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Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)Wiki

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Correlated Drug Terms (5)

Name (Synonyms) Correlation
drug2815 exercise brochure Wiki 0.71
drug1037 Health Care Worker Survey Wiki 0.71
drug465 COVID-19 Serology Wiki 0.50
drug2465 Telerehabilitation Wiki 0.35
drug1822 Placebo Wiki 0.04

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.06
D045169 Severe Acute Respiratory Syndrome NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There are 2 clinical trials

Clinical Trials

1 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

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) .

NCT04313127 COVID-19 Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Primary Outcomes

Description: Occurrence of adverse reactions post-vaccination

Measure: Safety indexes of adverse reactions

Time: 0-7 days post-vaccination

Secondary Outcomes

Description: Occurrence of adverse events post-vaccination

Measure: Safety indexes of adverse events

Time: 0-28 days post-vaccination

Description: Occurrence of serious adverse events post-vaccination

Measure: Safety indexes of SAE

Time: 0-28 days, within 6 mouths post-vaccination

Description: Occurrence of abnormal changes of laboratory safety examinations

Measure: Safety indexes of lab measures

Time: pre-vaccination, day 7 post-vaccination

Description: Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum

Measure: Immunogencity indexes of GMT(ELISA)

Time: day14,28，month 3,6 post-vaccination

Description: Geometric mean titer（GMT）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum

Measure: Immunogencity indexes of GMT(pseudoviral neutralization test method)

Time: day14,28，month 6 post-vaccination

Description: the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum

Measure: Immunogencity indexes of seropositivity rates(ELISA)

Time: day14,28，month 3,6 post-vaccination

Description: the seropositivity rates of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum

Measure: Immunogencity indexes of seropositivity rates(pseudoviral neutralization test method)

Time: day14,28，month 6 post-vaccination

Description: Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by ELISA in serum

Measure: Immunogencity indexes of GMI(ELISA)

Time: day14,28，month 3,6 post-vaccination

Description: Geometric mean fold increase（GMI）of S-specific antibodies against 2019 novel coronavirus tested by pseudoviral neutralization test method in serum

Measure: Immunogencity indexes of GMI(pseudoviral neutralization test method)

Time: day14,28，month 6 post-vaccination

Description: Geometric mean concentration（GMC）of anti-Ad5 vector neutralizing antibody responses

Measure: Immunogencity indexes of GMC(Ad5 vector)

Time: day、14,28，month3,6 post-vaccination

Description: Geometric mean fold increase（GMI）of anti-Ad5 vector neutralizing antibody responses

Measure: Immunogencity indexes of GMI(Ad5 vector)

Time: day、14,28，month3,6 post-vaccination

Description: specific cellular immune responses

Measure: Immunogencity indexes of cellular immune

Time: day 14, 28,month 6 post-vaccination

Other Outcomes

Description: Consistency analysis of S-specific antibodies against 2019 novel coronavirus tested by ELISA against those tested by pseudoviral neutralization test method

Measure: Consistency analysis(ELISA and pseudoviral neutralization test method)

Time: day,14,28, month 6 post-vaccination

Description: Relationship between Geometric mean titer (GMT) of S protein-specific antibodies against 2019 novel coronavirus and vaccine dose among study groups

Measure: Dose-response relationship（Humoral immunity）

Time: day14,28，month 3,6 post-vaccination

Description: Persistence analysis of anti-S protein antibodies among study groups

Measure: Persistence analysis of anti-S protein antibodies

Time: day14,28，month 3,6 post-vaccination

Description: Relationship between the appearance time of S-specific antibodies against 2019 novel coronavirus and the vaccination dose.

Measure: Time-dose-response relationship（Humoral immunity）

Time: day14,28，month 3,6 post-vaccination

Description: Relationship between cellular immune levels against 2019 novel coronavirus and vaccine dose among study groups

Measure: Dose-response relationship（ cellular immunity）

Time: day 14, 28,month 6 post-vaccination

Description: Persistence analysis of specific cellular immune response

Measure: Persistence analysis of cellular immuse

Time: day 14, 28,month 6 post-vaccination

Description: Relationship between the appearance time of cellular immunity against 2019 novel coronavirus and the vaccination dose.

