InfluenzaPhase 2/3NCT01582633
Assessment of Needle-free Disposable-syringe Jet Injector (DSJI) ID Dose-sparing of Pandemic A H1N1 Influenza Vaccine
A Phase 2/3 study testing 2012 trivalent influenza vaccine in people with Influenza, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This study will evaluate the immunological response and the safety profiles of seasonal, inactivated vaccine which contains in its composition the A/California/7/2009 H1N1 "pandemic" influenza virus, delivered via ID in reduced dose (0,1 mL) and (0,2 mL), and via IM in full dose (0,5 mL) delivered with needle-free… Read more about this study
- Who is it for?
- Ages 42 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- 2012 trivalent influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2012to Sep 2012
- Phase
- Phase 2/3
- 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 42 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 42 and up to 60 years of age.
- Available for follow up visits, at least at day 21.
- Written informed consent signed by the volunteer after reading and explanation.
Who cannot join
- Suspect or verified diagnosis of congenital or acquired immunodeficiency including AIDS.
- Suspect or verified diagnosis of malignant neoplasia, other than basocellular carcinoma.
- Volunteer ongoing treatment with high doses of systemic corticosteroids (equivalent to prednisone (2 mg/kg/d for more than two weeks) or on immunosuppressant therapy.
- Received or planning to receive a vaccine with live attenuated strain of virus within 30 days of the intended day(s) of study vaccination(s).
- Verified diagnosis of Influenza A/California/H1N1 or has already been immunized against (Influenza A/California/H1N1).
- Suspect or confirmed pregnancy (no need of pregnancy test, information on possible pregnancy is enough. These cases must be referred to routine vaccination).
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- Suspect or verified diagnosis of hypersensitivity to any ingredient of the vaccine, to egg proteins or any component of the vaccine or life-threatening reactions after previous administration of any influenza vaccine.
- Any other circumstances that may potentially damage the minor or prevent procedures from being carried out according to evaluation of the research team.
- Volunteer shows signs or symptoms of an active intercurrent disease (e.g. fever, rash, etc.) that may interfere with the evaluation of adverse events following immunization at the research team's discretion.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hosp das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403-000
Glacus Brito, MD, 551138731562, glacus@usp.br
Glacus Brito, MD
About this study
Official title: Assessment of Dose-sparing of Pandemic A/California/7/2009 H1N1 Influenza Vaccine Administered Intradermally by Needle-free Disposable-syringe Jet Injector (DSJI)
This study will evaluate the immunological response and the safety profiles of seasonal, inactivated vaccine which contains in its composition the A/California/7/2009 H1N1 "pandemic" influenza virus, delivered via ID in reduced dose (0,1 mL) and (0,2 mL), and via IM in full dose (0,5 mL) delivered with needle-free, disposable-syringe jet injector, and control group with via IM in full dose (0,5 mL) delivered syringes and needles in subjects from 42 to 60 years old.
Reduced doses into the skin will be delivered by an investigational intradermal model of a licensed, needle-free, disposable-syringe jet injector (DSJI) system, LECTRAJET® M3 RA manufactured by D'Antonio Consultants International, Inc. DSJIs avoid the drawbacks and dangers of conventional needle-syringe injection. Delivery by DSJI into the skin is also rapid and simple and overcomes the difficulty and patient discomfort of the traditional Mantoux needle method for skin injection, as used for BCG vaccination and tuberculosis skin testing.
Read more
Participants will be assessed for local and systemic adverse events by clinical observation immediately after injection and then upon return on day 21 after each injection. In addition, investigators will call participants by telephone on days 2 and 7 days to collect information local and systemic side effects.
Serum will be collected on day 21 after each injection, and assayed for hemagglutination inhibition (HAI) using conventional methods performed by the Virology Lab of the Instituto de Medicina Tropical de São Paulo, blinded to the study arm allocations of each participant. Information about the adverse events would be collected on days 1, 3 and 7 after dose delivery. The investigators assessing adverse reactions will be blinded to the study arm to which each subject was allocated.
The primary endpoint of the study is to evaluate the vaccine's immunogenicity by HAI, each dose in accordance with international parameters which include: seroconversion or significant title increase (SCR), the frequencies by study arm of seroprotection defined as a post-vaccination titer of >40 (1/dil) (SPR), as well as the Geometric Mean Titers (GMTRs) of post-vaccination sera.
