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Recombinant New Coronavirus Vaccine (CHO Cells) to Prevent SARS-CoV-2 Phase I Clinical Trial (≥60 Years Old)

NCT04550351 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-01-27

No results posted yet for this study

Summary

Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (≥60 years old) Research purpose: Main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccine (CHO cells) in healthy people aged 60 years and above. Secondary purpose: to initially explore the immunogenicity and durability of different doses of recombinant new coronavirus vaccine (CHO cells).

Overall design: A single-center, randomized, double-blind, placebo-controlled trial design was adopted.

Study population: a healthy population of 60 years and above, a total of 50 cases, both men and women.

Test groups: 20 cases in the low-dose group, 5 cases in the placebo group; 20 cases in the high-dose group, 5 cases in the placebo group.

Conditions

  • Coronavirus

Interventions

BIOLOGICAL

Biological/Vaccine: 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

Biological/Vaccine: 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

Biological/Vaccine: 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

  • Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-19
Primary Completion
2020-12-18
Completion
2021-12-31

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 NCT04550351 on ClinicalTrials.gov