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

COVID-19 Clinical Trial

Official title:
A First Time in Human Phase 1 Open-Label Study of the Safety, Tolerability, and Immunogenicity of COVIDITY Vaccine Administered by Needle-free Intradermal Injection or Needle-free Intramuscular Injection in Healthy Adults (COVIDITY-001)

Clinical Trial Summary

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

Clinical Trial Description

This is an open label, two-arm Phase 1 study to determine the safety, tolerability and immunogenicity of the SARS-CoV-2 COVIDITY vaccine, when administered using a needle-free injection device. COVIDITY consists of two doses of the plasmid DNA vaccine SCOV1 (administered on Day 1 and Day 29), followed by two doses of the plasmid DNA vaccine SCOV2 (not before Days 113 and 141 [doses 4 weeks apart]). A final end of study assessment will then be performed 6 weeks after last dose of study vaccine (Day 183 [earliest]). SCOV1 is expected to be active against the original SARS-CoV-2 strain and the B.1.1.7 (Alpha) variant, and to a slightly lesser extent against the B.1.351 (Beta) and P.1 (Gamma) variants. SCOV2 is expected to boost the effects of SCOV1 while providing further enhanced protection against the B.1.351 (Beta) and P.1 (Gamma) variants. Each dose of SCOV1 or SCOV2 will be administered via needle-free injection, either intradermally (0.2 mg doses; study Arm 1; PharmaJet Tropis® device) or intramuscularly (1.0 mg doses; study Arm 2; PharmaJet Stratis® device). Eligible injection sites include the outer aspect of the upper left or right arm (medial deltoid muscle) or the left or right outer thigh (lateralis muscle) for intradermal administration (Arm 1), and the outer aspect of the upper left or right arm (medial deltoid muscle) for intramuscular administration (Arm 2). This study is expected to enrol 40 participants (20 per study arm) at one study centre in South Africa. At least 15 participants in each arm should be negative for antibodies against SARS-CoV-2 upon entry into the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05047445
Study type Interventional
Source Scancell Ltd
Contact Robert Miller
Phone +44 (0)1865 582 690
Email [email protected]
Status Recruiting
Phase Phase 1
Start date September 30, 2021
Completion date June 2022
View Details
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