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COVID-19Phase 1NCT04552366

A Clinical Trial of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults

A Phase 1 study testing Ad5-nCoV in people with COVID-19, run by Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China 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 is a clinical trial to evaluate the safety and immunogenicity of a recombinant adenovirus 5 vectored COVID-19 vaccine (Ad5-nCoV) with two doses and with different adminstration routes in healthy adults aged 18 years 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?
Ad5-nCoV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
149 participants
Where
1 siteChina
Study dates
29 Sep 2020to 30 Apr 2021
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged 18 years and older;
  • 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 (about 6-8 months, depending on group);
  • Negative result of HIV screening;
  • Axillary temperature ≤37.0°C.
  • Negative IgG and IgM antibodies against COVID-19;
  • Good general health status, as determined by history and physical examination.

Who cannot join

  • Hematological examination is abnormal, or clinically significant as assessed by the study investigator (including white blood cell count, lymphocyte count, neutrophil count, eosinophil count, platelet, hemoglobin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, blood glucose and creatinine);
  • With oral ulcers, throat swelling and other oral diseases.
  • With symptoms of upper respiratory tract infection.
  • Personal history of seizure disorder, encephalopathy or psychosis;
  • Allergic history to any vaccine, or allergic to any ingredient of the Ad5-nCoV;
  • Any acute febrile disease or active infectious disease on the day of vaccination;
Show all 28Show fewer
  • History of SARS or COVID-19;
  • History of COVID-19 candidate vaccine administration;
  • History of chronic obstructive pulmonary disease (COPD).
  • Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension not controlled with medication;
  • Serious chronic disease or in the advanced stage that cannot be controlled well， such as asthma, diabetes and thyroid disease, etc.;
  • Congenital or acquired angioedema;
  • Suffered from urticaria within 1 year before receiving the trial vaccine.
  • Asplenia or functional asplenia;
  • Platelet disorder or other bleeding disorder that may cause intramuscular injection contraindication;
  • Faint with needles in intramuscular administration group;
  • Immunosuppressive medication, anti-allergic, cytotoxic therapy, inhaled corticosteroids (excluding surface corticosteroid therapy for acute non-complicated dermatitis) in the last 6 months;
  • Prior administration of blood products in last 4 months;
  • Other vaccination(s) or investigational drugs within 1 month before study onset;
  • 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;
  • Woman is pregnant or lactating, positive urine pregnancy test or plan to become pregnant during the next 8 months;
  • 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.).
  • Severe allergic reaction after the first dose of vaccination;
  • Severe adverse reactions causally related to the first vaccination;
  • For those newly discovered or newly occured after the first vaccination that does not meet the first-dose selection criteria or meets the first-dose exclusion criteria, the investigator will determine whether to continue participating in the study;
  • Other reasons for exclusion as deemed by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongnan Hospital

    Wuhan, Hubei, 430071

Other trials in China

About this study

Official title: A Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults Aged 18 Years and Older

This is a clinical trial to evaluate the safety and immunogenicity of a recombinant adenovirus 5 vectored COVID-19 vaccine (Ad5-nCoV) with two doses and with different adminstration routes in healthy adults aged 18 years and older.

Read the detailed description

A total of 168 healthy adult volunteers will be vaccinated in this clinical trial according to open, partly randomized design from the healthy adults aged 18 years and older. The safety and immunogenicity of intramuscular vaccination and mucosal vaccination of two doses of Ad5-nCoV in different administration schedules will be evaluated.

Conditions
COVID-19
Being tested
Ad5-nCoV
Keywords
COVID-19 vaccine, Ad5-nCoV
Medical subject headings
COVID-19

What participants receive

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

  • Ad5-nCoVBiological

    Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Study groups in NCT04552366
Study groupRoleWhat they receive
Group A: Intramuscular administrationExperimental24 subjects. 5E10 VP of Ad5-nCoV on Day 0 and on Day 56.
Receives: Biological: Ad5-nCoV
Group B: Mixed administrationExperimental24 subjects. An intramuscular administration of 5E10 VP of Ad5-nCoV on day 0 and a mucosal administration of 2E10 VP on Day 28.
Receives: Biological: Ad5-nCoV
Group C: Mucosal administration, high doseExperimental24 subjects. A mucosal administration of 2E10 VP of Ad5-nCoV on Day 0 and Day 28.
Receives: Biological: Ad5-nCoV
Group D: Mucosal administration, low doseExperimental24 subjects. A mucosal administration of 1E10 VP of Ad5-nCoV on day 0 and Day 28.
Receives: Biological: Ad5-nCoV
Group E: Intramuscular administration, one doseActive comparator24 subjects. An intramuscular administration of 5E10 VP of Ad5-nCoV on day 0.
Receives: Biological: Ad5-nCoV
Group F: Intramuscular administration, two dosesExperimental24 subjects. Two intramuscular administrations of 5E10 VP of Ad5-nCoV at left and right arms on day 0.
Receives: Biological: Ad5-nCoV

What is being measured

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

  1. Incidence of the AE in all groups

    The occurrence of AE in all groups within 0-7 days after each vaccination;

