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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

Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 26 May 2020

At a glance

  • Drugs Ad5-nCoV Tianjin CanSino Biotechnology (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; First in man
  • Acronyms APICTH; CTCOVID-19
  • Sponsors Tianjin CanSino Biotechnology
  • Most Recent Events

    • 26 May 2020 Results published in the the Lancet
    • 29 Mar 2020 Status changed from recruiting to active, no longer recruiting.
    • 25 Mar 2020 According to a Sartorius Stedim Biotech media release, Sartorius has supported CanSino Biologics Inc. and Maj. Gen. Chen Weis team at the Institute of Bioengineering at the Academy of Military Medical Sciences Bioenginee in China in their development of the first vaccine candidate against the novel coronavirus SARS-CoV-2 to enter clinical trials.

Trial Overview

Purpose

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).

Primary Endpoints

Safety indexes of adverse reactions

description: Occurrence of adverse reactions post-vaccination
time_frame: 0-7 days post-vaccination

Other Endpoints

Safety indexes of adverse events

description: Occurrence of adverse events post-vaccination
time_frame: 0-28 days post-vaccination

Safety indexes of SAE

description: Occurrence of serious adverse events post-vaccination
time_frame: 0-28 days, within 6 mouths post-vaccination

Safety indexes of lab measures

description: Occurrence of abnormal changes of laboratory safety examinations
time_frame: pre-vaccination, day 7 post-vaccination

Immunogencity indexes of GMT(ELISA)

description: Geometric mean titer GMT of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
time_frame: day14,28 month 3,6 post-vaccination

Immunogencity indexes of GMT(pseudoviral neutralization test method)

description: Geometric mean titer GMT of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
time_frame: day14,28 month 6 post-vaccination

Immunogencity indexes of seropositivity rates(ELISA)

description: the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
time_frame: day14,28 month 3,6 post-vaccination

Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method)

description: the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
time_frame: day14,28 month 6 post-vaccination

Immunogencity indexes of GMI(ELISA)

description: Geometric mean fold increase GMI of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
time_frame: day14,28 month 3,6 post-vaccination

Immunogencity indexes of GMI(pseudoviral neutralization test method)

description: Geometric mean fold increase GMI of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
time_frame: day14,28 month 6 post-vaccination

Immunogencity indexes of GMC(Ad5 vector)

description: Geometric mean concentration GMC of anti-Ad5 vector neutralizing antibody responses
time_frame: day 14,28 month3,6 post-vaccination

Immunogencity indexes of GMI(Ad5 vector)

description: Geometric mean fold increase GMI of anti-Ad5 vector neutralizing antibody responses
time_frame: day 14,28 month3,6 post-vaccination

Immunogencity indexes of cellular immune

description: specific cellular immune responses
time_frame: day 14, 28,month 6 post-vaccination

Consistency analysis(ELISA and pseudoviral neutralization test method)

description: Consistency analysis of S-specific antibodies against 2019 novel coronavirus tested by ELISA against those tested by pseudoviral neutralization test method
time_frame: day,14,28, month 6 post-vaccination

Dose-response relationship Humoral immunity

description: Relationship between Geometric mean titer (GMT) of S protein-specific antibodies against 2019 novel coronavirus and vaccine dose among study groups
time_frame: day14,28 month 3,6 post-vaccination

Persistence analysis of anti-S protein antibodies

description: Persistence analysis of anti-S protein antibodies among study groups
time_frame: day14,28 month 3,6 post-vaccination

Time-dose-response relationship Humoral immunity

description: Relationship between the appearance time of S-specific antibodies against 2019 novel coronavirus and the vaccination dose.
time_frame: day14,28 month 3,6 post-vaccination

Dose-response relationship cellular immunity

description: Relationship between cellular immune levels against 2019 novel coronavirus and vaccine dose among study groups
time_frame: day 14, 28,month 6 post-vaccination

Persistence analysis of cellular immuse

description: Persistence analysis of specific cellular immune response
time_frame: day 14, 28,month 6 post-vaccination

Time-dose-response relationship cellular immunity

description: Relationship between the appearance time of cellular immunity against 2019 novel coronavirus and the vaccination dose.
time_frame: day 14, 28,month 6 post-vaccination [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 108

    Actual: 108

  • Sex male & female
  • Age Group 18-60 years; adult

Patient Inclusion Criteria

- 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 - 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.

