Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines

Study Overview
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Brief Summary
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This is a prospective phase I study to evaluate the safety, tolerability and immunogenicity of nine adjuvanted candidate vaccines against pandemic influenza A (H1N1) virus.

Detailed Description
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The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil

Official Title
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Evaluation of Safety, Tolerability and Immunogenicity of Adjuvanted Candidate Vaccines Against Pandemic Influenza A (H1N1)

Conditions
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Influenza

Intervention / Treatment
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* Biological: pandemic vaccine 1
* Biological: pandemic vaccine 2
* Biological: pandemic vaccine 5
* Biological: pandemic vaccine 6
* Biological: pandemic vaccine 9
* Biological: pandemic vaccine 10
* Biological: pandmeic vaccine 11
* Biological: pandmeic vaccine 12
* Biological: pandmic vaccine 13
* Biological: placebo group 14


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Health adults of both genders Age ≥ 18 ≤ 50 years Able to understand every required study procedure Female volunteers should agree to take an acceptable contraceptive method Menopause is characterized by absence of menstrual flux for two consective years Normal values for pre-stablished laboratory assays Accpetance to participate and sign the consent form Exclusion Criteria: Any chronic condition Be on immunossupressive or stimulant therapy Have egg alergy Have past history of alergy to sazonal influenza vaccine Have received another inactivated vaccine within the prior 2 weeks or a live vaccine in the past four weeks to his/her participation in the study Acute infectious disease during seven days prior vaccination Female on breasthfeeding Confirmed prior infection by pandemic influenza A Participation in another clinical trial in the last 6 months Any other condition identified by the principal investigator which is considered not safe for enrollment of the volunteer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pandemic vaccine 1<br>7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3 | Biological: pandemic vaccine 1<br>* 7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3<br>* Other names: vaccine group C;|
| Experimental: pandemic vaccine 2<br>3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3 | Biological: pandemic vaccine 2<br>* 3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3<br>* Other names: vaccine group I;|
| Experimental: pandemic vaccine 5<br>7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion | Biological: pandemic vaccine 5<br>* 7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion<br>* Other names: vaccine group N;|
| Experimental: pandemic vaccine 6<br>3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion | Biological: pandemic vaccine 6<br>* 3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion<br>* Other names: vaccine group A;|
| Experimental: pandemic vaccine 9<br>7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion | Biological: pandemic vaccine 9<br>* 7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion<br>* Other names: vaccine group F;|
| Experimental: pandemic vaccine 10<br>3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion | Biological: pandemic vaccine 10<br>* 3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion<br>* Other names: vaccine group L;|
| Experimental: pandemic vaccine 11<br>7,5µg of A/H1N1 with Al(OH)3 | Biological: pandmeic vaccine 11<br>* 7,5µg of A/H1N1 with Al(OH)3<br>* Other names: vaccine group E;|
| Experimental: pandemic vaccine 12<br>3,75µg of A/H1N1 with Al(OH)3 | Biological: pandmeic vaccine 12<br>* 3,75µg of A/H1N1 with Al(OH)3<br>* Other names: vaccine group K;|
| Experimental: pandemic vaccine 13<br>15µg of A/H1N1 with no adjuvant | Biological: pandmic vaccine 13<br>* 15µg of A/H1N1 with no adjuvant<br>* Other names: vaccine group H;|
| Placebo Comparator: placebo group 14<br>placebo | Biological: placebo group 14<br>* All elements of the vaccine but antigen and adjuvant<br>* Other names: vaccine group B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay | Volunteers will receive two doses of vaccine,21 days apart. | 21 days after each vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability | Evaluation of local and systemic adverse effects throught the study period | 30 minutes and 72 hours after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, pandemic influenza A, adjuvant, safety