InfluenzaNCT01044095
Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus
A study testing FluMist® live, attenuated, intranasal seasonal influenza vaccine and Fluzone® inactivated influenza virus vaccine in people with Influenza, run by Armed Forces Research Institute of Medical Sciences, Thailand at 1 site in Thailand.
Trial summary
This will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine regimens in healthy volunteers using two commercially available seasonal influenza vaccines to compare immune responses and in vitro cross-reactivity against H5N1. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- FluMist® live, attenuated, intranasal seasonal influenza vaccine and Fluzone® inactivated influenza virus vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2009to Jun 2012
- Phase
- Interventional
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-49 years.
- Healthy as determined by the PI or designate
- Willing to give informed consent.
- Willing to attend follow-up appointments and undergo study procedures.
- US passport holder residing in Bangkok
- If military, have a letter of approval for participation from the chain of command (Unit Commander).
Who cannot join
- History of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine.
- Severe or life-threatening reaction to any previous vaccine.
- History of chronic respiratory illness, including asthma and sinusitis.
- History of heart disease
- History of kidney disease
- Metabolic disease such as diabetes
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- Immunocompromised as determined by the PI, or a household contact of an immunocompromised individual.
- History of Guillain-Barre syndrome.
- Blood disease including sickle cell disease and/or bleeding tendency (by history or based on medical records).
- Any influenza vaccination within the previous 6 months, or any other vaccine within 30 days of either dose of influenza vaccine.
- Pregnant woman or nursing mother or unwilling to use reliable contraception during the study period until the final day of follow-up.
- Blood donation within the preceding 3 months, or screening hemoglobin value of <12.5 g/dl.
- Receipt of blood products including immunoglobulins within the preceding 3 months.
- Receiving any of the following therapies: aspirin, warfarin, theophylline, phenytoin, aminopyrine, immunosuppressive drugs,
- Receipt of any antiviral agents within 48 hours of vaccine administration.
- HIV positive on screening blood tests.
- Any other condition that in the opinion of the study investigator warrants exclusion from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of In Vitro Cross-Reactivity With Avian Influenza H5N1 Virus in Healthy Volunteers Vaccinated With a Prime Boost Regimen of Seasonal Influenza Vaccine
This will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine regimens in healthy volunteers using two commercially available seasonal influenza vaccines to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will be spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral, cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine dose and compared with baseline values.
- Conditions
- Influenza
- Being tested
- FluMist® live, attenuated, intranasal seasonal influenza vaccine, Fluzone® inactivated influenza virus vaccine
- Keywords
- seasonal influenza vaccine, avian influenza H5N1, cross reactivity, prime boost
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluMist® live, attenuated, intranasal seasonal influenza vaccineBiological
FluMist® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril)
Fluzone® inactivated influenza virus vaccineBiological
Fluzone® inactivated influenza virus vaccine 0.5mL intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Autologous prime boost regimen 1 | Active comparator | FluMist® live intranasal vaccine (LAIV) 0.2mL (0.1mL per nostril): 2 doses separated by 8 weeks (+/- 7 days) Receives: Biological: FluMist® live, attenuated, intranasal seasonal influenza vaccine |
| Autologous prime boost regimen 2 | Active comparator | Fluzone® inactivated seasonal influenza virus vaccine intramuscularly: 2 doses separated by 8 weeks (+7 days) Receives: Biological: Fluzone® inactivated influenza virus vaccine |
| Heterologous prime boost regimen 1 | Experimental | FluMist® live, intranasal vaccine single dose, followed by Fluzone® inactivated influenza virus vaccine 8 weeks (+/-7 days) later Receives: Biological: FluMist® live, attenuated, intranasal seasonal influenza vaccine; Biological: Fluzone® inactivated influenza virus vaccine |
| Heterologous prime boost regimen 2 | Experimental | Fluzone® inactivated seasonal influenza virus vaccine single dose, followed by FluMist® live, intranasal seasonal influenza vaccine 0.2mL 8 weeks (+/- 7 days) later Receives: Biological: FluMist® live, attenuated, intranasal seasonal influenza vaccine; Biological: Fluzone® inactivated influenza virus vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
antibody titers
Measured: 12 weeks
Secondary outcomes (1)
safety of 2 doses of seasonal influenza vaccine in healthy adults
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startNov 2009
- Primary completionJul 2010
- Study completionJun 2012
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Research Institute of Medical Sciences, Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Delia B Bethell, BM BCh, Principal investigator, Armed Forces Research Institute of Medical Sciences, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044095
- Sponsor's protocol ID
- WRAIR1525
- Other IDs
- HSRRB No. A-15223
- Status last verified
- Jul 2013
- First submitted
- 6 Jan 2010
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bethell D, Saunders D, Jongkaewwattana A, Kramyu J, Thitithayanont A, Wiboon-ut S, Yongvanitchit K, Limsalakpetch A, Kum-Arb U, Uthaimongkol N, Garcia JM, Timmermans AE, Peiris M, Thomas S, Engering A, Jarman RG, Mongkolsirichaikul D, Mason C, Khemnu N, Tyner SD, Fukuda MM, Walsh DS, Pichyangkul S. Evaluation of in vitro cross-reactivity to avian H5N1 and pandemic H1N1 2009 influenza following prime boost regimens of seasonal influenza vaccination in healthy human subjects: a randomised trial. PLoS One. 2013;8(3):e59674. doi: 10.1371/journal.pone.0059674. Epub 2013 Mar 26.
