InfluenzaPhase 2NCT03845231
Mucosal and Systemic Immunity After Viral Challenge of Healthy Volunteers Vaccinated With Inactivated Influenza Vaccine Via the Intranasal Versus Intramuscular Route
A Phase 2 study testing Flucelvax(R) and Human Challenge virus in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Influenza (flu) is a contagious respiratory virus that makes humans sick. Usually its symptoms are mild, but they can be dangerous. Researchers want to see if one way of giving the flu vaccine is more effective than another. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Influenza
- What is being tested?
- Flucelvax(R) and Human Challenge virus
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2019to 28 Oct 2020
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Greater than or equal to 18 and less than or equal to 55 years of age.
- Non-smoker.
- Have not received influenza vaccination of any type (whether licensed or unlicensed experimental vaccine) on or after September 1, 2018. Participants who enroll in our study must be informed of the Centers for Disease Control and Prevention (CDC) recommendation to receive seasonal influenza vaccination annually. Enrollees accept that half of study participants will receive licensed approved vaccination per the usual route, and half will receive it by an unapproved route with unknown efficacy and side effects. Enrollees should not plan to receive seasonal influenza vaccination from another source from enrollment through the final study visit (Phase 2, Day 56).
- Willingness to remain in isolation for the duration of viral shedding (at a minimum 9 days) and to comply with all study requirements.
- A male subject is eligible for the study if he meets one of the following criteria, beginning at least 4 weeks prior to enrollment and continuing until 8 weeks after administration of the human challenge virus:
- Is infertile, including history of successful vasectomy.
Show all 18Show fewer
- Agrees to practice abstinence.
- Agrees that, with heterosexual intercourse with a fertile female partner, he will use a condom with spermicide and his female partner (including those who have undergone bilateral tubal ligation) will use an acceptable form of contraception (see inclusion criterion 6c).
- A female participant is eligible for this study if she is not pregnant or breastfeeding and meets one of the following criteria, beginning at least 4 weeks prior to enrollment and continuing until 8 weeks after administration of the human challenge virus::
- infertile, including postmenopausal status, (as defined by no menses for greater than or equal to 1 year) or history of hysterectomy.
- Agrees to practice abstinence.
- Agrees that, with heterosexual intercourse with a fertile male partner, she will use an acceptable form of contraception and her male partner will use a condom with spermicide. Acceptable effective methods of female contraception include the following: bilateral tubal ligation, implant of levonorgestrel, injectable progestogen, intrauterine device oral contraceptive pills and diaphragm with spermicide.
- Willing to have samples stored for future research.
- HIV uninfected with a negative test within 60 days of Phase 2, Day 0.
- Agrees not to use IN medications (including but not limited to nasal
- sprays, sinus rinses), over-the-counter medications (including but not
- limited to aspirin, decongestants, antihistamines, and other non-steroidal anti-inflammatory drugs), and herbal medications (including but not limited to herbal tea or St. John s Wort), from 14 days prior to study enrollment through the final study visit (Phase 2, Day 56), unless approved by the investigator
- Agrees not to donate blood or blood products from enrollment through the final study visit (Phase 2, Day 56).
Who cannot join
- Presence of self-reported or medically documented significant medical condition including but not limited to:
- Chronic pulmonary disease (e.g., asthma, emphysema).
- Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
- Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
- Immunosuppression, immune deficiency (such as IgA deficiency) or ongoing malignancy.
- Neurological and neurodevelopmental conditions (e.g., Bell s palsy, cerebral palsy, epilepsy, stroke, seizures).
Show all 36Show fewer
- Postinfectious or postvaccine neurological sequelae including Guillain Barre syndrome.
- Individual with body mass index less than or equal to 18 and greater than or equal to 40.
- Have close or household (i.e., share the same apartment or house) high-risk contacts including but not limited to:
- Persons greater than or equal to 65 years of age.
- Children less than or equal to 5 years of age.
- Residents of nursing homes.
- Persons of any age with significant chronic medical conditions such as:
- Chronic pulmonary disease (e.g., severe asthma, chronic obstructive pulmonary disease).
- Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
- Contacts who required medical follow-up or hospitalization during the past 5 years because of chronic metabolic disease (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
- Immunosuppression or cancer.
- Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
- Individuals who are receiving long-term aspirin therapy.
- Women who are pregnant or who are trying to become pregnant.
- Acute illness within 7 days prior to quadrivalent IIV administration or inoculation with the human challenge virus.
- Individuals who have grade 3 or above clinically significant laboratory values outside the limits thus specified by normal laboratory parameters.
- Clinically significant abnormality as deemed by the PI on echocardiographic (ECHO) testing.
- Clinically significant abnormality as deemed by the PI on the pulmonary function test (PFT).
- Known allergy to influenza vaccination or excipients contained in the influenza vaccine used.
