HIV/AIDS
Conditions
Interventions
1:Boost rTV vaccine at 24 weeks intervals
2:Boost rTV vaccine at 36 weeks intervals
3:Boost rTV vaccine at 48 weeks intervals
4:Boost placebo at 24 weeks intervals
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18 years to 55 years; 2. Willing to be followed for the planned duration of the study, and receive intravenous blood collection and sample storage from the first vaccination to 48 weeks after the last vaccination; 3. Understand and agree with the content of informed consent; 4. Willing to be tested for HIV and syphilis; 5. Willing to use an effective method of contraception with sexual partner, from 2 weeks before first vaccination to 48 weeks after last vaccination. Female subjects are willing to undergo urine pregnancy test.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating; 2. Have close contact with people who are pregnant or lactating in the one month after rTV vaccination; 3. Have listed diseases or medical history: 1) Have innate or acquired immune deficiency disease or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination; 2) Need treatment affecting immunization, or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination; 3) Suffering from immunosuppressive diseases, or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination; 4) Past or current suffering from eczema or atopic dermatitis; Currently suffering from diseases that cause skin damage; or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination; 5) Past or current high blood pressure, heart disease, diabetes, etc.; 6) History of syncope after vaccination or allergies; 7) Currently suffering from acute infectious diseases and febrile diseases 4. The following circumstances are: 1) Live attenuated vaccine received within 2 months or other vaccine within 2 weeks prior to enrollment; 2) Immunoglobin or blood products received within 4 months prior to enrollment; 3) Participation in another trial of a medicinal product, completed less than 30 days prior to enrollment; 4) Drug abuse, alcoholism , heavy smokers; 5. The following laboratory test abnormalities: 1) HIV diagnostic assay positive or suspicious; 2) CD4 count < 350/mm3; 3) WBC count =3.3×10^9/L or =12.0×10^9/L; 4) Biochemical test is above the normal reference range, and the results that are assessed by researchers as having clinical significance; 5) Other laboratory test abnormalities, and the results that are assessed by researchers as having clinical significance; 6. Not complying with study protocol or not obtaining informed consent because of medical, spiritual, social, occupational, and/or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indexes;HIV antigen-specific antibody;HIV specific T-Cellular immune responses; | — |
Secondary
| Measure | Time frame |
|---|---|
| HIV neutralizing antibody; | — |
Countries
China
Contacts
Public ContactYiming Shao
National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention
Outcome results
None listed