PubMed 23555741
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of In Vitro Cross-Reactivity With Avian Influenza H5N1 Virus in Healthy Volunteers Vaccinated With a Prime Boost Regimen of Seasonal Influenza Vaccine
- ClinicalTrials.gov ID
- NCT01044095
- Acronym / sponsor ID
- WRAIR1525
- Conditions
- Influenza
- Keywords
- seasonal influenza vaccine, avian influenza H5N1, cross reactivity, prime boost
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Armed Forces Research Institute of Medical Sciences, ThailandOther government
- Study start
- Nov 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Jan 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 will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine regimens in healthy volunteers using two commercially available seasonal influenza vaccines to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will be spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral, cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine dose and compared with baseline values.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Autologous prime boost regimen 1 | Active comparator | Biological: FluMist® live, attenuated, intranasal seasonal influenza vaccineFluMist® live intranasal vaccine (LAIV) 0.2mL (0.1mL per nostril): 2 doses separated by 8 weeks (+/- 7 days) |
| Autologous prime boost regimen 2 | Active comparator | Biological: Fluzone® inactivated influenza virus vaccineFluzone® inactivated seasonal influenza virus vaccine intramuscularly: 2 doses separated by 8 weeks (+7 days) |
| Heterologous prime boost regimen 1 | Experimental | Biological: FluMist® live, attenuated, intranasal seasonal influenza vaccine, Biological: Fluzone® inactivated influenza virus vaccineFluMist® live, intranasal vaccine single dose, followed by Fluzone® inactivated influenza virus vaccine 8 weeks (+/-7 days) later |
| Heterologous prime boost regimen 2 | Experimental | Biological: FluMist® live, attenuated, intranasal seasonal influenza vaccine, Biological: Fluzone® inactivated influenza virus vaccineFluzone® inactivated seasonal influenza virus vaccine single dose, followed by FluMist® live, intranasal seasonal influenza vaccine 0.2mL 8 weeks (+/- 7 days) later |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 18-49 years.
- Healthy as determined by the PI or designate
- Willing to give informed consent.
- Willing to attend follow-up appointments and undergo study procedures.
- US passport holder residing in Bangkok
Key exclusion criteria (17 listed)
- History of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine.
- Severe or life-threatening reaction to any previous vaccine.
- History of chronic respiratory illness, including asthma and sinusitis.
- History of heart disease
- History of kidney disease
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 |
|---|---|---|
| FluMist® live, attenuated, intranasal seasonal influenza vaccineFluMist® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril) | Biological | Autologous prime boost regimen 1, Heterologous prime boost regimen 1, Heterologous prime boost regimen 2 |
| Fluzone® inactivated influenza virus vaccineFluzone® inactivated influenza virus vaccine 0.5mL intramuscularly | Biological | Autologous prime boost regimen 2, Heterologous prime boost regimen 1, Heterologous prime boost regimen 2 |
Primary outcome
antibody titers
Time frame: 12 weeks
1 secondary outcome
safety of 2 doses of seasonal influenza vaccine in healthy adults
Time frame: 12 weeks
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 23 Jul 2013.
- Results publication: PubMed 23555741Bethell D, Saunders D, Jongkaewwattana A, Kramyu J, Thitithayanont A, Wiboon-ut S, Yongvanitchit K, Limsalakpetch A, Kum-Arb U, Uthaimongkol N, Garcia JM, Timmermans AE, Peiris M, Thomas S, Engering A, Jarman RG, Mongkolsirichaikul D, Mason C, Khemnu N, Tyner SD, Fukuda MM, Walsh DS, Pichyangkul S. Evaluation of in vitro cross-reactivity to avian H5N1 and pandemic H1N1 2009 influenza following prime boost regimens of seasonal influenza vaccination in healthy human subjects: a randomised trial. PLoS One. 2013;8(3):e59674. doi: 10.1371/journal.pone.0059674. Epub 2013 Mar 26.
- Related InfoLink provided by the sponsor.
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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.
Delia B Bethell, BM BCh principal investigator
Armed Forces Research Institute of Medical Sciences, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FluMist® live, attenuated, intranasal seasonal influenza vaccine and Fluzone® inactivated influenza virus vaccine in people with Influenza, run by Armed Forces Research Institute of Medical Sciences, Thailand at 1 site in Thailand.
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 17 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 23 Jul 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 Thailand. 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 (time frame: 12 weeks). 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 NCT01044095, 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 23 Jul 2013.