Back to resultsA Clinical Trial of A COVID-19 Vaccine Named Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, Vaccine, Ad5, Safety, Immunogencity, SARS-CoV-2, Adenovirus Vector
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.
Sites / Locations
- Taixing City center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
MID A
MID B
MIN A
MIN B
OLD A
OLD B
OLD C
EBOV A
EBOV B
Arm Description
20 participants(18-49), Ad5-nCoV , two doses, Intramuscular administration
10 participants(18-49), Ad5-nCoV-placebo , two doses, Intramuscular administration
100 participants(6-17), Ad5-nCoV , two doses, Intramuscular administration
50 participants(6-17), Ad5-nCoV-placebo , two doses, Intramuscular administration
100 participants(56 years of age and above), Ad5-nCoV , two doses(Low dose), Intramuscular administration
100 participants(56 years of age and above), Ad5-nCoV , two doses(Middle dose), Intramuscular administration
50 participants(56 years of age and above), Ad5-nCoV-placebo , two doses, Intramuscular administration
34 participants, Ad5-nCoV , two doses, Intramuscular administration
17 participants, Ad5-nCoV , two doses, Intramuscular administration
Outcomes
Primary Outcome Measures
Safety indexes of adverse reactions
Occurrence of adverse reactions post vaccination
Immunogencity indexes of GMT
Evaluate the Geometric mean titer (GMT) of IgG antibody
Immunogencity indexes of neutralizing antibody
Evaluate the Geometric mean titer (GMT) of neutralizing antibody
Secondary Outcome Measures
Safety indexes of adverse events
Occurrence of adverse reactions post-vaccination
Safety indexes of Hematological examination measures（Hemoglobin, WBC）
Occurrence of abnormal changes of Hematological examination indexes(only fit for MID and sentinel group)
Safety indexes of Blood routine measures(ALT, AST)
Occurrence of abnormal changes of lBlood routine indexes (only fit for MID and sentinel group)
Safety indexes of SAE
Occurrence of serious adverse events post-vaccination
Immunogencity indexes of GMT
Evaluate the Geometric mean titer of IgG antibody
Immunogencity indexes of neutralizing antibody
Evaluate the Geometric mean titer (GMT) of neutralizing antibody
Immunogencity indexes of cellular immune
Number of cell-mediated immune response against SARS-CoV-2（IL-2）
Full Information
NCT ID
NCT04566770
First Posted
September 22, 2020
Last Updated
October 28, 2022
Sponsor
CanSino Biologics Inc.
Collaborators
Beijing Institute of Biotechnology, Jiangsu Province Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT04566770
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 24, 2020 (Actual)
Primary Completion Date
September 21, 2021 (Actual)
Study Completion Date
January 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CanSino Biologics Inc.
Collaborators
Beijing Institute of Biotechnology, Jiangsu Province Centers for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Vaccine, Ad5, Safety, Immunogencity, SARS-CoV-2, Adenovirus Vector
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MID A
Arm Type
Experimental
Arm Description
20 participants(18-49), Ad5-nCoV , two doses, Intramuscular administration
Arm Title
MID B
Arm Type
Placebo Comparator
Arm Description
10 participants(18-49), Ad5-nCoV-placebo , two doses, Intramuscular administration
Arm Title
MIN A
Arm Type
Experimental
Arm Description
100 participants(6-17), Ad5-nCoV , two doses, Intramuscular administration
Arm Title
MIN B
Arm Type
Placebo Comparator
Arm Description
50 participants(6-17), Ad5-nCoV-placebo , two doses, Intramuscular administration
Arm Title
OLD A
Arm Type
Experimental
Arm Description
100 participants(56 years of age and above), Ad5-nCoV , two doses(Low dose), Intramuscular administration
Arm Title
OLD B
Arm Type
Experimental
Arm Description
100 participants(56 years of age and above), Ad5-nCoV , two doses(Middle dose), Intramuscular administration
Arm Title
OLD C
Arm Type
Placebo Comparator
Arm Description
50 participants(56 years of age and above), Ad5-nCoV-placebo , two doses, Intramuscular administration
Arm Title
EBOV A
Arm Type
Experimental
Arm Description
34 participants, Ad5-nCoV , two doses, Intramuscular administration
Arm Title
EBOV B
Arm Type
Placebo Comparator
Arm Description
17 participants, Ad5-nCoV , two doses, Intramuscular administration
Intervention Type
Biological
Intervention Name(s)
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intervention Description
Intramuscular other name:Ad5-nCoV
Intervention Type
Biological
Intervention Name(s)
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
Intervention Description
Intramuscular other name:Ad5-nCoV
Primary Outcome Measure Information:
Title
Safety indexes of adverse reactions
Description
Occurrence of adverse reactions post vaccination
Time Frame
within 14 days post each vaccination
Title
Immunogencity indexes of GMT
Description
Evaluate the Geometric mean titer (GMT) of IgG antibody
Time Frame
Day 28 post the second vaccination
Title
Immunogencity indexes of neutralizing antibody
Description
Evaluate the Geometric mean titer (GMT) of neutralizing antibody
Time Frame
Day 28 post the second vaccination
Secondary Outcome Measure Information:
Title
Safety indexes of adverse events
Description
Occurrence of adverse reactions post-vaccination
Time Frame
Day 0-7,0-14,0-28 post each vaccination
Title
Safety indexes of Hematological examination measures（Hemoglobin, WBC）
Description
Occurrence of abnormal changes of Hematological examination indexes(only fit for MID and sentinel group)
Time Frame
pre-vaccination, day 4 post each vaccination
Title
Safety indexes of Blood routine measures(ALT, AST)
Description
Occurrence of abnormal changes of lBlood routine indexes (only fit for MID and sentinel group)
Time Frame
pre-vaccination, day 4 post each vaccination
Title
Safety indexes of SAE
Description
Occurrence of serious adverse events post-vaccination
Time Frame
Within 6 months post the second vaccination
Title
Immunogencity indexes of GMT
Description
Evaluate the Geometric mean titer of IgG antibody
Time Frame
Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination
Title
Immunogencity indexes of neutralizing antibody
Description
Evaluate the Geometric mean titer (GMT) of neutralizing antibody
Time Frame
Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination
Title
Immunogencity indexes of cellular immune
Description
Number of cell-mediated immune response against SARS-CoV-2（IL-2）
Time Frame
Day 28 post the first vaccination, pre and day 28 post the second vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fengcai Zhu, MSD
Organizational Affiliation
Jiangsu Provincal Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taixing City center for Disease Control and Prevention
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34551104
Citation
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.
Results Reference
derived
Learn more about this trial
A Clinical Trial of A COVID-19 Vaccine Named Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
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