Background:
Influenza (flu) is a contagious respiratory illness caused by viruses. Flu symptoms can range from mild to severe, and the illness can be fatal. Vaccines help the body learn to prevent or fight infections such as flu. Some vaccines are combined with adjuvants. Adjuvants are special salts or fats that help vaccines work better. Researchers are looking for ways to make flu vaccines more effective.
Objective:
To test a new flu vaccine with and without a new adjuvant.
Eligibility:
Healthy adults aged 18 to 50. They must have had at least 1 flu vaccine since 2020.
Design:
Participants will have 12 clinic visits over 15 months.
The vaccine is given as an injection into the muscle of the upper arm. Participants will be vaccinated during 2 visits spaced 4 months apart. Half will receive just the vaccine; half will receive the vaccine plus the adjuvant. They will be monitored for at least 30 minutes after each shot.
Participants will keep a diary for 7 days after each shot. They check their temperature every day and record any symptoms.
Participants will have 10 follow-up clinic visits plus 4 phone calls. They will have 4 to 10 tablespoons of blood drawn at each clinic visit. Fluid samples will be collected from their nose and mouth. They will be checked for any health changes.
Participants may opt to undergo apheresis: Blood will be taken from the body through a needle inserted into a vein. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be returned to the body through a different needle.
Healthy adults between the ages of 18-50 years, inclusive
Based on history and physical examination, be in good general health and without a history of any of the conditions listed in the
Received at least one licensed influenza vaccine from the 2020-2021 influenza season through the 2024-2025 influenza season
Able and willing to complete the informed consent process
The ability to read and comprehend English as all consent and recruitment materials are in English.
Available for clinic visits for 68 weeks after the first dose, including through the 2025-2026 influenza season
Sequential
VRC-FLUMOS0122-00-VP
Biological/VaccineThe VRC-FLUMOS0122-00-VP (SteMos1) is composed of de novo engineered pentamer assembled with de novo engineered trimeric domains to an icosahedral core, projecting 20 HA stabilized stem trimers from four influenza A strains representing both Group 1 (H2, H5) and Group 2 (H7, H10) viruses.
ALFQ
Other interventionThe ALFQ drug product is a sterile suspension that contains 240 mcg of monophosphoryl 3-deacyl Lipid A (3D-PHAD) and 120 mcg QS-21
Safety and tolerability of 180 mg VRCFLUMOS0122-00-VP (SteMos1) vaccine with ALFQ adjuvant administered as a 2-dose regimen
Assessed by:-Frequency and severity of solicited local reactogenicity symptoms reported for 7 days following each injection, through resolution of symptoms.-Frequency and severity of solicited systemic reactogenicity symptoms reported for 7 days following each injection, through the resolution of symptoms.-Frequency and grade of any unsolicited AEs, including abnormal safety laboratory measures, during the 28-day follow-up period post each product administration.-Frequency and grade of unsolicited AEs assessed as related to the product during the 28-day follow-up period after each product administration, -Frequency of adverse events leading to participant s withdrawal at any time throughout the study. -Frequency of SAEs, AESI, MAAEs and new chronic medical conditions that require ongoing medical management at any time throughout the study.
Safety and tolerability of 60 mg VRCFLUMOS0122-00-VP (SteMos1) vaccine with ALFQ adjuvant administered as a 2-dose regimen
Assessed by:-Frequency and severity of solicited local reactogenicity symptoms reported for 7 days following each injection, through resolution of symptoms.-Frequency and severity of solicited systemic reactogenicity symptoms reported for 7 days following each injection, through the resolution of symptoms.-Frequency and grade of any unsolicited AEs, including abnormal safety laboratory measures, during the 28-day follow-up period post each product administration.-Frequency and grade of unsolicited AEs assessed as related to the product during the 28-day follow-up period after each product administration, -Frequency of adverse events leading to participant s withdrawal at any time throughout the study. -Frequency of SAEs, AESI, MAAEs and new chronic medical conditions that require ongoing medical management at any time throughout the study.
Safety and tolerability of 180 mg VRCFLUMOS0122-00-VP (SteMos1) vaccine without ALFQ adjuvant administered as a 2-dose regimen
Assessed by:-Frequency and severity of solicited local reactogenicity symptoms reported for 7 days following each injection, through resolution of symptoms.-Frequency and severity of solicited systemic reactogenicity symptoms reported for 7 days following each injection, through the resolution of symptoms.-Frequency and grade of any unsolicited AEs, including abnormal safety laboratory measures, during the 28-day follow-up period post each product administration.-Frequency and grade of unsolicited AEs assessed as related to the product during the 28-day follow-up period after each product administration, -Frequency of adverse events leading to participant s withdrawal at any time throughout the study. -Frequency of SAEs, AESI, MAAEs and new chronic medical conditions that require ongoing medical management at any time throughout the study.
Safety and tolerability of 60 mg VRCFLUMOS0122-00-VP (SteMos1) vaccine without ALFQ adjuvant administered as a 2-dose regimen
Assessed by:-Frequency and severity of solicited local reactogenicity symptoms reported for 7 days following each injection, through resolution of symptoms.-Frequency and severity of solicited systemic reactogenicity symptoms reported for 7 days following each injection, through the resolution of symptoms.-Frequency and grade of any unsolicited AEs, including abnormal safety laboratory measures, during the 28-day follow-up period post each product administration.-Frequency and grade of unsolicited AEs assessed as related to the product during the 28-day follow-up period after each product administration, -Frequency of adverse events leading to participant s withdrawal at any time throughout the study. -Frequency of SAEs, AESI, MAAEs and new chronic medical conditions that require ongoing medical management at any time throughout the study.
Antibody responses to 180 mcg VRCFLUMOS0122-00-VP (SteMos1) vaccine administered with ALFQ as a 2-dose regimen
Binding antibody responses to VRCFLUMOS0122-00-VP (SteMos1) with and without ALFQ adjuvant at Week 2 after the first vaccination and at Week 18, 2 weeks after the second vaccination.
Antibody responses to 60 mcg VRCFLUMOS0122-00-VP (SteMos1) vaccine administered with ALFQ as a 2-dose regimen
Binding antibody responses to VRCFLUMOS0122-00-VP (SteMos1) with and without ALFQ adjuvant at Week 2 after the first vaccination and at Week 18, 2 weeks after the second vaccination.
Antibody responses to 180 mcg VRCFLUMOS0122-00-VP (SteMos1) administered without ALFQ as a 2-dose regimen
Binding antibody responses to VRCFLUMOS0122-00-VP (SteMos1) with and without ALFQ adjuvant at Week 2 after the first vaccination and at Week 18, 2 weeks after the second vaccination.
Antibody responses to 60 mg VRCFLUMOS0122-00-VP (SteMos1) vaccine administered without ALFQ as a 2-dose regimen
Binding antibody responses to VRCFLUMOS0122-00-VP (SteMos1) with and without ALFQ adjuvant at Week 2 after the first vaccination and at Week 18, 2 weeks after the second vaccination.
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