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NCT Number: NCT01111968

Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP, São Paulo, Brazil

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pandemic vaccine 1

Biological

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

Other names: vaccine group C

pandemic vaccine 2

Biological

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

Other names: vaccine group I

pandemic vaccine 5

Biological

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

Other names: vaccine group N

pandemic vaccine 6

Biological

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

Other names: vaccine group A

pandemic vaccine 9

Biological

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

Other names: vaccine group F

pandemic vaccine 10

Biological

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

Other names: vaccine group L

pandmeic vaccine 11

Biological

7,5µg of A/H1N1 with Al(OH)3

Other names: vaccine group E

pandmeic vaccine 12

Biological

3,75µg of A/H1N1 with Al(OH)3

Other names: vaccine group K

pandmic vaccine 13

Biological

15µg of A/H1N1 with no adjuvant

Other names: vaccine group H

placebo group 14

Biological

All elements of the vaccine but antigen and adjuvant

Other names: vaccine group B

Primary outcomes

  1. the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay

    Time frame: 21 days after each vaccination

    Volunteers will receive two doses of vaccine,21 days apart.

Secondary outcomes

  1. Safety and tolerability

    Time frame: 30 minutes and 72 hours after vaccination

    Evaluation of local and systemic adverse effects throught the study period

Sponsors and collaborators

Lead sponsor

Butantan Institute

Other Gov

Collaborators

  • Hospital Universitario da USP
  • University of Sao Paulo

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Apr 28, 2010
Registry last updated
Feb 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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