HealthyPhase 1NCT01488188
Immunogenicity and Safety of Live Attenuated Influenza Vaccine (Flumist) Administered by Nasal and Sublingual Route
A Phase 1 study testing Influenza vaccine in people with Healthy, run by International Vaccine Institute at 1 site in South Korea.
Trial summary
Background: It is well established that live attenuated organisms can be highly effective vaccines, immune responses elicited can often be of greater magnitude and of longer duration than those produced by non-living antigens and are often able to confer protection after a single dose. Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to May 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers who are able and willing to give informed consent, following a detailed explanation of participation in the study.
- Volunteers who will be available for the duration of the study and available for scheduled and potential additional visits
Who cannot join
- Subjects with any clinically significant medical or psychiatric condition or clinically significant abnormal serum biochemistry or haematology results that, in opinion of the Investigator, preclude participation in the study.
- Female subjects who are pregnant (using urine test) or breast-feeding, or of childbearing potential and unwilling to use a reliable method of contraception (e.g. oral contraceptives or contraceptive during sexual activities such as a condom, contraceptive diaphragm, intrauterine device, hormonal contraceptive, or intercourse with a male partner who has had a vasectomy etc.) throughout the study period.
- Subjects who have known airway hypersensitivity to one of Flu vaccine excipients within 14 days prior to administration of study medication.
- Subjects who have known buccal hypersensitivity to any component of the vaccine or buffer solution used in this study, including subjects with phenylketonuria.
- Subjects with direct contact with at risk groups (e.g. patients in special care units, immuno-compromised individuals, pregnant women, children under 2 years of age and individuals over 70 years).
- Subjects with a known impairment of immune function including seropositive for HIV or those receiving (or have received in the 6 months prior to study entry) cytotoxic drugs immunosuppressive therapy (including systemic corticosteroids).
Show all 15Show fewer
- Subjects with a significant acute febrile illness (fever of 38.0 Celsius degree or more) at time of dosing.
- Subjects who have chronic diseases: Chronic diseases will include all autoimmune and immuno-compromising conditions and any other chronic condition, which at the judgement of the Investigator, may put the subject at higher risk of side effects from the study vaccine. Conditions in the latter category might include unexplained anaemia, hepato-biliary disease, uncontrolled hypertension, subjects with prosthetic joints or heart valves, etc.
- Subjects with a current problem, based on history, with substance abuse or with a history of substance abuse
- Subjects who are currently involved in a clinical trial, have taken an investigational drug or have received investigational or licensed vaccines in the preceding 4 weeks or anticipate receiving a vaccine other than study medication during the first 4 weeks of the study
- Subjects who have known hypersensitivity to eggs or egg proteins
- Subjects who have chronic respiratory infections or syndromes
- Unable to receive oral (sublingual) administration.
- Receiving anti-viral agents.
- Subjected to contraindications and/or precautions described in drug information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Controlled Study to Determine the Immunogenicity and Safety of Cold-adaptive Live Attenuated Influenza Vaccine (Flumist) Administered by the Nasal and Sublingual Route in Healthy Adult Volunteers
Background: It is well established that live attenuated organisms can be highly effective vaccines, immune responses elicited can often be of greater magnitude and of longer duration than those produced by non-living antigens and are often able to confer protection after a single dose. Unlike killed influenza vaccine preparations injected by the parenteral route, live influenza vaccines are able to induce potent secretory (mainly IgA) antibody responses in the airway mucosae and can also evoke cell mediated responses. T cell proliferation, cytokine production, cytotoxic T cell responses and antibody-dependent cell cytotoxicity have all been elicited by live attenuated vaccines.
There has been a history of the use of live attenuated flu vaccines as safe and effective vaccines for the prevention of flu in animals and humans. Live-attenuated cold-adapted influenza vaccines have been proved to be highly efficacious to protect against clinical fly symptoms. Among these, FluMist, a nasal vaccine formulation developed by Medimmune Inc, has been approved by the US FDA. Recent side by side clinical trials have demonstrated that this nasal vaccine was significantly superior to conventional killed flu vaccine in protecting against flu symptoms.
