InfluenzaPhase 1NCT01982331

Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/CALIFORNIA/66/395 (H2N2) Influenza Vaccine

A Phase 1 study testing LAIV H2N2 in people with Influenza, run by PATH at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a phase I study to evaluate the safety of a vaccine to protect against influenza viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of vaccine or placebo one month apart. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: LAIV H2N2
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 38 participants
Where: 1 siteRussia
Study dates: Oct 2013to Mar 2014
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 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Legal male or female adult aged 18 through 40 years
Literate and willing to provide written informed consent.
A signed informed consent.
Free of obvious health problems, as established by medical history and screening evaluations, including physical examination.
Capable and willing to complete diary cards and willing to return for all follow-up visits
Willing to comply with the rules of isolation unit (including willing and able to take oseltamivir influenza antiviral medication, should that be recommended by study physician).
For females, willing to take reliable birth control measures through day 56.

Who cannot join

Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during trial period.
Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until four weeks after study completion.
Practice of nasal irrigation on a regular basis within the past six months or has engaged in nasal irrigation within two weeks prior to enrollment.
Recent history of frequent nose bleeds (>5 within the past year).
Clinically relevant abnormal paranasal anatomy.
Recent history (within the past month) of rhino or sinus surgery, or surgery for any traumatic injury of the nose.

Show all 29Show fewer

Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever.
Other acute illness at the time of study enrollment.
Receipt of immune globulin or other blood products within three months prior to study enrollment or planned receipt during period of subject participation in the study.
Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants and/or other immune-modulating therapy within six months prior to study enrollment.
Participation in any previous trial of any H2N2 containing influenza vaccine.
History of asthma.
Hypersensitivity after previous administration of any influenza vaccine.
History of wheezing after past receipt of any live influenza vaccine.
Other adverse event (AE) following immunization (body temperature more than 40°C, collapse, non-febrile seizures, anaphylaxis), at least possibly related to previous receipt of any vaccine (not only influenza).
Suspected or known hypersensitivity to any study vaccine components, including chicken or egg protein.
Seasonal (autumnal) hypersensitivity to the natural environment
Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, metabolic, neurologic, psychiatric or renal functional abnormality, as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives. Subjects with physical examination findings or clinical laboratory screening results which would be graded 2 or higher on the AE severity grading scale (see Attachments) will be excluded from entry into the study and will be excluded from receipt of dose two of study vaccine or placebo.
History of leukemia or any other blood or solid organ cancer.
History of thrombocytopenic purpura or known bleeding disorder.
History of seizures.
Known or suspected immunosuppressive or immunodeficient condition of any kind, including HIV infection.
Known chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Known tuberculosis infection or evidence of previous tuberculosis exposure.
History of chronic alcohol abuse and/or illegal drug use.
Claustrophobia or sociophobia.
Pregnancy or lactation.
Any condition that, in the opinion of the investigator, would increase the health risk to the subject if participates in the study or would interfere with the evaluation of the study objectives.
Allergic, including anaphylactic, reactions to the introduction of any vaccines (not only influenza) in the subject's medical history

Trial locations and contacts

1 site in 1 country.

Russia1 site

Research Institute of Influenza
Saint Petersburg

Other trials in Russia

About this study

Official title: Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/California/66/395 (H2N2)Influenza Vaccine

Read the detailed description

The aim of this study is to evaluate the safety profile of two intranasal doses of LAIV A/17/California/66/395 (H2N2) in healthy adults in Russia. A(H2N2) viruses which are antigenically similar to the pandemic strain A/Singapore/1/57, continue to circulate in domestic and wild bird populations, as confirmed by routine moni¬toring of avian influenza viruses.

40 adults aged 18-40 will be enrolled. They will be randomized to receive vaccine or placebo. Blood and urine will be collected during the week following each vaccination and before the next vaccination to monitor safety. Blood samples will also be collected at several timepoints to assess the volunteer's immune response to the vaccine. The total duration of the study is 16 weeks for each volunteer.

