Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines
Evaluation of Safety, Tolerability and Immunogenicity of Adjuvanted Candidate Vaccines Against Pandemic Influenza A (H1N1)
1 other identifier
interventional
266
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 14, 2010
CompletedFirst Posted
Study publicly available on registry
April 28, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFebruary 6, 2013
February 1, 2013
11 months
April 14, 2010
February 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Safety and tolerability
30 minutes and 72 hours after vaccination
Study Arms (10)
pandemic vaccine 1
EXPERIMENTAL7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
pandemic vaccine 2
EXPERIMENTAL3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
pandemic vaccine 5
EXPERIMENTAL7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion
pandemic vaccine 6
EXPERIMENTAL3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion
pandemic vaccine 9
EXPERIMENTAL7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
pandemic vaccine 10
EXPERIMENTAL3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
pandemic vaccine 11
EXPERIMENTAL7,5µg of A/H1N1 with Al(OH)3
pandemic vaccine 12
EXPERIMENTAL3,75µg of A/H1N1 with Al(OH)3
pandemic vaccine 13
EXPERIMENTAL15µg of A/H1N1 with no adjuvant
placebo group 14
PLACEBO COMPARATORplacebo
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Butantan Institutelead
- Hospital Universitario da USPcollaborator
- University of Sao Paulocollaborator
Study Sites (2)
Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403-900, Brazil
Centro de Pesquisa Clínica do Hospital Universitário da USP
São Paulo, São Paulo, 05508000, Brazil
Related Publications (1)
Precioso AR, Miraglia JL, Campos LM, Goulart AC, Timenetsky Mdo C, Cardoso MR, Luna E, Mondini G, Guedes Jda S, Raw I. A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems. Vaccine. 2011 Nov 8;29(48):8974-81. doi: 10.1016/j.vaccine.2011.09.040. Epub 2011 Sep 21.
PMID: 21945258DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lucia MA Campos, MD. PhD
Children´s Institute - School of Medicine of University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2010
First Posted
April 28, 2010
Study Start
January 1, 2010
Primary Completion
December 1, 2010
Study Completion
March 1, 2011
Last Updated
February 6, 2013
Record last verified: 2013-02