COVID-19Phase 3NCT05124561
Study to Evaluate the inHaled Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) On the Protective-Efficacy in Adults (SeiHOPE)
A Phase 3 study testing Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH) in people with COVID-19, run by CanSino Biologics Inc..
Trial summary
This phase III clinical trial is an endpoint-driven randomized, double-blind, parallel-controlled, multicenter clinical trial, and around 13,000 subjects aged 18 years and above who have previously received 1 dose of intramuscular Ad5-nCoV will be recruited. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2021to 20 Aug 2022
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult volunteers aged 18 years and above who have received 1 dose of intramuscular Ad5-nCoV > 56 days at the enrollment.
- Volunteers who have provided informed consent and signed the informed consent form.
- Volunteers who are able and willing to comply with the requirements of the clinical study protocol, and can complete the entire follow-up period of this study.
Who cannot join
- Allergic to the active ingredient, any non-active ingredient, or substances used in the manufacturing process, or developed an allergy to similar vaccines in the past.
- History of severe anaphylactic reaction to vaccines (e.g., acute anaphylactic reactions, angioedema, dyspnea).
- History or family history of seizures, epilepsy, encephalopathy, or psychosis.
- Severe nasal or oral diseases, such as acute rhinitis (sinusitis), allergic rhinitis, oral ulcers, throat redness, and swelling.
- History of a definite diagnosis of COVID-19.
- Positive SARS-CoV-2 N antibody rapid screening kit (IgG and IgM) results.
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- Received COVID-19 vaccine other than Ad5-nCoV.
- Axillary temperature > 37.0°C.
- Severe cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, or severe hypertension and cannot be controlled by drugs.
- Lung function abnormalities such as asthma, chronic obstructive pulmonary disease, and pulmonary fibrosis.
- Acute febrile illness, symptoms of upper respiratory tract infection, or infectious diseases.
- Severe chronic diseases, or diseases of the progressive stage that cannot be steadily controlled, such as diabetes or thyroid disorders.
- Asplenia or functional asplenia.
- Thrombocytopenia or other coagulation disorder.
- Received immunosuppressant or immunomodulatory therapy (continuous oral or intravenous infusion for more than 14 days), anti-allergic therapy, cytotoxic therapy within the past 6 months. Inhalational and local steroids are allowed.
- Received blood products within 4 months before receiving the investigational vaccine.
- Received other vaccines within the past 14 days or plan to receive other vaccines 14 days after scheduled immunization with the investigational vaccine.
- Volunteers under antituberculous treatment or with active tuberculosis.
- Received blood/plasma products or immunoglobulin 60 days before immunization with the investigational vaccine or planned to receive blood/plasma products or immunoglobulin during the entire study period.
- Females who are positive for the urine pregnancy test, pregnant, or breastfeeding, or females who plan to conceive within 3 months (urine pregnancy test will only be performed in female volunteers of childbearing age).
- Volunteers who are judged by the investigator with any contradiction to the study protocol or affected the signing of informed consent due to various medical, psychological,social, or other conditions.
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial on the Efficacy, Safety, and Immunogenicity of Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation (Ad5-nCoV-IH) in Adults Aged 18 Years and Above Who Have Received One Dose of Intramuscular Ad5-nCoV
This phase III clinical trial is an endpoint-driven randomized, double-blind, parallel-controlled, multicenter clinical trial, and around 13,000 subjects aged 18 years and above who have previously received 1 dose of intramuscular Ad5-nCoV will be recruited. Volunteers should have been vaccinated with intramuscular Ad5-nCoV > 56 days prior to enrollment. All subjects will receive 1 dose of investigational vaccine or placebo through nebulized inhalation. The ratio of subjects in the vaccine group and placebo group is 1:1 and the efficacy and safety of the investigational vaccine will be followed up for 52 weeks after vaccination.
- Conditions
- COVID-19
- Being tested
- Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH), Placebo
- Keywords
- COVID-19, Vaccine, Inhalation, Ad5, Efficacy, Safety, Immunogenicity
- Medical subject headings
- COVID-19, Respiratory Aspiration, Alzheimer Disease 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)Biological
Nebulized inhalation through the mouth
PlaceboBiological
Nebulized inhalation through the mouth
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 6500 participants, Ad5-nCoV-IH, single dose, nebulized inhalation Receives: Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH) |
| Placebo group | Placebo comparator | 6500 participants, placebo, single dose, nebulized inhalation Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of COVID-19 cases.
The efficacy of Ad5-nCoV-IH in preventing virologically confirmed (PCR positive) COVID-19 disease.
Measured: Day 14 to 12 months post vaccination
Incidence of SAE
Evaluate the incidence of severe adverse events (SAE)
Measured: Within 12 months post vaccination
Secondary outcomes (12)
Incidence of COVID-19 cases
The efficacy of Ad5-nCoV-IH in preventing virologically confirmed (PCR positive) COVID-19 disease.
Measured: Day 28 to 12 months post vaccination
Incidence of severe COVID-19 cases
Evaluate the efficacy of Ad5-nCoV in preventing severe COVID-19 disease caused by SARS-CoV-2 infection.
Measured: Day 14 and Day 28 to 12 months post vaccination
Incidence of COVID-19 cases in different age groups
The efficacy of Ad5-nCoV-IH in preventing virologically confirmed (PCR positive) COVID-19 disease in participants between 18-59 years, and participants aged 60 years and above.
Measured: Day 14 and Day 28 to 12 months post vaccination
Incidence of Adverse Reactions (ARs)
Incidence of ARs within 30 minutes post vaccination in the safety cohort.
Measured: Within 30 minutes post vaccination
Incidence of Adverse Reactions (ARs)
Incidence of ARs within 14 days post vaccination in the safety cohort.
