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mRNA Vaccine
H1ssF-3928 Vaccine for Influenza
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 366
Awards & highlights
Summary
This trial studies the safety and effectiveness of a new vaccine in healthy adults aged 18-49. A separate group of 10 participants will receive licensed quadrivalent influenza vaccine. Up to 10 subjects per dose group will be enrolled.
Who is the study for?
Healthy adults aged 18-49, with stable blood pressure and pulse, a BMI of 18 to <35 kg/m^2, who've had an influenza vaccine in the last five seasons. Women must not be pregnant or breastfeeding and agree to contraception. Excludes those with immune conditions, recent drug abuse, psychiatric hospitalization, or certain medication use.
What is being tested?
The trial is testing a new mRNA-LNP flu vaccine called H1ssF_3928 at different doses (10 mcg, 25 mcg, and 50 mcg) against a licensed quadrivalent flu vaccine. It's an open-label study where healthy volunteers receive one dose intramuscularly to evaluate safety and immune response.
What are the potential side effects?
Potential side effects may include typical reactions at the injection site like pain or swelling, general symptoms such as fever or fatigue after vaccination. Since it's a Phase I trial focused on safety, close monitoring for any adverse events will occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through day 366
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 366
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Occurrence of any adverse events of special interest (AESIs) with VRC H1ssF_3928 mRNA-LNP vaccine.
Occurrence of solicited reactogenicity adverse events (AEs) with VRC H1ssF_3928 mRNA-LNP vaccine.
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Arm 4, Optimal DoseExperimental Treatment2 Interventions
10 healthy adult volunteer subjects from 18-49 years of age will receive the selected optimal dose of the H1ssF_3928 mRNA Vaccine, administered intramuscularly once. The optimal dosing group will be selected based on safety outcomes from the 10 mcg, 25 mcg, and 50 mcg dosing groups. For the optimal dose, the highest dose with no identified safety concerns as determined by the Safety Review Committee (SRC) will be selected. N =10
Group II: Arm 3, High DoseExperimental Treatment2 Interventions
10 healthy adult volunteer subjects from 18-49 years of age are split into two subgroups. The sentinel subgroup includes 2 vaccine recipients who will receive 50 mcg of the H1ssF_3928 mRNA Vaccine, administered intramuscularly once. The sentinel subgroup is observed for 8 days to monitor any early vaccine related adverse events. After the observation period, the remaining participants will receive the same dosage, 50 mcg of the H1ssF 3928 mRNA vaccine administered intramuscularly once. N = 10
Group III: Arm 2, Medium DoseExperimental Treatment2 Interventions
10 healthy adult volunteer subjects from 18-49 years of age are split into two subgroups. The sentinel subgroup includes 2 vaccine recipients who will receive 25 mcg of the H1ssF_3928 mRNA Vaccine, administered intramuscularly once. The sentinel subgroup is observed for 8 days to monitor any early vaccine related adverse events. After the observation period, the remaining participants will receive the same dosage, 25 mcg of the H1ssF 3928 mRNA vaccine administered intramuscularly once. N = 10
Group IV: Arm 1, Low DoseExperimental Treatment2 Interventions
10 healthy adult volunteer subjects from 18-49 years of age are split into two subgroups. The sentinel subgroup includes 2 vaccine recipients who will receive 10 mcg of the H1ssF_3928 mRNA Vaccine, administered intramuscularly once. The sentinel subgroup is observed for 8 days to monitor any early vaccine related adverse events. After the observation period, the remaining participants will receive the same dosage, 10 mcg of the H1ssF 3928 mRNA vaccine administered intramuscularly once. N = 10
Group V: Arm 5, IIV4Active Control1 Intervention
10 healthy adult volunteer subjects from 18-49 years of age will receive licensed Quadrivalent Influenza Vaccine (IIV4), administered intramuscularly once. Subjects receiving IIV4 will be followed for safety, but only their immune responses will be compared to those of participants receiving H1ssF_3928 mRNA Vaccine. N=10
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VRC-FLUNPF099-00-VP (H1ssF_3928)
2019
Completed Phase 1
~60
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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
3,302 Previous Clinical Trials
5,501,392 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My lab results show mild abnormalities.I have not been sick or had a fever in the last 3 days.I have taken steroids in the past 30 days.I have an immune system condition or autoimmune disease.I have been immunosuppressed due to treatment in the last 6 months.I have had Guillain-Barré Syndrome in the past.I haven't donated blood in the last 30 days and won't donate for 60 days after dosing.I haven't had vaccines other than the flu shot in the last 60 days and don't plan to get any in the next 60 days.I haven't had cancer treatment like chemo or radiation in the last 3 years.I have had a flu shot in the last 5 years.I have or recently had cancer or a blood-related cancer.I have not been hospitalized for psychiatric reasons or posed a danger to myself or others in the last 5 years.I have used high-dose inhaled or nebulized steroids in the last 30 days.I have a history of heart inflammation.I have a long-term liver condition, such as fatty liver disease.I can follow the study's procedures and attend all visits.I am using or willing to use birth control or practice abstinence.I have HIV, hepatitis B, or hepatitis C.I had the flu in the last 3 months.I am a male and do not need to avoid donating sperm or use contraception for this study.I have had or plan to get the flu shot around my study vaccination.I have received blood products or immunoglobulin within the last 3 months.I am receiving treatment for a blood clotting disorder.I am in good health without significant medical or psychiatric conditions.I am a man or a woman not pregnant or breastfeeding, aged 18-49.I agree not to donate sperm and to use contraception for 60 days after getting the VRC H1ssF_3928 vaccine.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 5, IIV4
- Group 2: Arm 4, Optimal Dose
- Group 3: Arm 3, High Dose
- Group 4: Arm 1, Low Dose
- Group 5: Arm 2, Medium Dose
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.
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