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COVID-19Phase 2CTII-nCoVNCT04341389

A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector)

A Phase 2 study testing Recombinant novel coronavirus vaccine (Adenovirus type 5 vector) 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 phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2. 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)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
508 participants
Where
1 siteChina
Study dates
12 Apr 2020to 31 Dec 2020
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older 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.
  • Axillary temperature ≤37.0°C.
  • The BMI index is 18.5-30.0.
  • 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 19Show 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

  • Hubei Provincial Center for Disease Control and Prevention

    Wuhan, Hubei

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Recombinant Novel Coronavirus Vaccine (Adenovirus Vector) in Healthy Adults Aged Above 18 Years

This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2.

Read the detailed description

This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age,inclusive, who meet all eligibility criteria. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2. 500 subjects will be enrolled, 250 subjects in middle-dose vaccine group, 125 subjects in low-dose and placebo group, respectively. Immunogenicity will be tested on days 0, 14, 28 and 6 months after vaccination

Conditions
COVID-19
Being tested
Recombinant novel coronavirus vaccine (Adenovirus type 5 vector), Placebo
Keywords
COVID-19 vaccine, Ad5-nCoV, SARS-CoV-2
Medical subject headings
COVID-19

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

    Also called Ad5-nCoV

    Intramuscular injection

  • PlaceboOther

    Also called Control

    Intramuscular injection

Study groups in NCT04341389
Study groupRoleWhat they receive
Arm 1Active comparator1×10^11vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0
Receives: Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)
Arm 2Active comparator5×10^10vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0
Receives: Biological: Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)
Arm 3Placebo comparatorPlacebo administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0
Receives: Other: Placebo

What is being measured

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

  1. Occurrence of adverse reactions

    Measured: 0-14 days post vaccination

  2. Anti SARS-CoV-2 S IgG antibody response(ELISA)

    Measured: 28 days post vaccination

  3. Neutralizing antibody response to SARS-CoV-2

    Measured: 28 days post vaccination

Secondary outcomes (6)

  1. Occurrence of adverse events

    Measured: 0-28 days post vaccination

  2. Occurrence of serious adverse reaction

    Measured: 0-6 months post vaccination

  3. Anti SARS-CoV-2 S IgG antibody response(ELISA)

    Measured: 0, 14 days and 6 months post vaccination

  4. Neutralizing antibody response to SARS-CoV-2

    Measured: 0 and 6 months post vaccination

  5. Neutralizing antibody response to Ad5-vector

    Measured: 0, 28 days and 6 months post vaccination

  6. IFN-γ ELISpot responses to SARS-CoV-2 spike protein

    Measured: 0 and 28 days 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 posted10 Apr 2020
  2. Study start12 Apr 2020
  3. Primary completion30 Nov 2020
  4. Study completion31 Dec 2020

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
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
508 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04341389
Sponsor's protocol ID
JSVCT089
Acronym
CTII-nCoV
Status last verified
May 2023
First submitted
7 Apr 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

  • 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 FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, Li JX, Yang BF, Wang L, Wang WJ, Wu SP, Wang Z, Wu XH, Xu JJ, Zhang Z, Jia SY, Wang BS, Hu Y, Liu JJ, Zhang J, Qian XA, Li Q, Pan HX, Jiang HD, Deng P, Gou JB, Wang XW, Wang XH, Chen W. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2020 Aug 15;396(10249):479-488. doi: 10.1016/S0140-6736(20)31605-6. Epub 2020 Jul 20.

    PubMed 32702299

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 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 8 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 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. 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?

Occurrence of adverse reactions (time frame: 0-14 days post 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 NCT04341389, 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 24 May 2023.

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