- Known allergy to lidocaine or phenylephrine.
- Known allergy to treatments for influenza (including but not limited to oseltamivir or nonsteroidal anti-inflammatory medications).
- Known allergy to 2 or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides).
- Anatomic or functional defects of the nasopharynx that could affect nasal sampling such as chronic rhinitis, nasal septal defect, nasal polyps or recent or remote nasal surgery
- Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment.
- Donation of blood or blood products within 3 months prior to study enrollment.
- Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) prior to enrollment.
- Receipt of any unlicensed vaccine within 6 months prior to enrollment.
- Self-reported or known history of alcoholism or drug abuse within 6 months prior to enrollment, or positive urine test for drugs of abuse (i.e., amphetamines, cocaine, benzodiazepines, opiates, metabolites, or tetrahydrocannabinol) at time of admission for viral challenge.
- Self-reported or known history of psychiatric or psychological issues that require treatment and are deemed by the PI to be a contraindication to protocol participation.
- Any condition or event that, in the judgment of the PI, is a contraindication to protocol participation or impairs the participant s ability to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Mucosal Correlates of Protection After Influenza Viral Challenge of Vaccinated and Unvaccinated Healthy Volunteers
Background:
Influenza (flu) is a contagious respiratory virus that makes humans sick. Usually its symptoms are mild, but they can be dangerous. Researchers want to see if one way of giving the flu vaccine is more effective than another.
Read more
Objective:
To compare the body s ability to fight infection when a flu vaccine is given in the nose versus the arm.
Eligibility:
Healthy, nonsmoking adults ages 18 55. They must be willing to stay in isolation for at least 9 days. They must not have had the flu vaccine since September 1, 2018.
Design:
Participants must be willing to use birth control or abstinence from visit 1 until 8 weeks after getting the flu virus.
Participants will have at least 3 clinic visits over about a month. Visits may include:
Medical history
Physical exam
Blood and urine tests
Nasal samples collected
Heart and lung function tests
At the first visit, participants will get either:
Flu vaccine as injection in an arm muscle plus salt water sprays in the nose
OR flu vaccine as sprays in the nose plus salt water injection in an arm
Within the next few months, participants will stay in an isolation room for at least 9 days. They will be with up to 20 participants. Those who test positive for recreational drugs will leave the study. Participants will:
Repeat study tests
Answer questions about flu symptoms
Have the flu virus sprayed into their nose once
Be monitored by a medical team
Participants will have at least 2 follow-up visits and repeat study tests.
Read the detailed description
The high morbidity and mortality associated with both pandemic and seasonal influenza and the threat of new potentially pandemic strains emerging makes influenza an important infectious disease and public health problem. Public health agencies must continue attempts to reduce the public health impact of this important virus.
Currently, influenza vaccination is the cornerstone of prophylaxis and the most effective method available to reduce the impact of influenza on the population. Current vaccines target the major surface protein, hemagglutinin (HA), and are standardized by stimulation of serum anti-HA antibodies as the primary correlate of protection. Measurements of serum antibodies to HA have become the gold standard for evaluating vaccines. The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) both define protective titers as a hemagglutination inhibition (HAI) titer of greater than or equal to 40. Recent vaccine effectiveness has been limited and, in some populations, estimated at as low as 10%. Improved methods of vaccination must be developed, but limited information regarding the true correlates of protection is available. Correlates of protection in the systemic circulation may be less informative than those located in the nasopharyngeal mucosa, which is the site of exposure to and infection with influenza virus.
This study is designed to characterize the mucosal and systemic immunologic correlates of protection from influenza infection in persons vaccinated and unvaccinated against influenza. Half of participants will receive current licensed quadrivalent inactivated influenza vaccine (IIV) administered via the intramuscular (IM) route at the standard dose, prior to challenge with influenza virus. The other half will receive no vaccination prior to challenge. Immunologic response and clinical outcomes in the human challenge model will be determined to characterize the two cohorts. In the vaccinated cohort, mucosal and systemic immune responses induced by IM administration of quadrivalent IIV will also be carefully explored. The thoughtful study of mucosal immunity to influenza is expected to identify novel correlates of protection. By administering quadrivalent IIV and then infecting participants with human challenge virus, we can evaluate in detail the immunologic responses after immunization and subsequent virus exposure. This controlled setting offers the ideal environment to query these responses and to identify targets of mucosal stimulation for future vaccine strategies. In addition, the detailed characterization of the mucosal and systemic immune responses after vaccination and challenge will represent a true advance in understanding influenza immunity.
- Conditions
- Influenza
- Being tested
- Flucelvax(R), Human Challenge virus
- Keywords
- Human Challenge, Vaccine, Immune Response, Challenge Study, Healthy Volunteer
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flucelvax(R)Biological
Cohort 1 will receive IM quadrivalent IIV (Flucelvax (R)) at the standard dose of 15 micrograms HA per strain (60 micrograms HA total).