    Measured: 0-7 days after each vaccination

  2. Seroconversion rate of the IgG antibody against SARS-CoV-2

    Seroconversion rate the IgG antibody against SARS-CoV-2 measured on Day 28 after last vaccination

    Measured: Day 28 after last vaccination

  3. Geomean titers of the IgG antibody against SARS-CoV-2

    Geomean titers of the IgG antibody against SARS-CoV-2 measured on Day 28 after last vaccination

    Measured: Day 28 after last vaccination

  4. Seroconversion rate of the neutralizing antibody against SARS-CoV-2

    Seroconversion rate of the neutralizing antibody against SARS-CoV-2 measured on Day 28 after last vaccination

    Measured: Day 28 after last vaccination

  5. Geomean titers of the neutralizing antibody against SARS-CoV-2

    Geomean titers of the neutralizing antibody against SARS-CoV-2 measured on Day 28 after last vaccination

    Measured: Day 28 after last vaccination

Secondary outcomes (10)

  1. Incidence of the AE in all groups

    The occurrence of AE in all groups within 0-30 minutes and 0-28 days after each vaccination.

    Measured: 0-30 minutes, 0-28 days after each vaccination

  2. Incidence of Serious adverse events (SAE) in all groups

    The occurrence of Serious adverse events (SAE) in all groups within 6 months after the final vaccination.

    Measured: 6 months after the final vaccination

  3. Geomean titers of the IgG antibody against SARS-CoV-2

    Geomean titers of the IgG antibody against SARS-CoV-2 measured on Day 0, 14, 28 and 56 after first vaccination and on Day 14 and Day168 after last vaccination.

    Measured: Day 0, 14, 28 and 56 after first vaccination and Day 14 and Day168 after last vaccination.

  4. Seroconversion rate of the IgG antibody against SARS-CoV-2

    Seroconversion rate of the IgG antibody against SARS-CoV-2 measured on Day 0, 14, 28 and 56 after first vaccination and on Day 14 and Day168 after last vaccination.

    Measured: Day 0, 14, 28 and 56 after first vaccination and Day 14 and Day168 after last vaccination.

  5. Geomean titers of the neutralizing antibody against SARS-CoV-2

    Geomean titers of the neutralizing antibody against SARS-CoV-2 measured on Day 0, 14, 28 and 56 after first vaccination and on Day 14 and Day168 after last vaccination.

    Measured: Day 0, 14, 28 and 56 after first vaccination and Day 14 and Day168 after last vaccination.

  6. Seroconversion rate of the neutralizing antibody against SARS-CoV-2

    Seroconversion rate of the neutralizing antibody against SARS-CoV-2 measured on Day 0, Day14, Day 28 or Day 56 after first vaccination and on day 14, day 28 and day168 after last vaccination.

    Measured: Day 0, 14, 28 and 56 after first vaccination and on Day 14 and Day168 after last vaccination.

  7. Cellular immune response by ELISpot

    The positive rate of IFN-γ stimulated by S protein overlapping peptide library detected by ELISpot on Day 0 and Day 14 after each vaccination

    Measured: Day 0 and Day 14 after each vaccination

  8. Geomean titers of neutralizing antibody response to Ad5-vector

    Geomean titers of neutralizing antibody response to Ad5-vector on Day 0, 14 and 28 after each vaccination.

    Measured: Day 0, 14 and 28 after each vaccination.

  9. Cellular immune response by ICS

    The positive rate of the specific cytokines expressed by CD4+ and CD8+ T lymphocytes stimulated by S protein overlapping peptide library detected by intracellular cytokine staining on Day 0 and Day 14 after each vaccination

    Measured: Day 0 and Day 14 after each vaccination

  10. Geomean titers of the IgA antibody against SARS-CoV-2

    Geomean titers of the IgA antibody against SARS-CoV-2 on Day 0, 14 and 28 after each vaccination.

    Measured: Day 0, 14 and 28 after each vaccination

Timeline

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

  1. First posted17 Sep 2020
  2. Study start29 Sep 2020
  3. Primary completion31 Dec 2020
  4. Study completion30 Apr 2021

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04552366
Sponsor's protocol ID
AMMS85-2004
Status last verified
May 2023
First submitted
15 Sep 2020
Last updated
24 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wu S, Huang J, Zhang Z, Wu J, Zhang J, Hu H, Zhu T, Zhang J, Luo L, Fan P, Wang B, Chen C, Chen Y, Song X, Wang Y, Si W, Sun T, Wang X, Hou L, Chen W. Safety, tolerability, and immunogenicity of an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in adults: preliminary report of an open-label and randomised phase 1 clinical trial. Lancet Infect Dis. 2021 Dec;21(12):1654-1664. doi: 10.1016/S1473-3099(21)00396-0. Epub 2021 Jul 26.

    PubMed 34324836

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ad5-nCoV in people with COVID-19, run by Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China at 1 site in China.

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 7 inclusion and 28 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 24 May 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. 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?

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 the AE in all groups (time frame: 0-7 days after each vaccination). The study lists 5 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 NCT04552366, which also lists 1 linked publication.

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 24 May 2023.

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