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COVID-19Phase 1CTCOVID-19NCT04313127

Phase I Clinical Trial of a COVID-19 Vaccine in 18-60 Healthy Adults

A Phase 1 study testing 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

The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteChina
Study dates
16 Mar 2020to 20 Feb 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 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Aged between 18 and 60 years.
  • Able to understand the content of informed consent and willing to sign the informed consent
  • Able and willing to complete all the secluded study process during the whole 6 months study follow-up period.
  • Negative in HIV diagnostic test.
  • Negative in serum antibodies (IgG and IgM) screening of COVID-19.
  • Normal in lung CT images (no imaging features of COVID-19
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  • Axillary temperature ≤37.0°C.
  • The BMI index is 18.5-30.0.
  • Negative in Nasopharyngeal swabs / sputum and anal swabs through RT-PCR
  • Laboratory tests such as hematological examination and clinical biochemistry examination are in the normal range or without meaning judged by clinical doctor.
  • General good health as established by medical history and physical examination.

Who cannot join

  • Family history of seizure, epilepsy, brain or mental disease
  • Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
  • Woman who is pregnant, breast-feeding or positive in β-HCG (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months
  • Any acute fever disease or infections.
  • History of SARS
  • Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease.
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  • Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc.
  • Hereditary angioneurotic edema or acquired angioneurotic edema
  • Urticaria in last one year
  • No spleen or functional spleen.
  • Platelet disorder or other bleeding disorder may cause injection contraindication
  • Faint at the sight of needles.
  • Prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months.
  • Prior administration of blood products in last 4 months
  • Prior administration of other research medicines in last 1 month
  • Prior administration of attenuated vaccine in last 1 month
  • Prior administration of inactivated vaccine in last 14 days
  • Current anti-tuberculosis prophylaxis or therapy
  • According to the judgement of investigator,various medical, psychological, social or other conditions, those could affect the subjects to sign informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hubei Provincial Center for Disease Control and Prevention

    Wuhan, Hubei

Other trials in China

About this study

Official title: A Single-center,Open-label，Dose-escalating Phase I Clinical Trial to Evaluate Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Healthy Adults Aged 18-60 Years Old

The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries.

In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment.

This study is a phase I clinical trial. The investigators intent to evaluate the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) .

Read the detailed description

This is a single-center,open-label，dose-escalating phase I clinical trial in healthy 18 to 60 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) manufactured by Beijing Institute of Biotechnology and CanSino Biologics Inc.One hundred and eight subjects will be enrolled into one of three cohorts and will receive an intramuscular (IM) injection of experimental vaccine or placebo on Days 1 in the deltoid muscle.

Conditions
COVID-19
Being tested
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Keywords
COVID-19, vaccine, Ad5, Safety, Immunogenicity, Infection, novel coronavirus, Dose-escalation
Medical subject headings
COVID-19, Alzheimer Disease 5, Infections

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)Biological

    Intramuscular other name:Ad5-nCoV

Study groups in NCT04313127
Study groupRoleWhat they receive
Low-dose GroupExperimentalSubjects received one dose of 5E10 vp Ad5-nCoV at 18 to 60 years old
Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Middle-dose GroupExperimentalSubjects received one dose of 1E11 vp Ad5-nCoV at 18 to 60 years old
Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
High-dose GroupExperimentalSubjects received one dose of 1.5E11vp Ad5-nCoV at 18 to 60 years old
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.

  1. Safety indexes of adverse reactions

    Occurrence of adverse reactions post-vaccination

    Measured: 0-7 days post-vaccination

Secondary outcomes (12)

  1. Safety indexes of adverse events

    Occurrence of adverse events post-vaccination

    Measured: 0-28 days post-vaccination

  2. Safety indexes of SAE

    Occurrence of serious adverse events post-vaccination

    Measured: 0-28 days, within 6 mouths post-vaccination

  3. Safety indexes of lab measures

    Occurrence of abnormal changes of laboratory safety examinations

    Measured: pre-vaccination, day 7 post-vaccination

  4. Immunogencity indexes of GMT(ELISA)

    Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum

    Measured: day14,28，month 3,6 post-vaccination

  5. Immunogencity indexes of GMT(pseudoviral neutralization test method)

    Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum

    Measured: day14,28，month 6 post-vaccination

  6. Immunogencity indexes of seropositivity rates(ELISA)

    the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum

    Measured: day14,28，month 3,6 post-vaccination

  7. Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method)

    the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum

    Measured: day14,28，month 6 post-vaccination

  8. Immunogencity indexes of GMI(ELISA)

    Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum

    Measured: day14,28，month 3,6 post-vaccination

  9. Immunogencity indexes of GMI(pseudoviral neutralization test method)

    Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum

    Measured: day14,28，month 6 post-vaccination

  10. Immunogencity indexes of GMC(Ad5 vector)

    Geometric mean concentration（GMC）of anti-Ad5 vector neutralizing antibody responses

    Measured: day、14,28，month3,6 post-vaccination

  11. Immunogencity indexes of GMI(Ad5 vector)

    Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses

    Measured: day、14,28，month3,6 post-vaccination

  12. Immunogencity indexes of cellular immune

    specific cellular immune responses

    Measured: day 14, 28,month 6 post-vaccination

Timeline

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

  1. First posted18 Mar 2020
  2. Study start16 Mar 2020
  3. Primary completion20 Jan 2021
  4. Study completion20 Feb 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
Sequential
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04313127
Sponsor's protocol ID
JSVCT088
Acronym
CTCOVID-19
Status last verified
May 2020
First submitted
15 Mar 2020
Last updated
4 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We support data sharing of the individual participant data. The individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendixes) will be shared. Individual participant data will be available beginning 3 months and ending one year following article publication. Supporting clinical documents including study protocol, statistical analysis plan (SAP), and the informed consent form (ICF) will be available immediately following publication for at least one year. Supporting clinical documents access information will be available at http://www.jshealth.com/. Researchers who provide a scientifically sound proposal will be allowed to access to the individual participant data. Proposals should be directed to jszfc@vip.sina.com or cw0226@foxmail.com.

Publications

  • Zhu FC, Li YH, Guan XH, Hou LH, Wang WJ, Li JX, Wu SP, Wang BS, Wang Z, Wang L, Jia SY, Jiang HD, Wang L, Jiang T, Hu Y, Gou JB, Xu SB, Xu JJ, Wang XW, Wang W, Chen W. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial. Lancet. 2020 Jun 13;395(10240):1845-1854. doi: 10.1016/S0140-6736(20)31208-3. Epub 2020 May 22.

    PubMed 32450106

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people with COVID-19, run by CanSino Biologics Inc. 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 11 inclusion and 19 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 4 Aug 2021. 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?

Safety indexes of adverse reactions (time frame: 0-7 days post-vaccination). 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 NCT04313127, 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 4 Aug 2021.

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