A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector)
- Conditions
- COVID-19
- Registration Number
- NCT04341389
- Lead Sponsor
- Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
- Brief Summary
This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2.
- Detailed Description
This is a phase II, randomised, double-blinded and placebo-controlled clinical trial in healthy adults above 18 years of age,inclusive, who meet all eligibility criteria. This clinical trial is designed to evaluate the immunogenicity and safety of Ad5-nCoV which encodes for a full-length spike (S) protein of SARS-CoV-2. 500 subjects will be enrolled, 250 subjects in middle-dose vaccine group, 125 subjects in low-dose and placebo group, respectively. Immunogenicity will be tested on days 0, 14, 28 and 6 months after vaccination
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 508
- 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.
- Axillary temperature ≤37.0°C.
- The BMI index is 18.5-30.0.
- 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
- CROSSOVER
- Primary Outcome Measures
Name Time Method Anti SARS-CoV-2 S IgG antibody response(ELISA) 28 days post vaccination Neutralizing antibody response to SARS-CoV-2 28 days post vaccination Occurrence of adverse reactions 0-14 days post vaccination
- Secondary Outcome Measures
Name Time Method Neutralizing antibody response to SARS-CoV-2 0 and 6 months post vaccination Occurrence of adverse events 0-28 days post vaccination Occurrence of serious adverse reaction 0-6 months post vaccination Anti SARS-CoV-2 S IgG antibody response(ELISA) 0, 14 days and 6 months post vaccination Neutralizing antibody response to Ad5-vector 0, 28 days and 6 months post vaccination IFN-γ ELISpot responses to SARS-CoV-2 spike protein 0 and 28 days post vaccination
Trial Locations
- Locations (1)
Hubei Provincial Center for Disease Control and Prevention
🇨🇳Wuhan, Hubei, China
Hubei Provincial Center for Disease Control and Prevention🇨🇳Wuhan, Hubei, China