Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines

Butantan Institute

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Biological: pandmic vaccine 13; Biological: pandmeic vaccine 12; Biological: pandemic vaccine 10; Biological: placebo group 14; Biological: pandmeic vaccine 11; Biological: pandemic vaccine 9; Biological: pandemic vaccine 2; Biological: pandemic vaccine 5; Biological: pandemic vaccine 6; Biological: pandemic vaccine 1

Study type: Interventional

Funder types: Other

Identifiers

NCT01111968

BUTVAC - Influenza A (H1N1)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 266 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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266 participants in 10 patient groups, including a placebo group

pandemic vaccine 1

Experimental group

Description:

7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3

Treatment:

Biological: pandemic vaccine 1

pandemic vaccine 2

Experimental group

Description:

3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3

Treatment:

Biological: pandemic vaccine 2

pandemic vaccine 5

Experimental group

Description:

7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion

Treatment:

Biological: pandemic vaccine 5

pandemic vaccine 6

Experimental group

Description:

3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion

Treatment:

Biological: pandemic vaccine 6

pandemic vaccine 9

Experimental group

Description:

7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion

Treatment:

Biological: pandemic vaccine 9

pandemic vaccine 10

Experimental group

Description:

3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion

Treatment:

Biological: pandemic vaccine 10

pandemic vaccine 11

Experimental group

Description:

7,5µg of A/H1N1 with Al(OH)3

Treatment:

Biological: pandmeic vaccine 11

pandemic vaccine 12

Experimental group

Description:

3,75µg of A/H1N1 with Al(OH)3

Treatment:

Biological: pandmeic vaccine 12

pandemic vaccine 13

Experimental group

Description:

15µg of A/H1N1 with no adjuvant

Treatment:

Biological: pandmic vaccine 13

placebo group 14

Placebo Comparator group

Description:

placebo

Treatment:

Biological: placebo group 14