Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06556147
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomized Placebo- and Active-controlled Observer-blind Study in Older Adults with Run-in in Young Adults to Evaluate the Safety Reactogenicity and Immunogenicity of Four Dose Levels of VXB-241 a Molecular Clamp Stabilized Prefusion F Glycoprotein Subunit Bivalent Vaccine Candidate for the Prevention of Lower Respiratory Tract Disease Caused by Respiratory Syncytial Virus RSV and Human Metapneumovirus HMPV
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purposes of this study are to assess the safety reactogenicity and immunogenicity of 4 dose levels of the bivalent combination Respiratory Syncytial Virus RSV human Metapneumovirus hMPV vaccine candidate VXB-241 when administered as a single-dose regimen to healthy adults 60 to 83 years of age and to assess the impact of revaccination approximately 1 year later
Detailed Description:
This is a multi-center study in older adults with run-in in young adults to evaluate the safety reactogenicity and immunogenicity of 4 dose levels of VXB-241 The total planned sample size is 136 randomized participants composed of 16 young adults 18 to 40 years of age and 120 older adults 60 to 83 years of age who are in good health which allows for many chronic conditions if well controlled and compatible with self-sufficiency in self-care and daily living activities
Recruitment will be in 2 stages
Stage 1 Sequential Cohort Stage N32 Four cohorts Cohorts 1 to 4 each of 8 participants will be enrolled sequentially In each cohort 4 young adults will be enrolled first followed by 4 older adults Young and older adult participants will be randomized with 31 ratio to VXB-241 at increasing dose 60 microgram mcg 120 mcg 240 mcg 480 mcg in Cohorts 1 to 4 respectively or Placebo A Safety Monitoring Committee will make recommendations on escalation from one cohort to the next and from Stage 1 to Stage 2 based on safety and reactogenicity data collected over 1 week after investigational medicinal product IMP dosing
Stage 2 Concurrent Group Stage N104 Older adult participants will be randomized concurrently with unequal randomization to 1 of 6 treatment groups VXB-241 60 mcg Group 1a VXB-241 120 mcg 1b VXB-241 240 mcg 1c VXB-241 480 mcg 1d commercial RSV vaccine Arexvy 2a Placebo 3a The planned total sample size of each treatment group combining Stage 1 and Stage 2 is N20
The overall planned duration of the study is approximately 6 months for young adult participants and approximately 2 years for older adult participants
At the end of the 1st year older adult participants will receive a second IMP vaccination revaccination participants who received VXB-241 at any dose will be assigned 11 to revaccination with VXB-241 Group 1e or Placebo 1f participants who received Arexvy will be revaccinated with Arexvy 2b participants who received Placebo will be revaccinated with VXB-241 3b The dose of VXB-241 for revaccination will be decided based on Year-1 results
Recruitment will be in 2 stages
Stage 1 Sequential Cohort Stage N32 Four cohorts Cohorts 1 to 4 each of 8 participants will be enrolled sequentially In each cohort 4 young adults will be enrolled first followed by 4 older adults Young and older adult participants will be randomized with 31 ratio to VXB-241 at increasing dose 60 microgram mcg 120 mcg 240 mcg 480 mcg in Cohorts 1 to 4 respectively or Placebo A Safety Monitoring Committee will make recommendations on escalation from one cohort to the next and from Stage 1 to Stage 2 based on safety and reactogenicity data collected over 1 week after investigational medicinal product IMP dosing
Stage 2 Concurrent Group Stage N104 Older adult participants will be randomized concurrently with unequal randomization to 1 of 6 treatment groups VXB-241 60 mcg Group 1a VXB-241 120 mcg 1b VXB-241 240 mcg 1c VXB-241 480 mcg 1d commercial RSV vaccine Arexvy 2a Placebo 3a The planned total sample size of each treatment group combining Stage 1 and Stage 2 is N20
The overall planned duration of the study is approximately 6 months for young adult participants and approximately 2 years for older adult participants
At the end of the 1st year older adult participants will receive a second IMP vaccination revaccination participants who received VXB-241 at any dose will be assigned 11 to revaccination with VXB-241 Group 1e or Placebo 1f participants who received Arexvy will be revaccinated with Arexvy 2b participants who received Placebo will be revaccinated with VXB-241 3b The dose of VXB-241 for revaccination will be decided based on Year-1 results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None