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Omicron BA.4/5-Delta COVID-19 Vaccine Phase I Clinical Trial

NCT06043388 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-09-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) after vaccination in people aged 18 and over. It is planned to screen 100 subjects who are 18 years old and above and more than 6 months since the last new coronavirus infection or new coronavirus vaccine. All subjects collected venous blood before vaccination, 14 days, 3 months, and 6 months after vaccination for immunological detection of neutralizing antibody of the new coronavirus prototype strain, Delta strain and Omicron strain (BA.4/5, XBB); All adverse events (AEs) within 30 minutes after vaccination, all AEs (including solicited and non-solicited AEs) on days 0-7, all AEs (non-solicited AEs) on days 8-30, and all AEs within 12 months after vaccination were collected. serious adverse events (SAE) and adverse events of special interest (AESI).

Conditions

Interventions

BIOLOGICAL

Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)

Inoculate one dose, 0.5ml，Intramuscular injection into the deltoid muscle of the upper arm

BIOLOGICAL

Placebo

Inoculate one dose, 0.5ml，Intramuscular injection into the deltoid muscle of the upper arm

Sponsors & Collaborators

  • Hunan Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Junshi Zhao, Master · Hunan Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2023-12-31
Completion
2024-11-30

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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 NCT06043388 on ClinicalTrials.gov