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NCT05945485Not yet recruiting

A Study to Evaluate the Safety and Immunogenicity of Two Doses of DCVC H1 HA mRNA-LNP in Healthy Adults

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
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1ClinicalTrials.govbiological
Verified
Study focus
Disease/Condition
Influenza
Drug/Device/Intervention
DCVC H1 HA mRNA vaccine
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Location
Iowa City, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Jul 20, 2023
End date
Aug 17, 2024
Enrollment
50 participants
Primary outcome

Number and percentage of participants experiencing any adverse events of special interest (AESIs),Number and percentage of participants experiencing any influenza like illnesses (ILI),Number and percentage of participants experiencing any medically-attended adverse events (MAAEs),,Number and percentage of participants experiencing any new-onset chronic medical conditions (NOCMCs),Number and percentage of participants experiencing any serious adverse events (SAEs),Number and percentage of participants experiencing any unsolicited adverse events (AEs),Number and percentage of participants experiencing solicited adverse events (AEs),Number and percentage of participants with clinical laboratory adverse events (AEs)

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 A/California/07/2009 (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. 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.

ICD-10 classifications
Influenza and pneumoniaInfluenza due to identified seasonal influenza virusInfluenza with other manifestations, seasonal influenza virus identifiedInfluenza with pneumonia, seasonal influenza virus identifiedInfluenza due to identified zoonotic or pandemic influenza virus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05945485
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05945485 through Pure Global AI's free database. This Phase 1 trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID) and is currently Not yet recruiting. The study focuses on Influenza. Target enrollment is 50 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.