Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults
- Conditions
- Influenza PreventionSeasonal Influenza
- Interventions
- Other: ALFQ
- Registration Number
- NCT06863142
- Brief Summary
Background:
Vaccines help the body learn to fight infections. Some vaccines are combined with adjuvants, which are added substances that make vaccines work better. FluMos-v2 is an experimental flu vaccine; ALFQ is an experimental adjuvant.
Objective:
To test FluMos-v2, with and without the ALFQ adjuvant, in healthy adults.
Eligibility:
Healthy adults aged 18 to 50 years. They must have received at least one flu vaccine from the 2020-21 season through the 2023-24 flu season. They must also agree not to receive the licensed 2025-26 flu vaccine.
Design:
Participants will have 12 clinic visits over 15 months.
Participants will be screened. They will have a physical exam and blood tests.
On 2 visits, about 4 months apart, participants will receive a vaccination. The shots will be given into the muscle of the upper arm. They will get a follow-up call the day after each shot. They will keep a daily diary for 7 days; they will record their temperature and any other symptoms they feel after each shot.
All clinic visits will include collection of blood, saliva, and nasal secretions. If participants develop flu symptoms (such as fever, runny nose, sore throat), they will be asked to come to the clinic.
About 2 weeks after each vaccination, participants may opt to undergo apheresis: Blood will be taken from the body through a needle inserted into one arm. 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 needle in the other arm.
- Detailed Description
Design:
This is a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of mosaic hexavalent influenza vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) with and without Army Liposome Formulation containing saponin QS-21 (ALFQ) adjuvant. The hypotheses are that the FluMos-v2 vaccine is safe and tolerable when administered alone or with ALFQ adjuvant, that this vaccine elicits antigen-specific immune responses, and that addition of the ALFQ adjuvant increases the magnitude and breadth of the elicited immune responses. The primary objective is to evaluate the safety and tolerability of the investigational vaccine with and without ALFQ adjuvant in healthy adults. Secondary objectives are related to the immunogenicity of the investigational vaccine with and without ALFQ adjuvant.
Study Products:
The investigational vaccine FluMos-v2 was developed by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID). The adjuvant, Army Liposome Formulation containing QS-21 (ALFQ), was developed, and provided by the Walter Reed Army Institute of Research (WRAIR).
The FluMos-v2 vaccine is composed of full-length HA trimers of the following 6 influenza strains:
Influenza A:
H1: A/Idaho/07/2018
H2: A/Singapore/1/1957
H3: A/Perth/1008/2019
H3: A/Darwin/106/2020
Influenza B:
B/Victoria lineage: B/Colorado/06/2017
B/Yamagata lineage: B/Phuket/3073/2013
VRC-FLUMOS0116-00-VP (FluMos-v2) is a sterile, aqueous buffered solution supplied in 3.0 mL single-dose glass vials containing 0.7 +/- 0.1 mL with a vaccine concentration of 180 mcg/mL.
The ALFQ drug product is a sterile suspension that contains 240 mcg of monophosphoryl 3-deacyl Lipid A (3D-PHAD(R)) and 120 mcg QS-21 that is vialed at 0.6 mL/vial in 3.0 mL glass vials. 0.5 mL of ALFQ adjuvant will be mixed with the 60 or 180 mcg dose of FluMos-v2 during preparation in the pharmacy prior to vaccination.
FluMos-v2 with and without ALFQ adjuvant will be administered intramuscularly (IM) in the deltoid muscle via needle and syringe.
Participants:
Healthy adults 18-50 years of age, inclusive, will be enrolled.
Study Plan:
Group 1 will open and enroll without any planned dose safety reviews, because the 180 mcg dose without adjuvant was evaluated as safe and tolerable in VRC 326 study. The adjuvanted dose groups, Groups 2, 3A, and 3B will proceed with the lower dose group enrolling first. There will be two interim dose safety reviews in this trial: the first will review the safety data for Group 2 (60 mcg of FluMos-v2 with ALFQ adjuvant). Enrollment for Group 2 will be limited to one participant per day for the first three participants. After the third participant's two-week post-vaccination visit, a safety review will decide whether to continue at the same dose level in Group 2 and open Group 3A and Group 3B to participants who will receive 180 mcg of FluMos-v2 with ALFQ adjuvant. Enrollment for Group 3A or Group 3B will also be limited to one participant per day for the first three participants. The second safety review is a dose continuation review for Group 3A and Group 3B (180 mcg of FluMos-v2 with ALFQ adjuvant). After the third participant's two-week post-vaccination visit, a safety review will determine whether to continue at the same dose level in Group 3A or Group 3B. Once all groups are open, participants will continue enrollment into each group at the discretion of the Principal Investigator (PI) to balance the number of enrollments in each group.
