Immunogenicity and Safety of Inactivated Hepatitis A Vaccine in HIV-infected People

Exclusion Criteria

• •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
• •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.
• •1. Vaccines of the same type other than the experimental vaccine were used during the study;
• •2. Any serious adverse reaction that is causally related to the experimental vaccination
• •3. Severe allergic reaction or hypersensitivity reaction after vaccination (including urticaria/rash occurring within 30 minutes after vaccination)
• •4. Pregnant after the first vaccination (those who had positive result for urine pregnancy test or those who are known to be pregnant)
• •5. Acute or recently diagnosed chronic disease that occurred after the first vaccination
• •6. 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
• •7. Suffering from acute illness (acute illness refers to moderate or severe illness with or without fever);
• •8. Axillary temperature ≥37.3℃ during vaccination;
• •9. Have received subunit vaccine or inactivated vaccine within 7 days, and have received live attenuated vaccine within 14 days
• •10. According to the investigator's judgment, participants who has any other factors that make him or her unsuitable for vaccination