Phase II/III Parallel, Double-blind, Non-inferiority Study With Active Control, to Evaluate the Immunogenicity and Safety of a Booster Immunization Scheme With a Single Intramuscular Dose of the Recombinant Vaccine Against SARS-CoV-2
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4,065
- 试验地点
- 14
- 主要终点
- Phase III - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum
研究概览
简要总结
This is a phase II/III parallel, double-blind, active-controlled, non-inferiority study to evaluate immunogenicity and safety of a booster immunization scheme of a single intramuscular dose of the recombinant vaccine against SARS-CoV-2 (AVX/COVID-12 vaccine) based on live recombinant Newcastle disease virus (rNDV) vector in healthy adults with a history of vaccination against COVID-19. The study is divided into two phases with immuno-bridging and 3000 healthy subjects showing evidence of prior immunity to SARS-CoV-2 are estimated to enrol. To verify non-inferiority in a determined number of subjects an intramuscular dose of the COVID-19 vaccine (ChAdOx-1-S[recombinant]) shall be used as active control in originally randomised subjects. The study shall be carried out in several sites of clinical research in Mexico.
详细描述
General objective:
To demonstrate immunogenicity and safety of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot in previously vaccinated subjects and prove non-inferiority producing neutralizing antibodies anti-COVID-19 from 14 days after administration in comparison to the active control, whose efficacy has been formerly established in a placebo-controlled clinical study.
Primary objective:
Phase II:
To demonstrate immunogenicity of the AVX/COVID-12 vaccine (108.0 EID50/dose) as a single intramuscular booster shot to increase levels of Spike protein to ACE2 binding-inhibitory antibodies, as well as to increase titres of neutralizing antibodies anti-COVID-19 from 14 days after vaccine administration.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomization of patients shall be carried out by a computerized system. Once the informed consent signed, the patient shall be allocated with a number coding with all his/her pseudonymously information during collection and completely anonymised during analysis.
The randomization of the first 400 study subjects will include, in addition to 1:1 randomization (experimental vaccine: active control), randomization to participate as a subsample subject for cellular immune response determinations.
Once the 1664 subjects have been randomised, the following study subjects shall be designated as experimental vaccine receptors until have enrolled all the study subjects.
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
- •People ≥18 years old.
- •Have received their informed consent.
- •Negative PCR test for SARS-CoV-2 during the screening visit.
- •Negative pregnancy test in women with child-bearing potential.
- •Commitment to maintain adequate prevention measures to avoid contagion by SARS-CoV-2 throughout their participation in the study considering their strict following for the first 14 days after the baseline visit (use of face masks in closed places, social distancing measures in open spaces and frequent handwashing).
- •Have been vaccinated with any of the approved vaccines against SARS-CoV-2 (at least once).
排除标准
- •History of hypersensibility or allergy to any of the vaccine compounds.
- •History of severe anaphylactic reactions of any cause.
- •Fever at the baseline visit.
- •Active participation in any other clinical trial or experimental intervention within last 3 months.
- •Have received any vaccine (experimental or approved) within 30 days before baseline visit, except for influenza vaccine.
- •The last anti-COVID vaccination was less than 4 months ago.
- •SARS-CoV-2 infection occurred in less than 1 month ago.
- •Pregnant or nursing women.
- •Child-bearing potential and sexually active women who do not use highly effective birth control methods (oral contraceptives, intrauterine device, subcutaneous implant, transdermal patch used at least within 3 months) at the time of enrolment. Fertile and sexually active men not willing to strictly use (in all relationships) barrier methods of birth control throughout study. Those participants (both sexes) not sexually active can participate in the study if they are committed to avoid sexual intercourse throughout study (6 months).
- •Chronic diseases that require use of immunosuppressive agents or immune response modulators (for instance: systemic corticosteroids, cyclosporine, rituximab, among others).
- •Cancer under active chemotherapy treatment.
- •Subjects with HIV infection history.
- •Subjects with chronic renal or liver disease who have shown an infectious condition that required hospitalization or treatment with intravenous drugs within the last year prior baseline visit.
研究组 & 干预措施
Phase II - Experimental
AVX-COVID/12 Dose: 10^8.0 EID50/ intramuscular dose Study parameters: Safety, Serological response, Cellular response
干预措施: AVX-COVID/12 (Biological)
Phase II - Active Control
ChAdOx-1-S[recombinant]) intramuscular Study parameters: Safety, Serological response, Cellular response
干预措施: ChAdOx-1-S[recombinant] (Biological)
Phase III - Experimental
AVX-COVID/12 Intramuscular Dose: 10^8.0 EID50/ intramuscular dose Study parameters: Safety, Serological response
干预措施: AVX-COVID/12 (Biological)
Phase III - Active Control
ChAdOx-1-S[recombinant]) intramuscular Study parameters: Safety, Serological response
干预措施: ChAdOx-1-S[recombinant] (Biological)
Phase III - Security
AVX-COVID/12 Intramuscular Dose: 10^8.0 EID50/ intramuscular dose Study parameters: Safety.
干预措施: AVX-COVID/12 (Biological)
Phase II- Experimental
AVX-COVID/12 Dose: 10^8.0 EID50/ intramuscular dose Study parameters: Safety, Serological response.
干预措施: AVX-COVID/12 (Biological)
结局指标
主要结局
Phase III - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum
时间窗: 14 to 17 days after vaccination
Serum IgG, neutralizing antibodies
Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum
时间窗: 14 to 17 days after vaccination
Serum IgG, neutralizing antibodies
Phase II - T-cell elicited responses
时间窗: Day 14
Percentage of cells expressing IL2, TNF-alpha and IFN-gamma by Flow cytometry after challenge with spike protein.
次要结局
- Phase II - Increase in titres of neutralizing anti SARS-CoV-2 IgG antibodies in serum(Day 180 after vaccination)
- Phase III - Incidence of symptomatic COVID-19 disease cases(From 14 days after vaccination)
- Phase II - T-cell elicited responses(Day 180 after vaccination)
- Phase III - Incidence of severe COVID-19 disease cases or mortality(From 14 days after vaccination)