COVID-19Phase 1/2NCT04840992

Phase I/II Clinical Trial of Recombinant Novel Coronavirus (COVID-19) Vaccine (Adenovirus Type 5 Vector) for Inhalation

A Phase 1/2 study testing Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation and Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people with COVID-19, run by CanSino Biologics Inc. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is a randomized, double-blind, placebo-controlled I/II clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation in adults 18 years of Age and Older. 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 Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation and Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 840 participants
Where: 1 siteChina
Study dates: 21 Apr 2021to 9 Aug 2022
Phase: Phase 1/2
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

Healthy adults 18 years of age and above at the time of enrollment;
Able to provide consent to participate in and having signed an Informed Consent Form (ICF);
Able and willing to complete all the scheduled study procedures during the whole study follow-up period;
HIV negative;
No nasal or oral diseases, such as acute rhinitis (sinusitis), allergic rhinitis, oral ulcers, sore throat, etc;
IgG ang IgM negative for Covid-19;
Axillary temperature ≤37.0℃;
No contact history of Covid-19.

Who cannot join

Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrollable medications (on-site measurement: systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg), etc;
Abnormal laboratory test indicators which investigator decide to be clinically significant; (Only Phase I volunteers)
Respiratory rate ≥17 per minute;
Abnormal lung function such as asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, etc;
Prior Covid-19 vaccinations;
Symptoms of upper respiratory track infections;

Show all 24Show fewer

Medical or family history of convulsions, epilepsy, encephalopathy, and psychosis disorders;
History of allergies to any ingredient of Ad5-nCoV, history of serious allergic reactions to any vaccine, history of allergies and immune diseases;
Acute febrile diseases and infectious diseases;
Medical history of SARS (SARS-CoV-1);
Severe chronic diseases or with advanced stage conditions which cannot be controlled smoothly, such as diabetes, thyroid disease, etc;
Congenital or acquired angioedema/neurological edema;
Urticaria history within 1 year before receiving the study vaccine;
Asplenia or functional asplenia;
Thrombocytopenia or other coagulation disorders (may cause contraindications for intramuscular injection);
Trypanophobia in intramuscular injection groups;
History of receiving immunosuppressant therapy (continuous oral or instillation for more than 14 days), anti-allergic therapy, cytotoxic therapy, nebulized corticosteroid therapy in the past 6 months;
Prior administration of blood products in last 4 months;
Other vaccination(s) or investigational drugs within 1 month before study onset, or planned use during the study period;
Prior administration of live attenuated vaccine within 1 month before study onset;
Prior administration of subunit or inactivated vaccine within 14 days before study onset;
Current anti-tuberculosis therapy;
Women who are pregnant or lactating, positive urine pregnancy test or plan to become pregnant during the whole study;
Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives or informed consent (i.e. medical, psychological, social or other conditions, etc.) Exclusion criteria for the phase II portion of the study will be detailed in an amended synopsis/study protocol.

Trial locations and contacts

1 site in 1 country.

China1 site

Jiangsu Provincal Center for Disease Control and Prevention
Nanjing, Jiangsu

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-Controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-nCoV for Inhalation in Adults 18 Years of Age and Older

Conditions: COVID-19
Being tested: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation, Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector), Placebo for Inhalation, Placebo
Keywords: COVID-19, Vaccine, Ad5, Safety, Immunogenicity, SARS-CoV-2, Adenovirus Vector, Aerogen Solo
Medical subject headings: COVID-19, Alzheimer Disease 5

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for InhalationBiological
Aerogen Solo
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)Biological
Intramuscular administration
Placebo for InhalationBiological
Aerogen Solo
PlaceboBiological
Intramuscular administration

