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

NCT05178134 | Completed Phase 2 Results

• 2 other identifiers: OEV-1252021-001541-13
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prophylaxis against diarrhea due to enterotoxigenic E. coli

Outcome Measures

Primary Outcomes (1)

• Vaccine Response

  The primary endpoint to be measured for each patient in the study is response (yes/no) to a vaccine. A vaccine responder will be defined by a ≥2-fold increase in IgA and/or IgG antibody levels against LTB in serum between post- compared to pre-immunization samples. The response rates (seroconversion rates) of IgA and/or IgG anti-LTB antibodies in serum will be derived and compared between the two treatment groups.

  3 weeks

Secondary Outcomes (1)

• Solicited Symptoms After Vaccination

  3 weeks

Other Outcomes (1)

• Levels of IgA and IgG Antibodies Mononuclear Cells (PBMCs)

  3 months

Study Arms (2)

The wet formulation of ETVAX.

ACTIVE COMPARATOR

The wet formulation consists of a liquid suspension of inactivated bacteria (ETEX 21-24) and LCTBA in one vial, freeze-dried dmLT adjuvant in a second vial, and effervescent buffer granules in a separate sachet. Prior to administration, the buffer is dissolved in 150 ml tap water, followed by the addition of the content of the vaccine vial (inactivated bacteria mixed with LCTBA) and reconstituted and diluted adjuvant dmLT from the second vial.

Biological: Etvax

The partially dried formulation of selected components of ETVAX.

ACTIVE COMPARATOR

The partially dried formulation, dmLT and LCTBA are spray-dried and mixed with the buffer granules and stabilizing excipients in a sachet. Prior to administration, the content of the buffer sachet (buffer, dmLT, and LCTBA) is dissolved in 150 ml tap water, followed by the addition of a liquid suspension of inactivated bacteria (ETEX 21-24).

Biological: Etvax

Interventions

Etvax BIOLOGICAL

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).

The wet formulation of ETVAX.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female aged 18-50 years, inclusive at the time of signing the informed consent.
• Healthy constitution as established by medical history and physical examination.
• Willing and able to give written informed consent for participation in the study.
• Able to comply with study activities, as judged by the Investigator.
• Female Participants:
• Women of child-bearing potential (for definition see Section 9.3.6 in the protocol):
• Have to agree to use an acceptable birth control method during participation in the investigation (see Section 9.3.6).
• A negative pregnancy test (beta human chorionic gonadotropin dipstick test in urine) at Visit 2/Day 1 will be required.
• Male Participants:
• Have to agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined in Section 9.3.6

You may not qualify if:

• An acute or chronic medical condition that, in the opinion of the investigator/physician, would render ingestion of the investigational products unsafe or would interfere with the evaluation of responses. This includes, but is not limited to gastrointestinal diseases, and autoimmune diseases.
• Current malignancy or history of malignancy during the last five years, based on anamnesis.
• Gastroenteritis within two weeks prior to vaccination.
• Regular use of laxatives, antacids or other agents that lower stomach acidity.
• Any planned major surgery during the duration of the study.
• After 10 minutes supine rest, any vital signs outside the following ranges:
• Systolic BP \> 160 mm Hg
• Diastolic BP \> 100 mm Hg
• Heart rate \< 40 or \>85 beats per minute
• Antibiotic therapy within two weeks prior to the vaccination.
• Known Hepatitis A, B, C, and/or HIV infection.
• Concomitant intake of immunomodulating drugs during the study period or less than 3 months prior to the first immunization, with the following exceptions: oral anti-histamines are not allowed during the study period or less than 3 weeks prior to the first immunization. Local anti-histamine treatment is allowed during the study period.
• Any other significant medical conditions (e.g. poorly controlled psychiatric condition) judged by the Investigator to preclude entry.
• Intends to receive any other vaccine during the study period, or within two weeks prior to trial vaccination.
• Has previously received Dukoral or any type of ETEC or cholera vaccines.

Sponsors & Collaborators

• Scandinavian Biopharma AB: lead
• Göteborg University: collaborator
• Aurevia: collaborator
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Clinical Trial Center, CTC

Gothenburg, 41346, Sweden

Location

MeSH Terms

Conditions

Vaccine-Preventable Diseases

Condition Hierarchy (Ancestors)

Infections

Results Point of Contact

• Title: Head of Clinical Development
• Organization: Scandinavian Biopharma Holding AB

info@scandinavianbiopharma.se

+4684705600

Study Officials

• Dan Curiac, MD

  Clinical Trial Center, CTC, Gothia Forum

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Other parts will be blinded except unblinded person who prepares the doses
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: January 5, 2022
• Study Start: November 8, 2021
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-08

Locations

SE (1)