A Single-arm, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant COVID-19 Vaccine (Adenovirus Vector) for Inhalation in People 21 to 65 Years Old (Previously Primed With Authorized Vaccines)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Wuhan BravoVax Co., Ltd.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Safety in terms of SAEs
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
In this trial, a single-arm, open-label study design will be used to evaluate the safety and tolerability after vaccination with escalating doses of the investigational vaccine (Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation, RCVi) at low, medium, and high doses in healthy adults (previously primed with authorized vaccines).
Investigators
Eligibility Criteria
Inclusion Criteria
- •People aged 21 to 65 years old, with body weight ≥ 50 kg for males and ≥ 45 kg for females, body mass index (BMI) within the range of 19.0-30.0 (including the boundary value), who can provide legal identification;
- •Subjects who agree to participate in this study voluntarily and sign an Informed Consent Form.
- •Subject who has the ability to understand the study procedures and be able to attend all scheduled follow-up;
- •Individuals who completed basic vaccination of licensed vaccine or further received the first booster dose vaccination 4\~12 months prior to recruitment in this study（including but not limited to mRNA or non-mRNA vaccine）.
- •Female subjects who are not pregnant or breast-feeding;
- •Women of childbearing age who agree to use effective contraception during the study; or have been using effective contraception within 2 weeks prior to enrollment.
Exclusion Criteria
- •Those who had fever (body temperature≥ 38.0 °C/100.4 °F), dry cough, fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath, and dyspnea in the past 14 days before vaccination;
- •Subject whose SARS-CoV-2 nucleic acid test result is positive;
- •Subject with a body temperature of ≥ 38.0 °C/100.4 °F (axillary temperature) on the day of enrollment;
- •Subject who has oral ulcers, throat swelling and other oral and nasopharyngeal diseases;
- •Subject with abnormal vital signs, physical examination and laboratory test indicators at screening that are judged by clinicians to be clinically significant;
- •Subject who has a previous history of severe allergy to any drug, food or vaccination, such as urticaria, anaphylactic shock, allergic laryngeal edema, allergic dyspnea, skin eczema, Henoch-Schonlein purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc.;
- •Subject who has suffered from acute disease or in the acute attack stage of chronic disease within 3 days before vaccination, or has used antipyretic, analgesic and anti-allergy drugs;
- •Subject within 6 months prior to vaccination participation in a coronavirus (MERS-CoV, SARS-CoV-2) vaccine and/or drug (small molecule) and/or antibody study; Participation in any clinical study within 3 months prior to vaccination or planned participation in other (drug or vaccine) clinical studies during the study;
- •Subject who has received other vaccines within 1 month before vaccination;
- •Subject who has used immunoenhancers or immunosuppressants in the past 3 months;
Outcomes
Primary Outcomes
Safety in terms of SAEs
Time Frame: within 6 months after vaccination
Number of Participants with SAEs
Safety in terms of adverse events
Time Frame: within 30 minutes after vaccination
Number of Participants with any local and systemic Adverse Events (AEs)
Safety in terms of unsolicited AEs
Time Frame: within 28 days after vaccination
Number of Participants with unsolicited AEs
Safety in terms of solicited AEs
Time Frame: within 7 days after vaccination
Number of Participants with solicited AEs
Safety in terms of laboratory-based AEs
Time Frame: 4 days after vaccination
Changes in laboratory test indicators of clinical significance after vaccination as compared with those before vaccination
Safety in terms of MAAEs and AESIs
Time Frame: within 6 months after vaccination
Incidence of all Medical Attended Adverse Events (MAAEs) requiring medical attention and Adverse Events of Special Interest (AESIs)
Secondary Outcomes
- Immunogenicity in terms of Humoral immune response by ELISA(15, 29 days, 3 and 6 months after vaccination)
- Immunogencity in terms of Cellular immune response(15 days after vaccination)
- Immunogencity in terms of Nab(15, 29 days, 3 and 6 months after vaccination)
- Immunogencity in terms of Mucosal immune response(15 days after vaccination)