Immunocompromised PatientsNCT01218685
Evaluation of Pandemic Influenza A (H1N1) Vaccine in Chronic and or Immunocompromised Patients, Elderly and Pregnants
An observational study of Immunocompromised Patients and Safety of Pandemic Influenza A (H1N1)Vaccine, run by Butantan Institute at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunocompromised Patients, Safety of Pandemic Influenza A (H1N1)Vaccine, Immunogenicity of Pandemic Influenza A (H1N1)Vaccine
- What is being tested?
- Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS
- How many people
- 1,152 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2010to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Volunteers able to understand and agree to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS
- Keywords
- Immunocompromised patients, Safety of pandemic influenza A (H1N1)vaccine, Immunogenicity of pandemic influenza A (H1N1)vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUSBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Health adults | Not described Receives: Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS | |
| Health children | Not described Receives: Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS | |
| Pregnants | Not described Receives: Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS | |
| Elderly over 65 years old | Not described Receives: Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS | |
| HIV patients | Not described Receives: Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS | |
| Kidney transplant | Not described Receives: Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS | |
| Oncologic patients | Not described Receives: Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS | |
| Rheumatologic adult patients | Not described Receives: Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS | |
| Rheumatologic children patients | Not described Receives: Biological: Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 days after vaccination
Secondary outcomes (1)
Safety of the vaccine
Evaluation of local and systemic adverse effects through the study period including 30 minutes after vaccination
Measured: 21 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immunocompromised PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butantan Institute
- Sponsor type
- Other government
- Collaborators
- University of Sao Paulo, Instituto Adolfo Lutz, Centro de Referencia e Treinamento em DST/AIDS
- Responsible party
- Sponsor
- Investigators
- Alexander Roberto Precioso, MD, PhD, Study chair, Butantan Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218685
- Sponsor's protocol ID
- BUTVAC-Influenza A (H1N1) 2.0
- Status last verified
- Feb 2013
- First submitted
- 8 Oct 2010
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22087267
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01218685
- Acronym / sponsor ID
- BUTVAC-Influenza A (H1N1) 2.0
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,152 participants (actual)
- Lead sponsor
- Butantan InstituteOther government
- Collaborators
- University of Sao Paulo, Instituto Adolfo Lutz, Centro de Referencia e Treinamento em DST/AIDS
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 11 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 months to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Volunteers able to understand and agree to participate in the study.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS1 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. | Biological | Elderly over 65 years old, HIV patients, Health adults, Health children, Kidney transplant, Oncologic patients, Pregnants, Rheumatologic adult patients, Rheumatologic children patients |
Primary outcome
Antibody titers of 1:40 or more for influenza A pandemic (H1N1)
Time frame: 21 days after vaccination
the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay
1 secondary outcome
Safety of the vaccine
Time frame: 21 days after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
- Derived from this study: PubMed 22087267Miraglia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Roberto Precioso, MD, PhD study chair
Butantan Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunocompromised Patients and Safety of Pandemic Influenza A (H1N1)Vaccine, run by Butantan Institute at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody titers of 1:40 or more for influenza A pandemic (H1N1) (time frame: 21 days after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01218685, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2013.