Conditions: Influenza
Being tested: LAIV H2N2, Placebo
Keywords: H2N2, vaccine
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LAIV H2N2Biological
Also called Monovalent A/17/California/66/395 (LAIV H2N2) vaccine
vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28
PlaceboOther
placebo delivered intranasally. .25cc to each nostril at day 0 and day 28

Study groups in NCT01982331
Study group	Role	What they receive
LAIV H2N2 vaccine	Experimental	LAIV H2N2 vaccine A/17/California/66/395 (H2N2) live monovalent influenza vaccine delivered intranasally 2 doses 1 month apart Receives: Biological: LAIV H2N2
Placebo	Placebo comparator	Placebo is composed of a lyophilizate containing the same concentrations of stabilizers as LAIV vaccine. It is prepared onsite in an identical fashion to the vaccine and delivered intranasally. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Immediate Reactions
Measured as observed by study staff or reported by the subject to study staff whether related or not related.
Measured: 2 hours
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1
Adverse events commonly associated with intranasal vaccination occurring greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throat, catarrhal nasopharynx. Solicited systemic reactions included: body temperature, feverishness/subjective fever, chills, cough, difficulty breathing, sore throat, headache, confusion, convulsions/seizures, fatigue/malaise, joint aches, muscle aches, pink or red eyes, draining eyes, swollen eyelids, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting.
Measured: 7 days
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2
Adverse events commonly associated with intranasal vaccination occurring greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throat, catarrhal nasopharynx. Solicited systemic reactions included: body temperature, feverishness/subjective fever, chills, cough, difficulty breathing, sore throat, headache, confusion, convulsions/seizures, fatigue/malaise, joint aches, muscle aches, pink or red eyes, draining eyes, swollen eyelids, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting.
Measured: 7 days
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1
All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff.
Measured: 7 days following each vaccination
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2
All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff.
Measured: 7 days following each vaccination

Secondary outcomes (10)

Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days.
Measured: Day 28, Day 56 and Day 112
Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days. Measured by microneutralization assay.
Measured: Day 28, Day 56 and Day 112
Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days. Measured by enzyme-linked immunosorbent assay (ELISA).
Measured: Day 28, Day 56 and Day 112
Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days. Measured by enzyme-linked immunosorbent assay (ELISA).
Measured: Day 28, Day 56 and Day 112
Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination.
Measured: Day 28 and Day 56
Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination.
Measured: Day 28 and Day 56
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.
Measured: Days 0-6 and Days 28-34
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.
Measured: Days 0-6 and Days 28-34
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.
Measured: Days 0-6 and Days 28-34
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.
Measured: Days 1-6 and Days 29-34

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Mar 2014

First posted13 Nov 2013 (estimated)
Study startOct 2013
Primary completionJan 2014
Study completionMar 2014

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.
Publications (2)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: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01982331
Sponsor's protocol ID: LAIV-H2N2-01
Status last verified: Feb 2019
First submitted: 30 Oct 2013
Last updated: 26 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Rak A, Donina S, Zabrodskaya Y, Rudenko L, Isakova-Sivak I. Cross-Reactivity of SARS-CoV-2 Nucleocapsid-Binding Antibodies and Its Implication for COVID-19 Serology Tests. Viruses. 2022 Sep 14;14(9):2041. doi: 10.3390/v14092041.
PubMed 36146847
Kiseleva I, Dubrovina I, Fedorova E, Larionova N, Isakova-Sivak I, Bazhenova E, Pisareva M, Kuznetsova V, Flores J, Rudenko L. Genetic stability of live attenuated vaccines against potentially pandemic influenza viruses. Vaccine. 2015 Dec 8;33(49):7008-14. doi: 10.1016/j.vaccine.2015.09.050. Epub 2015 Oct 2.
PubMed 26432909

