Trials Sponsors Conditions Drugs Pricing

Conditions

Treat and Prevent Covid-19 Infection

Keywords

Lentiviral vector, Covid-19/aAPC vaccine

Outcome Measures

Primary Outcomes (3)

Frequency of vaccine events
Frequency of vaccine events such as fever, rash, and abnormal heart function.
Measured from Day 0 through Day 28
Frequency of serious vaccine events
Frequency of serious vaccine events
Measured from Day 0 through Day 28
Proportion of subjects with positive T cell response
14 and 28 days after randomization

Secondary Outcomes (6)

28-day mortality
Measured from Day 0 through Day 28
Duration of mechanical ventilation if applicable
Measured from Day 0 through Day 28
Proportion of patients in each category of the 7-point scale
7,14 and 28 days after randomization
Proportion of patients with normalized inflammation factors
7 and 14 days after randomization
Clinical improvement based on the 7-point scale if applicable
28 days after randomization
+1 more secondary outcomes

Study Arms (1)

Injection of Covid-19/aAPC vaccine

EXPERIMENTAL

Biological: Pathogen-specific aAPC

Interventions

Pathogen-specific aAPCBiological

The subjects will receive three injections of 5x10\^6 each Covid-19/aAPC vaccine via subcutaneous injections.

Injection of Covid-19/aAPC vaccine

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age6 Months - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Healthy and Covid-19-positive volunteers
The interval between the onset of symptoms and randomized is within 7 days in Covid-19 patients. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms can be used;

Sponsors & Collaborators

Shenzhen Geno-Immune Medical Institute
Otherlead

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

Study Officials

Lung-Ji Chang
Shenzhen Geno-Immune Medical Institute
PRINCIPAL INVESTIGATOR

Enrollment

100 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: President

Study Record Dates

First Submitted

March 5, 2020

First Posted

March 9, 2020

Study Start

June 1, 2026

Actual (reported)

Safety and Immunity of Covid-19 aAPC Vaccine

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (6)

Study Arms (1)

Injection of Covid-19/aAPC vaccine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (6)

Study Arms (1)

Injection of Covid-19/aAPC vaccine

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations