A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector)

Conditions

COVID-19

Keywords

COVID-19 vaccine, Ad5-nCoV, SARS-CoV-2

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

Jialu Feng, Wen-Juan Wang, Pengfei Jin, Hui Zheng, Lairun Jin et al. (10 authors)

Human Vaccines & Immunotherapeutics2023-07-102 citations

10.1080/21645515.2023.2230760

COVID-19 vaccines

Dinesh Kaul

Current Medicine Research and Practice2021-01-011 citations

10.4103/cmrp.cmrp_11_21

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.

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.

2020-07-20893 citations

10.1016/s0140-6736(20)31605-6

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.

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.

2020-05-221,004 citations

10.1016/s0140-6736(20)31208-3

Interventions

BIOLOGICALRecombinant novel coronavirus vaccine (Adenovirus type 5 vector)

Intramuscular injection

OTHERPlacebo

Intramuscular injection

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Occurrence of adverse reactions	0-14 days post vaccination
Anti SARS-CoV-2 S IgG antibody response(ELISA)	28 days post vaccination
Neutralizing antibody response to SARS-CoV-2	28 days post vaccination

Secondary

Measure	Time frame
Neutralizing antibody response to SARS-CoV-2	0 and 6 months post vaccination
Occurrence of adverse events	0-28 days post vaccination
IFN-γ ELISpot responses to SARS-CoV-2 spike protein	0 and 28 days post vaccination
Neutralizing antibody response to Ad5-vector	0, 28 days and 6 months 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

Countries

China

Outcome results

None listed