HIV/AIDS
Conditions
Interventions
1:boost rTV vaccine at week 0
2:receive rTV vaccine at week 0
Sponsors
Beijing Youan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects who completed HIV vaccine (Combined use of DNA vaccine and Recombinant Vaccine Tiantan) phase IIa clinical trial; 2. Aged 18 years to 55 years; 3. Willing to be followed for the planned duration of the study, and receive intravenous blood collection and sample storage in the 6 months after rTV vaccination; 4. Understand and agree with the content of informed consent; 5. Willing to be tested for HIV and syphilis; 6. 2 weeks Before and 6 months after receiving rTV, willing to use an effective method of contraception with sexual partner. Female subjects are willing to undergo urine pregnancy test before each vaccination and at the follow-up visit.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating, or plan pregnancy during the study, or have close contact with people who are pregnant or lactating in the one month after rTV vaccination; 2.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) History of syncope after vaccination or allergies; 3. 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; 4. The following laboratory test abnormalities: 1) HIV diagnostic assay positive or suspicious, HIV RNA diagnostic assay positive; 2) CD4 count < 350/mm3; 3) Hematology and biochemical test is above the normal reference range, and the results that are assessed by researchers as having clinical significance; 4) Other laboratory test abnormalities,and the results that are assessed by researchers as having clinical significance; 5. 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 |
|---|---|
| Hematology;biochemical test;urinalysis;HIV diagnostic assay;HIV RNA diagnostic assay;HIV specific T-Cellular immune responses;HIV antigen-specific antibody; | — |
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