Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in HIV-infected People Aged 1-40 Years: A Phase IV Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Approximately 400 HIV-infected participants aged 1-40 years old will be recruited according to the inclusion and exclusion criteria. Among them, more than 180 participants will be recruited in the immunogenicity and safety study. Each of them will receive 2 doses of HAV vaccines with a 6-month interval. Blood samples will be drawn before and 1 month after each dose to detect the HAV anitibodies to evaluate the immunogenicity of the vaccines. Other people will be recruited in the safety study and receive at least one dose of HAV vaccine. All the participants will report the adverse events within one month after each dose.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 40
Healthy Volunteers: f
View:

• HIV-infected participants aged 1-40 years old

• The HIV viral loads of participants in the past 12 months were supposed to be less than 200 copies/ml

• Participants or his/her guardian can fully understand and voluntarily sign the informed consent 4. Participants who are willing to participate in the 7-month follow-up 5. Participants who can provide valid legal identification

Locations
Other Locations
China
Liuzhou People's Hospital
RECRUITING
Liuzhou
Contact Information
Primary
Zhongsheng Jiang
jiangzs1111@126.com
13768348458
Time Frame
Start Date: 2023-12-19
Estimated Completion Date: 2024-12-20
Participants
Target number of participants: 400
Treatments
Experimental: Participants aged 1-17 years old
Participants aged 1-17 years old in the immunogenicity and safety study
Experimental: HAV susceptible participants aged 18-40 years old
HAV susceptible participants aged 18-40 years old in the immunogenicity and safety study
Experimental: HAV unsusceptible participants aged 18-40 years old
HAV unsusceptible participants aged 18-40 years old in the immunogenicity and safety study
Experimental: Other participants aged 18-40 years old
Other participants aged 18-40 years old in the safety study
Related Therapeutic Areas
Sponsors
Leads: LiuZhou People's Hospital
Collaborators: Sinovac Biotech Co., Ltd

This content was sourced from clinicaltrials.gov

Similar Clinical Trials