NCT05005156已完成2 期
A Phase IIb Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of Two Doses of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Adults 18 Years of Age and Older, Living With HIV.
Fundación Huésped4 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2021年6月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 4
- 主要终点
- Suppression of HIV viral load at 24 and 52 weeks
研究概览
简要总结
A randomized, double-blind, placebo -controlled, phase IIb clinical trial to evaluate the efficacy, safety and immunogenicity of one or two doses of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in adults 18 years of age and older, living with HIV, on stable treatment, and virologically suppressed for at least 6 months
Protocol number: FH-58
详细描述
Primary Safety Objectives:
- Evaluate the incidence of solicited adverse reactions within 7 days after vaccination.
- Evaluate the incidence of unsolicited adverse events within 28 days after vaccination.
- Evaluate the HIV viral load 24 and 52 weeks after vaccination
- Evaluate the incidence of serious adverse events (SAE) and medically attended adverse events (MAE) within 52 weeks after vaccination in all participants.
Primary Immunogenicity Objectives:
- Evaluate the seroconversion rate of S-RBD IgG antibody on Day 28, Day 84 and Week 24 and Week 52 after vaccination, measured by ELISA.
- Evaluate the immunogenicity of two doses of the vaccine.
Secondary Safety Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults of 18 years of age, and older.
- •Confirmed HIV infection
- •At least two HIV plasma viral load (pVL) below 40 copies in the last 12 months, one within the last 60 days (value obtained at Screening visit can be used for the value within the last 60 days)
- •A CD4 count at screening equal or above 300 cells/mL and a CD4 percentage equal or above 15 % within the previous 60 days (value obtained at Screening visit can be used for the value within the last 60 days)
- •Participant must be on a stable highly active anti-retroviral treatment (HAART) for 6 months (unless the change is due to tolerability, in which case the regimen can be for only the previous 3 months) and with an estimated adherence of ≥80% within the last 60 days. - A HAART regimen (as defined by the Argentinean ART guidelines), means a combination of 2 NRTIs plus one INSTI or a NNRTI or a boosted PI or a dual combination of dolutegravir and 3TC.
- •Able and willing (in the Investigator's opinion) to comply with all study requirements.
- •Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner/personal doctor and access all medical records when relevant to study procedures.
- •Healthy adults, or stable-healthy adults who may have a pre-existing medical condition that does not meet any exclusion criteria. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
- •For females of childbearing potential only, willingness to practice continuous effective contraception (see glossary) for 30 days prior to enrollment in the study, for 90 days after receiving vaccination during the study, and have a negative pregnancy test on the day(s) of screening/ vaccination (First Injection Visit and Second Injection Visit).
- •Males participating in this study who are involved in heterosexual sexual activity must agree to practice adequate contraception (see glossary) and refrain from donating sperm for 90 days after receiving the study vaccination.
- •Agreement to refrain from blood donation during the study.
- •Provide written informed consent.
排除标准
- •Participation in any other COVID-19 prophylactic drug trials for the duration of the study.
- •Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalization due to COVID-
- •The study team should be informed as soon as possible.
- •Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study.
- •Note: Disclosure of serostatus post enrolment may accidentally unblind participants to group allocation. Participation in this trial can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys
- •Planned receipt of any vaccine (licensed or investigational), other than the study intervention, within 14 days before and after study vaccination
- •Prior receipt of an investigational or licensed vaccine likely to impact on the interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus or SARS vaccines)
- •Administration of immunoglobulins and/or any blood products within the three months prior to the planned administration of the vaccine candidate
- •Any confirmed or suspected immunosuppressive or immunodeficient state (other than living with HIV, on stable treatment, and virologically suppressed for at least 6 months); asplenia; recurrent severe infections and chronic use (more than 14 days) of immunosuppressant medication within the past 6 months. Topical steroids or short-term (course lasting ≤14 days) oral steroids are not an exclusion
- •Active opportunistic infections or other AIDS-defining illness in the last six months.
- •History of allergic disease or reactions likely to be exacerbated by any component of Ad5-nCoV
- •Any history of angioedema
- •Any history of anaphylaxis to any vaccine component
- •Pregnancy, lactation or willingness/intention to become pregnant within 90 days after receiving study vaccine
- •Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
- •History of serious psychiatric condition likely to affect participation in the study
- •Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture
- •Suspected or known current alcohol or drug dependency
- •Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well-controlled comorbidities are allowed)
- •History of laboratory-confirmed COVID-19
- •Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban)
- •Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
研究组 & 干预措施
Placebo for Ad5-nCoV
Placebo Comparator
Placebo for Ad5-nCoV, 0.5 mL/vial
干预措施: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV) (Biological)
Active vaccine Ad5-nCoV
Experimental
Active vaccine Ad5-nCoV, 0.5 mL/vial
干预措施: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV) (Biological)
结局指标
主要结局
Suppression of HIV viral load at 24 and 52 weeks
时间窗: 52 weeks after vaccination
Percentage of suppressed HIV viral load
Evaluate the incidence of solicited adverse reactions at 7 days after vaccination
时间窗: 7 days after vaccine
Evaluate the incidence of solicited adverse reactions at 7 days after vaccination
Evaluate the incidence of unsolicited adverse events at 28 days after vaccination
时间窗: 28 days after vaccine
Evaluate the incidence of unsolicited adverse events at 28 days after vaccination
Evaluate the incidence of serious adverse events (SAE) and medically attended adverse events
时间窗: 52 weeks after vaccination in all participants.
Evaluate the incidence of serious adverse events (SAE) and medically attended adverse events events (MAE)
Compare antibody response in both group
时间窗: during 52 weeks after vaccination
compare the seroconversion rate of S-RBD IgG antibody of one dose versus two doses of the vacccine
Evaluate the antibody response attended adverse
时间窗: during 52 weeks after vaccination
● Evaluate the seroconversion rate of S-RBD IgG antibody on Day 28, Day 84 and Week 24 and Week 52 after vaccination, measured by ELISA.
次要结局
- Evaluate impact in ratio CD4/CD8(during 52 weeks after vaccination)
- Geometric mean antibody titers(during 52 weeks after vaccination)
- Evaluate impact in CD4* cell(during 52 weeks after vaccination)
- Geometric Mean Increase(during 52 weeks after vaccination)
- Evaluate the seroconversion rate of pseudo-virus neutralizing antibody(during 52 weeks after vaccination)
- Evaluate impact in chemokines(during 52 weeks after vaccination)
研究者
Pedro Cahn
Scientific Director, MD; PhD
Fundación Huésped
研究点 (4)
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