NL-OMON48531已完成不适用
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Protein ConM SOSIP.v7 gp140 Vaccine, Adjuvanted with MPLA Liposomes, in Healthy, HIV-Uninfected Adults - ACTHIVE-001
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
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. Men and women, aged between 18 and 50 years on the day of screening.
- •2. Willing to comply with the requirements of the protocol and available for
- •follow-up for the planned duration of the study.
- •3. Willing and able to give written informed consent.
- •4. Willing to undergo HIV testing, risk reduction counselling and receive HIV
- •test results, including the possibility of vaccine-induced seropositivity
- •5. All individuals engaging in sexual activity that could lead to pregnancy
- •must commit to use of an effective method of contraception for four months
- •following Investigational Medicinal Product administration.
- •6. All female volunteers must be willing to undergo urine pregnancy tests.
- •7. Willing to abstain from donating blood, eggs or sperm from the day of first
- •vaccination until at least 3 months after the end of their participation in the
- •8. All volunteers must be registered with a general practitioner.
排除标准
- •1. Confirmed HIV-1 or HIV-2 infection
- •2. Self-reported risk for HIV exposure or STIs prior to screening.
- •3. If female, pregnant or planning a pregnancy during the period of enrolment
- •until four months after the last study vaccination; or lactating.
- •4. Any clinically relevant medical condition that is considered in the opinion
- •of the investigator to make the volunteer unsuitable for participation in the
- •study (under which underlying haematological disorders, specified infectious
- •diseases, hyposplenia, auto-immune diseases, bleeding disorders, seizure
- •disorders, immunodeficiency, gastrointestinal, hepatic and cardiopulmonary
- •disorders). This also includes a history of malignancy in the past five years
- •(prior to screening) or ongoing malignancy. (Note: A history of a completely
- •excised malignancy that is considered cured is not an exclusion).
- •5. Receipt of any vaccine within 60 days of vaccination with the
- •Investigational Medicinal Product.
- •6. Receipt of blood products or blood-derived products within four months of
- •7. Participation in another clinical trial of an Investigational Medicinal
- •Product currently, within the previous three months or expected participation
- •during this study. Concurrent participation in an observational study, not
- •involving medicinal products and not requiring any blood or tissue sample
- •collection is not an exclusion criterion.
- •8. Prior receipt of another investigational HIV vaccine or HIV monoclonal
- •antibody (product). (Note: receipt of placebo in a previous HIV vaccine trial
- •will not exclude a volunteer from participation if documentation is available.)
- •9. Known hypersensitivity to any component of the vaccine formulation used in
- •this trial, or severe or multiple allergies to drugs or pharmaceutical agents.
- •10. Positive reaction in antinuclear antibody (ANA) screen and/or subsequent
- •anti-dsDNA assessment; or clinically significant immunoglobulin (IgA, IgG or
- •IgM) values.
- •11. Use of any medications, including over-the-counter products, which, in the
- •opinion of the investigators, would either interfere with the study or
- •potentially cause harm to the volunteer. Use of corticosteroids,
- •immunosuppressants, chemotherapeutics, anti-tuberculosis or other medications
- •considered significant by the investigator within the previous six months.
- •Specified exceptions apply.
- •12. Unable to read and speak Dutch or English to a fluency level adequate for
- •the full comprehension of procedures required in participation and consent.
研究者
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