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NCT05968989Recruiting

Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) in Healthy Adults

VRC 326 (001614): A Phase I Open-Label Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) in Healthy Adults
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1ClinicalTrials.govbiological
Study focus
Disease/Condition
Influenza
Drug/Device/Intervention
VRC-FLUMOS0116-00-VP( FLUMos-v2)
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Funder
National Institutes of Health Clinical Center (CC)
Location
Bethesda, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Aug 14, 2023
End date
Dec 16, 2024
Enrollment
24 participants
Primary outcome

To evaluate the safety and tolerability,To evaluate the safety and tolerability

Summary

Background:
 
 Influenza (flu) virus causes 3 to 5 million cases of severe illness and up to 650,000 deaths
 per year worldwide. Current vaccines work well against single strains of flu virus. But no
 single vaccine works well against all flu viruses that can cause illness.
 
 Objective:
 
 To test an experimental flu vaccine (FluMos-v2) in healthy adults.
 
 Eligibility:
 
 Healthy adults aged 18 to 50 years.
 
 Design:
 
 Participants will have 11 clinic visits in 10 months. They must agree not to get a licensed
 flu vaccine while taking part in this study.
 
 FluMos-v2 will be given with a needle injected into a muscle in the upper arm. Participants
 will receive a follow-up phone call the following day.
 
 Participants will be given a diary card, a ruler, and a thermometer. They will take their
 temperature every day for 7 days after receiving the shot. They will measure any skin changes
 at the injection site. They will record their findings and how they feel.
 
 Participants will receive a second FluMos-v2 shot after 4 months. They will repeat the other
 follow-up steps.
 
 Participants will have 9 other clinic visits. Blood will be drawn at each visit.
 
 Participants should also come to the clinic if they develop flu-like symptoms during the
 study.
 
 Participants may opt for an apheresis 2 weeks after each shot: Blood will be removed through
 a needle in the vein of 1 arm. The blood will run through a machine that separates out the
 white blood cells. The remaining blood is returned through a needle in the other arm.

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
NCT05968989
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05968989 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 Recruiting. The study focuses on Influenza. Target enrollment is 24 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.