NCT04552366

Brief Summary

This is a clinical trial to evaluate the safety and immunogenicity of a recombinant adenovirus 5 vectored COVID-19 vaccine (Ad5-nCoV) with two doses and with different adminstration routes in healthy adults aged 18 years and older.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for phase_1 covid19

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

September 29, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

May 24, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

September 15, 2020

Last Update Submit

May 22, 2023

Conditions

COVID-19

Keywords

COVID-19 vaccineAd5-nCoV

Outcome Measures

Primary Outcomes (5)

  • Incidence of the AE in all groups

    The occurrence of AE in all groups within 0-7 days after each vaccination;

    0-7 days after each vaccination

  • Seroconversion rate of the IgG antibody against SARS-CoV-2

    Seroconversion rate the IgG antibody against SARS-CoV-2 measured on Day 28 after last vaccination

    Day 28 after last vaccination

  • Geomean titers of the IgG antibody against SARS-CoV-2

    Geomean titers of the IgG antibody against SARS-CoV-2 measured on Day 28 after last vaccination

    Day 28 after last vaccination

  • Seroconversion rate of the neutralizing antibody against SARS-CoV-2

    Seroconversion rate of the neutralizing antibody against SARS-CoV-2 measured on Day 28 after last vaccination

    Day 28 after last vaccination

  • Geomean titers of the neutralizing antibody against SARS-CoV-2

    Geomean titers of the neutralizing antibody against SARS-CoV-2 measured on Day 28 after last vaccination

    Day 28 after last vaccination

Secondary Outcomes (10)

  • Incidence of the AE in all groups

    0-30 minutes, 0-28 days after each vaccination

  • Incidence of Serious adverse events (SAE) in all groups

    6 months after the final vaccination

  • Geomean titers of the IgG antibody against SARS-CoV-2

    Day 0, 14, 28 and 56 after first vaccination and Day 14 and Day168 after last vaccination.

  • Seroconversion rate of the IgG antibody against SARS-CoV-2

    Day 0, 14, 28 and 56 after first vaccination and Day 14 and Day168 after last vaccination.

  • Geomean titers of the neutralizing antibody against SARS-CoV-2

    Day 0, 14, 28 and 56 after first vaccination and Day 14 and Day168 after last vaccination.

  • +5 more secondary outcomes

Study Arms (6)

Group A: Intramuscular administration

EXPERIMENTAL

24 subjects. 5E10 VP of Ad5-nCoV on Day 0 and on Day 56.

Biological: Ad5-nCoV

Group B: Mixed administration

EXPERIMENTAL

24 subjects. An intramuscular administration of 5E10 VP of Ad5-nCoV on day 0 and a mucosal administration of 2E10 VP on Day 28.

Biological: Ad5-nCoV

Group C: Mucosal administration, high dose

EXPERIMENTAL

24 subjects. A mucosal administration of 2E10 VP of Ad5-nCoV on Day 0 and Day 28.

Biological: Ad5-nCoV

Group D: Mucosal administration, low dose

EXPERIMENTAL

24 subjects. A mucosal administration of 1E10 VP of Ad5-nCoV on day 0 and Day 28.

Biological: Ad5-nCoV

Group E: Intramuscular administration, one dose

ACTIVE COMPARATOR

24 subjects. An intramuscular administration of 5E10 VP of Ad5-nCoV on day 0.

Biological: Ad5-nCoV

Group F: Intramuscular administration, two doses

EXPERIMENTAL

24 subjects. Two intramuscular administrations of 5E10 VP of Ad5-nCoV at left and right arms on day 0.

Biological: Ad5-nCoV

Interventions

Ad5-nCoVBIOLOGICAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Group A: Intramuscular administrationGroup B: Mixed administrationGroup C: Mucosal administration, high doseGroup D: Mucosal administration, low doseGroup E: Intramuscular administration, one doseGroup F: Intramuscular administration, two doses

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years and older;
  • Able to provide consent to participate in and having signed an Informed Consent Form (ICF);
  • Able and willing to complete all the scheduled study procedures during the whole study follow-up period (about 6-8 months, depending on group);
  • Negative result of HIV screening;
  • Axillary temperature ≤37.0°C.
  • Negative IgG and IgM antibodies against COVID-19;
  • Good general health status, as determined by history and physical examination.

You may not qualify if:

  • Hematological examination is abnormal, or clinically significant as assessed by the study investigator (including white blood cell count, lymphocyte count, neutrophil count, eosinophil count, platelet, hemoglobin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, blood glucose and creatinine);
  • With oral ulcers, throat swelling and other oral diseases.
  • With symptoms of upper respiratory tract infection.
  • Personal history of seizure disorder, encephalopathy or psychosis;
  • Allergic history to any vaccine, or allergic to any ingredient of the Ad5-nCoV;
  • Any acute febrile disease or active infectious disease on the day of vaccination;
  • History of SARS or COVID-19;
  • History of COVID-19 candidate vaccine administration;
  • History of chronic obstructive pulmonary disease (COPD).
  • Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension not controlled with medication;
  • Serious chronic disease or in the advanced stage that cannot be controlled well， such as asthma, diabetes and thyroid disease, etc.;
  • Congenital or acquired angioedema;
  • Suffered from urticaria within 1 year before receiving the trial vaccine.
  • Asplenia or functional asplenia;
  • Platelet disorder or other bleeding disorder that may cause intramuscular injection contraindication;
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan Hospital

Wuhan, Hubei, 430071, China

Location

Related Publications (1)

  • Wu S, Huang J, Zhang Z, Wu J, Zhang J, Hu H, Zhu T, Zhang J, Luo L, Fan P, Wang B, Chen C, Chen Y, Song X, Wang Y, Si W, Sun T, Wang X, Hou L, Chen W. Safety, tolerability, and immunogenicity of an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in adults: preliminary report of an open-label and randomised phase 1 clinical trial. Lancet Infect Dis. 2021 Dec;21(12):1654-1664. doi: 10.1016/S1473-3099(21)00396-0. Epub 2021 Jul 26.

    PMID: 34324836DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Ad5-nCoV vaccine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2020

First Posted

September 17, 2020

Study Start

September 29, 2020

Primary Completion

December 31, 2020

Study Completion

April 30, 2021

Last Updated

May 24, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)