InfluenzaPhase 1NCT01111968
Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines
A Phase 1 study testing pandemic vaccine 1, pandemic vaccine 2 and pandemic vaccine 5 in people with Influenza, run by Butantan Institute at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- pandemic vaccine 1, pandemic vaccine 2 and pandemic vaccine 5
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 2 sitesBrazil
- Study dates
- Jan 2010to Mar 2011
- Phase
- Phase 1
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP
São Paulo, São Paulo, 05403-900
Centro de Pesquisa Clínica do Hospital Universitário da USP
São Paulo, São Paulo, 05508000
About this study
Official title: Evaluation of Safety, Tolerability and Immunogenicity of Adjuvanted Candidate Vaccines Against Pandemic Influenza A (H1N1)
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.
Read the detailed description
The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil
- Conditions
- Influenza
- Being tested
- pandemic vaccine 1, pandemic vaccine 2, pandemic vaccine 5, pandemic vaccine 6, pandemic vaccine 9
- Keywords
- vaccine, pandemic influenza A, adjuvant, safety
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pandemic vaccine 1Biological
Also called vaccine group C
7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
pandemic vaccine 2Biological
Also called vaccine group I
3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
pandemic vaccine 5Biological
Also called vaccine group N
7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion
pandemic vaccine 6Biological
Also called vaccine group A
3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion
pandemic vaccine 9Biological
Also called vaccine group F
7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
pandemic vaccine 10Biological
Also called vaccine group L
3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
pandmeic vaccine 11Biological
Also called vaccine group E
7,5µg of A/H1N1 with Al(OH)3
pandmeic vaccine 12Biological
Also called vaccine group K
3,75µg of A/H1N1 with Al(OH)3
pandmic vaccine 13Biological
Also called vaccine group H
15µg of A/H1N1 with no adjuvant
placebo group 14Biological
Also called vaccine group B
All elements of the vaccine but antigen and adjuvant
| Study group | Role | What they receive |
|---|---|---|
| pandemic vaccine 1 | Experimental | 7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3 Receives: Biological: pandemic vaccine 1 |
| pandemic vaccine 2 | Experimental | 3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3 Receives: Biological: pandemic vaccine 2 |
| pandemic vaccine 5 | Experimental | 7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion Receives: Biological: pandemic vaccine 5 |
| pandemic vaccine 6 | Experimental | 3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion Receives: Biological: pandemic vaccine 6 |
| pandemic vaccine 9 | Experimental | 7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion Receives: Biological: pandemic vaccine 9 |
| pandemic vaccine 10 | Experimental | 3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion Receives: Biological: pandemic vaccine 10 |
| pandemic vaccine 11 | Experimental | 7,5µg of A/H1N1 with Al(OH)3 Receives: Biological: pandmeic vaccine 11 |
| pandemic vaccine 12 | Experimental | 3,75µg of A/H1N1 with Al(OH)3 Receives: Biological: pandmeic vaccine 12 |
| pandemic vaccine 13 | Experimental | 15µg of A/H1N1 with no adjuvant Receives: Biological: pandmic vaccine 13 |
| placebo group 14 | Placebo comparator | placebo Receives: Biological: placebo group 14 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 days after each vaccination
Secondary outcomes (1)
Safety and tolerability
Evaluation of local and systemic adverse effects throught the study period
Measured: 30 minutes and 72 hours after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2010
- Study completionMar 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 InfluenzaStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butantan Institute
- Sponsor type
- Other government
- Collaborators
- Hospital Universitario da USP, University of Sao Paulo
- Responsible party
- Sponsor
- Investigators
- Lucia MA Campos, MD. PhD, Principal investigator, Children´s Institute - School of Medicine of University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111968
- Sponsor's protocol ID
- BUTVAC - Influenza A (H1N1)
- Status last verified
- Feb 2013
- First submitted
- 14 Apr 2010
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Precioso AR, Miraglia JL, Campos LM, Goulart AC, Timenetsky Mdo C, Cardoso MR, Luna E, Mondini G, Guedes Jda S, Raw I. A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems. Vaccine. 2011 Nov 8;29(48):8974-81. doi: 10.1016/j.vaccine.2011.09.040. Epub 2011 Sep 21.
