Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576024
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-03-20
Brief Title:
Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in HIV-infected People
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in HIV-infected People Aged 1-40 Years A Phase IV Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Approximately 400 HIV-infected participants aged 1-40 years old will be recruited in terms of inclusion and exclusion criteria All participants will receive one dose of hepatitis A vaccine and have their blood and urine samples collected before and after vaccination for laboratory-related indicator testing At least 120 HAV-susceptible participants with anti-HAV antibodies negative before vaccination and 60 HAV-unsusceptible participants with anti-HAV antibodies positive before vaccination aged 18-40 years old and an unlimited number of HIV-infected children aged 1-17 years old will be included into immunogenicity study with rest participants included into safety study Participants in immunogenicity study will receive the second dose of hepatitis A vaccination with a 6-month interval Blood and urine samples will be collected 1 month6months before second vaccination and 7 months 1month after second vaccination after the first vaccination Participants in safety study will receive second vaccination voluntarily Adverse events in both immunogenicity and safety study will be collected within 30 days after each dose of vaccination using smartphone mini program or diary cards
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None