influenza flu
Conditions
Interventions
Twincer®-administered dry powder excipient (inulin and HBS, arm 1) and Twincer®-
administered dry powder influenza vaccine (at 15, 30 and 45 micrograms, arm
2-4).
Sponsors
Rijksuniversiteit Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Healthy male or non-pregnant female (as indicated by a negative urine pregnancy test immediately prior to study treatment) between the ages of 18 and 59 years, inclusive; ;- Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to one year) must agree to practice adequate contraception (i.e., barrier method, abstinence, and licensed hormonal methods) for the entire study period;;- Is in good health, as determined by vital signs (heart rate, blood pressure, body temperature), medical history, self-reported illness, general physical examination, electrocardiogram (EKG), blood chemistry test (electrolytes, renal/kidney function, liver function, C-reactive protein, complete blood count), chest x-ray and clinical judgment of the Investigator; ;- Able to understand and comply with planned study procedures;;- Able to provide written informed consent
Exclusion criteria
Exclusion criteria: - Has a history of severe reactions following immunization with contemporary influenza virus vaccines.;- Is allergic to egg or egg products.;- Persons with immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy.;- Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential) or women who are breastfeeding.;- Has a history of any serious disease:;Acute disseminated encephalomyelitis (ADEM);;Active neoplastic disease;;Any hematologic malignancy;;Asthma/COPD or severe allergic disease;;Bleeding disorders;;Chronic Hepatitis B and/or C infection;;Chronic liver disease;;Diabetes mellitus;;Guillain-Barre;;HIV;;Rheumatism or other autoimmune diseases;;Severe renal disease;;Transplant recipients;;Unstable or progressive neurological disorders.;- Receipt of medicines/treatments that would affect evaluation of immunogenicity:;(1) Oral or parenteral steroids, high-dose inhaled steroids (greater than 800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs;;(2) Immunoglobulin or other blood products (within the 3 months prior to treatment in this study);;(3) Experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to treatment in this study, or expects to receive an experimental agent (during the 180 day study period).;(4) Influenza antiviral medication (within 1 month prior to treatment in this study).;- Has received any influenza vaccine within 6 months prior to treatment in this study.;- Has influenza-like illness within 6 months prior to treatment in this study.;- Has an acute illness, including an oral temperature greater than 38 degrees Celsius, within 1 week of treatment.;- Has a history of alcohol or drug abuse deemed unsuitable for inclusion by the investigator (based on the units used according to the trial subject);- Has a smoking habit deemed unsuitable for inclusion by the investigator (based on the units used according to the trial subject).;- Ineligible subject based on the judgement of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For safety and tolerability: (1) Occurrence and intensity of subjects experiencing acute AEs 6hr after the study treatments (for stage I and II); (2) Occurrence of subjects experiencing >20% reduction in FEV after the study treatments (for stage I and II); (3) Occurrence and intensity of solicited and unsolicited local and systemic AEs after the study treatments (for stage II only); (4) Occurrence of SAEs and AESIs during the 180 day study period (for stage II only). For immunogenicity (for stage II only): (1) Geometric mean titer (GMT) of serum hemagglutination inhibition (HAI) with 95% confidence interval (CI) on day 0, 21 and 180; (2) seroconversion rate (SCR) of HAI on day 21 and 180; (3) seroprotection rate (SPR) of HAI on 21 and 180; (4) Mean-fold increase in HAI titer from baseline. (5) Geometric mean concentration (GMC) of influenza-specific IgG in serum, nasal wash and sputum samples with 95% CI on day 0, 21 and 180; (5) GMC of influenza-specific IgA in serum, nasal wash and sputum samples with 95% CI on day 0, 21 and 180. | — |
Countries
Netherlands
Outcome results
None listed