A Clinical Trial of A COVID-19 Vaccine Named Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
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
1 other identifier
interventional
480
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started Sep 2020
Typical duration for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2020
CompletedStudy Start
First participant enrolled
September 24, 2020
CompletedFirst Posted
Study publicly available on registry
September 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2022
CompletedOctober 31, 2022
October 1, 2022
12 months
September 22, 2020
October 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Safety indexes of adverse reactions
Occurrence of adverse reactions post vaccination
within 14 days post each vaccination
Immunogencity indexes of GMT
Evaluate the Geometric mean titer (GMT) of IgG antibody
Day 28 post the second vaccination
Immunogencity indexes of neutralizing antibody
Evaluate the Geometric mean titer (GMT) of neutralizing antibody
Day 28 post the second vaccination
Secondary Outcomes (7)
Safety indexes of adverse events
Day 0-7,0-14,0-28 post each vaccination
Safety indexes of Hematological examination measures（Hemoglobin, WBC）
pre-vaccination, day 4 post each vaccination
Safety indexes of Blood routine measures(ALT, AST)
pre-vaccination, day 4 post each vaccination
Safety indexes of SAE
Within 6 months post the second vaccination
Immunogencity indexes of GMT
Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination
- +2 more secondary outcomes
Study Arms (9)
MID A
EXPERIMENTAL20 participants(18-49), Ad5-nCoV , two doses, Intramuscular administration
MID B
PLACEBO COMPARATOR10 participants(18-49), Ad5-nCoV-placebo , two doses, Intramuscular administration
MIN A
EXPERIMENTAL100 participants(6-17), Ad5-nCoV , two doses, Intramuscular administration
MIN B
PLACEBO COMPARATOR50 participants(6-17), Ad5-nCoV-placebo , two doses, Intramuscular administration
OLD A
EXPERIMENTAL100 participants(56 years of age and above), Ad5-nCoV , two doses(Low dose), Intramuscular administration
OLD B
EXPERIMENTAL100 participants(56 years of age and above), Ad5-nCoV , two doses(Middle dose), Intramuscular administration
OLD C
PLACEBO COMPARATOR50 participants(56 years of age and above), Ad5-nCoV-placebo , two doses, Intramuscular administration
EBOV A
EXPERIMENTAL34 participants, Ad5-nCoV , two doses, Intramuscular administration
EBOV B
PLACEBO COMPARATOR17 participants, Ad5-nCoV , two doses, Intramuscular administration
Interventions
Intramuscular other name:Ad5-nCoV
Intramuscular other name:Ad5-nCoV
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taixing City center for Disease Control and Prevention
Taizhou, Jiangsu, 210000, China
Related Publications (2)
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.
PMID: 37428653DERIVEDZhu 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.
PMID: 34551104DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fengcai Zhu, MSD
Jiangsu Provincal Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2020
First Posted
September 28, 2020
Study Start
September 24, 2020
Primary Completion
September 21, 2021
Study Completion
January 19, 2022
Last Updated
October 31, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share