NCT04840992

Brief Summary

This study is a randomized, double-blind, placebo-controlled I/II clinical trial, in order to evaluate the safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation in adults 18 years of Age and Older.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
840

participants targeted

Target at P75+ for phase_1 covid19

Timeline
Completed

Started Apr 2021

Typical duration for phase_1 covid19

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

April 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

April 21, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2022

Completed
Last Updated

February 8, 2023

Status Verified

October 1, 2022

Enrollment Period

1.2 years

First QC Date

April 8, 2021

Last Update Submit

February 7, 2023

Conditions

COVID-19

Keywords

COVID-19VaccineAd5SafetyImmunogenicitySARS-CoV-2Adenovirus VectorAerogen Solo

Outcome Measures

Primary Outcomes (2)

  • Incidence of Adverse Reactions (AR)

    The occurrence of Adverse Reactions (AR) in all groups

    0-14 days after each vaccination

  • Incidence of Serious Adverse Events (SAE)

    The occurrence of Serious Adverse Events (SAE) in all groups

    Within the first and final vaccination up until 12 months after the final vaccination

Secondary Outcomes (16)

  • Incidence of Adverse Events/Reactions (AE/AR)

    Within 0-7 days after each vaccination

  • Incidence of Adverse Events/Reactions (AE/AR)

    Within 0-28 days after each vaccination

  • Changes in laboratory test indicators

    4 days after each vaccination

  • GMT of Covid-19 S protein RBD specific antibody

    Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose

  • Seroconversion rate of Covid-19 S protein RBD specific antibody

    Before the first dose, 28 days after first dose, before the second dose, 14 days after the second dose

  • +11 more secondary outcomes

Study Arms (22)

A1a Phase I low 2 doses

EXPERIMENTAL

Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

A1b Phase I placebo low 2 doses

PLACEBO COMPARATOR

Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo

Biological: Placebo for Inhalation

A2a Phase I medium 2 doses

EXPERIMENTAL

Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

A2b Phase I placebo medium 2 doses

PLACEBO COMPARATOR

Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo

Biological: Placebo for Inhalation

A3a Phase I high 2 doses

EXPERIMENTAL

Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

A3b Phase I placebo high 2 doses

PLACEBO COMPARATOR

Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo

Biological: Placebo for Inhalation

A4a Phase I combine 2 doses

EXPERIMENTAL

1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for InhalationBiological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

A4b Phase I placebo combine 2 doses

PLACEBO COMPARATOR

6 subjects, Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart

Biological: Placebo for InhalationBiological: Placebo

A5a Phase I single dose

EXPERIMENTAL

Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

A5b Phase I placebo single dose

PLACEBO COMPARATOR

6 subjects, Placebo containing 0 vp, 1 dose Aerogen Solo

Biological: Placebo for Inhalation

B1a Phase II low 2 doses

EXPERIMENTAL

Ad5-nCoV containing 0.5E10 vp, 2 doses 56 days apart, Aerogen Solo

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

B1b Phase II placebo low 2 doses (18-59)

PLACEBO COMPARATOR

Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo

Biological: Placebo for Inhalation

B2a Phase II medium 2 doses

EXPERIMENTAL

Ad5-nCoV containing 1E10 vp, 2 doses 56 days apart, Aerogen Solo

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

B2b Phase II placebo medium 2 doses

PLACEBO COMPARATOR

Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo

Biological: Placebo for Inhalation

B3a Phase II high 2 doses

EXPERIMENTAL

Ad5-nCoV containing 2E10 vp, 2 doses 56 days apart, Aerogen Solo

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

B3b Phase II placebo high 2 doses

PLACEBO COMPARATOR

Placebo containing 0 vp, 2 doses 56 days apart, Aerogen Solo

Biological: Placebo for Inhalation

B4a Phase II combine 2 doses

EXPERIMENTAL

1 dose Intramuscular Injection, Ad5-nCoV containing 5E10 vp, 1 dose Aerogen Solo, Ad5-nCoV containing 2E10 vp, 56 days apart

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for InhalationBiological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

B4b Phase II placebo combine 2 doses

PLACEBO COMPARATOR

Placebo containing 0 vp, 1 dose Intramuscular Injection, 1 dose Aerogen Solo, 56 days apart

