Phase Ⅰ Clinical Trial of a Candidate COVID-19 Vaccine

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)

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).

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19
• Intervention / Treatment: Biological: Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Long Xu, Ph.D.; Phone Number: 8251 +86 27 8798 8585; Email: ct@bravovax.com

Study Locations

• Singapore
  • Singapore, Singapore
    • National University Hospital
    • Principal Investigator: Paul Tambyah, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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;
• Subject who was diagnosed with congenital or acquired immunodeficiency, or suspected to have systemic diseases that may interfere with the conduct or completion of the study, such as tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV), syphilis infection, etc.;
• Subject who was diagnosed with serious diseases, congenital anomalies or chronic disease that may interfere with the conduct or completion of the study (including but not limited to: allergy to vaccines, asthma and other respiratory diseases or chronic bronchitis, hypertension, hypotension, heart disease, kidney disease, diabetes mellitus (type 1 or type 2), autoimmune diseases, thalassemia, malignant tumor, atopy, existing skin diseases, etc.);
• Subject who has received blood or blood-related products (such as blood transfusion, use of human albumin, human immunoglobulin, etc.) within the past 6 months;
• Subject with a history or family history of convulsions, epilepsy, encephalopathy and psychosis;
• Subject with functional asplenia or splenectomy caused by any situation;
• Subject who has any condition that, in the opinion of the investigator, may interfere with the evaluation of the objectives of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose; 21~65 year old healthy subjects, received low dose of RCVi	Biological: Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation; 0.2mL/dose, Inhalation using a nebulizer; Other Names: RCVi
Experimental: Medium dose; 21~65 year old healthy subjects, received medium dose of RCVi	Biological: Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation; 0.2mL/dose, Inhalation using a nebulizer; Other Names: RCVi
Experimental: High dose; 21~65 year old healthy subjects, received high dose of RCVi	Biological: Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation; 0.2mL/dose, Inhalation using a nebulizer; Other Names: RCVi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety in terms of adverse events	Number of Participants with any local and systemic Adverse Events (AEs)	within 30 minutes after vaccination
Safety in terms of solicited AEs	Number of Participants with solicited AEs	within 7 days after vaccination
Safety in terms of unsolicited AEs	Number of Participants with unsolicited AEs	within 28 days after vaccination
Safety in terms of laboratory-based AEs	Changes in laboratory test indicators of clinical significance after vaccination as compared with those before vaccination	4 days after vaccination
Safety in terms of SAEs	Number of Participants with SAEs	within 6 months after vaccination
Safety in terms of MAAEs and AESIs	Incidence of all Medical Attended Adverse Events (MAAEs) requiring medical attention and Adverse Events of Special Interest (AESIs)	within 6 months after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity in terms of Humoral immune response by ELISA	GMT of S protein specific antibody by ELISA	15, 29 days, 3 and 6 months after vaccination
Immunogencity in terms of Nab	GMT, seroconversion rate and GMFI of neutralizing antibody (NAb) response	15, 29 days, 3 and 6 months after vaccination
Immunogencity in terms of Cellular immune response	Intracellular cytokine levels (ICS) in T lymphocytes	15 days after vaccination
Immunogencity in terms of Mucosal immune response	Anti-SARS-CoV-2 S protein mucosal IgA antibodies	15 days after vaccination

Collaborators and Investigators

• Sponsor: Wuhan BravoVax Co., Ltd.
• Collaborators: National University Hospital, Singapore; Shanghai BravoBio Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: January 29, 2023
• First Submitted That Met QC Criteria: January 29, 2023
• First Posted (Actual): January 31, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Inhalation; COVID-19 Vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: BV-C315A-I-2022004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No