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Virus Therapy
DCVC H1 HA mRNA Vaccine for Flu
Phase 1
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 394
Awards & highlights
Study Summary
This trial tests safety and effectiveness of a new intramuscular mRNA vaccine for influenza A/California/07/2009 (H1N1) in 18-49 yr olds. Primary goal is to assess safety, secondary is to compare antibody responses to a standard dose of inactivated vaccine.
Who is the study for?
Healthy adults aged 18-49 with stable blood pressure, not pregnant or breastfeeding, and without significant health conditions can join. They must agree to use contraception and avoid sperm donation for specified periods around vaccination. Exclusions include drug abuse, liver disease, immune disorders, recent corticosteroid use, severe reactions to vaccines, certain heart conditions, psychiatric hospitalization within the past 5 years.Check my eligibility
What is being tested?
The trial is testing a new mRNA vaccine (DCVC H1 HA) against H1N1 influenza in healthy adults. Participants will receive varying doses (10 mcg up to an optimal dose determined by safety outcomes) compared with a standard quadrivalent flu vaccine. The study aims to find the safest effective dose.See study design
What are the potential side effects?
Potential side effects may include typical vaccine reactions like soreness at injection site, fever or chills shortly after receiving the shot. Since it's an early-phase trial assessing safety and immunogenicity of different doses of DCVC H1 HA mRNA Vaccine versus a standard flu shot.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through day 394
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 394
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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)
+5 moreSecondary outcome measures
Geometric mean fold rise (GMFR) in homologous H1-specific MN antibody
Geometric mean fold rise (GMFR) in homologous H1-specific anti-stalk serum antibodies
Geometric mean fold rise in homologous H1-specific HAI antibody
+6 moreTrial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Arm 4Experimental Treatment2 Interventions
Healthy adults, 18 to 49 years of age will receive a selected dose mcg of DCVC H1 HA mRNA vaccine administered intramuscularly to the upper arm/deltoid at days 1 and 29. The DCVC H1 HA mRNA vaccine dose for Arm 4 will be selected based on interim analysis of safety and immunogenicity data from Arms 1-3. N = 10
Group II: Arm 3Experimental Treatment2 Interventions
Healthy adults, 18 to 49 years of age will receive 50 mcg of DCVC H1 HA mRNA vaccine administered intramuscularly to the upper arm/deltoid at days 1 and 29. A safety evaluation will occur to ensure the safety data support proceeding to the optimal dose group. N = 10
Group III: Arm 2Experimental Treatment2 Interventions
Healthy adults, 18 to 49 years of age will receive 25 mcg of DCVC H1 HA mRNA vaccine administered intramuscularly to the upper arm/deltoid at days 1 and 29. A dose escalation safety evaluation will occur to ensure the safety data support proceeding to the higher dose group. N = 10
Group IV: Arm 1Experimental Treatment2 Interventions
Healthy adults, 18 to 49 years of age will receive 10 mcg of DCVC H1 HA mRNA Vaccine administered intramuscularly to the upper arm/deltoid at days 1 and 29. A dose escalation safety evaluation will occur to ensure the safety data support proceeding to the higher dose group. N = 10
Group V: Arm 5Active Control1 Intervention
Healthy adults, 18 to 49 years of age will receive 60 mcg of Licensed quadrivalent inactivated influenza vaccine (IIV4), Fluzone Quadrivalent, administered intramuscularly to the upper arm/deltoid at days 1 and 29. N = 10
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,485,187 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had Guillain-Barré Syndrome in the past.I have a history of heart inflammation.I have or recently had cancer in my blood.I have a long-term liver condition.I have been sick or had a fever in the last 3 days.I can follow the study's procedures and attend all visits.I have used steroids in the past month.I agree not to donate sperm and to use contraception for 90 days after my last vaccine dose.I have an immune system condition or autoimmune disease.I have been immunosuppressed due to treatment in the last 6 months.I haven't had cancer treatment or radiation in the last 3 years.I have used high-dose inhaled or nebulized steroids in the last 30 days.I had the flu within the last 3 months.I have not donated blood or blood products in the last 30 days.I am using or willing to use birth control or practice true abstinence.I do not have any undiagnosed or untreated ongoing health issues.I have not taken part in any clinical trials or received experimental treatments in the last 60 days.I am in good health without significant medical or psychiatric conditions.I cannot become pregnant because I am post-menopausal or have been surgically sterilized.I have received the flu vaccine in the last 90 days.I am a male participant and do not need to change my sexual or sperm donation practices for this study.I've been close to someone with COVID-19 or the flu recently.I have HIV, hepatitis B, or hepatitis C.I am a man or a woman not pregnant or breastfeeding, aged 18-49.I have received blood products or immunoglobulin within the last 3 months.I have not been hospitalized for mental health issues, attempted suicide, or been confined for being a danger to myself or others in the last 5 years.I am receiving treatment for a blood clotting disorder.My BMI is between 18 and 35, and I weigh at least 110 lbs.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 2
- Group 3: Arm 4
- Group 4: Arm 5
- Group 5: Arm 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks are associated with the first arm of this trial?
"Without a significant amount of data to assess efficacy or safety, our team has appraised Arm 1's risk with a score of one."
Answered by AI
What are the prerequisites for enrolling in this trial?
"To meet the criteria for this clinical trial, participants must present with influenza and be aged between 18 and 49. The total number of eligible patients is limited to 50 individuals."
Answered by AI
Does this clinical investigation allow participants aged 25 and above?
"This clinical trial is only available to patients between the ages of 18 and 49. Those younger than 18, as well as those over 65, can explore 39 or 79 different medical studies respectively."
Answered by AI
Is there still an opportunity to participate in this experiment?
"The information found on clinicaltrials.gov reveals that this specific medical trial is not currently recruiting for patients. This research project was initially posted to the website on July 20th, 2023 and last updated on July 6th,2023. Despite being inactive at present, there are many alternate trials which have open enrollment opportunities available now."
Answered by AI
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