PACTR202009737295685尚未招募1 期
A Randomized, Double-Blind Phase 1 Trial to Evaluate the Safety and Immunogenicity ofPriming with Env-C Plasmid DNA Vaccine Alone, with Different Adjuvants, or with anAdjuvanted HIV Env gp145 C.6980 Protein Vaccine and Boosting with the AdjuvantedHIV Env gp145 C.6980 Protein Vaccine with or without the Env-C Plasmid DNA Vaccinein Healthy HIV Uninfected Adults in Kenya
IAID0 个研究点目标入组 126 人开始时间: 2020年7月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
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
- •INCLUSION CRITERIA
- •1. Healthy, male and female participant aged 18 to 40 years and available for 26
- •2. Must be at low risk for HIV infection per investigator assessment and using
- •the study risk assessment tool.
- •3. Must be able to understand and complete the informed consent process.
- •4. Must be capable of reading English or Kiswahili.
- •5. Must agree to a home visit.
- •6. Must complete a Test of Understanding (TOU) before enrollment. Must
- •answer 9 out of 10 questions correctly, with a maximum of three attempts.
- •7. Must be in good general health without a clinically significant medical history.
- •8. HIV-uninfected per diagnostic algorithm within 45 days of enrollment.
- •9. Laboratory values:
- •Hemoglobin:
- •12.5-18.1 g/dL men
- •11.0-16.1 g/dL women
- •White Cell Count:
- •2.7-7.7 x 103 cells/µL men
- •3.0-9.1 x 103 cells/µL women
- •Platelets:
- •125-370 103 cells/µL men
- •125-444 103 cells/µL women
- •ALT and AST: =1.25 institutional upper limit of the reference range
- •Creatinine: =1.25 institutional upper limit of the reference range
- •Urinalysis: (dipstick) for blood and protein less than 1+ and negative glucose
- •Female-Specific Criteria:
- •10. Negative urine pregnancy test for women at screening, the day of each
- •vaccination, and before any invasive procedure.
- •11. Already using and commits to continued use of an adequate birth control
- •method for 45 days before to the first vaccine/placebo vaccination and for at
- •least 90 days after the final vaccine/placebo vaccination. Adequate birth
- •control is defined as follows: Contraceptive medications delivered orally,
- •intramuscularly, vaginally, or implanted, underneath the skin, surgical
- •methods (hysterectomy or bilateral tubal ligation), condoms with spermicide,
- •diaphragms, intrauterine device (IUD
排除标准
- •1. Three or more sexual partners in the previous 24 weeks
- •2. Commercial sex work
- •3. Non-adherence to condom use in the absence of a long-term monogamous
- •relationship
- •4. Intravenous drug use in the previous year.
- •5. A sexually transmitted infection in the previous 24 weeks
- •6. Asplenia: any condition resulting in the absence of a functional spleen
- •7. Bleeding disorder diagnosed by a medical doctor (e.g., factor deficiency,
- •coagulopathy, or platelet disorder requiring special precautions)
- •8. Breastfeeding or pregnant (positive pregnancy test) women or planning to
- •become pregnant during the window between study enrollment and three
- •months after the last vaccination visit.
- •9. Any past, ongoing, or in remission history of treated or untreated autoimmune
- •10. Has known active Hepatitis B virus infection (or positive HBsAg).
- •11. History of anaphylaxis or other serious adverse reaction to vaccines or allergies
- •or reactions likely to be exacerbated by any component of the vaccine and
- •placebo, including antibiotics or excipients
- •12. Absolute Neutrophil Count (ANC):
- •<1.0 x 103 cells/µL
- •13. Participant has received any of the following substances:
- •Chronic use of therapies that may modify immune response, such as intravenous
- •(IV) immune globulin and systemic corticosteroids (in doses of >20 mg/day
- •prednisone equivalent for periods exceeding 10 days)
- •The following exceptions are permitted and will not exclude study participation:
- •o use of corticosteroid nasal spray for rhinitis,
- •o topical corticosteroids for an acute uncomplicated dermatitis; or
- •o A short course (10 days or less, or a single injection) of corticosteroid for a
- •non-chronic condition (based on investigator clinical judgment) at least 2
- •weeks before enrollme
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