PACTR202407739287108尚未招募1 期
An Experimental Medicine Vaccine Trial of Mosaic HIV-1 Envelope Trimer Immunogens Administered to People Living With HIV PLWH) in Africa, Randomized for Assessment of Fractional Doses
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
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
- •1. Confirmed HIV-1 infection (HIV Ab+ or HIV RNA+) by documentation in the medical records or in-clinic HIV testing;
- •2. CD4 = 300 cells/µl;
- •3. Currently on ART, and documentation of continuous combination ART (cART) treatment with suppression of plasma HIV-1 viral load < 50 copies / ml for greater than 6 months, measured on at least 2 independent occasions, and with a viral load < 50 copies / ml at time of screening (within 42 days prior to IP administration). cART is defined as a regimen including = 2 compounds, e.g., 2 nucleoside reverse transcriptase inhibitors plus either nonnucleoside reverse transcriptase inhibitor or protease inhibitor or integrase inhibitor.
- •4. Having serum neutralization breadth of at least 20% using a 12-virus global panel at screening.
- •5. At least 18 years of age on the day of screening and has not reached his or her 51st birthday on the day of signing the Informed Consent Document.
- •6. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
- •7. 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 administration of the investigational product; written informed consent will be obtained from the participant before any study-related procedures are performed.
- •8. All sexually active female participants capable of becoming pregnant must commit to use an effective method of contraception for 4 months following IP administration, including:
- •a. Condoms (male or female) with or without spermicide
- •b. Diaphragm or cervical cap with spermicide
- •c. Intrauterine device, or contraceptive implant
- •d. Hormonal contraception
- •e. 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
排除标准
- •1. Any clinically significant acute or chronic medical condition, other than HIV infection, that is considered progressive or in the opinion of the investigator makes the participant unsuitable for participation in the study.
- •2. History of AIDS-defining illness or CD4 < 200 cells/µl.
- •3. If female, pregnant, lactating or planning a pregnancy during the period of screening through completion of the study.
- •4. In the past 6 months a history of alcohol or substance use, judged by the Investigator to potentially interfere with participant study compliance.
- •5. Bleeding disorder that was diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions). Note: A participant who states that he or she has easy bruising or bleeding but does not have a formal diagnosis and has intramuscular injections and blood draws without any adverse experience, is eligible.
- •6. History of a splenectomy.
- •7. Receipt of live attenuated vaccine within the previous 60 days or planned receipt within 60 days after administration of IP; or receipt of other vaccine within the previous 14 days or planned receipt within 14 days of administration of the IP (exception is live attenuated influenza vaccine within 14 days).
- •8. Receipt of blood transfusion or blood-derived products within the previous 3 months.
- •9. Participation in another clinical trial of an investigational product currently, within the previous 3 months or expected participation during this study.
- •10. Prior receipt of an investigational HIV vaccine candidate, monoclonal antibody, or polyclonal immunoglobulin (note: receipt of placebo in a previous HIV vaccine or monoclonal antibody trial will not exclude a participant from participation if documentation is available and the Medical Monitor gives approval.
- •11. History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory
- •difficulties, angioedema);
研究者
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