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Phase I Clinical Study of Recombinant Novel Coronavirus Vaccine

NCT04445194 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-12-03

No results posted yet for this study

Summary

In this trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups. The first-stage randomized participants in the low-dose group (20 cases) and the placebo group (5 cases) were evaluated for 7 days. After the 7-day safety data was evaluated and agreed by the DSMB, the second-stage study was conducted. Into the high-dose group (20 cases) and placebo group (5 cases) subjects; follow-up to 30 days, after the safety assessment by the investigator and consent, then inoculate the second dose. Observation was performed for 1.0 hour after the second dose. The researchers conducted a safety evaluation and agreed to follow-up after discharge.

Conditions

  • Coronavirus

Interventions

BIOLOGICAL

Recombinant new coronavirus vaccine (CHO cell) low-dose group

Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).

BIOLOGICAL

Recombinant new coronavirus vaccine (CHO cells) high-dose group

Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).

BIOLOGICAL

Recombinant new coronavirus vaccine (CHO cells) placebo group

Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).

Sponsors & Collaborators

  • The Second Affiliated Hospital of Chongqing Medical University

    collaborator OTHER

  • Beijing Chao Yang Hospital

    collaborator OTHER

  • Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hong Ren, master · The Second Affiliated Hospital of Chongqing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-22
Primary Completion
2020-10-22
Completion
2021-09-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04445194 on ClinicalTrials.gov