Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334393
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-06
Brief Title:
Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated Adjuvanted Whole Zika Virus Vaccine Candidate VLA1601 in Healthy Adults
Sponsor:
Valneva Austria GmbH
Organization:
Valneva Austria GmbH
Study Overview
Official Title:
A Phase 1 Double-blind Randomized Dose Finding Clinical Trial With an Open-label run-in Part to Assess the Safety and Immunogenicity of an Inactivated Adjuvanted Whole Zika Virus Vaccine Candidate VLA1601 in Healthy Flavivirus-naïve Adults Aged 18 to 49 Years
Status:
RECRUITING
Status Verified Date:
2024-03
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 phase 1 clinical trial consists of an initial open-label sentinel run-in n25 and a randomized double-blind dose-finding n125 investigating three antigen dose levels low medium and high of VLA1601 and bedside mixing of the low-dose formulation with one of the two additional adjuvants CpG1018 3M-052-AFAP 60-702 VLA1601 will be administered according to a two-dose regimen ie on Day 1 and Day 29
The primary objective of this trial is to assess the safety and tolerability of the vaccine candidate up to 7 days after each vaccination and to assess the immune response induced by the vaccine candidate 28 days after the second vaccination Additionally safety and immune response of the vaccine candidate will be monitored throughout the trial
The primary objective of this trial is to assess the safety and tolerability of the vaccine candidate up to 7 days after each vaccination and to assess the immune response induced by the vaccine candidate 28 days after the second vaccination Additionally safety and immune response of the vaccine candidate will be monitored throughout the trial
Detailed Description:
VLA1601 is a second generation highly purified inactivated whole ZIKV vaccine candidate adsorbed on aluminum hydroxide designed for active immunization for the prevention of disease caused by the flavivirus ZIKV
This phase 1 clinical trial consists of an initial open-label sentinel run-in n25 and a randomized double-blind dose-finding n125 investigating three antigen dose levels low medium and high of VLA1601 and bedside mixing of the low-dose formulation with one of the two additional adjuvants CpG1018 3M-052-AFAP 60-702 VLA1601 will be administered according to a two-dose regimen ie on Day 1 and Day 29 The screening period can last up to 21 days
The trial will begin with the enrolment of 25 sentinel participants 5 participants in each of the 5 treatment arms in a sequential open-label staggered dose-escalation The sentinel safety data will be closely monitored by the sponsors Safety Review Committee SRC The SRC will decide on the start of the next treatment arms during the run-in open-label part of the trial An independent Data and Safety Monitoring Board DSMB will review safety data of all sentinels upon favorable recommendation from the DSMB and sponsor decision the trial will continue with the randomized part
Approximately 125 participants will be randomized 11111 into 5 treatment arms
Primary objects include the assessment of safety and tolerability of VLA1601 up to 7 days following each vaccination and assessment of immunogenicity at 28 days post second vaccination
Following a sponsor review of available safety and immunogenicity data up to 6 months after the second vaccination the most favorable treatment arms will be selected for an on-site visit at Day 395 for long-term safety and immunogenicity assessment All other treatment arms will be followed only by phone-call for the Day 395 assessment of long-term safety
This phase 1 clinical trial consists of an initial open-label sentinel run-in n25 and a randomized double-blind dose-finding n125 investigating three antigen dose levels low medium and high of VLA1601 and bedside mixing of the low-dose formulation with one of the two additional adjuvants CpG1018 3M-052-AFAP 60-702 VLA1601 will be administered according to a two-dose regimen ie on Day 1 and Day 29 The screening period can last up to 21 days
The trial will begin with the enrolment of 25 sentinel participants 5 participants in each of the 5 treatment arms in a sequential open-label staggered dose-escalation The sentinel safety data will be closely monitored by the sponsors Safety Review Committee SRC The SRC will decide on the start of the next treatment arms during the run-in open-label part of the trial An independent Data and Safety Monitoring Board DSMB will review safety data of all sentinels upon favorable recommendation from the DSMB and sponsor decision the trial will continue with the randomized part
Approximately 125 participants will be randomized 11111 into 5 treatment arms
Primary objects include the assessment of safety and tolerability of VLA1601 up to 7 days following each vaccination and assessment of immunogenicity at 28 days post second vaccination
Following a sponsor review of available safety and immunogenicity data up to 6 months after the second vaccination the most favorable treatment arms will be selected for an on-site visit at Day 395 for long-term safety and immunogenicity assessment All other treatment arms will be followed only by phone-call for the Day 395 assessment of long-term safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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