Acquired immune deficiency syndrome
Conditions
Interventions
Experimental Group:Administration of the Trivalent Influenza Virus Split Vaccine
Control Group 1:Hiv-infected individuals were not vaccinated with IIV3 (randomly assigned and enrolled using a stratified randomized design method, with a target enrollment of 236 people). On day 0, d
Control Group 2:Non-hiv-infected individuals receive IIV3 vaccination. On day 0, blood samples for pre-immunization humoral immunity were collected. One dose of IIV3 (0.5ml) was administered, diary ca
Sponsors
Zhejiang Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. HIV infected / non-infected individuals aged 18 and above. 2. The subject has not received any influenza vaccine within the year prior to enrollment. 3. The subject should be at least one month away from the last dose of attenuated vaccine; The interval between vaccination with inactivated vaccines or other vaccines is >= 14 days. 4. For women of childbearing age who have received vaccination, if they have no plans to have children within the first 3 months after screening and have taken effective contraceptive measures within 2 weeks before screening. 5. Before entering this study, medical history and clinical examination were conducted, and the body temperature was less than 37.3 ?. 6. The subjects or their guardians have the ability to understand the research procedures, voluntarily sign the informed consent form with informed consent, comply with the requirements of the clinical research protocol, and are able and willing to complete the entire prescribed research plan.
Exclusion criteria
Exclusion criteria: 1. Known allergy to any component of the vaccine, including eggs, adjuvants, formaldehyde, gentamicin sulfate, and Triton X-100; 2. Pregnant or lactating women; 3. History of allergic reactions to the study vaccine or other influenza vaccines (e.g., acute allergic reactions, angioneurotic edema, difficulty breathing); 4. Personal or family history of convulsions, encephalopathy, psychiatric disorders, uncontrolled epilepsy, or other progressive neurological disorders, and history of Guillain-Barré Syndrome; 5. Use of immunosuppressants within one month prior to enrollment; 6. Receipt of blood products or immunoglobulin within three months prior to enrollment, or any other condition that may interfere with study results; 7. History of diagnosed thrombocytopenia or other coagulation disorders that may contraindicate intramuscular injection; 8. Suffering from acute illnesses (e.g., acute febrile diseases or infectious diseases) or in the acute exacerbation phase of chronic diseases; 9. Any condition that, in the investigator's opinion, may affect the assessment of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity markers;Safety indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Protection efficacy indicators; | — |
Countries
China
Contacts
Public ContactXiaohua Qi
Zhejiang Provincial Center for Disease Control and Prevention
Outcome results
None listed