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

• ClinicalTrials.gov Identifier: NCT04566770
• Recruitment Status: Recruiting
• First Posted: September 28, 2020
• Last Update Posted: November 27, 2020
• Sponsor: CanSino Biologics Inc.
• Collaborators: Beijing Institute of Biotechnology; Jiangsu Province Centers for Disease Control and Prevention
• Information provided by (Responsible Party): CanSino Biologics Inc.

Tracking Information

• First Submitted Date: September 22, 2020
• First Posted Date: September 28, 2020
• Last Update Posted Date: November 27, 2020
• Actual Study Start Date: September 24, 2020
• Estimated Primary Completion Date: August 21, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 24, 2020)

• Safety indexes of adverse reactions [ Time Frame: within 14 days post each vaccination ]
  Occurrence of adverse reactions post vaccination
• Immunogencity indexes of GMT [ Time Frame: Day 28 post the second vaccination ]
  Evaluate the Geometric mean titer (GMT) of IgG antibody
• Immunogencity indexes of neutralizing antibody [ Time Frame: Day 28 post the second vaccination ]
  Evaluate the Geometric mean titer (GMT) of neutralizing antibody

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 25, 2020)

• Safety indexes of adverse events [ Time Frame: Day 0-7,0-14,0-28 post each vaccination ]
  Occurrence of adverse reactions post-vaccination
• Safety indexes of Hematological examination measures（Hemoglobin, WBC） [ Time Frame: pre-vaccination, day 4 post each vaccination ]
  Occurrence of abnormal changes of Hematological examination indexes(only fit for MID and sentinel group)
• Safety indexes of Blood routine measures(ALT, AST) [ Time Frame: pre-vaccination, day 4 post each vaccination ]
  Occurrence of abnormal changes of lBlood routine indexes (only fit for MID and sentinel group)
• Safety indexes of SAE [ Time Frame: Within 6 months post the second vaccination ]
  Occurrence of serious adverse events post-vaccination
• Immunogencity indexes of GMT [ Time Frame: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination ]
  Evaluate the Geometric mean titer of IgG antibody
• Immunogencity indexes of neutralizing antibody [ Time Frame: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination ]
  Evaluate the Geometric mean titer (GMT) of neutralizing antibody
• Immunogencity indexes of cellular immune [ Time Frame: Day 28 post the first vaccination, pre and day 28 post the second vaccination ]
  Number of cell-mediated immune response against SARS-CoV-2（IL-2）

Original Secondary Outcome Measures (submitted: September 24, 2020)

• Safety indexes of adverse events [ Time Frame: Day 0-7,0-14,0-28 post each vaccination ]
  Occurrence of adverse reactions post-vaccination
• Safety indexes of Hematological examination measures [ Time Frame: pre-vaccination, day 4 post each vaccination ]
  Occurrence of abnormal changes of Hematological examination indexes(only fit for MID and sentinel group)
• Safety indexes of Blood routine measures [ Time Frame: pre-vaccination, day 4 post each vaccination ]
  Occurrence of abnormal changes of lBlood routine indexes (only fit for MID and sentinel group)
• Safety indexes of SAE [ Time Frame: Within 6 months post the second vaccination ]
  Occurrence of serious adverse events post-vaccination
• Immunogencity indexes of GMT [ Time Frame: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination ]
  Evaluate the Geometric mean titer of IgG antibody
• Immunogencity indexes of neutralizing antibody [ Time Frame: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination ]
  Evaluate the Geometric mean titer (GMT) of neutralizing antibody
• Immunogencity indexes of cellular immune [ Time Frame: Day 28 post the first vaccination, pre and day 28 post the second vaccination ]
  Number of cell-mediated immune response against SARS-CoV-2（IL-2）

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Clinical Trial of A COVID-19 Vaccine Named Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
• 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
• Brief 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 .

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).

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: COVID-19

Intervention

• Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  Intramuscular other name:Ad5-nCoV
• Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
  Intramuscular other name:Ad5-nCoV

Study Arms

• Experimental: MID A
  20 participants(18-49), Ad5-nCoV , two doses, Intramuscular administration
  Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
• Placebo Comparator: MID B
  10 participants(18-49), Ad5-nCoV-placebo , two doses, Intramuscular administration
  Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
• Experimental: MIN A
  100 participants(6-17), Ad5-nCoV , two doses, Intramuscular administration
  Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
• Placebo Comparator: MIN B
  50 participants(6-17), Ad5-nCoV-placebo , two doses, Intramuscular administration
  Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
• Experimental: OLD A
  100 participants(56 years of age and above), Ad5-nCoV , two doses(Low dose), Intramuscular administration
  Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
• Experimental: OLD B
  100 participants(56 years of age and above), Ad5-nCoV , two doses(Middle dose), Intramuscular administration
  Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
• Placebo Comparator: OLD C
  50 participants(56 years of age and above), Ad5-nCoV-placebo , two doses, Intramuscular administration
  Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
• Experimental: EBOV A
  34 participants, Ad5-nCoV , two doses, Intramuscular administration
  Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
• Placebo Comparator: EBOV B
  17 participants, Ad5-nCoV , two doses, Intramuscular administration
  Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 24, 2020): 481
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 20, 2022
• Estimated Primary Completion Date: August 21, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Wenjuan Wang, MSD; 025-83759911; wangwj@jscdc.cn

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04566770
• Other Study ID Numbers: JSVCT093
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: CanSino Biologics Inc.
• Study Sponsor: CanSino Biologics Inc.

Collaborators

• Beijing Institute of Biotechnology
• Jiangsu Province Centers for Disease Control and Prevention

Investigators

• Principal Investigator: Fengcai Zhu, MSD; Jiangsu Provincal Center for Disease Control and Prevention

• PRS Account: CanSino Biologics Inc.
• Verification Date: September 2020