Phase I Clinical Trial of a COVID-19 Vaccine in 18-60 Healthy Adults
- Conditions
- COVID-19
- Interventions
- Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
- Registration Number
- NCT04313127
- Lead Sponsor
- CanSino Biologics Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description High-dose Group Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Subjects received one dose of 1.5E11vp Ad5-nCoV at 18 to 60 years old Middle-dose Group Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Subjects received one dose of 1E11 vp Ad5-nCoV at 18 to 60 years old Low-dose Group Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Subjects received one dose of 5E10 vp Ad5-nCoV at 18 to 60 years old
- Primary Outcome Measures
Name Time Method Safety indexes of adverse reactions 0-7 days post-vaccination Occurrence of adverse reactions post-vaccination
- Secondary Outcome Measures
Name Time Method Immunogencity indexes of GMT(ELISA) day14,28，month 3,6 post-vaccination Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method) day14,28，month 6 post-vaccination the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMC(Ad5 vector) day、14,28，month3,6 post-vaccination Geometric mean concentration（GMC）of anti-Ad5 vector neutralizing antibody responses
Safety indexes of adverse events 0-28 days post-vaccination Occurrence of adverse events post-vaccination
Safety indexes of lab measures pre-vaccination, day 7 post-vaccination Occurrence of abnormal changes of laboratory safety examinations
Immunogencity indexes of GMT(pseudoviral neutralization test method) day14,28，month 6 post-vaccination Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of GMI(ELISA) day14,28，month 3,6 post-vaccination Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of GMI(pseudoviral neutralization test method) day14,28，month 6 post-vaccination Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum
Immunogencity indexes of cellular immune day 14, 28,month 6 post-vaccination specific cellular immune responses
Safety indexes of SAE 0-28 days, within 6 mouths post-vaccination Occurrence of serious adverse events post-vaccination
Immunogencity indexes of seropositivity rates(ELISA) day14,28，month 3,6 post-vaccination the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum
Immunogencity indexes of GMI(Ad5 vector) day、14,28，month3,6 post-vaccination Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses
Trial Locations
- Locations (1)
Hubei Provincial Center for Disease Control and Prevention
🇨🇳Wuhan, Hubei, China