Clinical trial NCT04313127: Phase I Clinical Trial of a COVID-19 Vaccine in 18-60 Healthy Adults
Official title: A Single-center,Open-label，Dose-escalating Phase I Clinical Trial to Evaluate Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Healthy Adults Aged 18-60 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Keywords: COVID-19
vaccine
Ad5
Safety
Immunogenicity
Infection
novel coronavirus
Dose-escalation
Lead sponsor: CanSino Biologics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
name: Jiangsu Province Centers for Disease Control and Prevention
name: Hubei Provincial Center for Disease Control and Prevention
name: Tongji Hospital
First posted: 2020-03-18
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries.

In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment.

This study is a phase I clinical trial. The investigators intent to evaluate the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) .

Detailed description: This is a single-center,open-label，dose-escalating phase I clinical trial in healthy 18 to 60 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) manufactured by Beijing Institute of Biotechnology and CanSino Biologics Inc.One hundred and eight subjects will be enrolled into one of three cohorts and will receive an intramuscular (IM) injection of experimental vaccine or placebo on Days 1 in the deltoid muscle.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 60 years.
* 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.
* Normal in lung CT images (no imaging features of COVID-19
* Axillary temperature ≤37.0°C.
* The BMI index is 18.5-30.0.
* Negative in Nasopharyngeal swabs / sputum and anal swabs through RT-PCR
* Laboratory tests such as hematological examination and clinical biochemistry examination are in the normal range or without meaning judged by clinical doctor.
* 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: 0-7 days post-vaccination
Secondary outcomes:
measure: Safety indexes of adverse events
timeFrame: 0-28 days post-vaccination
measure: Safety indexes of SAE
timeFrame: 0-28 days, within 6 mouths post-vaccination
measure: Safety indexes of lab measures
timeFrame: pre-vaccination, day 7 post-vaccination
measure: Immunogencity indexes of GMT(ELISA)
timeFrame: day14,28，month 3,6 post-vaccination
measure: Immunogencity indexes of GMT(pseudoviral neutralization test method)
timeFrame: day14,28，month 6 post-vaccination
measure: Immunogencity indexes of seropositivity rates(ELISA)
timeFrame: day14,28，month 3,6 post-vaccination
measure: Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method)
timeFrame: day14,28，month 6 post-vaccination
measure: Immunogencity indexes of GMI(ELISA)
timeFrame: day14,28，month 3,6 post-vaccination
measure: Immunogencity indexes of GMI(pseudoviral neutralization test method)
timeFrame: day14,28，month 6 post-vaccination
measure: Immunogencity indexes of GMC(Ad5 vector)
timeFrame: day、14,28，month3,6 post-vaccination
measure: Immunogencity indexes of GMI(Ad5 vector)
timeFrame: day、14,28，month3,6 post-vaccination
measure: Immunogencity indexes of cellular immune
timeFrame: day 14, 28,month 6 post-vaccination
Other outcomes:
measure: Consistency analysis(ELISA and pseudoviral neutralization test method)
timeFrame: day,14,28, month 6 post-vaccination
measure: Dose-response relationship（Humoral immunity）
timeFrame: day14,28，month 3,6 post-vaccination
measure: Persistence analysis of anti-S protein antibodies
timeFrame: day14,28，month 3,6 post-vaccination
measure: Time-dose-response relationship（Humoral immunity）
timeFrame: day14,28，month 3,6 post-vaccination
measure: Dose-response relationship（ cellular immunity）
timeFrame: day 14, 28,month 6 post-vaccination
measure: Persistence analysis of cellular immuse
timeFrame: day 14, 28,month 6 post-vaccination
measure: Time-dose-response relationship（cellular immunity）
timeFrame: day 14, 28,month 6 post-vaccination
Locations:
city: Wuhan
country: China
facility: Hubei Provincial Center for Disease Control and Prevention
state: Hubei
Study officials:
affiliation: Jiangsu Province Centers for Disease Control and Prevention
name: Zhu Fengcai
role: PRINCIPAL_INVESTIGATOR
affiliation: Hubei Provincial Center for Disease Control and Prevention
name: Guan Xuhua
role: PRINCIPAL_INVESTIGATOR
affiliation: Tongji Hospital
name: Wang Wei
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhu FC, Li YH, Guan XH, Hou LH, Wang WJ, Li JX, Wu SP, Wang BS, Wang Z, Wang L, Jia SY, Jiang HD, Wang L, Jiang T, Hu Y, Gou JB, Xu SB, Xu JJ, Wang XW, Wang W, Chen W. Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial. Lancet. 2020 Jun 13;395(10240):1845-1854. doi: 10.1016/S0140-6736(20)31208-3. Epub 2020 May 22.