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.
The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
266
7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion
Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil
Centro de Pesquisa Clínica do Hospital Universitário da USP
São Paulo, São Paulo, Brazil
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.
Time frame: 21 days after each vaccination
Safety and tolerability
Evaluation of local and systemic adverse effects throught the study period
Time frame: 30 minutes and 72 hours after vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion
7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
7,5µg of A/H1N1 with Al(OH)3
3,75µg of A/H1N1 with Al(OH)3
15µg of A/H1N1 with no adjuvant
All elements of the vaccine but antigen and adjuvant