NL-OMON54857招募中不适用
A randomized, double-blinded, placebo-controlled, dose-escalation phase 1 clinical trial to evaluate the safety and immunogenicity of recombinant HIV-1 envelope protein BG505 SOSIP.GT1.1 gp140 Vaccine, Adjuvanted in healthy, HIV-uninfected adults - IAVI C101
International AIDS Vaccine Initiative (IAVI)0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
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
- 18 至 99（—）
入选标准
- •1. Healthy adults 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
- •51 birthday on the day of first IP administration;
- •3. Willing to comply with the requirements of the protocol and be 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 IP
- •administration 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 volunteers born female who are engaging in sexual activity that could
- •lead to pregnancy must commit to use an effective method of contraception at
- •the time of the first IP administration and for 4 months following the last IP
- •administration;
- •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 Study Protocol;
- •9. All sexually active volunteers born male, regardless of reproductive
- •potential, must be willing to use an effective method of contraception (such as
- •consistent condom use) from the day of the first IP administration until at
- •least 4 months after the last IP administration;
- •10. Willing to forgo donations of blood, or any other tissues during the study
- •and, for those who test HIV-positive due to IP-induced antibodies, until the
- •anti-HIV antibody titers become undetectable.
排除标准
- •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 systemic
- •corticosteroids (the use of topical or inhaled steroids is permitted),
- •immunosuppressive, anticancer, antituberculosis or other medications considered
- •significant by the investigator within the previous 6 months. Specified
- •exceptions apply (refer to the Study Protocol);
- •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 behavior which put the volunteer at risk for HIV infection within 6
- •months prior to IP administration. Refer to the Study protocol for further
- •5. If female, pregnant or planning a pregnancy during the period of enrolment
- •until 4 months after the last IP administration; 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 diagnosis: chronic hepatitis B infection
- •(HbsAg-positive), current hepatitis C infection (HCV Ab positive and HCV RNA
- •positive or interferon-alfa treatment for hepatitis C infection in the past
- •year or interferon-alfa-free treatment for hepatitis C infection completed in
- •the past 6 months), or active syphilis (screening and confirmatory tests);
- •8. History of splenectomy;
- •9. Any of the abnormal laboratory parameters listed in the Study Protocol;
- •10. Receipt of live attenuated vaccine within the previous 30 days or planned
- •receipt within 30 days after IP administration; or receipt of other vaccine
- •within the previous 14 days or planned receipt within 14 days after IP
- •administration. (Exception is live attenuated influenza vaccine within 14
- •11. Receipt of blood transfusion or blood-derived products within the previous
- •12. Participation in another clinical trial of an investigational product
- •currently, within the previous 3 months or expected participation during this
- •study; concurrent participation in an observational trial not requiring blood
- •or tissue sample collection is not an exclusion;
- •13. Prior receipt of any investigational HIV vaccine candidate or HIV
- •monoclonal antibody
- •Note: receipt of placebo in a previous HIV vaccine trial or monoclonal antibody
- •trial will not exclude a volunteer from participation if documentation is
- •available and the Medical Monitor gives approval;
- •14. History of significant local or systemic reactogenicity to vaccines (e.g.,
- •anaphylaxis, respiratory difficulties, angioedema, injection site necrosis or
- •ulceration);
- •15. Psychiatric condition that compromises safety of the volunteer and
- •precludes compliance with the protocol. Specifically excluded are persons with
- •psychoses within the past 3 years, ongoing risk for suicide, or history of
- •suicide attempt or gesture within the past 3 years;
- •16. Seizure disorder: A volunteer who has had a seizure in the last 3 years is
- •excluded. (Not excluded: a volunteer wit
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