Measured: Within 14 days post vaccination
Incidence of Adverse Events (AEs)
Incidence of AEs within 28 days post vaccination in the safety cohort.
Measured: Within 28 days post vaccination
Immunogenicity of S-RBD IgG antibody (ELISA method)
Seroconversion rate of S-RBD IgG antibody post vaccination.
Measured: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of S-RBD IgG antibody (ELISA method)
GMT of S-RBD IgG antibody post vaccination.
Measured: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of S-RBD IgG antibody (ELISA method)
GMI of S-RBD IgG antibody post vaccination.
Measured: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of neutralizing antibodies
Seroconversion rate of neutralizing antibodies post vaccination.
Measured: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of neutralizing antibodies
GMT of neutralizing antibodies post vaccination.
Measured: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of neutralizing antibodies
GMI of neutralizing antibodies post vaccination.
Measured: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start15 Dec 2021 (estimated)
- Primary completion15 Apr 2022 (estimated)
- Study completion20 Aug 2022 (estimated)
Why it stopped: The trial protocol was not approved by the regulatory authorities.
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.
- More trials run by CanSino Biologics Inc.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CanSino Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Institute of Biotechnology
- Responsible party
- Sponsor
- Investigators
- Fengcai Zhu, Principal investigator, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124561
- Sponsor's protocol ID
- CS-CTP-AD5NCOV-IH-Ⅲ
- Status last verified
- Nov 2021
- First submitted
- 17 Nov 2021
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial on the Efficacy, Safety, and Immunogenicity of Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation (Ad5-nCoV-IH) in Adults Aged 18 Years and Above Who Have Received One Dose of Intramuscular Ad5-nCoV
- ClinicalTrials.gov ID
- NCT05124561
- Acronym / sponsor ID
- CS-CTP-AD5NCOV-IH-Ⅲ
- Conditions
- COVID-19
- Keywords
- COVID-19, Vaccine, Inhalation, Ad5, Efficacy, Safety, Immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The trial protocol was not approved by the regulatory authorities.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CanSino Biologics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Institute of Biotechnology
- Study start
- 15 Dec 2021 (estimated)
- Primary completion
- 15 Apr 2022 (estimated)
- Study completion
- 20 Aug 2022 (estimated)
- First posted
- 18 Nov 2021 (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.
This phase III clinical trial is an endpoint-driven randomized, double-blind, parallel-controlled, multicenter clinical trial, and around 13,000 subjects aged 18 years and above who have previously received 1 dose of intramuscular Ad5-nCoV will be recruited. Volunteers should have been vaccinated with intramuscular Ad5-nCoV > 56 days prior to enrollment. All subjects will receive 1 dose of investigational vaccine or placebo through nebulized inhalation. The ratio of subjects in the vaccine group and placebo group is 1:1 and the efficacy and safety of the investigational vaccine will be followed up for 52 weeks after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)6500 participants, Ad5-nCoV-IH, single dose, nebulized inhalation |
| Placebo group | Placebo comparator | Biological: Placebo6500 participants, placebo, single dose, nebulized inhalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult volunteers aged 18 years and above who have received 1 dose of intramuscular Ad5-nCoV > 56 days at the enrollment.
- Volunteers who have provided informed consent and signed the informed consent form.
- Volunteers who are able and willing to comply with the requirements of the clinical study protocol, and can complete the entire follow-up period of this study.
Key exclusion criteria (21 listed)
- Allergic to the active ingredient, any non-active ingredient, or substances used in the manufacturing process, or developed an allergy to similar vaccines in the past.
- History of severe anaphylactic reaction to vaccines (e.g., acute anaphylactic reactions, angioedema, dyspnea).
- History or family history of seizures, epilepsy, encephalopathy, or psychosis.
- Severe nasal or oral diseases, such as acute rhinitis (sinusitis), allergic rhinitis, oral ulcers, throat redness, and swelling.
- History of a definite diagnosis of COVID-19.
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 (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)Nebulized inhalation through the mouth | Biological | Experimental group |
| PlaceboNebulized inhalation through the mouth | Biological | Placebo group |
Primary outcome
Incidence of COVID-19 cases.
Time frame: Day 14 to 12 months post vaccination
The efficacy of Ad5-nCoV-IH in preventing virologically confirmed (PCR positive) COVID-19 disease.
Incidence of SAE
Time frame: Within 12 months post vaccination
Evaluate the incidence of severe adverse events (SAE)
12 secondary outcomes
Incidence of COVID-19 cases
Time frame: Day 28 to 12 months post vaccination
Incidence of severe COVID-19 cases
Time frame: Day 14 and Day 28 to 12 months post vaccination
Incidence of COVID-19 cases in different age groups
Time frame: Day 14 and Day 28 to 12 months post vaccination
Incidence of Adverse Reactions (ARs)
Time frame: Within 30 minutes post vaccination
Incidence of Adverse Reactions (ARs)
Time frame: Within 14 days post vaccination
Incidence of Adverse Events (AEs)
Time frame: Within 28 days post vaccination
Immunogenicity of S-RBD IgG antibody (ELISA method)
Time frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of S-RBD IgG antibody (ELISA method)
Time frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of S-RBD IgG antibody (ELISA method)
Time frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of neutralizing antibodies
Time frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of neutralizing antibodies
Time frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Immunogenicity of neutralizing antibodies
Time frame: Day 14, Day 28, Week 24, and Week 52 post-vaccination
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Fengcai Zhu principal investigator
Jiangsu Province Centers for Disease Control and Prevention
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH) in people with COVID-19, run by CanSino Biologics Inc..
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 3 inclusion and 21 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: withdrawn, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of COVID-19 cases. (time frame: Day 14 to 12 months post vaccination). The study lists 2 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 18 Jun 2023.