Clinical trial NCT01218685: Evaluation of Pandemic Influenza A (H1N1) Vaccine in Chronic and or Immunocompromised Patients, Elderly and Pregnants
Official title: Evaluation Aof Safety and Immunogenicity of Non-adjuvanted Pandemic Influenza A (H1N1) Vaccine in Chronic and or Immunocompromised Patients, Elderly and Pregnants, Produced by Butantan Institute
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunocompromised Patients
Safety of Pandemic Influenza A (H1N1)Vaccine
Immunogenicity of Pandemic Influenza A (H1N1)Vaccine
Keywords: Immunocompromised patients
Safety of pandemic influenza A (H1N1)vaccine
Immunogenicity of pandemic influenza A (H1N1)vaccine
Lead sponsor: Butantan Institute
Sponsor class: OTHER_GOV
Collaborators: name: University of Sao Paulo
name: Insituto Adolfo Lutz
name: Centro de Referencia e Treinamento em DST/AIDS
First posted: 2010-10-11
Enrollment: 1152
Sex: ALL
Minimum age (years): 6
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers with chronic and or immunocompromised disease, elderly and pregnant in follow - up at the institutions participants in the study will be recruited.

Brief summary: The objective of this study is to describe the safety and immunogenicity of a non-adjuvanted vaccine against pandemic influenza A (H1N1)in patients with chronic and or immunocompromised disease, elderly and pregnants. The primary immunological endpoint is to analyze the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay 21 days after 1 dose of the vaccine. Volunteers will be monitored for safety during 21 days after vaccination. Volunteers will be recruited based on inclusion and exclusion criteria. Vaccine composition is: 15 micrograms of split inactivated virus (A/California/7/2009 (H1N1) (NYMC X179A). The hypothesis of the study is that the vaccine is safe and immunogenic in the volunteers recruited.


Eligibility criteria: Inclusion Criteria:

* Volunteers able to understand and agree to participate in the study.

Exclusion Criteria:

* Have egg allergy
* Have past history of allergy to seasonal influenza vaccine
* Have received another inactivated vaccine within the prior 2 weeks or live vaccine in the past four weeks to his/her participation in the study
* Acute infectious disease during seven days prior vaccination
* Confirmed prior infection by pandemic influenza A (H1N1)
* Have participated in another clinical trial in the last 6 months
* Any other condition identified by the principal investigators which is considered not safe for enrollment of the volunteer.

Primary outcomes:
measure: Antibody titers of 1:40 or more for influenza A pandemic (H1N1)
timeFrame: 21 days after vaccination
Secondary outcomes:
measure: Safety of the vaccine
timeFrame: 21 days after vaccination
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Avenida Vital Brasil 1500
Study officials:
affiliation: Butantan Foundation
name: Alexander Roberto Precioso, MD, PhD
role: STUDY_CHAIR
References:
citation: Miraglia JL, Abdala E, Hoff PM, Luiz AM, Oliveira DS, Saad CG, Laurindo IM, Viso AT, Tayra A, Pierrotti LC, Azevedo LS, Campos LM, Aikawa NE, Timenetsky Mdo C, Luna E, Cardoso MR, Guedes Jda S, Raw I, Kalil J, Precioso AR. Immunogenicity and reactogenicity of 2009 influenza A (H1N1) inactivated monovalent non-adjuvanted vaccine in elderly and immunocompromised patients. PLoS One. 2011;6(11):e27214. doi: 10.1371/journal.pone.0027214. Epub 2011 Nov 8.