Study groups in NCT04840992
Study group	Role	What they receive
A1a Phase I low 2 doses	Experimental	Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
A1b Phase I placebo low 2 doses	Placebo comparator	Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo Receives: Biological: Placebo for Inhalation
A2a Phase I medium 2 doses	Experimental	Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
A2b Phase I placebo medium 2 doses	Placebo comparator	Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo Receives: Biological: Placebo for Inhalation
A3a Phase I high 2 doses	Experimental	Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
A3b Phase I placebo high 2 doses	Placebo comparator	Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo Receives: Biological: Placebo for Inhalation
A4a Phase I combine 2 doses	Experimental	1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation; Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
A4b Phase I placebo combine 2 doses	Placebo comparator	6 subjects, Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart Receives: Biological: Placebo for Inhalation; Biological: Placebo
A5a Phase I single dose	Experimental	Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
A5b Phase I placebo single dose	Placebo comparator	6 subjects, Placebo containing 0 vp, 1 dose Aerogen Solo Receives: Biological: Placebo for Inhalation
B1a Phase II low 2 doses	Experimental	Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
B1b Phase II placebo low 2 doses (18-59)	Placebo comparator	Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo Receives: Biological: Placebo for Inhalation
B2a Phase II medium 2 doses	Experimental	Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
B2b Phase II placebo medium 2 doses	Placebo comparator	Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo Receives: Biological: Placebo for Inhalation
B3a Phase II high 2 doses	Experimental	Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
B3b Phase II placebo high 2 doses	Placebo comparator	Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo Receives: Biological: Placebo for Inhalation
B4a Phase II combine 2 doses	Experimental	1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation; Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
B4b Phase II placebo combine 2 doses	Placebo comparator	Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart Receives: Biological: Placebo for Inhalation; Biological: Placebo
B5a Phase II intramuscular single dose	Experimental	Ad5-nCoV containing 5E10 vp, 1 dose Intramuscular Injection Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
B5b Phase II placebo intramuscular single dose	Placebo comparator	placebo containing 0 vp, 1 dose Intramuscular Injection Receives: Biological: Placebo
B6a Phase II Aerogen Solo single dose	Experimental	Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation
B6b Phase II placebo Aerogen Solo single dose	Placebo comparator	placebo containing 0 vp, 1 dose Aerogen Solo Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Adverse Reactions (AR)
The occurrence of Adverse Reactions (AR) in all groups
Measured: 0-14 days after each vaccination
Incidence of Serious Adverse Events (SAE)
The occurrence of Serious Adverse Events (SAE) in all groups
Measured: Within the first and final vaccination up until 12 months after the final vaccination

Secondary outcomes (16)

Incidence of Adverse Events/Reactions (AE/AR)
The occurence of Adverse Events/Reactions (AE/AR) in all groups
Measured: Within 0-7 days after each vaccination
Incidence of Adverse Events/Reactions (AE/AR)
The occurence of Adverse Events/Reactions (AE/AR) in all groups
Measured: Within 0-28 days after each vaccination
Changes in laboratory test indicators
Changes in laboratory test indicators (including white blood cell count, lymphocyte count, etc), and respiratory rate in all groups
Measured: 4 days after each vaccination
GMT of Covid-19 S protein RBD specific antibody
GMT of S protein RBD specific antibody by ELISA
Measured: Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose
Seroconversion rate of Covid-19 S protein RBD specific antibody
Seroconversion rate of S protein RBD specific antibody by ELISA
Measured: Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose
GMI of Covid-19 S protein RBD specific antibody
GMI of S protein RBD specific antibody by ELISA
Measured: Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose
GMT of SARS-CoV-2 neutralizing antibody
GMT of SARS-CoV-2 neutralizing antibody against pseudovirus
Measured: Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Seroconversion rate of SARS-CoV-2 neutralizing antibody against pseudovirus
Measured: Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose
GMI of SARS-CoV-2 neutralizing antibody
GMI of SARS-CoV-2 neutralizing antibody against pseudovirus
Measured: Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose
GMT of SARS-CoV-2 neutralizing antibody
Measured: 28 days after the final vaccination
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Measured: 28 days after the final vaccination
Cellular immune response
The positive rate of IFN-γ stimulated by S protein ELISpot
Measured: Before the first dose, 14 days after the first dose
Cellular immune response
The positive rate of TNF-α stimulated by S protein ELISpot
Measured: Before the first dose, 14 days after the first dose
Cellular immune response
The positive rate of IL-5 stimulated by S protein ELISpot
Measured: Before the first dose, 14 days after the first dose
Cellular immune response
The positive rate of IL-4 stimulated by S protein ELISpot
Measured: Before the first dose, 14 days after the first dose
Cellular immune response
The positive rate of IL-13 stimulated by S protein ELISpot
Measured: Before the first dose, 14 days after the first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Apr 20219 Aug 2022

