Evaluation of Pandemic Influenza A (H1N1) Vaccine in Chronic and or Immunocompromised Patients, Elderly and Pregnants

NCT01218685 | Completed DMC

• 1 other identifier: BUTVAC-Influenza A (H1N1) 2.0
• Study Type: observational
• Target: 1,152
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Antibody titers of 1:40 or more for influenza A pandemic (H1N1)

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

  21 days after vaccination

Secondary Outcomes (1)

• Safety of the vaccine

  21 days after vaccination

Study Arms (9)

Health adults

Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS

Health children

Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS

Pregnants

Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS

Elderly over 65 years old

Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS

HIV patients

Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS

Kidney transplant

Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS

Oncologic patients

Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS

Rheumatologic adult patients

Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS

Rheumatologic children patients

Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS

Interventions

Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS BIOLOGICAL

1 full dose of 15 micrograms, IM, for volunteers 9 years of age or older; children 6 months to 2 years of age, half of the dose,IM, with 21 days interval; children 3 years old up to 8 years old, 1 full dose, IM, twice, with 21 days interval.

Elderly over 65 years old; HIV patients; Health adults; Health children; Kidney transplant; Oncologic patients; Pregnants; Rheumatologic adult patients; Rheumatologic children patients

Eligibility Criteria

• Age: 6 Months - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Butantan Institute: lead
• University of Sao Paulo: collaborator
• Insituto Adolfo Lutz: collaborator
• Centro de Referencia e Treinamento em DST/AIDS: collaborator

Study Sites (1)

Avenida Vital Brasil 1500

São Paulo, São Paulo, 05503-900, Brazil

Location

Related Publications (1)

• 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.

  PMID: 22087267 DERIVED

Study Officials

• Alexander Roberto Precioso, MD, PhD

  Butantan Foundation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 11, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: April 1, 2011
• Last Updated: February 6, 2013

Record last verified: 2013-02

Locations

BR (1)