Read the detailed description
This study will evaluate the immunological response and the safety profiles of seasonal, inactivated vaccine which contains in its composition the A/California/7/2009 H1N1 "pandemic" influenza virus, delivered via ID in reduced dose (0,1 mL) and (0,2 mL), and via IM in full dose (0,5 mL) delivered with needle-free, disposable-syringe jet injector, and control group with via IM in full dose (0,5 mL) delivered syringes and needles in subjects from 42 to 60 years old.
Reduced doses into the skin will be delivered by an investigational intradermal model of a licensed, needle-free, disposable-syringe jet injector (DSJI) system, LECTRAJET® M3 RA manufactured by D'Antonio Consultants International, Inc. ( East Syracuse, NY, USA) . DSJIs avoid the drawbacks and dangers of conventional needle-syringe injection. Delivery by DSJI into the skin is also rapid and simple and overcomes the difficulty and patient discomfort of the traditional Mantoux needle method for skin injection, as used for BCG vaccination and tuberculosis skin testing.
Participants will be assessed for local and systemic adverse events by clinical observation immediately after injection and then upon return on day 21 after each injection. In addition, investigators will call participants by telephone on days 2 and 7 days to collect information local and systemic side effects. Adverse events will be classified and analyzed according to case definitions established by the Brighton Collaboration Group.
Serum will be collected on day 21 after each injection, and assayed for hemagglutination inhibition (HAI) using conventional methods performed by the Virology Lab of the Instituto de Medicina Tropical de São Paulo, blinded to the study arm allocations of each participant. Information about the adverse events would be collected on days 1, 3 and 7 after dose delivery. The investigators assessing adverse reactions will be blinded to the study arm to which each subject was allocated.
The primary endpoint of the study is to evaluate the vaccine's immunogenicity by HAI, each dose in accordance with international parameters which include: seroconversion or significant title increase (SCR), the frequencies by study arm of seroprotection defined as a post-vaccination titer of >40 (1/dil) (SPR), as well as the Geometric Mean Titers (GMTRs) of post-vaccination sera.
Participants will be excluded if they have a prior history of influenza disease caused by A/California/7/2009 H1N1 or prior vaccination for same, among other exclusion and inclusion criteria to apply. Participants will be excluded retroactively from analysis if their pre-vaccination HAI assay discovers pre-existing seroprotective titers of >40 against pandemic virus, representing preexisting H1N1 exposure or vaccination
- Conditions
- Influenza
- Being tested
- 2012 trivalent influenza vaccine
- Keywords
- vaccine, influenza, needle free jet injector, Intradermal, sparing dose
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2012 trivalent influenza vaccineBiological
2012 trivalent influenza vaccine:
- influenza A/California/7/2009 (H1N1)
- influenza A/Perth/16/2009 (H3N2)
- influenza B/Brisbane/60/2008 Single dose.
| Study group | Role | What they receive |
|---|---|---|
| 0.1 ml ID dose | Experimental | Dose of 0.1 ml ID trivalent 2012 influenza vaccine administered by disposable needle-free jet injector Receives: Biological: 2012 trivalent influenza vaccine |
| 0.2 ml ID dose | Experimental | Dose of 0.2 ml ID trivalent 2012 influenza vaccine administered by disposable needle-free jet injector Receives: Biological: 2012 trivalent influenza vaccine |
| 0.5 ml IM dose - needle-free | Experimental | Dose of 0.5 ml IM trivalent 2012 influenza vaccine administered by disposable needle-free jet injector Receives: Biological: 2012 trivalent influenza vaccine |
| 0.5 ml IM - needle and syringe | Active comparator | Dose of 0.5 ml IM trivalent 2012 influenza vaccine administered by needle and syringe Receives: Biological: 2012 trivalent influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
Assess whether the experimental and standard dosages/delivery routes (ID and IM) for each age group met all modified criteria for assessment of influenza vaccines 21 days after vaccination for soroconversion for A/California/7/2009 H1N1 influenza virus.