If a current participant is discontinued from the protocol, a new participant may be enrolled at the discretion of the PI in order to collect required safety or immunogenicity data.
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.
The study schema is as follows:
VRC 328 Vaccination Schema
Group - 1
Participants - 12
Day 0 - 180 mcg
Week 16 - 180 mcg
Product - FluMos-v2
Group - 2
Participants - 5
Day 0 - 60 mcg
Week 16 - 60 mcg
Product - FluMos-v2 + 0.5 mL ALFQ
Group - 3A
Participants - 12
Day 0 - 180 mcg
Week 16 - 180 mcg
Product - FluMos-v2 + 0.5 mL ALFQ
Group - 3B\*
Participants - 0-6
Day 0 - 180 mcg
Week 16 - 180 mcg
Product - FluMos-v2 + 0.5 mL ALFQ
Total
Participants - 35\*\*
\*Enrollment in Group 3B is optional and includes participants who have previously taken part in the following influenza vaccine studies:
VRC 316 (ONLY participants enrolled in Groups 2, 3A, and 4A; HA-F A/Sing or DNA A/Sing vaccines) or VRC 321 (H1ssF_3928 vaccine) or VRC 323 (H10ssF-6473 vaccine).
\*\*Enrollment of up to 45 participants is permitted if additional participants are needed for safety or immunogenicity evaluations.
Study Duration:
Participants will be evaluated for 68 weeks following the first vaccine administration, including through the 2025-2026 influenza season.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group 1 VRC-FLUMOS0116-00-VP 180 mcg of FluMos-v2 Day 0 and Week 16 Group 2 VRC-FLUMOS0116-00-VP 60 mcg of FluMos-v2 + 0.5 ml of ALFQ Day 0 and Week 16 Group 2 ALFQ 60 mcg of FluMos-v2 + 0.5 ml of ALFQ Day 0 and Week 16 Group 3A VRC-FLUMOS0116-00-VP 180 mcg of FluMos-v2 + 0.5 ml of ALFQ Day 0 and Week 16 Group 3A ALFQ 180 mcg of FluMos-v2 + 0.5 ml of ALFQ Day 0 and Week 16 Group 3B VRC-FLUMOS0116-00-VP 180 mcg of FluMos-v2 + 0.5 ml of ALFQ Day 0 and Week 16 Group 3B ALFQ 180 mcg of FluMos-v2 + 0.5 ml of ALFQ Day 0 and Week 16
- Primary Outcome Measures
Name Time Method Safety and tolerability of the FluMos-v2 (180 mcg) vaccine with ALFQ adjuvant administered to healthy adults at Day 0 and Week 16. Through 68 weeks following the first vaccine administration, including through the 2025-2026 influenza season. To evaluate the safety and tolerability of a 2 dose regimen with ALFQ adjuvant.
Safety and tolerability of the FluMos-v2 (60 mcg) vaccine with ALFQ adjuvant administered to healthy adults at Day 0 and Week 16. Through 68 weeks following the first vaccine administration, including through the 2025-2026 influenza season. To evaluate the safety and tolerability of a 2 dose regimen with ALFQ adjuvant.
Safety and tolerability of the FluMos-v2 (180 mcg) vaccine administered alone to healthy adults at Day 0 and Week 16. Through 68 weeks following the first vaccine administration, including through the 2025-2026 influenza season To evaluate the safety and tolerability of a 2 dose regimen
- Secondary Outcome Measures
Name Time Method Antibody responses to the FluMos-v2 (180 mcg) vaccine administered alone as a 2 dose regimen to healthy adults at 2 weeks after each injection at Week 2 and Week 18. Through 18 weeks following the first vaccine administration, including through the 2025-2026 influenza season. To evaluate antibody responses
Antibody responses to the FluMos-v2 (180 mcg) with ALFQ adjuvant vaccine administered as a 2 dose regimen to healthy adults at 2 weeks after each injection at Week 2 and Week 18. Through 18 weeks following the first vaccine administration, including through the 2025-2026 influenza season. To evaluate antibody responses
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Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States