Read more
Sublingual administration of live influenza virus at a dose lethal by the nasal route was well tolerated and did not redirect virus to the olfactory bulb. In addition, in a recent Phase I clinical study (NCT00820144) conducted in France, the sublingual administration of recombinant cholera toxin B subunit (rCTB,up to 1 mg) in healthy adult volunteers was found to be safe.
A major issue has arisen regarding the ease with which vaccines could be administered to young children, especially infants, and to elderly subjects in whom nasal vaccination has not been possible and/or approved due to difficulties of administering nasal vaccines in infants and to undesired side effects related to frequent rhinitis and sneezing episodes in elderly subjects. This study is designed to investigate the safety, tolerability and immunogenicity of a new route of administration of vaccines, using the nasal FluMist formulation as prototype vaccine.
Objectives: To evaluate the immunogenicity and safety of a nasal and sublingual influenza virus vaccine (FluMist) in healthy adult volunteers
Study design: This will be a randomized study on a total 40 subjects; each 20 subjects will receive vaccine via nasal and sublingual route, respectively
- Conditions
- Healthy
- Being tested
- Influenza vaccine
- Keywords
- Influenza vaccine, nasal route, sublingual route, immunogenicity, 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.
Influenza vaccineBiological
Also called Flumist (2011-2012)
Administration of 1 dose (0.2 ml) by nasal route
Influenza vaccineBiological
Also called Flumist (2011-2012)
Administration of 1 dose (0.2 ml) by sublingual route
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccine-Nasal | Active comparator | Nasal administration Receives: Biological: Influenza vaccine |
| Influenza vaccine -Sublingual | Active comparator | Sublingual administration Receives: Biological: Influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passive Haemagglutination Inhibition Titer.
Passive haemagglutination inhibition titer of serum at 21 days after vaccination.
Measured: 21 days after vaccination
Secondary outcomes (3)
Blood Immunoglobulin G (IgG) and Immunoglobulin A (IgA)-Antibody Secreting Cell Number to Flu Virus
Flu virus-specific IgG- and IgA -antibody secreting cells per ml of blood at 7 days after vaccination
Measured: 7 days after vaccination
Salivary IgA
Salivary Flu-specific IgA titer at Days 21 after vaccination
Measured: 21 days after vaccination
Cell Mediated Immune Responses
Interferon gamma production in peripheral blood monocyte (PBMC) after in vitro re-stimulation with influenza virus antigen at 21 days 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 posted8 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Vaccine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yu, M.D., Principal investigator, Seoul National University HospitalCecil Czerkinsky, Ph.D., Principal investigator, International Vaccine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488188
- Sponsor's protocol ID
- FM-01 V1
- Status last verified
- Nov 2013
- First submitted
- 4 Dec 2011
- Last updated
- 23 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Study to Determine the Immunogenicity and Safety of Cold-adaptive Live Attenuated Influenza Vaccine (Flumist) Administered by the Nasal and Sublingual Route in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01488188
- Acronym / sponsor ID
- FM-01 V1
- Conditions
- Healthy
- Keywords
- Influenza vaccine, nasal route, sublingual route, immunogenicity, safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- International Vaccine InstituteUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Posted 23 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: It is well established that live attenuated organisms can be highly effective vaccines, immune responses elicited can often be of greater magnitude and of longer duration than those produced by non-living antigens and are often able to confer protection after a single dose. Unlike killed influenza vaccine preparations injected by the parenteral route, live influenza vaccines are able to induce potent secretory (mainly IgA) antibody responses in the airway mucosae and can also evoke cell mediated responses. T cell proliferation, cytokine production, cytotoxic T cell responses and antibody-dependent cell cytotoxicity have all been elicited by live attenuated vaccines.
