Clinical trial NCT04566770: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID-19
Vaccine
Ad5
Safety
Immunogencity
SARS-CoV-2
Adenovirus Vector
Lead sponsor: CanSino Biologics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Beijing Institute of Biotechnology
name: Jiangsu Province Centers for Disease Control and Prevention
First posted: 2020-09-28
Enrollment: 480
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Safety indexes of adverse reactions
timeFrame: within 14 days post each vaccination
measure: Immunogencity indexes of GMT
timeFrame: Day 28 post the second vaccination
measure: Immunogencity indexes of neutralizing antibody
timeFrame: Day 28 post the second vaccination
Secondary outcomes:
measure: Safety indexes of adverse events
timeFrame: Day 0-7,0-14,0-28 post each vaccination
measure: Safety indexes of Hematological examination measures（Hemoglobin, WBC）
timeFrame: pre-vaccination, day 4 post each vaccination
measure: Safety indexes of Blood routine measures(ALT, AST)
timeFrame: pre-vaccination, day 4 post each vaccination
measure: Safety indexes of SAE
timeFrame: Within 6 months post the second vaccination
measure: Immunogencity indexes of GMT
timeFrame: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination
measure: Immunogencity indexes of neutralizing antibody
timeFrame: Day 28 post the first vaccination, pre the second vaccination ,Month 6 post the second vaccination
measure: Immunogencity indexes of cellular immune
timeFrame: Day 28 post the first vaccination, pre and day 28 post the second vaccination
Other outcomes:
Locations:
city: Taizhou
country: China
facility: Taixing City center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Jiangsu Provincal Center for Disease Control and Prevention
name: Fengcai Zhu, MSD
role: PRINCIPAL_INVESTIGATOR
References:
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.