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COVID-19Phase 2NCT04566770

A Clinical Trial of A COVID-19 Vaccine Named Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

A Phase 2 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

This study is a randomized, double-blind, placebo -controlled IIb clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people 6 years old and above and . Read more about this study

Who is it for?
Ages 6 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)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
480 participants
Where
1 siteChina
Study dates
24 Sep 2020to 19 Jan 2022
Phase
Phase 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 6 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Aged 18 to 55 years old in MID group; aged 6-17 years old in MIN group; aged 56 years and above in OLD group; aged in EBO group is not limited.
  • 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.
  • Axillary temperature ≤37.0°C.
  • 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.
Show all 18Show fewer
  • 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

  • Taixing City center for Disease Control and Prevention

    Taizhou, Jiangsu, 210000

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo -Controlled Phase IIb Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-nCoV in Person 6 Years of Age and Older and Those Who Have Previously Been Vaccinated With Ad5-EBOV

This study is a randomized, double-blind, placebo -controlled IIb clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people 6 years old and above and .

Read the detailed description

This is a phase IIb clinical trial to evaluate safety and immuogenicity of Ad5-nCoV developed by Cansino and Beijing Institute of Biotechnology in health people aged 6 years old and above.

The study will be double-blind, placebo-controlled trial with participants randomly allocated 2:1 to placebo and experimental vaccine .

The immunization schedule is two doses intramuscular injections (deltoid).

Conditions
COVID-19
Being tested
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector), Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
Keywords
COVID-19, Vaccine, Ad5, Safety, Immunogencity, SARS-CoV-2, Adenovirus Vector
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)Biological

    Intramuscular other name:Ad5-nCoV

  • Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placeboBiological

    Intramuscular other name:Ad5-nCoV

Study groups in NCT04566770
Study groupRoleWhat they receive
MID AExperimental20 participants(18-49), Ad5-nCoV , two doses, Intramuscular administration
Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
MID BPlacebo comparator10 participants(18-49), Ad5-nCoV-placebo , two doses, Intramuscular administration
Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
MIN AExperimental100 participants(6-17), Ad5-nCoV , two doses, Intramuscular administration
Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
MIN BPlacebo comparator50 participants(6-17), Ad5-nCoV-placebo , two doses, Intramuscular administration
Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
OLD AExperimental100 participants(56 years of age and above), Ad5-nCoV , two doses(Low dose), Intramuscular administration
Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
OLD BExperimental100 participants(56 years of age and above), Ad5-nCoV , two doses(Middle dose), Intramuscular administration
Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
OLD CPlacebo comparator50 participants(56 years of age and above), Ad5-nCoV-placebo , two doses, Intramuscular administration
Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
EBOV AExperimental34 participants, Ad5-nCoV , two doses, Intramuscular administration
Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
EBOV BPlacebo comparator17 participants, Ad5-nCoV , two doses, Intramuscular administration
Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo

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: within 14 days post each vaccination

  2. Immunogencity indexes of GMT

    Evaluate the Geometric mean titer (GMT) of IgG antibody

    Measured: Day 28 post the second vaccination

  3. Immunogencity indexes of neutralizing antibody

    Evaluate the Geometric mean titer (GMT) of neutralizing antibody

    Measured: Day 28 post the second vaccination

Secondary outcomes (7)

  1. Safety indexes of adverse events

    Occurrence of adverse reactions post-vaccination

    Measured: Day 0-7,0-14,0-28 post each vaccination

  2. Safety indexes of Hematological examination measures（Hemoglobin, WBC）

    Occurrence of abnormal changes of Hematological examination indexes(only fit for MID and sentinel group)

    Measured: pre-vaccination, day 4 post each vaccination

  3. Safety indexes of Blood routine measures(ALT, AST)

    Occurrence of abnormal changes of lBlood routine indexes (only fit for MID and sentinel group)

    Measured: pre-vaccination, day 4 post each vaccination

  4. Safety indexes of SAE

    Occurrence of serious adverse events post-vaccination

    Measured: Within 6 months post the second vaccination

  5. Immunogencity indexes of GMT

    Evaluate the Geometric mean titer of IgG antibody

    Measured: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination

  6. Immunogencity indexes of neutralizing antibody

    Evaluate the Geometric mean titer (GMT) of neutralizing antibody

    Measured: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination

  7. Immunogencity indexes of cellular immune

    Number of cell-mediated immune response against SARS-CoV-2（IL-2）

    Measured: Day 28 post the first vaccination, pre and day 28 post the second vaccination

Timeline

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

  1. First posted28 Sep 2020
  2. Study start24 Sep 2020
  3. Primary completion21 Sep 2021
  4. Study completion19 Jan 2022

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04566770
Sponsor's protocol ID
JSVCT093
Status last verified
Oct 2022
First submitted
22 Sep 2020
Last updated
31 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Feng JL, Wang WJ, Jin PF, Zheng H, Jin LR, Xia X, Zhang XY, Li ZP, Li JX, Zhu FC. Comparison of antibody persistency through one year between one-dose and two-dose regimens of Ad5-nCoV vaccine for COVID-19. Hum Vaccin Immunother. 2023 Aug 1;19(2):2230760. doi: 10.1080/21645515.2023.2230760.

    PubMed 37428653

  • Zhu F, Jin P, Zhu T, Wang W, Ye H, Pan H, Hou L, Li J, Wang X, Wu S, Wang Y, Gou J, Huang H, Wu H, Wang X, Chen W. Safety and Immunogenicity of a Recombinant Adenovirus Type-5-Vectored Coronavirus Disease 2019 (COVID-19) Vaccine With a Homologous Prime-Boost Regimen in Healthy Participants Aged >/=6 Years: A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Trial. Clin Infect Dis. 2022 Aug 24;75(1):e783-e791. doi: 10.1093/cid/ciab845.

    PubMed 34551104

Questions about this trial

What is this clinical trial studying?

A Phase 2 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 7 inclusion and 18 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 31 Oct 2022. 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 phase mean?

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?

Safety indexes of adverse reactions (time frame: within 14 days post each vaccination). The study lists 3 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 NCT04566770, 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 31 Oct 2022.

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