/min/1.73m), or receiving dialysis.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis B
• HIV Infections
• Immunization; Infection
• Infection
• Viral Hepatitis B

Intervention

Drug:
• Engerix-B
The vaccine contains HBsAg which was produced by genetic engineering yeast. It stimulates the active immunity generated by human immune system toward the HBsAg.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccine efficacy	The proportion of patients with Anti-HBs antibody higher than 10mIU/ml	week 28
Secondary	High-titer response	The proportion of patients with Anti-HBs antibody higher than 100mIU/ml	week 28
Secondary	Long-term efficacy	The proportion of anti-HBs antibody titers higher than 10mIU/ml	48 weeks
Secondary	Long-term high-titer response	The proportion of anti-HBs antibody titers higher than 100mIU/ml	48 weeks
Secondary	Hepatitis B incident infection rate	new HBsAg and anti-HBc antibody seroconversion	48 weeks,
Secondary	Hepatitis C infection and syphilis infection rate	new hepatitis C infection and syphilis infection	at 24 week, 48 weeks
Secondary	HIV seroconversion among HIV-negative MSM	new HIV seroconversion among HIV-negative MSM	at 24 weeks, 48 weeks