PACTR202006565880683招募中1 期
A randomized, double-blinded, placebo-controlled, dose-escalation phase 1 clinical trial to evaluate the safety and immunogenicity of recombinant HIV envelope protein BG505 SOSIP.664 gp140 Vaccine, Adjuvanted, in healthy, HIV uninfected adult
IAVI0 个研究点目标入组 60 人开始时间: 2020年6月4日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •12.Inclusion Criteria
- •1.Healthy male and female, including transgender individuals, as assessed by a medical history, physical exam, and laboratory tests
- •2.At least 18 years of age on the day of screening and has not reached his/her 51st birthday on the day of first vaccination
- •3.Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
- •4.In the opinion of the Principal Investigator or designee and based on Assessment of Informed Consent Understanding results, has understood the information provided and potential impact and/or risks linked to vaccination and participation in the trial; written informed consent will be obtained from the volunteer before any study-related procedures are performed
- •5.Willing to undergo HIV testing, risk reduction counselling and receive HIV test results
- •6.All individuals born female engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception for 4 months following the last investigational product administration, including:
- •Condoms (male or female) with or without spermicide
- •Diaphragm or cervical cap with spermicide
- •Intrauterine device, or contraceptive implant
- •Hormonal contraception
- •Successful vasectomy in the male partner (considered successful if a woman reports that a male partner has [1] documentation of azoospermia by microscopy (< 1 year ago), or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post-vasectomy)
- •Not be of reproductive potential, such as having undergone hysterectomy, bilateral oophorectomy, or tubal ligation, postmenopausal (> 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone [FSH] level > 40 IU/L); surgically sterile: no additional contraception required
- •Note: The Sponsor considers the above methods of contraception to be effective. More restrictive measures may be required by the site.
- •7.All volunteers born female, who are not heterosexually active at screening, must agree to utilize an effective method of contraception if they become heterosexually active, as outlined above
- •8.All volunteers born female must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Procedures (Appendix A and B)
- •9.All sexually active volunteers born male (unless anatomically sterile or in a monogamous relationship with a female partner who uses a documented method of birth control) must be willing to use an effective method of contraception (such as consistent condom use) from the day of first vaccination until at least 4 months after the last vaccination.
- •10.Willing to forgo donations of blood, or any other tissues during the study and, for those who test HIV-positive due to vaccine-induced antibodies, until the anti-HIV antibody titers become undetectable
排除标准
- •Exclusion Criteria
- •1.Confirmed HIV-1 or HIV-2 infection
- •2.Any clinically relevant abnormality on history or examination including history of immunodeficiency or autoimmune disease; use of corticosteroids (the use of topical, nasal, or inhaled steroids is permitted), immunosuppressive, anticancer, anti-tuberculosis or other medications considered significant by the investigator within the previous 6 months. The following exceptions are permitted and will not exclude study participation: use of corticosteroid nasal spray for rhinitis, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on investigator clinical judgment) at least 2 weeks prior to enrolment in this study
- •3.Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the investigator makes the volunteer unsuitable for participation in the study
- •4.Reported risk for HIV infection within 12 months prior to vaccination, as defined by:
- •Unprotected sexual intercourse with a known HIV infected person, a partner known to be at high risk for HIV infection or a casual partner (i.e., no continuing established relationship)
- •Engaged in sex work
- •Frequent excessive daily alcohol use or frequent binge drinking, or any use of illicit drugs
- •History of newly-acquired syphilis, gonorrhea, non-gonococcal urethritis, HSV-2, chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B
- •US sites: Four or more sexual partners; Kenya site: three or more sexual partners
- •5.If female, pregnant or planning a pregnancy during the period of enrolment until 4 months after the last study vaccination; or lactating
- •6.Bleeding disorder that was diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions.) (Note: A volunteer who states that he or she has easy bruising or bleeding, but does not have a formal diagnosis and has IM injections and blood draws without any adverse experience, is eligible)
- •7.Infectious disease: chronic hepatitis B infection (HbsAg-positive), current hepatitis C infection (for US sites: HCV Ab positive and HCV RNA positive, for Kenyan site: HCV Ab positive only) treatment for chronic hepatitis C infection in the past year, or active syphilis (positive RPR confirmed by TPHA); active tuberculosis (for African site only)
- •8.History of splenectomy
- •9.Any of the following abnormal laboratory parameters listed below:
- •?Absolute Neutrophil Count (ANC) – all volunteers: =1,000/mm3
- •?Absolute Lymphocyte Count (ALC) – all volunteers: =650/mm3
- •?Hemoglobin - African volunteers: <9.5 g/dl in females; <11.0 g/dl in males
- •?Hemoglobin - US volunteers: <10.5 g/dl in females; <11.0 g/dl in males
- •?Platelets - African volunteers: <100,000 cells/mm3
- •?Platelets - US volunteers: <125,000 cells/mm3
- •?Creatinine >1.1 x upper limit of normal (ULN)
- •?ALT >1.25 x ULN
- •?AST >1.25 x ULN
- •Clinically significant abnormal dipstick confirmed by microscopy:
- •?Protein = 1+ or more
- •?Blood = 2+ or more (not due to menses)
- •10.Receipt of live attenuated vaccine within the previous 30 days or planned receipt within 30 days after vaccination with Investigational Product;
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