COVID-19Phase 1NCT05706324
Phase Ⅰ Clinical Trial of a Candidate COVID-19 Vaccine
A Phase 1 study testing Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation in people with COVID-19, run by Wuhan BravoVax Co., Ltd. at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2023to Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- COVID-19
- Being tested
- Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation
- Keywords
- Inhalation, COVID-19 Vaccine
- Medical subject headings
- COVID-19, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for InhalationBiological
Also called RCVi
0.2mL/dose, Inhalation using a nebulizer
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | 21~65 year old healthy subjects, received low dose of RCVi Receives: Biological: Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation |
| Medium dose | Experimental | 21~65 year old healthy subjects, received medium dose of RCVi Receives: Biological: Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation |
| High dose | Experimental | 21~65 year old healthy subjects, received high dose of RCVi Receives: Biological: Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety in terms of adverse events
Number of Participants with any local and systemic Adverse Events (AEs)
Measured: within 30 minutes after vaccination
Safety in terms of solicited AEs
Number of Participants with solicited AEs
Measured: within 7 days after vaccination
Safety in terms of unsolicited AEs
Number of Participants with unsolicited AEs
Measured: 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
Measured: 4 days after vaccination
Safety in terms of SAEs
Number of Participants with SAEs
Measured: 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)
Measured: within 6 months after vaccination
Secondary outcomes (4)
Immunogenicity in terms of Humoral immune response by ELISA
GMT of S protein specific antibody by ELISA
Measured: 15, 29 days, 3 and 6 months after vaccination
Immunogencity in terms of Nab
GMT, seroconversion rate and GMFI of neutralizing antibody (NAb) response
Measured: 15, 29 days, 3 and 6 months after vaccination
Immunogencity in terms of Cellular immune response
Intracellular cytokine levels (ICS) in T lymphocytes
Measured: 15 days after vaccination
Immunogencity in terms of Mucosal immune response
Anti-SARS-CoV-2 S protein mucosal IgA antibodies
Measured: 15 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study startJun 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan BravoVax Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National University Hospital, Singapore, Shanghai BravoBio Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706324
- Sponsor's protocol ID
- BV-C315A-I-2022004
- Status last verified
- Nov 2022
- First submitted
- 29 Jan 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05706324
- Acronym / sponsor ID
- BV-C315A-I-2022004
- Conditions
- COVID-19
- Keywords
- Inhalation, COVID-19 Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wuhan BravoVax Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- National University Hospital, Singapore, Shanghai BravoBio Co., Ltd.
- Study start
- Jun 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Biological: Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation21~65 year old healthy subjects, received low dose of RCVi |
| Medium dose | Experimental | Biological: Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation21~65 year old healthy subjects, received medium dose of RCVi |
| High dose | Experimental | Biological: Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation21~65 year old healthy subjects, received high dose of RCVi |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for InhalationAlso: RCVi0.2mL/dose, Inhalation using a nebulizer | Biological | High dose, Low dose, Medium dose |
Primary outcome
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 solicited AEs
Time frame: within 7 days after vaccination
Number of Participants with solicited AEs
Safety in terms of unsolicited AEs
Time frame: within 28 days after vaccination
Number of Participants with unsolicited 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 SAEs
Time frame: within 6 months after vaccination
Number of Participants with SAEs
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)
4 secondary outcomes
Immunogenicity in terms of Humoral immune response by ELISA
Time frame: 15, 29 days, 3 and 6 months after vaccination
Immunogencity in terms of Nab
Time frame: 15, 29 days, 3 and 6 months after vaccination
Immunogencity in terms of Cellular immune response
Time frame: 15 days after vaccination
Immunogencity in terms of Mucosal immune response
Time frame: 15 days after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation in people with COVID-19, run by Wuhan BravoVax Co., Ltd. at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Long Xu, Ph.D. (+86 27 8798 8585 ext. 8251, ct@bravovax.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety in terms of adverse events (time frame: within 30 minutes after vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.