Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06190509
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-19
Brief Title:
Assessing the Safety Immune Response and Early Efficacy of a Candida Vaccine in Women With Recurrent Vulvovaginal Candidiasis A Randomized Controlled Study
Sponsor:
LimmaTech Biologics AG
Organization:
LimmaTech Biologics AG
Study Overview
Official Title:
Candi5V01 A FTIH Phase III Randomized and Controlled Study to Test Safety Immunogenicity and Preliminary Efficacy of a Pentavalent Bioconjugate Vaccine Candi5V Against Candida in Women With Recurrent Vulvovaginal Candidiasis
Status:
RECRUITING
Status Verified Date:
2023-12
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:
In this study the pentavalent bioconjugate candidate vaccine Candi5V against Candida will be tested to obtain first-time-in-human FTIH data on its safety immunogenicity and preliminary efficacy in women with recurrent vulvovaginal candidiasis
Detailed Description:
This is a First Time In Human FTIH phase III double-blind randomized placebo-controlled study to evaluate the safety immunogenicity and preliminary efficacy of the candidate pentavalent bioconjugate vaccine Candi5V administered twice 2 months apart with or without adjuvant
The study will be conducted in two subsequent steps
Step 1 safety cohort staggered enrolment of small groups of women with history of RVVC sequentially administered with the half dose of Candi5V non-adjuvanted and with adjuvant or placebo followed by groups administered with the target dose of Candi5V non-adjuvanted and with adjuvant or placebo
Step 2 target cohort concurrent enrolment of women with history of RVVC randomized 111 to Candi5V Candi5V adjuvant and placebo
All study participants will be followed for 12 months after the second vaccination to assess the vaccine safety profile the immunological response and the recurrence of any VVC episode
The study will be conducted in two subsequent steps
Step 1 safety cohort staggered enrolment of small groups of women with history of RVVC sequentially administered with the half dose of Candi5V non-adjuvanted and with adjuvant or placebo followed by groups administered with the target dose of Candi5V non-adjuvanted and with adjuvant or placebo
Step 2 target cohort concurrent enrolment of women with history of RVVC randomized 111 to Candi5V Candi5V adjuvant and placebo
All study participants will be followed for 12 months after the second vaccination to assess the vaccine safety profile the immunological response and the recurrence of any VVC episode
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-507527-28-00 | OTHER | CTIS | None |