Influenza
Conditions
Keywords
influenza vaccine, M2e, Universal influenza vaccine
Brief summary
1. To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population. 2. To assess the immunogenicity (anti-M2e serum antibody concentration) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. as measured by an enzyme-linked immunosorbent assay (ELISA) in a healthy adult population.
Interventions
BIOLOGICALVAX102
Universal M2e influenza vaccine
Sponsors
VaxInnate Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult men or women aged 18 to 49 years inclusive. * Able and willing to provide written informed consent to participate. * Healthy, as determined by medical history, physical examination, and vital signs. * Willing to receive the unlicensed (VAX102) vaccine given as an i.m. or s.c. injection. * Willing to provide multiple blood specimens collected by venipuncture. * Females should avoid becoming pregnant during the course of the study * Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of the first and preceding receipt of the second (booster) vaccination. * Must exhibit comprehension of the study requirements; expressed availability for the required study period and expect to reside in the study area during the entire study period, and ability to attend scheduled visits.
Exclusion criteria
* Persons under 18 years old or 50 years or older. * Persons with chronic illnesses such as cancer, diabetes, liver or kidney disease. * Person currently pregnant, nursing mothers or planning a pregnancy within one month of vaccination. * Persons who have had a prior serious reaction to influenza vaccine. * Persons with a history of anaphylactic-type reaction to injected vaccines. * Persons with a history of drug or chemical abuse in the year preceding the study. * Persons who received an influenza vaccine for the current influenza season or those who plan to receive an influenza vaccine while participating in the study. * Persons who received any other vaccine within one week prior to enrollment (may delay enrollment). * Persons who have had a respiratory illness or illness with fever within three days of study enrollment (may delay enrollment). * Persons currently participating in another research study involving any study medications (medicines or vaccines).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | 0 to 7 days after vaccination | Solicited local and general symptoms experienced within 7 days after vaccination 1. |
| Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | 14 days after vaccination | Solicited local and general symptoms experienced within 14 days after vaccination 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-M2e Serum Antibody Concentration | 42 days (+/- 2) | Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VAX102 IM Given as 1 µg intramuscular | 30 |
| VAX102 SC Given as 2 µg subcutaneous | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | VAX102 IM | VAX102 SC | Total |
|---|---|---|---|
| Age Continuous | 27.3 years STANDARD_DEVIATION 7.64 | 26.7 years STANDARD_DEVIATION 8.74 | 27 years STANDARD_DEVIATION 8.14 |
| Sex: Female, Male Female | 13 Participants | 15 Participants | 28 Participants |
| Sex: Female, Male Male | 17 Participants | 15 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 30 |
| serious Total, serious adverse events | 1 / 28 | 0 / 30 |
Outcome results
Primary
Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0)
Solicited local and general symptoms experienced within 7 days after vaccination 1.
Time frame: 0 to 7 days after vaccination
Population: The population analyzed included all participants receiving at least 1 dose of the vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Redness | 0 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Swelling | 2 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Bruising | 0 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Arm Pain | 23 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Headache | 5 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Fatigue | 4 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Joint Pain | 4 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Muscle Aches | 13 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Chills | 0 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Sweating | 1 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Muscle Aches | 10 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Redness | 13 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Fatigue | 4 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Swelling | 3 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Sweating | 1 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Bruising | 0 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Joint Pain | 3 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Arm Pain | 21 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Chills | 0 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 1 (Day 0) | Headache | 3 participants |
Primary
Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28)
Solicited local and general symptoms experienced within 14 days after vaccination 2
Time frame: 14 days after vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Redness | 0 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Swelling | 0 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Bruising | 0 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Arm pain | 0 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Headache | 0 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Fatigue | 0 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Joint Pain | 0 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Muscle Aches | 0 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Chills | 0 participants |
| VAX102 1.0 µg i.m. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Sweating | 0 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Muscle Aches | 0 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Redness | 0 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Fatigue | 1 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Swelling | 0 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Sweating | 0 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Bruising | 0 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Joint Pain | 0 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Arm pain | 0 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Chills | 0 participants |
| VAX102 2.0 µg s.c. | Number of Participants With Local and Systemic Symptoms Post Vaccination 2 (Day 28) | Headache | 0 participants |
Secondary
Anti-M2e Serum Antibody Concentration
Anti-M2e Serum Antibody Concentration summarized by study visit using the per-protocol population.
Time frame: 42 days (+/- 2)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VAX102 1.0 µg i.m. | Anti-M2e Serum Antibody Concentration | Baseline | 0.011 Titers |
| VAX102 1.0 µg i.m. | Anti-M2e Serum Antibody Concentration | Day 14 | 0.376 Titers |
| VAX102 1.0 µg i.m. | Anti-M2e Serum Antibody Concentration | Day 28 | 0.255 Titers |
| VAX102 1.0 µg i.m. | Anti-M2e Serum Antibody Concentration | Day 42 | 1.121 Titers |
| VAX102 2.0 µg s.c. | Anti-M2e Serum Antibody Concentration | Day 42 | 2.062 Titers |
| VAX102 2.0 µg s.c. | Anti-M2e Serum Antibody Concentration | Baseline | 0.012 Titers |
| VAX102 2.0 µg s.c. | Anti-M2e Serum Antibody Concentration | Day 28 | 0.248 Titers |
| VAX102 2.0 µg s.c. | Anti-M2e Serum Antibody Concentration | Day 14 | 0.375 Titers |