Phase II Study to Evaluate Immunogenicity and Safety in Subjects With Evidence of Prior Immunity to SARS-CoV-2 of a Single Intramuscular or Intranasal Dose of the Live Recombinant Newcastle Disease Virus Based AVX/COVID-12 Vaccine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 4
- 主要终点
- T-cell elicited responses
研究概览
简要总结
This is a Phase II study with single-blinded safety phase followed by double-blinded randomization, placebo-controlled, of administration of a single dose by two different administration routes (intramuscular route or intranasal route), to evaluate immunogenicity and safety of the recombinant SARS-CoV-2 vaccine (AVX/COVID-12 vaccine) based a live Newcastle disease viral vector (rNDV) in 396 healthy subjects with evidence of prior immunity to SARS-CoV-2, followed by a booster response assessment with an intramuscular dose of COVID-19 vaccine (ChAdOx-1 -S[recombinant]) in subjects originally randomized to the placebo arm at several research sites in Mexico City.
详细描述
General objective:
To demonstrate immunogenicity due to the administration of a single dose of AVX/COVID-12 vaccine at a dose of 108.0 EID50%/dose by the intramuscular or intranasal route in subjects with evidence of prior immunity to SARS-CoV-2.
Primary objectives:
- To demonstrate an increase in the total titers of neutralizing anti-Spike IgG antibodies in serum, as well as an increase in the proportion of peripheral blood T lymphocytes that produce interferon gamma in response to stimulation with Spike protein or peptides derived from Spike protein, 14 days after intramuscular administration of a single dose of AVX/COVID-12 vaccine (108.0 EID50%/dose) compared to the response obtained after administration of placebo.
- To demonstrate an increase in the total titers of neutralizing anti-Spike IgG antibodies in serum, as well as an increase in the proportion of peripheral blood T lymphocytes that produce interferon gamma in response to stimulation with Spike protein or peptides derived from Spike protein, 14 days after intranasal administration of a single dose of AVX/COVID-12 vaccine (108.0 EID50%/dose) compared with the response obtained after administration of placebo.
Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
The first sentinel group (6 of each previous vaccine) will be without masked only to the subjects to ensure safety measurement in each group. The randomized double-mask placebo-controlled phase will begin when the safety committee, after evaluating the information from the sentinel group of the first three subjects (by vaccine and by specific route of administration), gives authorization to continue with the recruitment. It will be conducted through a computerized assignment system. Randomization for the double-masking phase of the study will be carried out using a computer assignment system.
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
- •Be ≥ 18 years old.
- •Indistinct sex.
- •Having given their informed consent.
- •No respiratory problems during the last 21 days prior to administration of the single dose.
- •No conditions or alterations in the physical examination, laboratory values and cabinet that in the opinion of the investigator may interfere with the participation of the subject in the study or require a more detailed medical study.
- •Negative PCR test for SARS-CoV-2 during the screening visit.
- •Negative pregnancy test in women with pregnancy potential.
- •Signature of commitment for the use of highly effective contraceptive methods for at least 30 days after administration of the intramuscular injection or intranasal.
- •In case of presenting any chronic disease with medical management, it must be controlled and stable without changes in treatment during the last three months prior to the scrutiny visit.
- •Commitment to maintain adequate prevention measures to avoid the contagion by SARS-CoV-2 during their participation in the study, considering themselves these strict use during the first 14 days after the baseline visit (Use of face masks in closed places, social distancing measures in spaces open, and frequent hand washing).
- •Present detectable titers of anti-Spike IgG in peripheral serum during the visit of screening with titers less than 1,200 U/mL in a chemiluminescence test.
- •Submit proof of vaccination 4 months or more after the last vaccination
- •Have been vaccinated with the complete program of any of the following vaccines against SARS-CoV-2:
- •AstraZeneca
- •Sinopharm
- •Johnson & Johnson (Janssen)
- •Sputnik V
排除标准
- •History of hypersensitivity or allergy to any of the components of the vaccine.
- •History of severe anaphylactic reactions from any cause.
- •History of seizures.
- •Uncontrolled chronic diseases.
- •Chronic diseases that require management with immunosuppressive agents or immune response modulators (eg, systemic corticosteroids, cyclosporine, rituximab among others).
- •Oncological disease.
- •Active participation, or during the last 3 months in any other clinical study or research experimental intervention.
- •Use within 30 days prior to screening evaluation of any drug or herbal supplement, or alternative medicine (for example, transfer factor, chlorine dioxide, etc.) aimed at treating or preventing complications or contagion by SARS-CoV-2, or any other condition.
- •Febrile illness at the time of the screening visit.
- •Have received any vaccine (experimental or approved) during the 60 days prior to the scrutiny visit.
- •Having received a blood transfusion or blood components during the last 4 months prior to the scrutiny hearing.
- •Have been a plasma donor during the last 4 months prior to the visit of scrutiny.
- •Have undergone dialysis or hemodialysis procedures during the last year prior to the scrutiny visit.
- •Work on poultry or gamecock farms.
- •History of substance abuse problems that in the opinion of the investigator could interfere with the subject's ability to adequately comply with the protocol guidelines.
研究组 & 干预措施
Intramuscular
10 8.0 EID 50/dose intramuscular
干预措施: Recombinant NDV Vectored Vaccine for SARS-CoV-2 (Biological)
Intranasal
10 8.0 EID 50/dose intranasal
干预措施: Recombinant NDV Vectored Vaccine for SARS-CoV-2 (Biological)
Intramuscular Placebo
Physiological saline solution of Sodium Chloride at 0.9% Intramuscular After mask opening ChAdOx-1-S[recombinant]) Intramuscular
干预措施: Placebo (Biological)
Intranasal Placebo
Physiological saline solution of Sodium Chloride at 0.9% Intranasal After mask opening ChAdOx-1-S[recombinant]) Intramuscular
干预措施: Placebo (Biological)
结局指标
主要结局
T-cell elicited responses
时间窗: Day 14
Percentage of cells expressing IL2, TNFalpha and IFNgamma by Flow cytometry after challenge with spike protein
Titers of circulating anti SARS-CoV-2 antibodies
时间窗: Day 14
Serum IgG, neutralizing antibodies
次要结局
- Titers of circulating anti SARS-CoV-2 antibodies(Day 365)
- T-cell elicited responses(Day 365)