Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP (SteMos1) With and Without ALFQ Adjuvant in Healthy Adults
- Conditions
- Influenza PreventionPandemic Influenza Prevention
- Interventions
- Biological: VRC-FLUMOS0122-00-VP (SteMos1) with and without Army Liposome Formulation containing saponin QS-21 (ALFQ) Adjuvant
- Registration Number
- NCT07111078
- Brief Summary
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.
- Detailed Description
Design:
This is a phase I, open-label, dose escalation study to evaluate the safety, tolerability, and immunogenicity of the stem quadrivalent influenza vaccine VRCFLUMOS0122- 00-VP (SteMos1) with and without Army Liposome Formulation containing saponin QS-21 (ALFQ) adjuvant. The hypotheses are that the SteMos1 vaccine is safe and tolerable when administered alone or with ALFQ adjuvant, that this vaccine elicits vaccine specific immune responses, and that addition of the ALFQ adjuvant increases the magnitude and breadth of the elicited immune responses.
Objectives:
Primary Objective:
* To evaluate the safety and tolerability of 60 mcg of SteMos1 without adjuvant administered IM via needle and syringe as a 2-dose regimen to healthy adults
* To evaluate the safety and tolerability of 180 mcg of SteMos1 without adjuvant administered IM via needle and syringe as a 2-dose regimen to healthy adults
* To evaluate the safety and tolerability of 60 mcg of SteMos1 plus ALFQ administered IM via needle and syringe as a 2-dose regimen to healthy adults
* To evaluate the safety and tolerability of 180 mcg of SteMos1 plus ALFQ administered IM via needle and syringe as a 2-dose regimen to healthy adults
Secondary Objective:
* To evaluate antibody responses, at two weeks after each injection, to 60 mcg of SteMos1 without adjuvant administered IM via needle and syringe as a 2-dose regimen.
* To evaluate antibody responses, at two weeks after each injection, to 180 mcg of SteMos1 without adjuvant administered IM via needle and syringe as a 2-dose regimen
* To evaluate antibody responses, at two weeks after each injection, to 60 mcg of SteMos1 plus ALFQ administered IM via needle and syringe as a 2-dose regimen
* To evaluate antibody responses, at two weeks after each injection, to 180 mcg of SteMos1 plus ALFQ administered IM via needle and syringe as a 2-dose regimen
Exploratory Objectives:
- To evaluate the specificity and functionality of the immune response induced by SteMos1vaccine with and without ALFQ adjuvant at various timepoints throughout the study
Endpoints:
Primary Endpoints:
* 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
Secondary Endpoints:
- Binding antibody responses to VRCFLUMOS0122- 00-VP (SteMos1) with and without ALFQ adjuvant at Week 2 (Visit 04) after the first vaccination and at Week 18 (Visit 09), 2 weeks after the second vaccination
Exploratory Endpoints:
* Neutralizing antibody responses measured at various timepoints
* Frequency and magnitude of HA-specific B-cell responses at various time points throughout the study.
* Frequency and magnitude of antigen-specific T cell responses measured at various timepoints
* Binding antibody responses to the de novo engineered pentamer and trimer moieties (I53_dn5) measured at various time points throughout the study.
* Antigen-specific immune responses in mucosal compartments, measured using nasal and saliva samples at various time points throughout the study.
* Correlations between immunogenetic/immunological markers and vaccine response outcomes, including antibody titers and safety outcomes through whole genome sequencing (WGS).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 56
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group 1 VRC-FLUMOS0122-00-VP (SteMos1) with and without Army Liposome Formulation containing saponin QS-21 (ALFQ) Adjuvant 60 mcg of SteMos1 on Day 0 and Week 16 Group 2 VRC-FLUMOS0122-00-VP (SteMos1) with and without Army Liposome Formulation containing saponin QS-21 (ALFQ) Adjuvant 180 mcg of SteMos1 on Day 0 and Week 16 Group 5- optional VRC-FLUMOS0122-00-VP (SteMos1) with and without Army Liposome Formulation containing saponin QS-21 (ALFQ) Adjuvant SteMos1 \[dose TBD based on interim analysis of data from Groups 3-4\] + 0.5 ml of ALFQ on Day 0 and Week 16 Group 3 VRC-FLUMOS0122-00-VP (SteMos1) with and without Army Liposome Formulation containing saponin QS-21 (ALFQ) Adjuvant 60 mcg of SteMos1 + 0.5 ml of ALFQ on Day 0 and Week 16 Group 4 VRC-FLUMOS0122-00-VP (SteMos1) with and without Army Liposome Formulation containing saponin QS-21 (ALFQ) Adjuvant 180 mcg of SteMos1 + 0.5 ml of ALFQ on Day 0 and Week 16
- Primary Outcome Measures
Name Time Method To evaluate the safety and tolerability of SteMos1 (60 mcg) vaccine without ALFQ adjuvant administered as a 2-dose regimen Though 52 weeks after the second vaccine administration Solicited reactogenicity will be evaluated using a 7-day diary card. Assessment of vaccine safety will include clinical observation and monitoring of hematological and chemical parameters at clinical visits throughout the study.
To evaluate the safety and tolerability of SteMos1 (180 mcg) vaccine without ALFQ adjuvant administered as a 2-dose regimen Though 52 weeks after the second vaccine administration Solicited reactogenicity will be evaluated using a 7-day diary card. Assessment of vaccine safety will include clinical observation and monitoring of hematological and chemical parameters at clinical visits throughout the study.
To evaluate the safety and tolerability of SteMos1 (60 mcg) vaccine with ALFQ adjuvant administered as a 2-dose regimen Though 52 weeks after the second vaccine administration Solicited reactogenicity will be evaluated using a 7-day diary card. Assessment of vaccine safety will include clinical observation and monitoring of hematological and chemical parameters at clinical visits throughout the study.
To evaluate the safety and tolerability of SteMos1 (180 mcg) vaccine with ALFQ adjuvant administered as a 2-dose regimen Though 52 weeks after the second vaccine administration Solicited reactogenicity will be evaluated using a 7-day diary card. Assessment of vaccine safety will include clinical observation and monitoring of hematological and chemical parameters at clinical visits throughout the study.
- Secondary Outcome Measures
Name Time Method Antibody responses to SteMos1 (180 mcg) vaccine administered without ALFQ as a 2-dose regimen Two weeks after each injection Binding antibody responses
Antibody responses to SteMos1 (60 mcg) vaccine administered without ALFQ as a 2-dose regimen Two weeks after each injection Binding antibody responses
Antibody responses to SteMos1 (60 mcg) vaccine administered with ALFQ as a 2-dose regimen Two weeks after each injection Binding antibody responses
Antibody responses to SteMos1 (180 mcg) vaccine administered with ALFQ as a 2-dose regimen Two weeks after each injection Binding antibody responses
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States
National Institutes of Health Clinical Center🇺🇸Bethesda, Maryland, United StatesVRC ClinicContact301-451-8715vaccines@nih.gov