Completed

CTII-nCoVA 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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)

+ Placebo

BiologicalOther
Who is being recruted

COVID-19+9

+ Coronaviridae Infections

+ Infections

Over 18 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-ControlledPhase 2
Interventional
Study Start: April 2020
See protocol details

Summary

Principal SponsorInstitute of Biotechnology, Academy of Military Medical Sciences, PLA of China
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 12, 2020

Actual date on which the first participant was enrolled.

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

Official TitleA 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
NCT04341389
Principal SponsorInstitute of Biotechnology, Academy of Military Medical Sciences, PLA of China
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

508 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

COVID-19Coronaviridae InfectionsInfectionsLung DiseasesPneumoniaPneumonia, ViralRespiratory Tract DiseasesRespiratory Tract InfectionsRNA Virus InfectionsVirus DiseasesCoronavirus InfectionsNidovirales Infections

Criteria

8 inclusion criteria required to participate
Axillary temperature ≤37.0°C.
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.
Show More Criteria
19 exclusion criteria prevent from participating
Major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease.
Any acute fever disease or infections.
Hereditary angioneurotic edema or acquired angioneurotic edema
Subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
1×10\^11vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0

Group II

Active Comparator
5×10\^10vp of Ad5-nCoV administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0

Group III

Placebo
Placebo administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 0

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Hubei Provincial Center for Disease Control and Prevention

Wuhan, ChinaOpen Hubei Provincial Center for Disease Control and Prevention in Google Maps
CompletedOne Study Center