Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines

Phase 1

Completed

• Conditions: Influenza
• Interventions: 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

• Registration Number: NCT01111968
• Lead Sponsor: Butantan Institute

Brief Summary

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

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

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-04-14
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-05
• Last Update Posted: 2013-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pandemic vaccine 1	pandemic vaccine 1	7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
pandemic vaccine 2	pandemic vaccine 2	3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
pandemic vaccine 5	pandemic vaccine 5	7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion
pandemic vaccine 6	pandemic vaccine 6	3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion
pandemic vaccine 9	pandemic vaccine 9	7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
pandemic vaccine 10	pandemic vaccine 10	3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
pandemic vaccine 11	pandmeic vaccine 11	7,5µg of A/H1N1 with Al(OH)3
pandemic vaccine 12	pandmeic vaccine 12	3,75µg of A/H1N1 with Al(OH)3
pandemic vaccine 13	pandmic vaccine 13	15µg of A/H1N1 with no adjuvant
placebo group 14	placebo group 14	placebo

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	30 minutes and 72 hours after vaccination	Evaluation of local and systemic adverse effects throught the study period

Trial Locations

Locations (2)

Centro de Pesquisa Clínica do Hospital Universitário da USP; 🇧🇷 Sao Paulo, Brazil

Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP; 🇧🇷 Sao Paulo, Brazil