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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 25 February 2019
Main ID:  ChiCTR1900021422
Date of registration: 2019-02-20
Prospective Registration: Yes
Primary sponsor: Beijing Youan Hospital, Capital Medical University
Public title: Phase IIa study of HIV vaccine (Combined use of DNA vaccine and Recombinant Vaccine Tiantan) to evaluate different immune procedures
Scientific title: Safety and Immunogenicity Study of rTV Vaccine Boost at different intervals in HIV –negative Healthy Human Subjects
Date of first enrolment: 2019-02-21
Target sample size: 1:40;2:40;3:40;4:40;
Recruitment status: Pending
URL:  http://www.chictr.org.cn/showproj.aspx?proj=35164
Study type:  Prevention
Study design:  Parallel  
Phase:  2
Countries of recruitment
China
Contacts
Name: Yingqi Wu   
Address:  155 Changbai Road, Changping District, Beijing, China
Telephone: +86 010 82805534
Email: wyqwps221@sina.com
Affiliation:  National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention
Name: Yiming Shao   
Address:  155 Changbai Road, Changping District, Beijing, China
Telephone: +86 010 58900981
Email: yshao@bjmu.edu.cn
Affiliation:  National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention
Key inclusion & exclusion 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: 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.


Age minimum: 18
Age maximum: 55
Gender: Both
Health Condition(s) or Problem(s) studied
HIV/AIDS
Intervention(s)
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;
Primary Outcome(s)
Safety indexes;HIV antigen-specific antibody;HIV specific T-Cellular immune responses;
Secondary Outcome(s)
HIV neutralizing antibody;
Secondary ID(s)
Source(s) of Monetary Support
National Science and Technology Major Project for Infectious Diseases Prevention and Control
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Aijuan Sheng
8 Toutiao Street West, Youanmenwai, Fengtai District, Beijing, China
Results
Results available:
Date Posted:
Date Completed:
URL:
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