Human Challenge virusOther
A dose of 10^7 50% tissue culture infective dose (TCID50) of human challenge virus will be administered intranasally to all participants using a nasal sprayer.
| Study group | Role | What they receive |
|---|---|---|
| unvaccinated | Other | will receive no Flucelvax vaccination and will receive human challenge virus Receives: Other: Human Challenge virus |
| Vaccinated | Experimental | will receive Flucelvax vaccination and human challenge virus Receives: Biological: Flucelvax(R); Other: Human Challenge virus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza infection
The main focus of the study will be to characterize the mucosal and systemic immunologic correlates of protection from influenza infection in each of the two cohorts.
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start29 Apr 2019
- Primary completion20 Dec 2019
- Study completion28 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Matthew J Memoli, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845231
- Sponsor's protocol ID
- 190058
- Other IDs
- 19-I-0058
- Status last verified
- 6 Nov 2020
- First submitted
- 16 Feb 2019
- Last updated
- 10 Nov 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ainai A, Tamura S, Suzuki T, Ito R, Asanuma H, Tanimoto T, Gomi Y, Manabe S, Ishikawa T, Okuno Y, Odagiri T, Tashiro M, Sata T, Kurata T, Hasegawa H. Characterization of neutralizing antibodies in adults after intranasal vaccination with an inactivated influenza vaccine. J Med Virol. 2012 Feb;84(2):336-44. doi: 10.1002/jmv.22273.
PubMed 22170556Gould VMW, Francis JN, Anderson KJ, Georges B, Cope AV, Tregoning JS. Nasal IgA Provides Protection against Human Influenza Challenge in Volunteers with Low Serum Influenza Antibody Titre. Front Microbiol. 2017 May 17;8:900. doi: 10.3389/fmicb.2017.00900. eCollection 2017.
PubMed 28567036Flannery B, Chung JR, Belongia EA, McLean HQ, Gaglani M, Murthy K, Zimmerman RK, Nowalk MP, Jackson ML, Jackson LA, Monto AS, Martin ET, Foust A, Sessions W, Berman L, Barnes JR, Spencer S, Fry AM. Interim Estimates of 2017-18 Seasonal Influenza Vaccine Effectiveness - United States, February 2018. MMWR Morb Mortal Wkly Rep. 2018 Feb 16;67(6):180-185. doi: 10.15585/mmwr.mm6706a2.
PubMed 29447141
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mucosal Correlates of Protection After Influenza Viral Challenge of Vaccinated and Unvaccinated Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03845231
- Acronym / sponsor ID
- 190058
- Conditions
- Influenza
- Keywords
- Human Challenge, Vaccine, Immune Response, Challenge Study, Healthy Volunteer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 19 Feb 2019 (actual)
- 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.
Background:
Influenza (flu) is a contagious respiratory virus that makes humans sick. Usually its symptoms are mild, but they can be dangerous. Researchers want to see if one way of giving the flu vaccine is more effective than another.
Objective:
To compare the body s ability to fight infection when a flu vaccine is given in the nose versus the arm.
Eligibility:
Healthy, nonsmoking adults ages 18 55. They must be willing to stay in isolation for at least 9 days. They must not have had the flu vaccine since September 1, 2018.
Design:
Participants must be willing to use birth control or abstinence from visit 1 until 8 weeks after getting the flu virus.
Participants will have at least 3 clinic visits over about a month. Visits may include:
Medical history
Physical exam
Blood and urine tests
Nasal samples collected
Heart and lung function tests
At the first visit, participants will get either:
Flu vaccine as injection in an arm muscle plus salt water sprays in the nose
OR flu vaccine as sprays in the nose plus salt water injection in an arm
Within the next few months, participants will stay in an isolation room for at least 9 days. They will be with up to 20 participants. Those who test positive for recreational drugs will leave the study. Participants will:
Repeat study tests
Answer questions about flu symptoms
Have the flu virus sprayed into their nose once
Be monitored by a medical team
Participants will have at least 2 follow-up visits and repeat study tests.
Detailed description
The high morbidity and mortality associated with both pandemic and seasonal influenza and the threat of new potentially pandemic strains emerging makes influenza an important infectious disease and public health problem. Public health agencies must continue attempts to reduce the public health impact of this important virus.
Currently, influenza vaccination is the cornerstone of prophylaxis and the most effective method available to reduce the impact of influenza on the population. Current vaccines target the major surface protein, hemagglutinin (HA), and are standardized by stimulation of serum anti-HA antibodies as the primary correlate of protection. Measurements of serum antibodies to HA have become the gold standard for evaluating vaccines. The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) both define protective titers as a hemagglutination inhibition (HAI) titer of greater than or equal to 40. Recent vaccine effectiveness has been limited and, in some populations, estimated at as low as 10%. Improved methods of vaccination must be developed, but limited information regarding the true correlates of protection is available. Correlates of protection in the systemic circulation may be less informative than those located in the nasopharyngeal mucosa, which is the site of exposure to and infection with influenza virus.
