A Clinical Trial of A COVID-19 Vaccine Named Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
NCT ID: NCT04566770
Last Updated: 2022-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
480 participants
INTERVENTIONAL
2020-09-24
2022-01-19
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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MID A
20 participants(18-49), Ad5-nCoV , two doses, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular other name:Ad5-nCoV
MID B
10 participants(18-49), Ad5-nCoV-placebo , two doses, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
Intramuscular other name:Ad5-nCoV
MIN A
100 participants(6-17), Ad5-nCoV , two doses, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular other name:Ad5-nCoV
MIN B
50 participants(6-17), Ad5-nCoV-placebo , two doses, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
Intramuscular other name:Ad5-nCoV
OLD A
100 participants(56 years of age and above), Ad5-nCoV , two doses(Low dose), Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular other name:Ad5-nCoV
OLD B
100 participants(56 years of age and above), Ad5-nCoV , two doses(Middle dose), Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular other name:Ad5-nCoV
OLD C
50 participants(56 years of age and above), Ad5-nCoV-placebo , two doses, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
Intramuscular other name:Ad5-nCoV
EBOV A
34 participants, Ad5-nCoV , two doses, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular other name:Ad5-nCoV
EBOV B
17 participants, Ad5-nCoV , two doses, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
Intramuscular other name:Ad5-nCoV
Interventions
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Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular other name:Ad5-nCoV
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo
Intramuscular other name:Ad5-nCoV
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
ALL
Yes
Sponsors
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Beijing Institute of Biotechnology
OTHER
Jiangsu Province Centers for Disease Control and Prevention
NETWORK
CanSino Biologics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Fengcai Zhu, MSD
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincal Center for Disease Control and Prevention
Locations
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Taixing City center for Disease Control and Prevention
Taizhou, Jiangsu, China
Countries
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References
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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.
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.
Other Identifiers
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JSVCT093
Identifier Type: -
Identifier Source: org_study_id
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