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A Randomized, Phase I Study of DNA Vaccine OC-007 as a Booster Dose of COVID-19 Vaccine

NCT05685953 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-03-27

No results posted yet for this study

Summary

This is a randomized, placebo-controlled, double-blinded phase I study, designed to evaluate the safety including reactogenicity and immunogenicity of this investigational DNA vaccine delivered intramuscularly by in vivo EP in human adults. The vaccine doses will be given to healthy adults aged 18 to 60 years, who have been previously vaccinated against COVID-19 with 3 doses of either Comirnaty® or Spikevax®, or both in any combination ≥3 months ago.

Conditions

  • COVID-19 Respiratory Infection
  • COVID-19 Vaccine Adverse Reaction

Interventions

BIOLOGICAL

DNA vaccine OC-007

Plasmid DNA vaccine

OTHER

Placebo

0.9% NaCl solution

Sponsors & Collaborators

  • Matti Sällberg

    lead OTHER

Principal Investigators

  • Matti Sällberg, PhD · Department of Laboratory Medicine, Karolinska Institute, Stockholm

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-02-08
Primary Completion
2024-03-13
Completion
2024-03-13

Countries

  • Sweden

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 NCT05685953 on ClinicalTrials.gov