This study is designed to characterize the mucosal and systemic immunologic correlates of protection from influenza infection in persons vaccinated and unvaccinated against influenza. Half of participants will receive current licensed quadrivalent inactivated influenza vaccine (IIV) administered via the intramuscular (IM) route at the standard dose, prior to challenge with influenza virus. The other half will receive no vaccination prior to challenge. Immunologic response and clinical outcomes in the human challenge model will be determined to characterize the two cohorts. In the vaccinated cohort, mucosal and systemic immune responses induced by IM administration of quadrivalent IIV will also be carefully explored. The thoughtful study of mucosal immunity to influenza is expected to identify novel correlates of protection. By administering quadrivalent IIV and then infecting participants with human challenge virus, we can evaluate in detail the immunologic responses after immunization and subsequent virus exposure. This controlled setting offers the ideal environment to query these responses and to identify targets of mucosal stimulation for future vaccine strategies. In addition, the detailed characterization of the mucosal and systemic immune responses after vaccination and challenge will represent a true advance in understanding influenza immunity.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unvaccinated | Other | Other: Human Challenge viruswill receive no Flucelvax vaccination and will receive human challenge virus |
| Vaccinated | Experimental | Biological: Flucelvax(R), Other: Human Challenge viruswill receive Flucelvax vaccination and human challenge virus |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- sprays, sinus rinses), over-the-counter medications (including but not
- limited to aspirin, decongestants, antihistamines, and other non-steroidal anti-inflammatory drugs), and herbal medications (including but not limited to herbal tea or St. John s Wort), from 14 days prior to study enrollment through the final study visit (Phase 2, Day 56), unless approved by the investigator
Key exclusion criteria (36 listed)
- Presence of self-reported or medically documented significant medical condition including but not limited to:
- Have close or household (i.e., share the same apartment or house) high-risk contacts including but not limited to:
- Acute illness within 7 days prior to quadrivalent IIV administration or inoculation with the human challenge virus.
- Individuals who have grade 3 or above clinically significant laboratory values outside the limits thus specified by normal laboratory parameters.
- Clinically significant abnormality as deemed by the PI on echocardiographic (ECHO) testing.
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 |
|---|---|---|
| Flucelvax(R)Cohort 1 will receive IM quadrivalent IIV (Flucelvax (R)) at the standard dose of 15 micrograms HA per strain (60 micrograms HA total). | Biological | Vaccinated |
| Human Challenge virusA dose of 10^7 50% tissue culture infective dose (TCID50) of human challenge virus will be administered intranasally to all participants using a nasal sprayer. | Other | Vaccinated, unvaccinated |
Primary outcome
Influenza infection
Time frame: 1 yr
The main focus of the study will be to characterize the mucosal and systemic immunologic correlates of protection from influenza infection in each of the two cohorts.
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 10 Nov 2020.
- Background: PubMed 22170556Ainai A, Tamura S, Suzuki T, Ito R, Asanuma H, Tanimoto T, Gomi Y, Manabe S, Ishikawa T, Okuno Y, Odagiri T, Tashiro M, Sata T, Kurata T, Hasegawa H. Characterization of neutralizing antibodies in adults after intranasal vaccination with an inactivated influenza vaccine. J Med Virol. 2012 Feb;84(2):336-44. doi: 10.1002/jmv.22273.
- Background: PubMed 28567036Gould VMW, Francis JN, Anderson KJ, Georges B, Cope AV, Tregoning JS. Nasal IgA Provides Protection against Human Influenza Challenge in Volunteers with Low Serum Influenza Antibody Titre. Front Microbiol. 2017 May 17;8:900. doi: 10.3389/fmicb.2017.00900. eCollection 2017.
- Background: PubMed 29447141Flannery B, Chung JR, Belongia EA, McLean HQ, Gaglani M, Murthy K, Zimmerman RK, Nowalk MP, Jackson ML, Jackson LA, Monto AS, Martin ET, Foust A, Sessions W, Berman L, Barnes JR, Spencer S, Fry AM. Interim Estimates of 2017-18 Seasonal Influenza Vaccine Effectiveness - United States, February 2018. MMWR Morb Mortal Wkly Rep. 2018 Feb 16;67(6):180-185. doi: 10.15585/mmwr.mm6706a2.
- NIH Clinical Center Detailed Web PageLink 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.
Matthew J Memoli, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flucelvax(R) and Human Challenge virus in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 18 inclusion and 36 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 10 Nov 2020. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Influenza infection (time frame: 1 yr). 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 NCT03845231, which also lists 3 linked publications.
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 10 Nov 2020.