A Phase 1a, Single-Blind, Randomized Comparative Clinical Trial Evaluating the Impact of Vaccine Formulation on the Safety and Immunogenicity of the COV2 Vaccine in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Primary safety endpoints
研究概览
简要总结
This is a Phase 1a, single-country, single-centre, single-blinded, COV2 vaccine formulation randomized trial designed to investigate and compare the safety and immunogenicity of two COV2 vaccine formulations. COV2 is a nasal, investigational vaccine against COVID-19, based on a serotype 5 adenoviral vector producing modified SARS-CoV-2 spike protein.
Participants will receive one of the two COV2 formulations in two doses on Day 0 and Day 28.
This trial consists of two parts; Part 1 is a vaccination phase assessing safety and immunogenicity and Part 2 is a long-term immunogenicity follow-up assessing persistence of immune response.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has voluntarily signed the written informed consent
- •Male or female aged ≥18 to ≤75 years
- •Good general health based upon the results of the medical history, laboratory tests, physical examination, ENT clinical examination, and vital signs as assessed by the investigator
- •Prior vaccination with at least two doses of any COVID-19 vaccine with last dose obtained ≥180 days before the planned baseline (Day 0) visit
- •Has a personal smartphone, tablet or computer with internet access, and is considered willing and able to report the data in the ePRO and to comply with the reporting timelines
- •Willing and able to comply with the instructions to participants
- •Not of childbearing potential or willing and able to use a highly effective contraception method consistently and correctly during the entire trial
排除标准
- •Pregnant, planning to become pregnant, or breastfeeding women
- •Received any investigational drug < 180 days prior baseline
- •Antigen positivity or PCR confirmed SARS-CoV-2 infection less than 180 days apart from screening or during screening and/or baseline
- •Any SARS-CoV vaccination was administrated < 180 days prior the planned baseline (Day 0) visit
- •Any other vaccination within 60 days prior the planned baseline (Day 0) visit
- •Administration of immunoglobulins or blood products within 90 days prior baseline
- •Current use of immunosuppressant medication (except topical and inhaled steroids, which are permitted in indications not prohibited in the exclusion criteria)
- •Use of steroid nasal sprays within 30 days prior to screening
- •Use of any oral or nasal decongestants within 7 days prior to screening
- •Any confirmed or suspected immunodeficient state
- •Chronic respiratory diseases (except treatment -controlled asthma)
- •Severe chronic cardiovascular and endocrinological diseases (e.g., medicine or insulin treated diabetes), liver and renal insufficiency or serious psychiatric diseases
- •- Medication for elevated cholesterol or blood pressure or dietary treated diabetes or hypothyreosis are not exclusion criteria
- •Any diagnosed disease or abnormality in the nasal or upper respiratory tract, such as acute/chronic rhinosinusitis; nasal polyposis; mucosal pathology or tumor of nasal cavity, pharynx or nasopharynx; significant obstructive nasal deformity; recurrent epistaxis; sleep apnea; anosmia
- •- History of adenoidectomy and/or tonsillectomy are not exclusion criteria
- •Severe obesity (BMI ≥ 35)
- •Cancer treated within 5 years
- •Known allergy/hypersensitivity to any ingredients of the COV2 vaccine
- •Previous anaphylactic reaction
- •Any clinically significant abnormal finding in the screening laboratory tests
- •Inability to sign ICF or to understand and comply with trial related instructions and requirements
- •Individuals who are employees of, or directly affiliated with, the sponsor, or site staff or their immediate family members.
研究组 & 干预措施
COV2 vaccine in Formulation A
COV2 vaccine given in formulation A in 2 doses as a nasal spray, 28 days between each dose.
干预措施: COVID-19 Vaccines (Biological)
COV2 vaccine in formulation B
COV2 vaccine given in formulation B in 2 doses as a nasal spray, 28 days between each dose.
干预措施: COVID-19 Vaccines (Biological)
结局指标
主要结局
Primary safety endpoints
时间窗: From Day 0 to day 56
Incidence of Treatment-emergent expected and unexpected adverse events
Primary immunogenicity endpoint
时间窗: Day 56 from baseline
The percentage of participants achieving ≥2-fold rise (seroresponse) in SARS-CoV-2 serum neutralizing antibody (NAb) titers against Omicron BA.5 variant
次要结局
未报告次要终点