Influenza Prophylaxis
Conditions
Keywords
Jet Injector, Stratis®, PharmaJet, Jet Injection
Brief summary
The primary objective of this study was to evaluate if administration of a seasonal flu vaccine using a jet injector device is comparable to traditional needle and syringe delivery for eliciting an immune response. A secondary objective was to compare the safety of the two delivery methods.
Detailed description
Needle-free jet injection devices create a fine stream of pressurized liquid that is able to deliver vaccines and other pharmaceutical products beneath the skin. Design aspects such as quality, pressure, orifice size, angle of injection relative to skin and injection stream coherence control the depth to which the product is delivered. This technology provides a safer delivery option for patients and healthcare staff by removing the need for needles for the administration of vaccines. In addition to improved safety, additional benefits of using jet injectors include more consistent and reliable dose volume delivery, reduced vaccine waste, diminished need to transport large quantities of sharps, reduced risk of needle sticks, syringe reuse, and costs associated with sharps waste. Jet injectors offer a needle-free procedure to those individuals who are adverse to needles. This study compared the efficacy of a disposable syringe jet injection device (Stratis) with traditional needle and syringe (NS) administration for the delivery of a trivalent inactivated influenza vaccine. Efficacy was evaluated by comparing measures of hemagglutination inhibition (HI); specifically GMTs, seroconversion and seroprotection. Safety of the two administration devices was evaluated by comparison of incidence of solicited local and systemic adverse events.
Interventions
DEVICEStratis Jet Injector
Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
DEVICENeedle and Syringe
Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
BIOLOGICAL2011-2012 Fluzone trivalent inactivated influenza vaccine
Sponsors
PharmaJet, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* Female and male subjects ages 18 to 59 years * Healthy volunteers * Able to provide informed consent and understand study procedures per ICH/GCP guidelines * Plans to remain in study area for length of the trial; able to adhere to study visit and follow-up schedule * Able to complete study diary
Exclusion criteria
* Unwilling or unable to undergo the two blood draws per protocol * Have received influenza vaccination in the last twelve months * Have received any vaccination in the last month * Currently taking antibiotics, steroids, phenytoin, chemotherapy, or other immunosuppressive drugs * Received recent blood, blood products, or parenteral preparations of immunoglobulin (within 3 months) * Suffers from allergic reactions to egg, gelatin, or neomycin or has a history of anaphylactic shock, asthma, urticaria, or other allergic reactions to vaccinations. * Had any serious adverse event associated with a prior vaccination * Has immunodeficiency or autoimmune disease (including HIV) * History of chronic alcohol abuse * Participating in another study concurrently * Pregnant or breastfeeding during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) | 28 days | The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio (GMT with Needle-Free / GMT with Needle and Syringe) antigen will not exceed 1.5 fold. |
| The Percentage of Participants Achieving Seroconversion | 28 days | Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (\<1:10), attainment of a post-immunization titer of ≥1:40. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Solicited Local or Systemic Adverse Events | 4 days | Vaccine reactogenicity will be collected on a patient-completed diary card daily for seven days post-vaccination. The following adverse events will be solicited on the diary card: injection site tenderness, injection site pain, injection site redness, injection site swelling, injection site itching, injection site bruising, fatigue, muscle aches, headache, decreased appetite, fever, pruritus. |
Countries
United States
Participant flow
Recruitment details
Up to 100 subjects between the ages of 18 and 59 were planned with 83 subjects enrolled and 82 subjects vaccinated. Pre- and post-vaccination serum samples were collected from 78 subjects and were analyzed in the Efficacy population.
Pre-assignment details
A total of 83 subjects were recruited and 78 (39 Stratis® and 39 NS) completed the study. One Stratis® group subject (subject # 23) discontinued from the study prior to vaccination.
Participants by arm
| Arm | Count |
|---|---|
| PharmaJet Stratis Injector Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using the Stratis Jet Injector
Stratis Jet Injector: Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
2011-2012 Fluzone trivalent inactivated influenza vaccine | 39 |
| Needle and Syringe Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using Needle and Syringe
Needle and Syringe: Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
2011-2012 Fluzone trivalent inactivated influenza vaccine | 39 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Needle and Syringe | Total | PharmaJet Stratis Injector |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 78 Participants | 39 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 4 Participants | 6 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 31 Participants | 65 Participants | 34 Participants |
| Region of Enrollment United States | 39 participants | 78 participants | 39 participants |
| Sex: Female, Male Female | 26 Participants | 54 Participants | 28 Participants |
| Sex: Female, Male Male | 13 Participants | 24 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 36 / 39 | 32 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 |
Outcome results
Primary
Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT)
The GMT criterion for non-inferiority for the upper limit of the 95% CIs of the GMT ratio (GMT with Needle-Free / GMT with Needle and Syringe) antigen will not exceed 1.5 fold.
Time frame: 28 days
Population: The immunogenicity analyses were conducted using data from subjects in the immunogenicity population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Stratis Jet Injector | Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) | A/ H1N1 Day 0 | 3.55 Titers | Standard Deviation 1.19 |
| Stratis Jet Injector | Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) | A H1N1 Day 28 | 6.19 Titers | Standard Deviation 0.98 |
| Stratis Jet Injector | Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) | A/ H3N2 Day 0 | 3.55 Titers | Standard Deviation 1.3 |
| Stratis Jet Injector | Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) | A/H3N2 Day 28 | 6.31 Titers | Standard Deviation 1.28 |
| Stratis Jet Injector | Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) | B Day 0 | 2.57 Titers | Standard Deviation 0.51 |
| Stratis Jet Injector | Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) | B Day 28 | 4.17 Titers | Standard Deviation 1 |
| Needle and Syringe | Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) | B Day 0 | 2.53 Titers | Standard Deviation 0.45 |
| Needle and Syringe | Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) | A/ H1N1 Day 0 | 3.49 Titers | Standard Deviation 1.28 |
| Needle and Syringe | Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) | A/H3N2 Day 28 | 6.14 Titers | Standard Deviation 1.16 |
| Needle and Syringe | Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) | A H1N1 Day 28 | 6.13 Titers | Standard Deviation 1.05 |
| Needle and Syringe | Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) | B Day 28 | 4.17 Titers | Standard Deviation 1.1 |
| Needle and Syringe | Anti Influenza Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) | A/ H3N2 Day 0 | 3.49 Titers | Standard Deviation 1.4 |
Primary
The Percentage of Participants Achieving Seroconversion
Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (\<1:10), attainment of a post-immunization titer of ≥1:40.
Time frame: 28 days
Population: Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in the Immunogenicity Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratis Jet Injector | The Percentage of Participants Achieving Seroconversion | A/H1N1 | 79.5 Percentage of Subjects Seroconverted |
| Stratis Jet Injector | The Percentage of Participants Achieving Seroconversion | A/H3N2 | 89.7 Percentage of Subjects Seroconverted |
| Stratis Jet Injector | The Percentage of Participants Achieving Seroconversion | B | 59.0 Percentage of Subjects Seroconverted |
| Needle and Syringe | The Percentage of Participants Achieving Seroconversion | A/H3N2 | 85.0 Percentage of Subjects Seroconverted |
| Needle and Syringe | The Percentage of Participants Achieving Seroconversion | A/H1N1 | 85.0 Percentage of Subjects Seroconverted |
| Needle and Syringe | The Percentage of Participants Achieving Seroconversion | B | 65.0 Percentage of Subjects Seroconverted |
Secondary
Percentage of Subjects With Solicited Local or Systemic Adverse Events
Vaccine reactogenicity will be collected on a patient-completed diary card daily for seven days post-vaccination. The following adverse events will be solicited on the diary card: injection site tenderness, injection site pain, injection site redness, injection site swelling, injection site itching, injection site bruising, fatigue, muscle aches, headache, decreased appetite, fever, pruritus.
Time frame: 4 days
Population: Data included in the analysis were collected on a 4-Day Diary Card from the safety population and grade \>1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stratis Jet Injector | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Tenderness | 95 Percentage of Subjects |
| Stratis Jet Injector | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Pain | 68 Percentage of Subjects |
| Stratis Jet Injector | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Redness | 61 Percentage of Subjects |
| Stratis Jet Injector | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Swelling | 50 Percentage of Subjects |
| Stratis Jet Injector | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Itching | 34 Percentage of Subjects |
| Stratis Jet Injector | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Bruising | 26 Percentage of Subjects |
| Stratis Jet Injector | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Fatigue | 34 Percentage of Subjects |
| Stratis Jet Injector | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Muscle Aches | 47 Percentage of Subjects |
| Stratis Jet Injector | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Headache | 34 Percentage of Subjects |
| Stratis Jet Injector | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Decreased Appetite | 16 Percentage of Subjects |
| Stratis Jet Injector | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Fever | 16 Percentage of Subjects |
| Stratis Jet Injector | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Pruritis | 24 Percentage of Subjects |
| Needle and Syringe | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Fever | 18 Percentage of Subjects |
| Needle and Syringe | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Tenderness | 80 Percentage of Subjects |
| Needle and Syringe | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Fatigue | 38 Percentage of Subjects |
| Needle and Syringe | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Pain | 58 Percentage of Subjects |
| Needle and Syringe | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Decreased Appetite | 20 Percentage of Subjects |
| Needle and Syringe | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Redness | 25 Percentage of Subjects |
| Needle and Syringe | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Muscle Aches | 33 Percentage of Subjects |
| Needle and Syringe | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Swelling | 20 Percentage of Subjects |
| Needle and Syringe | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Pruritis | 10 Percentage of Subjects |
| Needle and Syringe | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Itching | 13 Percentage of Subjects |
| Needle and Syringe | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Headache | 28 Percentage of Subjects |
| Needle and Syringe | Percentage of Subjects With Solicited Local or Systemic Adverse Events | Bruising | 20 Percentage of Subjects |