Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05945485
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2023-06-30
Brief Title:
A Study to Evaluate the Safety and Immunogenicity of Two Doses of DCVC H1 HA mRNA-LNP in Healthy Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase 1 Comparator-Controlled Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of Two Doses of DCVC H1 HA mRNA-LNP in Healthy Adults
Status:
RECRUITING
Status Verified Date:
2024-09
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 1 comparator-controlled dosage escalation study of an intramuscularly administered mRNA-LNP vaccine DCVC H1 HA mRNA Vaccine encoding full-length H1 HA of influenza ACalifornia072009 H1N1 in up to 50 adult volunteers aged 18 to 49 years designed to assess vaccine safety and immunogenicity at varying doses Eligible participants will be sequentially enrolled into dosing groups 10 mcg 25 mcg 50 mcg and selected optimal dose of DCVC H1 HA mRNA Vaccine Dosing will commence at the lowest dose 10 mcg and only escalate to the next higher dose if safety concerns are not identified Up to ten subjects will be enrolled per dosing group An optimal dosing group will be selected based on safety outcomes from the 10 mcg 25 mcg and 50 mcg dosing group For the optimal dose the highest dose with no identified safety concerns as determined by the SRC will be selected This approach will allow determination of an optimal dosing group which will include 10 optimal dose vaccine recipients Ten separate participants will be enrolled to receive standard quadrivalent inactivated influenza vaccine IIV4 The primary goal of this study is to assess the safety of two doses of DCVC H1 HA mRNA Vaccine administered intramuscularly in healthy adults 18-49 yrs at dosage levels of 10 mcg 25 mcg and 50 mcg
Detailed Description:
This is a Phase 1 comparator-controlled dosage escalation study of an intramuscularly administered mRNA-LNP vaccine DCVC H1 HA mRNA Vaccine encoding full-length H1 HA of influenza ACalifornia072009 H1N1 in up to 50 adult volunteers aged 18 to 49 years designed to assess vaccine safety and immunogenicity at varying doses Eligible participants will be sequentially enrolled into dosing groups 10 mcg 25 mcg 50 mcg and selected optimal dose of DCVC H1 HA mRNA Vaccine Dosing will commence at the lowest dose 10 mcg and only escalate to the next higher dose if safety concerns are not identified Up to ten subjects will be enrolled per dosing group An optimal dosing group will be selected based on safety outcomes from the 10 mcg 25 mcg and 50 mcg dosing group For the optimal dose the highest dose with no identified safety concerns as determined by the SRC will be selected This approach will allow determination of an optimal dosing group which will include 10 optimal dose vaccine recipients Ten separate participants will be enrolled to receive standard quadrivalent inactivated influenza vaccine IIV4 The primary goal of this study is to assess the safety of two doses of DCVC H1 HA mRNA Vaccine administered intramuscularly in healthy adults 18-49 yrs at dosage levels of 10 mcg 25 mcg and 50 mcg The secondary goal of this study is to assess the serum antibody responses to two doses of DCVC H1 HA mRNA Vaccine administered intramuscularly 28 days apart in healthy adults at dosage levels of 10 mcg 25 mcg and 50 mcg in comparison to a standard dose of IIV4
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 75N93019C00054 | None | None | None |