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A First Time in Human Phase 1 Open-Label Study of the COVIDITY Vaccine Administered by Needle-free Injection

NCT05047445 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-11-25

No results posted yet for this study

Summary

The main objectives of this study are to assess the safety, tolerability and immunogenicity of the candidate SARS-CoV-2 vaccine, COVIDITY, when administered using a needle-free ID or IM injection device.

Conditions

Interventions

BIOLOGICAL

COVIDITY (SCOV1 and SCOV2) administered via needle-free intradermal injection

Two 0.2 mg doses of the plasmid DNA vaccine SCOV1 (administered on Day 1 and Day 29), followed by two 0.2 mg doses of the plasmid DNA vaccine SCOV2 (not before Days 113 and 141 \[doses 4 weeks apart\]).

BIOLOGICAL

COVIDITY (SCOV1 and SCOV2) administered via needle-free intramuscular injection

Two 1.0 mg doses of the plasmid DNA vaccine SCOV1 (administered on Day 1 and Day 29), followed by two 1.0 mg doses of the plasmid DNA vaccine SCOV2 (not before Days 113 and 141 \[doses 4 weeks apart\]).

BIOLOGICAL

COVIDITY (SCOV2 only) administered via needle-free intradermal injection to vaccine naive and/or previously vaccinated participants

Two 0.8 mg doses of the plasmid DNA vaccine SCOV2 administered on Day 1 and Day 29

BIOLOGICAL

COVIDITY (SCOV2 only) administered via needle-free intramuscular injection to vaccine naive and/or previously vaccinated participants

Two 4.0 mg doses of the plasmid DNA vaccine SCOV2 administered on Day 1 and Day 29

BIOLOGICAL

COVIDITY (SCOV2 only) administered via needle-free intradermal injection to previously infected participants

A single 0.8 mg dose of the plasmid DNA vaccine SCOV2 administered on Day 1

BIOLOGICAL

COVIDITY (SCOV2 only) administered via needle-free intramuscular injection to previously infected participants

A single 4.0 mg dose of the plasmid DNA vaccine SCOV2 administered on Day 1

Sponsors & Collaborators

  • Scancell Ltd

    lead INDUSTRY

Principal Investigators

  • Rodney Dawson, MD · University of Cape Town Lung Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

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 NCT05047445 on ClinicalTrials.gov