Safety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu Vaccine

Study Overview
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Brief Summary
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To evaluate the safety and tolerability of the an adjuvanted influenza vaccine combined with CpG7909 at three different doses of CpG 7909 as a single intramuscular (IM) administration in healthy adults. Safety will be assessed by observation of symptoms, physical examination findings and laboratory safety testing.

Official Title
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A Phase 1, Randomized, Controlled, Observer-Blinded, Dose Escalation Study of the Safety, Tolerability and Immunogenicity of a Single Dose of Adjuvanted Influenza Vaccine Combined With CpG7909 in Healthy Adults

Conditions
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Influenza Infection

Intervention / Treatment
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* Biological: Subunit influenza vaccine
* Biological: Adjuvanted influenza vaccine
* Biological: Adjuvanted influenza vaccine combined with CpG7909
* Biological: Adjuvanted influenza vaccine combine with CpG7909
* Biological: Adjuvanted influenza vaccine combine with CpG7909


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects aged 18 to ≤40 years Exclusion Criteria: Any serious disease, hypersensitivity to egg or vaccine components, neurological symptoms or positive antibody test against dsDNA, RF, ANA or thyroid. Abnormal TSH from blood samples collected during the screening visit;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Biological: Subunit influenza vaccine<br>* 0.5 mL single dose vaccine<br>|
| Active Comparator: 2<br> | Biological: Adjuvanted influenza vaccine<br>* 0.5 mL single dose vaccine<br>|
| Experimental: 3<br> | Biological: Adjuvanted influenza vaccine combined with CpG7909<br>* 0.5 ml influenza vaccine combined with 10 mcg of CpG7909<br>|
| Experimental: 4<br> | Biological: Adjuvanted influenza vaccine combine with CpG7909<br>* 0.5 mL single dose vaccine combined with 30 mcg of CpG7909<br>|
| Experimental: 5<br> | Biological: Adjuvanted influenza vaccine combine with CpG7909<br>* 0.5 mL single dose vaccine combined with 100 mcg of CpG7909<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of humoral immunogenicity for each antigen |  | 22 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of vaccine-induced B and T cell immune responses |  | 72 hours | 
| Measure of alterated biomarkers and measure of safety |  | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adjuvanted Influenza Vaccine