Measured: 21 days
Secondary outcomes (2)
Safety
Evaluate frequency and severity of local and systemic adverse events following immunization between investigational (reduced dose) and control (standard dose) adult groups up to 21 days after vaccination in accordance with the definitions of the Brighton Collaboration Group.
Measured: 21 days
Seasonal influenza immunogenicity
Assess whether the experimental and standard dosages/delivery routes (ID and IM) for each age group met all modified criteria for assessment of influenza vaccines 21 days after vaccination for soroconversion for 2012 seasonal influenza viruses.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- D'Antonio Consultants International, Inc., Sao Paulo, Secretaria de Estado da Saúde
- Responsible party
- Sponsor
- Investigators
- Glacus Brito, MD, Principal investigator, Hosp das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582633
- Sponsor's protocol ID
- CAPPesq 0015/2010
- Status last verified
- Jun 2012
- First submitted
- 19 Apr 2012
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dose-sparing of Pandemic A/California/7/2009 H1N1 Influenza Vaccine Administered Intradermally by Needle-free Disposable-syringe Jet Injector (DSJI)
- ClinicalTrials.gov ID
- NCT01582633
- Acronym / sponsor ID
- CAPPesq 0015/2010
- Conditions
- Influenza
- Keywords
- vaccine, influenza, needle free jet injector, Intradermal, sparing dose
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- D'Antonio Consultants International, Inc., Sao Paulo, Secretaria de Estado da Saúde
- Study start
- Jul 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 20 Apr 2012 (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 study will evaluate the immunological response and the safety profiles of seasonal, inactivated vaccine which contains in its composition the A/California/7/2009 H1N1 "pandemic" influenza virus, delivered via ID in reduced dose (0,1 mL) and (0,2 mL), and via IM in full dose (0,5 mL) delivered with needle-free, disposable-syringe jet injector, and control group with via IM in full dose (0,5 mL) delivered syringes and needles in subjects from 42 to 60 years old.
Reduced doses into the skin will be delivered by an investigational intradermal model of a licensed, needle-free, disposable-syringe jet injector (DSJI) system, LECTRAJET® M3 RA manufactured by D'Antonio Consultants International, Inc. DSJIs avoid the drawbacks and dangers of conventional needle-syringe injection. Delivery by DSJI into the skin is also rapid and simple and overcomes the difficulty and patient discomfort of the traditional Mantoux needle method for skin injection, as used for BCG vaccination and tuberculosis skin testing.
Participants will be assessed for local and systemic adverse events by clinical observation immediately after injection and then upon return on day 21 after each injection. In addition, investigators will call participants by telephone on days 2 and 7 days to collect information local and systemic side effects.
Serum will be collected on day 21 after each injection, and assayed for hemagglutination inhibition (HAI) using conventional methods performed by the Virology Lab of the Instituto de Medicina Tropical de São Paulo, blinded to the study arm allocations of each participant. Information about the adverse events would be collected on days 1, 3 and 7 after dose delivery. The investigators assessing adverse reactions will be blinded to the study arm to which each subject was allocated.
The primary endpoint of the study is to evaluate the vaccine's immunogenicity by HAI, each dose in accordance with international parameters which include: seroconversion or significant title increase (SCR), the frequencies by study arm of seroprotection defined as a post-vaccination titer of >40 (1/dil) (SPR), as well as the Geometric Mean Titers (GMTRs) of post-vaccination sera.
Detailed description
This study will evaluate the immunological response and the safety profiles of seasonal, inactivated vaccine which contains in its composition the A/California/7/2009 H1N1 "pandemic" influenza virus, delivered via ID in reduced dose (0,1 mL) and (0,2 mL), and via IM in full dose (0,5 mL) delivered with needle-free, disposable-syringe jet injector, and control group with via IM in full dose (0,5 mL) delivered syringes and needles in subjects from 42 to 60 years old.
Reduced doses into the skin will be delivered by an investigational intradermal model of a licensed, needle-free, disposable-syringe jet injector (DSJI) system, LECTRAJET® M3 RA manufactured by D'Antonio Consultants International, Inc. ( East Syracuse, NY, USA) . DSJIs avoid the drawbacks and dangers of conventional needle-syringe injection. Delivery by DSJI into the skin is also rapid and simple and overcomes the difficulty and patient discomfort of the traditional Mantoux needle method for skin injection, as used for BCG vaccination and tuberculosis skin testing.