PubMed 21945258
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 of Safety, Tolerability and Immunogenicity of Adjuvanted Candidate Vaccines Against Pandemic Influenza A (H1N1)
- ClinicalTrials.gov ID
- NCT01111968
- Acronym / sponsor ID
- BUTVAC - Influenza A (H1N1)
- Conditions
- Influenza
- Keywords
- vaccine, pandemic influenza A, adjuvant, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Butantan InstituteOther government
- Collaborators
- Hospital Universitario da USP, University of Sao Paulo
- Study start
- Jan 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 28 Apr 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.
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.
Detailed description
The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| pandemic vaccine 1 | Experimental | Biological: pandemic vaccine 17,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3 |
| pandemic vaccine 2 | Experimental | Biological: pandemic vaccine 23,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3 |
| pandemic vaccine 5 | Experimental | Biological: pandemic vaccine 57,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion |
| pandemic vaccine 6 | Experimental | Biological: pandemic vaccine 63,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion |
| pandemic vaccine 9 | Experimental | Biological: pandemic vaccine 97,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion |
| pandemic vaccine 10 | Experimental | Biological: pandemic vaccine 103,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion |
| pandemic vaccine 11 | Experimental | Biological: pandmeic vaccine 117,5µg of A/H1N1 with Al(OH)3 |
| pandemic vaccine 12 | Experimental | Biological: pandmeic vaccine 123,75µg of A/H1N1 with Al(OH)3 |
| pandemic vaccine 13 | Experimental | Biological: pandmic vaccine 1315µg of A/H1N1 with no adjuvant |
| placebo group 14 | Placebo comparator | Biological: placebo group 14placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| pandemic vaccine 1Also: vaccine group C7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3 | Biological | pandemic vaccine 1 |
| pandemic vaccine 2Also: vaccine group I3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3 | Biological | pandemic vaccine 2 |
| pandemic vaccine 5Also: vaccine group N7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion | Biological | pandemic vaccine 5 |
| pandemic vaccine 6Also: vaccine group A3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion | Biological | pandemic vaccine 6 |
| pandemic vaccine 9Also: vaccine group F7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion | Biological | pandemic vaccine 9 |
| pandemic vaccine 10Also: vaccine group L3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion | Biological | pandemic vaccine 10 |
| pandmeic vaccine 11Also: vaccine group E7,5µg of A/H1N1 with Al(OH)3 | Biological | pandemic vaccine 11 |
| pandmeic vaccine 12Also: vaccine group K3,75µg of A/H1N1 with Al(OH)3 | Biological | pandemic vaccine 12 |
| pandmic vaccine 13Also: vaccine group H15µg of A/H1N1 with no adjuvant | Biological | pandemic vaccine 13 |
| placebo group 14Also: vaccine group BAll elements of the vaccine but antigen and adjuvant | Biological | placebo group 14 |
Primary outcome
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.
1 secondary outcome
Safety and tolerability
Time frame: 30 minutes and 72 hours 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 21945258Precioso AR, Miraglia JL, Campos LM, Goulart AC, Timenetsky Mdo C, Cardoso MR, Luna E, Mondini G, Guedes Jda S, Raw I. A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems. Vaccine. 2011 Nov 8;29(48):8974-81. doi: 10.1016/j.vaccine.2011.09.040. Epub 2011 Sep 21.
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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.
Lucia MA Campos, MD. PhD principal investigator
Children´s Institute - School of Medicine of University of Sao Paulo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pandemic vaccine 1, pandemic vaccine 2 and pandemic vaccine 5 in people with Influenza, run by Butantan Institute at 2 sites 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 6 inclusion and 10 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 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay (time frame: 21 days after each 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 NCT01111968, 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.