Biological: Placebo for InhalationBiological: Placebo

B5a Phase II intramuscular single dose

EXPERIMENTAL

Ad5-nCoV containing 5E10 vp, 1 dose Intramuscular Injection

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

B5b Phase II placebo intramuscular single dose

PLACEBO COMPARATOR

placebo containing 0 vp, 1 dose Intramuscular Injection

Biological: Placebo

B6a Phase II Aerogen Solo single dose

EXPERIMENTAL

Ad5-nCoV containing 1E10 vp, 1 dose Aerogen Solo

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation

B6b Phase II placebo Aerogen Solo single dose

PLACEBO COMPARATOR

placebo containing 0 vp, 1 dose Aerogen Solo

Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Interventions

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for InhalationBIOLOGICAL

Aerogen Solo

A1a Phase I low 2 dosesA2a Phase I medium 2 dosesA3a Phase I high 2 dosesA4a Phase I combine 2 dosesA5a Phase I single doseB1a Phase II low 2 dosesB2a Phase II medium 2 dosesB3a Phase II high 2 dosesB4a Phase II combine 2 dosesB6a Phase II Aerogen Solo single dose
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)BIOLOGICAL

Intramuscular administration

A4a Phase I combine 2 dosesB4a Phase II combine 2 dosesB5a Phase II intramuscular single doseB6b Phase II placebo Aerogen Solo single dose
Placebo for InhalationBIOLOGICAL

Aerogen Solo

A1b Phase I placebo low 2 dosesA2b Phase I placebo medium 2 dosesA3b Phase I placebo high 2 dosesA4b Phase I placebo combine 2 dosesA5b Phase I placebo single doseB1b Phase II placebo low 2 doses (18-59)B2b Phase II placebo medium 2 dosesB3b Phase II placebo high 2 dosesB4b Phase II placebo combine 2 doses
PlaceboBIOLOGICAL

Intramuscular administration

A4b Phase I placebo combine 2 dosesB4b Phase II placebo combine 2 dosesB5b Phase II placebo intramuscular single dose

Eligibility Criteria

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

You may qualify if:

  • Healthy adults 18 years of age and above at the time of enrollment;
  • 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;
  • HIV negative;
  • No nasal or oral diseases, such as acute rhinitis (sinusitis), allergic rhinitis, oral ulcers, sore throat, etc;
  • IgG ang IgM negative for Covid-19;
  • Axillary temperature ≤37.0℃;
  • No contact history of Covid-19.

You may not qualify if:

  • Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrollable medications (on-site measurement: systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg), etc;
  • Abnormal laboratory test indicators which investigator decide to be clinically significant; (Only Phase I volunteers)
  • Respiratory rate ≥17 per minute;
  • Abnormal lung function such as asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, etc;
  • Prior Covid-19 vaccinations;
  • Symptoms of upper respiratory track infections;
  • Medical or family history of convulsions, epilepsy, encephalopathy, and psychosis disorders;
  • History of allergies to any ingredient of Ad5-nCoV, history of serious allergic reactions to any vaccine, history of allergies and immune diseases;
  • Acute febrile diseases and infectious diseases;
  • Medical history of SARS (SARS-CoV-1);
  • Severe chronic diseases or with advanced stage conditions which cannot be controlled smoothly, such as diabetes, thyroid disease, etc;
  • Congenital or acquired angioedema/neurological edema;
  • Urticaria history within 1 year before receiving the study vaccine;
  • Asplenia or functional asplenia;
  • Thrombocytopenia or other coagulation disorders (may cause contraindications for intramuscular injection);
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangsu Provincal Center for Disease Control and Prevention

Nanjing, Jiangsu, China

Location

Related Publications (2)

  • Zhu Y, Tang R, Li X, Chen X, Wang X, Wang Y, Wang R, Zhu F, Li J. Vaccination with Adenovirus Type 5 Vector-Based COVID-19 Vaccine as the Primary Series in Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 1/2 Clinical Trial. Vaccines (Basel). 2024 Mar 11;12(3):292. doi: 10.3390/vaccines12030292.

    PMID: 38543926DERIVED

  • Xia X, Tan ZM, Wan P, Zheng H, Tang R, Chen XQ, Guo XL, Zhu T, Feng JL, Zhong J, Li XL, Zhang ZY, Zhu FC, Li JX. Environmental Impact Assessment for the Use of an Orally Aerosolized Adenovirus Type-5 Vector-Based COVID-19 Vaccine in Randomized Clinical Trials. J Infect Dis. 2023 Sep 15;228(6):715-722. doi: 10.1093/infdis/jiad134.

    PMID: 37202147DERIVED

MeSH Terms

Conditions

COVID-19Alzheimer Disease 5

Interventions

Inhalation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiratory MechanicsRespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Fengcai Zhu, MSD

    Jiangsu Provincal Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 12, 2021

Study Start

April 21, 2021

Primary Completion

July 8, 2022

Study Completion

August 9, 2022

Last Updated

February 8, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)