HIV/AIDS
Conditions
Interventions
High-dose vaccine:450 ug p24 vaccine
High-dose control:1.5ml placebo
low-dose vaccine:300 ug p24 vaccine
low-dose control:1ml placebo
Sponsors
Beijing Youan Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Adult male and female aged 18–60 years; 2. HIV-1 infected volunteers on a stable antiretroviral regimen for = 6 months prior to entry and with HIV-1 viral load 350 cells/µL documented within 30 days of entry; 4. Stated willingness to tell their identity and follow visits; 5. Not pregnant or planning to conceive during duration of trial; 6. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Volunteers who are pregnant, are breastfeeding or with intent to conceive during the study duration; 2. Prior participation in any HIV-1 vaccine trial within 5 years prior to study entry; 3. Receipt of blood products, immunoglobulin, or immunotherapy within 12 weeks of study entry; 4. Vaccination of attenuated live vaccine, inactivated vaccine, subunit vaccine and anti-allergy therapy, or other testing drug within 30 days of study entry; 5. Vaccination of anthrax vaccine or experienced with anthrax infection; 6. Suspected TB or ongoing anti-TB treatment; 7. Acute or chronic viral hepatitis; 8. A history of serious adverse reactions, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and abdominal pain, following administration of any vaccines, or a history of hypersensitivity specifically to any components of study vaccine; 9. Active opportunistic infection or malignancy requiring systemic therapy within 30 days of study entry or likely to require systemic therapy during the study, or any acute medical condition that in the opinion of the investigator may obscure the ability to observe the safety or activity of the study vaccine treatment; 10. Active alcohol or drug use or a mental or psychiatric condition that, in the opinion of the investigator is likely to compromise the ability to adhere to the protocol schedule; 11. Abnormal blood chemistry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| general information;Physical Examination;Safety index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity; | — |
Countries
China
Contacts
Public ContactHao Wu
Beijing YouAn Hospital, Capital Medical University
Outcome results
None listed