H1ssF-3928 Vaccine for Influenza

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a Phase 1, single-site, open-label, comparator-controlled dose escalating study of an intramuscularly (IM) administered mRNA-LNP vaccine encoding for (Vaccine Research Center) VRC H1ssF 3928 of up to 50 healthy adult volunteers aged 18 to 49 years, inclusive. This study is designed to assess the safety and immunogenicity of one dose of H1ssF 3928 mRNA Vaccine. Eligible participants will be sequentially enrolled into dosing groups (10 mcg, 25 mcg, and 50 mcg, selected optimal dose) to receive the H1ssF 3928 mRNA Vaccine at the specified dose. A separate group of 10 participants will receive licensed quadrivalent influenza vaccine (IIV4). 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. Dosing of H1ssF 3928 mRNA Vaccine will commence at the lowest dose (10 mcg) and only escalate to the next highest dose if safety concerns are not identified. Up to ten subjects will be enrolled per dosing cohort. Reactogenicity and adverse event (AE) information through Day 7 and clinical laboratory results through Day 8 from the first three dosing groups will guide the selection of an optimal dose group to include 10 subjects who will receive the optimal dose of mRNA-LNP. The primary objective of this study is to assess the safety of a single dose of VRC H1ssF 3928 mRNA-LNP vaccine administered IM in healthy adults, 18-49 yrs, at doses of 10 mcg, 25 mcg, and 50 mcg.

Eligibility Criteria

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.

Inclusion Criteria

Body mass index (BMI) of 18 kg/m^2 (inclusive) to <35 kg/m^2 at screening

Provide written informed consent prior to initiation of any study procedure

I have had a flu shot in the last 5 years.

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Exclusion Criteria

Has a positive urine toxicology screen

My lab results show mild abnormalities.

I have not been sick or had a fever in the last 3 days.

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Treatment Details

Interventions

VRC H1ssF-3928 mRNA-LNP (mRNA Vaccine)

Trial OverviewThe 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.

Participant Groups

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