Clinical trial NCT04341389: A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector)
Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Recombinant Novel Coronavirus Vaccine (Adenovirus Vector) in Healthy Adults Aged Above 18 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: COVID-19 vaccine
Ad5-nCoV
SARS-CoV-2
Lead sponsor: Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China
Sponsor class: OTHER
Collaborators: name: CanSino Biologics Inc.
name: Jiangsu Province Centers for Disease Control and Prevention
name: Hubei Provincial Center for Disease Control and Prevention
name: Zhongnan Hospital
First posted: 2020-04-10
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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

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.
* Axillary temperature ≤37.0°C.
* The BMI index is 18.5-30.0.
* 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: Occurrence of adverse reactions
timeFrame: 0-14 days post vaccination
measure: Anti SARS-CoV-2 S IgG antibody response(ELISA)
timeFrame: 28 days post vaccination
measure: Neutralizing antibody response to SARS-CoV-2
timeFrame: 28 days post vaccination
Secondary outcomes:
measure: Occurrence of adverse events
timeFrame: 0-28 days post vaccination
measure: Occurrence of serious adverse reaction
timeFrame: 0-6 months post vaccination
measure: Anti SARS-CoV-2 S IgG antibody response(ELISA)
timeFrame: 0, 14 days and 6 months post vaccination
measure: Neutralizing antibody response to SARS-CoV-2
timeFrame: 0 and 6 months post vaccination
measure: Neutralizing antibody response to Ad5-vector
timeFrame: 0, 28 days and 6 months post vaccination
measure: IFN-γ ELISpot responses to SARS-CoV-2 spike protein
timeFrame: 0 and 28 days post vaccination
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei Provincial Center for Disease Control and Prevention
state: Hubei
Study officials:
affiliation: Jiangsu Province Centers of Disease Control and Prevention
name: Fengcai Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhu FC, Guan XH, Li YH, Huang JY, Jiang T, Hou LH, Li JX, Yang BF, Wang L, Wang WJ, Wu SP, Wang Z, Wu XH, Xu JJ, Zhang Z, Jia SY, Wang BS, Hu Y, Liu JJ, Zhang J, Qian XA, Li Q, Pan HX, Jiang HD, Deng P, Gou JB, Wang XW, Wang XH, Chen W. Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2020 Aug 15;396(10249):479-488. doi: 10.1016/S0140-6736(20)31605-6. Epub 2020 Jul 20.