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Optimising DNA Vaccinations in Healthy Volunteers

NCT03663998 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-01-27

No results posted yet for this study

Summary

This is a two part study to evaluate the immunogenicity and tolerability of DNA-C CN54ENV plasmid DNA (CN54ENV) administered with electroporation (EP), with and without DNA encoding recombinant interleukin-12 (GENEVAX® IL-12). Part 1 is exploratory and designed to select conditions capable of promoting enhanced B cell responses in a limited number of volunteers. Part 2 is dependent upon Part 1 and is designed to study the fine specificity of the B-cell immune responses to CN54ENV DNA in an expanded number of subjects. Data from both stages will be combined for safety and immunological analysis.

Conditions

Interventions

BIOLOGICAL

CN54ENV DNA

CN54ENV DNA concentration 4 ± 0.7 mg/mL is formulated in 1 x PBS All administrations of CN54ENV will be by in vivo electroporation using the Ichor Medical Systems TriGrid Delivery System for intramuscular (TDS-IM) or intradermal use (TDS-ID) and will be delivered into the upper thigh(s).

BIOLOGICAL

GENEVAX® IL-12 DNA

GENEVAX® IL-12 DNA, concentration 2 mg/mL with a fill volume of 1.0 mL (1.0 ± 0.1mL), is formulated in 30 mM citrate buffer. GENEVAX® IL-12 DNA is mixed with the CN54ENV DNA immediately prior to administration.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Julie Fox, MD · King's College London

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2015-08-15
Primary Completion
2017-05-10
Completion
2018-04-10

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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 NCT03663998 on ClinicalTrials.gov