Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111968
• Other study ID #: BUTVAC - Influenza A (H1N1)
• Status: Completed
• Phase: Phase 1
• First received: April 14, 2010
• Last updated: February 5, 2013
• Start date: January 2010
• Est. completion date: March 2011

Study information

• Verified date: February 2013
• Source: Butantan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• pandemic vaccine 1
7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
• pandemic vaccine 2
3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
• pandemic vaccine 5
7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion
• pandemic vaccine 6
3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion
• pandemic vaccine 9
7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
• pandemic vaccine 10
3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
• pandmeic vaccine 11
7,5µg of A/H1N1 with Al(OH)3
• pandmeic vaccine 12
3,75µg of A/H1N1 with Al(OH)3
• pandmic vaccine 13
15µg of A/H1N1 with no adjuvant
• placebo group 14
All elements of the vaccine but antigen and adjuvant

Locations

Country	Name	City	State
Brazil	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

Sponsors (3)

Lead Sponsor	Collaborator
Butantan Institute	Hospital Universitario da USP, University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety and tolerability	Evaluation of local and systemic adverse effects throught the study period	30 minutes and 72 hours after vaccination	Yes