Status:
COMPLETED
Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in HIV-infected People
Lead Sponsor:
LiuZhou People's Hospital
Collaborating Sponsors:
Sinovac Biotech Co., Ltd
Conditions:
Hepatitis A
Immunodeficiency
Eligibility:
All Genders
1-50 years
Phase:
PHASE4
Brief Summary
Approximately 400 HIV-infected participants aged 1-50 years old will be recruited according to the inclusion and exclusion criteria. Among them, more than 180 participants will be recruited in the imm...
Detailed Description
Approximately 400 HIV-infected participants aged 1-50 years old will be recruited in terms of inclusion and exclusion criteria. All participants will receive one dose of the hepatitis A vaccine and ha...
Eligibility Criteria
Inclusion
- HIV-infected participants aged 1-50 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
Exclusion
- Participants who have infected with hepatitis A;
- Participants who have been vaccinated with inactivated or live-attenuated hepatitis A vaccine, or hepatitis A and B combined vaccine
- Participants who are allergic constitution or severe allergic to vaccines or components in the past (such as acute allergic reaction, angioedema, dyspnea, etc.)
- Pregnant women and lactating women
- People suffering from uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barré syndrome, demyelinating diseases, etc.)
- Participants with fever (axillary temperature ≥37.3℃) during vaccination, or acute exacerbation of chronic diseases, or participants with uncontrolled severe chronic diseases, or suffering from acute diseases
- Participants who have received other experimental drugs within 30 days before vaccination with the experimental vaccine
- Participants who have received live-attenuated vaccine withins 14 days before vaccination with the experimental vaccine
- Participants who have received subunit or inactivated vaccines within 7 days before vaccination with experimental vaccine
- According to the investigator's judgment, participants who has any other factors that make him or her unsuitable for vaccination
- Exclusion Criteria of second vaccination:
- Participants who meet one of the following events (1) to (4), should not receive the second vaccination, but can continue other study steps according to the investigator's judgment; if participants who meet one of the following events (5) or (6), can still receive the second vaccination according to the investigator's judgment.
- Participants who meet one of the following events (7) to (10) can postponed the second vaccination within the time window specified in the protocal.
- Vaccines of the same type other than the experimental vaccine were used during the study;
- Any serious adverse reaction that is causally related to the experimental vaccination
- Severe allergic reaction or hypersensitivity reaction after vaccination (including urticaria/rash occurring within 30 minutes after vaccination)
- Pregnant after the first vaccination (those who had positive result for urine pregnancy test or those who are known to be pregnant)
- Acute or recently diagnosed chronic disease that occurred after the first vaccination
- Other reactions (including severe pain, severe swelling, severe limitation of activity, persistent high fever, severe headache, or other systemic or local reactions) are diagonosed by investigator
- Suffering from acute illness (acute illness refers to moderate or severe illness with or without fever);
- Axillary temperature ≥37.3℃ during vaccination;
- Have received subunit vaccine or inactivated vaccine within 7 days, and have received live attenuated vaccine within 14 days
- According to the investigator's judgment, participants who has any other factors that make him or her unsuitable for vaccination
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2025
Estimated Enrollment :
392 Patients enrolled
Trial Details
Trial ID
NCT06576024
Start Date
December 19 2023
End Date
April 25 2025
Last Update
December 31 2025
Active Locations (1)
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1
Liuzhou People's Hospital
Liuchow, Guangxi, China