Phase Ⅰ Clinical Trial of a Candidate COVID-19 Vaccine

NCT05706324 | Unknown Phase 1

• 1 other identifier: BV-C315A-I-2022004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19

Keywords

Inhalation; COVID-19 Vaccine

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Immunogenicity in terms of Humoral immune response by ELISA

  15, 29 days, 3 and 6 months after vaccination

• Immunogencity in terms of Nab

  15, 29 days, 3 and 6 months after vaccination

• Immunogencity in terms of Cellular immune response

  15 days after vaccination

• Immunogencity in terms of Mucosal immune response

  15 days after vaccination

Study Arms (3)

Low dose

EXPERIMENTAL

21\~65 year old healthy subjects, received low dose of RCVi

Biological: Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation

Medium dose

EXPERIMENTAL

21\~65 year old healthy subjects, received medium dose of RCVi

Biological: Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation

High dose

EXPERIMENTAL

21\~65 year old healthy subjects, received high dose of RCVi

Biological: Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation

Interventions

Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation BIOLOGICAL

0.2mL/dose, Inhalation using a nebulizer

Also known as: RCVi

High dose; Low dose; Medium dose

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Wuhan BravoVax Co., Ltd.: lead
• National University Hospital, Singapore: collaborator
• Shanghai BravoBio Co., Ltd.: collaborator

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

COVID-19; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Long Xu, Ph.D.

CONTACT

+86 27 8798 8585; ct@bravovax.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: January 31, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: July 1, 2024
• Last Updated: April 25, 2023

Record last verified: 2022-11

Locations

SG (1)