Phase IIa Study of AIDS Vaccine (Combined Use of DNA Vaccine and Recombinant Vaccinia Virus Tiantan)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Occurrence, intensity and relationship to vaccination of local and general adverse events
研究概览
简要总结
This trial studies the safety and immunogenicity of a HIV clade B'/C DNA vaccine followed by recombinant vaccinia virus rTV boost in HIV-uninfected healthy volunteers at low or high risk of HIV infection. In addition, the effect of different intervals of the prime-boost will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to be followed for the planned duration of the study, and receive intravenous blood collection and sample storage in the 16~20 months after first vaccination;
- •Understand and agree with the content of informed consent;
- •Volunteers at low risk of HIV infection, or high-risk men who have sex with men (MSM）, who had have oral sex or anal sex with another man in the past 6 months ;
- •Willing to be tested for HIV and syphilis;
- •Before 2 weeks of the first vaccination and after 12 months of the last vaccination, 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.
排除标准
- •Have close contact with people who are pregnant or lactating in the one month after vaccination of rTV vaccine;
- •Have listed diseases or medical history:
- •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;
- •Need treatment affecting immunization, e.g. use corticosteroids for more than 2 weeks or use immunosuppressives, e.g. alkylating, anti-metabolite or radiotherapy, etc.; or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination;
- •Suffering from immunosuppressive diseases such as cancer, organ or stem cell transplants, non-agammaglobulinemia, etc.; or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination;
- •Past or current suffering from eczema or atopic dermatitis; currently suffering from diseases that cause skin damage such as: burns, scald, chicken pox, impetigo, shingles, psoriasis, etc.; or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination;
- •Past or current high blood pressure, heart disease, diabetes, thyroid disease, asthma, angioedema, asplenia syndrome, mental illness, epilepsy, severe anemia, leukopenia and thrombocytopenia, etc.;
- •History of syncope after vaccination or allergies;
- •Currently suffering from acute infectious diseases and febrile diseases；
- •The following circumstances are:
- •Live attenuated vaccine received within 2 months or other vaccine within 2 weeks prior to enrollment;
- •Immunoglobin or blood products received within 4 months prior to enrollment;
- •Participation in another trial of a medicinal product, completed less than 30 days prior to enrollment;
- •Drug abuse, alcoholism, heavy smokers；
- •The following laboratory test abnormalities, except for the results that are assessed by researchers as being no clinical significance：
- •HIV diagnostic assay positive or suspicious, HIV RNA diagnostic assay positive;
- •Anti-DNA antibody or anti-nuclear antibody positive;
- •Other laboratory test abnormalities;
- •Not complying with study protocol or not obtaining informed consent because of medical, spiritual, social, occupational, and/or other reasons.
研究组 & 干预措施
group A
DNA vaccine prime at week 0,4,8 and rTV boost at week 16
干预措施: DNA vaccine (Biological)
group A
DNA vaccine prime at week 0,4,8 and rTV boost at week 16
干预措施: rTV boost (Biological)
group B
DNA vaccine prime at week 0,4,8 and rTV boost at week 24
干预措施: DNA vaccine (Biological)
group B
DNA vaccine prime at week 0,4,8 and rTV boost at week 24
干预措施: rTV boost (Biological)
group C
DNA vaccine prime at week 0,4,8 and rTV boost at week 32
干预措施: DNA vaccine (Biological)
group C
DNA vaccine prime at week 0,4,8 and rTV boost at week 32
干预措施: rTV boost (Biological)
group D
DNA vaccine prime with the addition of electroporation at week 0, 4, 8 and rTV boost at week 24
干预措施: DNA vaccine prime with the addition of electroporation (Biological)
group D
DNA vaccine prime with the addition of electroporation at week 0, 4, 8 and rTV boost at week 24
干预措施: rTV boost (Biological)
结局指标
主要结局
Occurrence, intensity and relationship to vaccination of local and general adverse events
时间窗: 28-day follow-up after rTV vaccination
Occurrence, intensity and relationship to vaccination of clinically significant abnormal haematology and biochemistry values (grade 4)
时间窗: During the study period (Month 0-20)
Occurrence and relationship to vaccination of any serious AEs (SAEs)
时间窗: During the study period (Month 0-20)
test HIV specific T cell response by ELISPOT
时间窗: 2wk, 4wk, 14wk, 24wk after rTV vaccination
test HIV specific antibody by ELISA
时间窗: 2wk, 4wk, 14wk, 24wk, 48wk after rTV vaccination
次要结局
- test HIV specific T cell response by ICS(4wk, 8wk, 14wk, 48wk after rTV vaccination)
- HIV neutralizing antibody test(4wk, 14wk, 48wk after rTV vaccination)
- vaccinia virus antibody test(2wk, 4wk, 24wk after rTV vaccination)