There has been a history of the use of live attenuated flu vaccines as safe and effective vaccines for the prevention of flu in animals and humans. Live-attenuated cold-adapted influenza vaccines have been proved to be highly efficacious to protect against clinical fly symptoms. Among these, FluMist, a nasal vaccine formulation developed by Medimmune Inc, has been approved by the US FDA. Recent side by side clinical trials have demonstrated that this nasal vaccine was significantly superior to conventional killed flu vaccine in protecting against flu symptoms.
Sublingual administration of live influenza virus at a dose lethal by the nasal route was well tolerated and did not redirect virus to the olfactory bulb. In addition, in a recent Phase I clinical study (NCT00820144) conducted in France, the sublingual administration of recombinant cholera toxin B subunit (rCTB,up to 1 mg) in healthy adult volunteers was found to be safe.
A major issue has arisen regarding the ease with which vaccines could be administered to young children, especially infants, and to elderly subjects in whom nasal vaccination has not been possible and/or approved due to difficulties of administering nasal vaccines in infants and to undesired side effects related to frequent rhinitis and sneezing episodes in elderly subjects. This study is designed to investigate the safety, tolerability and immunogenicity of a new route of administration of vaccines, using the nasal FluMist formulation as prototype vaccine.
Objectives: To evaluate the immunogenicity and safety of a nasal and sublingual influenza virus vaccine (FluMist) in healthy adult volunteers
Study design: This will be a randomized study on a total 40 subjects; each 20 subjects will receive vaccine via nasal and sublingual route, respectively
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccine-Nasal | Active comparator | Biological: Influenza vaccineNasal administration |
| Influenza vaccine -Sublingual | Active comparator | Biological: Influenza vaccineSublingual administration |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers who are able and willing to give informed consent, following a detailed explanation of participation in the study.
- Volunteers who will be available for the duration of the study and available for scheduled and potential additional visits
Key exclusion criteria (15 listed)
- Subjects with any clinically significant medical or psychiatric condition or clinically significant abnormal serum biochemistry or haematology results that, in opinion of the Investigator, preclude participation in the study.
- Female subjects who are pregnant (using urine test) or breast-feeding, or of childbearing potential and unwilling to use a reliable method of contraception (e.g. oral contraceptives or contraceptive during sexual activities such as a condom, contraceptive diaphragm, intrauterine device, hormonal contraceptive, or intercourse with a male partner who has had a vasectomy etc.) throughout the study period.
- Subjects who have known airway hypersensitivity to one of Flu vaccine excipients within 14 days prior to administration of study medication.
- Subjects who have known buccal hypersensitivity to any component of the vaccine or buffer solution used in this study, including subjects with phenylketonuria.
- Subjects with direct contact with at risk groups (e.g. patients in special care units, immuno-compromised individuals, pregnant women, children under 2 years of age and individuals over 70 years).
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 |
|---|---|---|
| Influenza vaccineAlso: Flumist (2011-2012)Administration of 1 dose (0.2 ml) by nasal route | Biological | Influenza vaccine-Nasal |
| Influenza vaccineAlso: Flumist (2011-2012)Administration of 1 dose (0.2 ml) by sublingual route | Biological | Influenza vaccine -Sublingual |
Primary outcome
Passive Haemagglutination Inhibition Titer.
Time frame: 21 days after vaccination
Passive haemagglutination inhibition titer of serum at 21 days after vaccination.
3 secondary outcomes
Blood Immunoglobulin G (IgG) and Immunoglobulin A (IgA)-Antibody Secreting Cell Number to Flu Virus
Time frame: 7 days after vaccination
Salivary IgA
Time frame: 21 days after vaccination
Cell Mediated Immune Responses
Time frame: 21 days after vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Kyung-Sang Yu, M.D. principal investigator
Seoul National University Hospital
Cecil Czerkinsky, Ph.D. principal investigator
International Vaccine Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Influenza vaccine in people with Healthy, run by International Vaccine Institute at 1 site in South Korea.
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 2 inclusion and 15 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 Dec 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 South Korea. 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 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?
Yes. Results are posted in the registry (first posted 23 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Passive Haemagglutination Inhibition Titer. (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?
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 Dec 2013.