Participants will be assessed for local and systemic adverse events by clinical observation immediately after injection and then upon return on day 21 after each injection. In addition, investigators will call participants by telephone on days 2 and 7 days to collect information local and systemic side effects. Adverse events will be classified and analyzed according to case definitions established by the Brighton Collaboration Group.
Serum will be collected on day 21 after each injection, and assayed for hemagglutination inhibition (HAI) using conventional methods performed by the Virology Lab of the Instituto de Medicina Tropical de São Paulo, blinded to the study arm allocations of each participant. Information about the adverse events would be collected on days 1, 3 and 7 after dose delivery. The investigators assessing adverse reactions will be blinded to the study arm to which each subject was allocated.
The primary endpoint of the study is to evaluate the vaccine's immunogenicity by HAI, each dose in accordance with international parameters which include: seroconversion or significant title increase (SCR), the frequencies by study arm of seroprotection defined as a post-vaccination titer of >40 (1/dil) (SPR), as well as the Geometric Mean Titers (GMTRs) of post-vaccination sera.
Participants will be excluded if they have a prior history of influenza disease caused by A/California/7/2009 H1N1 or prior vaccination for same, among other exclusion and inclusion criteria to apply. Participants will be excluded retroactively from analysis if their pre-vaccination HAI assay discovers pre-existing seroprotective titers of >40 against pandemic virus, representing preexisting H1N1 exposure or vaccination
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.1 ml ID dose | Experimental | Biological: 2012 trivalent influenza vaccineDose of 0.1 ml ID trivalent 2012 influenza vaccine administered by disposable needle-free jet injector |
| 0.2 ml ID dose | Experimental | Biological: 2012 trivalent influenza vaccineDose of 0.2 ml ID trivalent 2012 influenza vaccine administered by disposable needle-free jet injector |
| 0.5 ml IM dose - needle-free | Experimental | Biological: 2012 trivalent influenza vaccineDose of 0.5 ml IM trivalent 2012 influenza vaccine administered by disposable needle-free jet injector |
| 0.5 ml IM - needle and syringe | Active comparator | Biological: 2012 trivalent influenza vaccineDose of 0.5 ml IM trivalent 2012 influenza vaccine administered by needle and syringe |
Who may qualify
- Ages
- 42 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between 42 and up to 60 years of age.
- Available for follow up visits, at least at day 21.
- Written informed consent signed by the volunteer after reading and explanation.
Key exclusion criteria (9 listed)
- Suspect or verified diagnosis of congenital or acquired immunodeficiency including AIDS.
- Suspect or verified diagnosis of malignant neoplasia, other than basocellular carcinoma.
- Volunteer ongoing treatment with high doses of systemic corticosteroids (equivalent to prednisone (2 mg/kg/d for more than two weeks) or on immunosuppressant therapy.
- Received or planning to receive a vaccine with live attenuated strain of virus within 30 days of the intended day(s) of study vaccination(s).
- Verified diagnosis of Influenza A/California/H1N1 or has already been immunized against (Influenza A/California/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 |
|---|---|---|
| 2012 trivalent influenza vaccine2012 trivalent influenza vaccine: * influenza A/California/7/2009 (H1N1) * influenza A/Perth/16/2009 (H3N2) * influenza B/Brisbane/60/2008 Single dose. | Biological | 0.1 ml ID dose, 0.2 ml ID dose, 0.5 ml IM - needle and syringe, 0.5 ml IM dose - needle-free |
Primary outcome
Immunogenicity
Time frame: 21 days
Assess whether the experimental and standard dosages/delivery routes (ID and IM) for each age group met all modified criteria for assessment of influenza vaccines 21 days after vaccination for soroconversion for A/California/7/2009 H1N1 influenza virus.
2 secondary outcomes
Safety
Time frame: 21 days
Seasonal influenza immunogenicity
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
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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.
Glacus Brito, MD principal investigator
Hosp das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 2012 trivalent influenza vaccine in people with Influenza, run by University of Sao Paulo General Hospital 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 21 Jun 2012. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Glacus Brito, MD (551138731562, glacus@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2012.