First posted12 Apr 2021
Study start21 Apr 2021
Primary completion8 Jul 2022
Study completion9 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 840 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04840992
Sponsor's protocol ID: JSVCT092
Status last verified: Oct 2022
First submitted: 8 Apr 2021
Last updated: 8 Feb 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Zhu Y, Tang R, Li X, Chen X, Wang X, Wang Y, Wang R, Zhu F, Li J. Vaccination with Adenovirus Type 5 Vector-Based COVID-19 Vaccine as the Primary Series in Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 1/2 Clinical Trial. Vaccines (Basel). 2024 Mar 11;12(3):292. doi: 10.3390/vaccines12030292.
PubMed 38543926
Xia X, Tan ZM, Wan P, Zheng H, Tang R, Chen XQ, Guo XL, Zhu T, Feng JL, Zhong J, Li XL, Zhang ZY, Zhu FC, Li JX. Environmental Impact Assessment for the Use of an Orally Aerosolized Adenovirus Type-5 Vector-Based COVID-19 Vaccine in Randomized Clinical Trials. J Infect Dis. 2023 Sep 15;228(6):715-722. doi: 10.1093/infdis/jiad134.
PubMed 37202147

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-Controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-nCoV for Inhalation in Adults 18 Years of Age and Older
ClinicalTrials.gov ID: NCT04840992
Acronym / sponsor ID: JSVCT092
Conditions: COVID-19
Keywords: COVID-19, Vaccine, Ad5, Safety, Immunogenicity, SARS-CoV-2, Adenovirus Vector, Aerogen Solo
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 840 participants (actual)
Lead sponsor: CanSino Biologics Inc.Industry (pharma, biotech, devices)
Collaborators: Beijing Institute of Biotechnology, Jiangsu Province Centers for Disease Control and Prevention
Study start: 21 Apr 2021 (actual)
Primary completion: 8 Jul 2022 (actual)
Study completion: 9 Aug 2022 (actual)
First posted: 12 Apr 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 22

Arm	Type	Receives
A1a Phase I low 2 doses	Experimental	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for InhalationAd5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo
A1b Phase I placebo low 2 doses	Placebo comparator	Biological: Placebo for InhalationPlacebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
A2a Phase I medium 2 doses	Experimental	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for InhalationAd5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo
A2b Phase I placebo medium 2 doses	Placebo comparator	Biological: Placebo for InhalationPlacebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
A3a Phase I high 2 doses	Experimental	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for InhalationAd5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo
A3b Phase I placebo high 2 doses	Placebo comparator	Biological: Placebo for InhalationPlacebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
A4a Phase I combine 2 doses	Experimental	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation, Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart
A4b Phase I placebo combine 2 doses	Placebo comparator	Biological: Placebo for Inhalation, Biological: Placebo6 subjects, Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart
A5a Phase I single dose	Experimental	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for InhalationAd5-nCoV containing 1E10 vp, 1 dose Aerogen Solo
A5b Phase I placebo single dose	Placebo comparator	Biological: Placebo for Inhalation6 subjects, Placebo containing 0 vp, 1 dose Aerogen Solo
B1a Phase II low 2 doses	Experimental	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for InhalationAd5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo
B1b Phase II placebo low 2 doses (18-59)	Placebo comparator	Biological: Placebo for InhalationPlacebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
B2a Phase II medium 2 doses	Experimental	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for InhalationAd5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo
B2b Phase II placebo medium 2 doses	Placebo comparator	Biological: Placebo for InhalationPlacebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
B3a Phase II high 2 doses	Experimental	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for InhalationAd5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo
B3b Phase II placebo high 2 doses	Placebo comparator	Biological: Placebo for InhalationPlacebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo
B4a Phase II combine 2 doses	Experimental	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation, Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart
B4b Phase II placebo combine 2 doses	Placebo comparator	Biological: Placebo for Inhalation, Biological: PlaceboPlacebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart
B5a Phase II intramuscular single dose	Experimental	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)Ad5-nCoV containing 5E10 vp, 1 dose Intramuscular Injection
B5b Phase II placebo intramuscular single dose	Placebo comparator	Biological: Placeboplacebo containing 0 vp, 1 dose Intramuscular Injection
B6a Phase II Aerogen Solo single dose	Experimental	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for InhalationAd5-nCoV containing 1E10 vp, 1 dose Aerogen Solo
B6b Phase II placebo Aerogen Solo single dose	Placebo comparator	Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)placebo containing 0 vp, 1 dose Aerogen Solo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Healthy adults 18 years of age and above at the time of enrollment;
Able to provide consent to participate in and having signed an Informed Consent Form (ICF);
Able and willing to complete all the scheduled study procedures during the whole study follow-up period;
HIV negative;
No nasal or oral diseases, such as acute rhinitis (sinusitis), allergic rhinitis, oral ulcers, sore throat, etc;

Key exclusion criteria (24 listed)

Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrollable medications (on-site measurement: systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg), etc;
Abnormal laboratory test indicators which investigator decide to be clinically significant; (Only Phase I volunteers)
Respiratory rate ≥17 per minute;
Abnormal lung function such as asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, etc;
Prior Covid-19 vaccinations;

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 Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for InhalationAerogen Solo	Biological	A1a Phase I low 2 doses, A2a Phase I medium 2 doses, A3a Phase I high 2 doses, A4a Phase I combine 2 doses, A5a Phase I single dose, B1a Phase II low 2 doses, B2a Phase II medium 2 doses, B3a Phase II high 2 doses, B4a Phase II combine 2 doses, B6a Phase II Aerogen Solo single dose
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)Intramuscular administration	Biological	A4a Phase I combine 2 doses, B4a Phase II combine 2 doses, B5a Phase II intramuscular single dose, B6b Phase II placebo Aerogen Solo single dose
Placebo for InhalationAerogen Solo	Biological	A1b Phase I placebo low 2 doses, A2b Phase I placebo medium 2 doses, A3b Phase I placebo high 2 doses, A4b Phase I placebo combine 2 doses, A5b Phase I placebo single dose, B1b Phase II placebo low 2 doses (18-59), B2b Phase II placebo medium 2 doses, B3b Phase II placebo high 2 doses, B4b Phase II placebo combine 2 doses
PlaceboIntramuscular administration	Biological	A4b Phase I placebo combine 2 doses, B4b Phase II placebo combine 2 doses, B5b Phase II placebo intramuscular single dose

Primary outcome

Incidence of Adverse Reactions (AR)
Time frame: 0-14 days after each vaccination
The occurrence of Adverse Reactions (AR) in all groups
Incidence of Serious Adverse Events (SAE)
Time frame: Within the first and final vaccination up until 12 months after the final vaccination
The occurrence of Serious Adverse Events (SAE) in all groups

16 secondary outcomes

Incidence of Adverse Events/Reactions (AE/AR)
Time frame: Within 0-7 days after each vaccination
Incidence of Adverse Events/Reactions (AE/AR)
Time frame: Within 0-28 days after each vaccination
Changes in laboratory test indicators
Time frame: 4 days after each vaccination
GMT of Covid-19 S protein RBD specific antibody
Time frame: Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose
Seroconversion rate of Covid-19 S protein RBD specific antibody
Time frame: Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose
GMI of Covid-19 S protein RBD specific antibody
Time frame: Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose
GMT of SARS-CoV-2 neutralizing antibody
Time frame: Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Time frame: Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose
GMI of SARS-CoV-2 neutralizing antibody
Time frame: Before the first dose, 28 days after the first dose, before the second dose, 14 days after the second dose
GMT of SARS-CoV-2 neutralizing antibody
Time frame: 28 days after the final vaccination
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Time frame: 28 days after the final vaccination
Cellular immune response
Time frame: Before the first dose, 14 days after the first dose
Cellular immune response
Time frame: Before the first dose, 14 days after the first dose
Cellular immune response
Time frame: Before the first dose, 14 days after the first dose
Cellular immune response
Time frame: Before the first dose, 14 days after the first dose
Cellular immune response
Time frame: Before the first dose, 14 days after the first dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
Derived from this study: PubMed 38543926Zhu Y, Tang R, Li X, Chen X, Wang X, Wang Y, Wang R, Zhu F, Li J. Vaccination with Adenovirus Type 5 Vector-Based COVID-19 Vaccine as the Primary Series in Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 1/2 Clinical Trial. Vaccines (Basel). 2024 Mar 11;12(3):292. doi: 10.3390/vaccines12030292.
Derived from this study: PubMed 37202147Xia X, Tan ZM, Wan P, Zheng H, Tang R, Chen XQ, Guo XL, Zhu T, Feng JL, Zhong J, Li XL, Zhang ZY, Zhu FC, Li JX. Environmental Impact Assessment for the Use of an Orally Aerosolized Adenovirus Type-5 Vector-Based COVID-19 Vaccine in Randomized Clinical Trials. J Infect Dis. 2023 Sep 15;228(6):715-722. doi: 10.1093/infdis/jiad134.
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, MSD principal investigator

Jiangsu Provincal Center for Disease Control and Prevention

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 24 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: finished, as of the sponsor's last update on 8 Feb 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 China. 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. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 Adverse Reactions (AR) (time frame: 0-14 days after each 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?

On the ClinicalTrials.gov record for NCT04840992, which also lists 2 linked publications.

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 8 Feb 2023.