Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-26 @ 6:23 PM
Study NCT ID:
NCT05178134
Status:
COMPLETED
Last Update Posted:
2025-08-19
First Post:
2021-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2 Bridging Study to Assess the New Formulation of ETVAX
Sponsor:
Scandinavian Biopharma AB
Organization:
Study Overview
Official Title:
A Phase 2 Immunological Bridging Study Assessing the Non-inferiority of a New Formulation of ETVAX®. A Prospective Double-blind, Randomized Study in Healthy Volunteers.
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
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. A total number of 126 subjects is planned to be included in each arm of the study, i.e. 252 subjects in total. Assuming a 10% dropout rate the target number of subjects to be recruited per study arm is therefore 140, i.e. 280 subjects in total. Healthy volunteers between 18-50 years will be eligible for enrolment into the study.
Eligible subjects will be randomized on Day 1 (Visit 2) to receive either of the two oral formulations of ETVAX (1:1) and consecutively included the study. The treatment allocation (Wet formulation/Partially dried formulation) will be double-blind. The study subjects will receive two oral doses, two weeks apart (Day 1/Visit 2 and Day 15 /Visit 3).The dosing will occur at the clinic (CTC in Gothenburg, Sweden). A follow-up visit will be performed 7 days after the last (second) dose in all study subjects
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.
The secondary endpoint to be measured for each patient in the study is the occurrence of solicited symptoms for six days after each vaccination (day of vaccination and five subsequent days).
Exploratory analyses will be done to evaluate if ETVAX vaccination induces circulating antigen specific memory B- and/or T cells that can be assessed using recently established laboratory assays.
For the exploratory analyses, subgroups of subjects (n=20-40, evenly distributed between the two treatment arms) will participate in additional follow-up visits 5± 1, 30± 7 and 90± 14 days after the second dose. Blood samples will be collected on all exploratory visits. The extra visits and analyses for exploratory analyses may continue after the main part of the study has been completed and the database locked.
Eligible subjects will be randomized on Day 1 (Visit 2) to receive either of the two oral formulations of ETVAX (1:1) and consecutively included the study. The treatment allocation (Wet formulation/Partially dried formulation) will be double-blind. The study subjects will receive two oral doses, two weeks apart (Day 1/Visit 2 and Day 15 /Visit 3).The dosing will occur at the clinic (CTC in Gothenburg, Sweden). A follow-up visit will be performed 7 days after the last (second) dose in all study subjects
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.
The secondary endpoint to be measured for each patient in the study is the occurrence of solicited symptoms for six days after each vaccination (day of vaccination and five subsequent days).
Exploratory analyses will be done to evaluate if ETVAX vaccination induces circulating antigen specific memory B- and/or T cells that can be assessed using recently established laboratory assays.
For the exploratory analyses, subgroups of subjects (n=20-40, evenly distributed between the two treatment arms) will participate in additional follow-up visits 5± 1, 30± 7 and 90± 14 days after the second dose. Blood samples will be collected on all exploratory visits. The extra visits and analyses for exploratory analyses may continue after the main part of the study has been completed and the database locked.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-001541-13 | EUDRACT_NUMBER | None | View |