MedTrace Logo

A Phase 2 Bridging Study to Assess the New Formulation of ETVAX

NCT05178134 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2025-08-19

Study results available
· View outcomes & findings →

Summary

This is a phase 2,prospective double-blind, randomized, parallel-group study with the aim to demonstrate non-inferiority, in terms of immunogenicity, between the wet formulation and a newly developed partially dried formulation of selected components of ETVAX.

Conditions

  • Healty Volunteers
  • Preventable Disease, Vaccine

Interventions

BIOLOGICAL

Etvax

Preparation of complete Wet formulation. The vaccine supplied as a liquid, is mixed with the 150 ml of sodium bicarbonate buffer solution on the day of preparation for use on dosing day. Just prior to administration 10 µg of dmLT is added by pipette (50 µl).

BIOLOGICAL

Etvax

Preparation of partially dry formulation. The partially dry formulation of vaccine is prepared by adding the effervescent powder containing the dmLT and LCTBA to 150 ml of water. After mixing, the content of the vaccine vial is added to the mixture and the vaccine is administered to the volunteer within 30 minutes after adding the buffer powder to the water.

Sponsors & Collaborators

  • Göteborg University

    collaborator OTHER

  • Aurevia

    collaborator INDUSTRY

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Scandinavian Biopharma AB

    lead INDUSTRY

Principal Investigators

  • Dan Curiac, MD · Clinical Trial Center, CTC, Gothia Forum

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2022-10-20
Completion
2022-10-20

Countries

  • Sweden

Study Locations

More Related Trials

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 NCT05178134 on ClinicalTrials.gov