Patient Exclusion Criteria

- 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. - 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 Details

Identifiers

Identifier Owner
NCT04313127 ClinicalTrials.gov: US National Institutes of Health
JSVCT088 -

Organisations

  • Sponsors Tianjin CanSino Biotechnology
  • Affiliations Tianjin CanSino Biotechnology

Trial Dates

  • Initiation Dates

    Planned : 19 Mar 2020

    Actual : 16 Mar 2020

  • Primary Completion Dates

    Planned : 30 Dec 2020

  • End Dates

    Planned : 20 Dec 2022

Other Details

  • Design open; prospective; sequential
  • Phase of Trial Phase I
  • Location China
  • Focus Adverse reactions; First in man

Interventions

Drugs Route Formulation
Ad5-nCoV Tianjin CanSino BiotechnologyPrimary Drug Intramuscular Injection

High-dose Group

Subjects received one dose of 1.5E11vp Ad5-nCoV at 18 to 60 years old
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Intramuscular other name:Ad5-nCoV)

Low-dose Group

Subjects received one dose of 5E10 vp Ad5-nCoV at 18 to 60 years old
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Intramuscular other name:Ad5-nCoV)

Middle-dose Group

Subjects received one dose of 1E11 vp Ad5-nCoV at 18 to 60 years old
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Intramuscular other name:Ad5-nCoV)

Results

Publications

  1. 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. Internet-Doc 2020;.

    Available from: URL: http://link.adisinsight.com/z4GDi

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Guan Xuhua Hubei Provincial Center for Disease Control and Prevention China
Wang Wei Tongji Hospital
-
Wang Wenjuan
025-83759911 wangwj@jscdc.cn
show details
-
Wang Zhao
13476011311 markwangzhao@qq.com
show details
Hubei Provincial Center for Disease Control and Prevention China
Zhu Fengcai Jiangsu Province Centers for Disease Control and Prevention
-

Centres

Centre Name Location Trial Centre Country
-
-
-
CanSino Biologics Inc.
-
-
Hubei Provincial Center for Disease Control and Prevention
-
-
Hubei Provincial Center for Disease Control and Prevention Wuhan, Hubei China
Institute of Biotechnology, Academy of Military Medical Sciences. PLA of China
-
-
Jiangsu Province Centers for Disease Control and Prevention
-
-
Tongji Hospital
-
-

Trial History

Event Date Event Type Comment
26 May 2020 Results Results published in the the Lancet Updated 26 May 2020
15 Apr 2020 Other trial event Last checked against the ClinicalTrials.gov record. Updated 15 Apr 2020
29 Mar 2020 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 02 Apr 2020
25 Mar 2020 Other trial event According to a Sartorius Stedim Biotech media release, Sartorius has supported CanSino Biologics Inc. and Maj. Gen. Chen Weis team at the Institute of Bioengineering at the Academy of Military Medical Sciences Bioenginee in China in their development of the first vaccine candidate against the novel coronavirus SARS-CoV-2 to enter clinical trials. Updated 01 Apr 2020
23 Mar 2020 New trial record New trial record Updated 23 Mar 2020
20 Mar 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 26 Mar 2020
17 Mar 2020 Other trial event According to a CanSinoBIO media release, the company has received approval to initiate Phase I clinical trial of Recombinant Coronavirus Vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV) in China. Updated 30 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. 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. Internet-Doc 2020;.

    Available from: URL: http://link.adisinsight.com/z4GDi
  3. CanSinoBIO. CanSinoBIO's Investigational Vaccine Against COVID-19 Approved for Phase 1 Clinical Trial in China. Media-Rel 2020;.

    Media Release
  4. Sartorius Stedim Biotech. Sartorius Supports the Development of the First Vaccine Candidate Against the Novel Coronavirus to Enter Clinical Trials. Media-Rel 2020;.

    Media Release
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