Measure: Time-dose-response relationship（cellular immunity）

Time: day 14, 28,month 6 post-vaccination

2 A Randomized, Observer-Blind, Dose-escalation Phase I/II Clinical Trial of Ad5-nCoV Vaccine in Healthy Adults From 18 to <85 Years of Age in Canada

This study is a phase I /II adaptive clinical trial to evaluate the safety, tolerability and the Immunogenicity of Ad5-nCoV in healthy adults from 18 to <55 and 65 to <85 years of age，with the randomized, observer-blind, dose-escalation design

NCT04398147 COVID-19 Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Biological: Placebo

Primary Outcomes

Description: The occurrence of Solicited AE in all groups within 0-6 days after each vaccination;

Measure: Incidence of the Solicited AE in all groups

Time: 0-6 days after each vaccination

Description: The occurrence of Unsolicited AE in all groups within 0-28 days after each vaccination.

Measure: Incidence of Unsolicited AE in all groups

Time: 0-28 days after each vaccination

Description: The occurrence of Serious adverse events (SAE) in all groups within 6 months after the final vaccination.

Measure: Incidence of Serious adverse events (SAE) in all groups

Time: 6 months after the final vaccination

Secondary Outcomes

Description: Geometric mean titer (GMT) of the IgG antibody against SARS-CoV-2 measured on Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group (ELISA method);

Measure: Geometric mean titer (GMT) of the IgG antibody against SARS-CoV-2 (ELISA method);

Time: Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group

Description: Seroconversion rate (%of subjects with 4-fold or greater increase in antibody level) of the IgG antibody against SARS-CoV-2 measured on Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group (ELISA method );

Measure: Seroconversion rate of the IgG antibody against SARS-CoV-2(ELISA method )

Time: Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

Description: Geometric Mean Increase Ratio (GMI) of the specific antibody against SARS-CoV-2 measured on Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group (ELISA method);

Measure: Geometric Mean Increase Ratio (GMI) of the specific antibody against SARS-CoV-2(ELISA method);

Time: Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

Description: Geometric mean titer (GMT) of the neutralizing antibody against SARS-CoV-2 measured on Day 0, Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group (Pseudo-viral neutralization assay)

Measure: Geometric mean titer (GMT) of the neutralizing antibody against SARS-CoV-2(Pseudo-viral neutralization assay)

Time: Day 0, Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group

Description: Seroconversion rate of the neutralizing antibody against SARS-CoV-2 measured on Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group(Pseudo-viral neutralization assay);

Measure: Seroconversion rate of the neutralizing antibody against SARS-CoV-2(Pseudo-viral neutralization assay)

Time: Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

Description: Geometric mean increase ratio (GMI) of neutralizing antibody against SARS-CoV-2 measured on Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group (Pseudo-viral neutralization assay)

Measure: Geometric mean increase ratio (GMI) of neutralizing antibody against SARS-CoV-2 (Pseudo-viral neutralization assay)

Time: Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

Description: Geometric Mean Titer (GMT) of the neutralizing antibody against adenovirus type 5 vector measured on Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group;

Measure: Geometric Mean Titer (GMT) of the neutralizing antibody against adenovirus type 5 vector

Time: Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group

Description: Geometric mean increase ratio (GMI) of the neutralizing antibody against adenovirus type 5 vector measured on Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

Measure: Geometric mean increase ratio (GMI) of the neutralizing antibody against adenovirus type 5 vector

Time: Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group

Description: The positive rate of IFN-γ stimulated by S protein overlapping peptide library detected by ELISpot

Measure: cellular immune response by ELISpot

Time: on Day 0, Day 14, Day 28 and Day 168 in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group

Description: The positive rate of IFN-γ, TNF-α, and IL-2 expressed by CD4+ and CD8+ T lymphocytes stimulated by S protein overlapping peptide library detected by Intracellular Cytokine Staining (ICS);

Measure: cellular immune response by ICS

Time: Day 0, Day 14, Day 28 and Day 168 in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group

No related HPO nodes (Using clinical trials)