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/California/66/395 (H2N2)Influenza Vaccine
ClinicalTrials.gov ID: NCT01982331
Acronym / sponsor ID: LAIV-H2N2-01
Conditions: Influenza
Keywords: H2N2, vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: PATHUniversity, hospital or other
Collaborators: Ministry of Health, Russian Federation, Institute of Experimental Medicine, Russia
Study start: Oct 2013
Primary completion: Jan 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 13 Nov 2013 (estimated)
Results: Posted 6 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
LAIV H2N2 vaccine	Experimental	Biological: LAIV H2N2LAIV H2N2 vaccine A/17/California/66/395 (H2N2) live monovalent influenza vaccine delivered intranasally 2 doses 1 month apart
Placebo	Placebo comparator	Other: PlaceboPlacebo is composed of a lyophilizate containing the same concentrations of stabilizers as LAIV vaccine. It is prepared onsite in an identical fashion to the vaccine and delivered intranasally.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Legal male or female adult aged 18 through 40 years
Literate and willing to provide written informed consent.
A signed informed consent.
Free of obvious health problems, as established by medical history and screening evaluations, including physical examination.
Capable and willing to complete diary cards and willing to return for all follow-up visits

Key exclusion criteria (29 listed)

Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during trial period.
Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until four weeks after study completion.
Practice of nasal irrigation on a regular basis within the past six months or has engaged in nasal irrigation within two weeks prior to enrollment.
Recent history of frequent nose bleeds (>5 within the past year).
Clinically relevant abnormal paranasal anatomy.

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
LAIV H2N2Also: Monovalent A/17/California/66/395 (LAIV H2N2) vaccinevaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28	Biological	LAIV H2N2 vaccine
Placeboplacebo delivered intranasally. .25cc to each nostril at day 0 and day 28	Other	Placebo

Primary outcome

Percentage of Participants With Immediate Reactions
Time frame: 2 hours
Measured as observed by study staff or reported by the subject to study staff whether related or not related.
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1
Time frame: 7 days
Adverse events commonly associated with intranasal vaccination occurring greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throat, catarrhal nasopharynx. Solicited systemic reactions included: body temperature, feverishness/subjective fever, chills, cough, difficulty breathing, sore throat, headache, confusion, convulsions/seizures, fatigue/malaise, joint aches, muscle aches, pink or red eyes, draining eyes, swollen eyelids, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting.
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2
Time frame: 7 days
Adverse events commonly associated with intranasal vaccination occurring greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throat, catarrhal nasopharynx. Solicited systemic reactions included: body temperature, feverishness/subjective fever, chills, cough, difficulty breathing, sore throat, headache, confusion, convulsions/seizures, fatigue/malaise, joint aches, muscle aches, pink or red eyes, draining eyes, swollen eyelids, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting.
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1
Time frame: 7 days following each vaccination
All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff.
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2
Time frame: 7 days following each vaccination
All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff.

10 secondary outcomes

Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies
Time frame: Day 28, Day 56 and Day 112
Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies
Time frame: Day 28, Day 56 and Day 112
Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies
Time frame: Day 28, Day 56 and Day 112
Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies
Time frame: Day 28, Day 56 and Day 112
Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa
Time frame: Day 28 and Day 56
Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens
Time frame: Day 28 and Day 56
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Time frame: Days 0-6 and Days 28-34
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Time frame: Days 0-6 and Days 28-34
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Time frame: Days 0-6 and Days 28-34
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Time frame: Days 1-6 and Days 29-34

Results and safety

Results posted to the registry on 6 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LAIV H2N2 Vaccine	28	28
Placebo	10	10

Primary outcome: Percentage of Participants With Immediate Reactions

Time frame: 2 hours. Count of participants. Unit: Participants

Measure	LAIV H2N2 Vaccine n = 28	Placebo n = 10
Vaccination 1: Yes	0	0
Vaccination 1: No	28	10
Vaccination 2: Yes	0	0
Vaccination 2: No	28	10

Primary outcome: Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1

Time frame: 7 days. Count of participants. Unit: Participants

Measure	LAIV H2N2 Vaccine n = 28	Placebo n = 10
Any solicited local or systemic reaction: Yes	13	5
Any solicited local or systemic reaction: No	15	5
Any solicited local reaction: Yes	4	2
Any solicited local reaction: No	24	8
Any solicited systemic reaction: Yes	13	4
Any solicited systemic reaction: No	15	6

Primary outcome: Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2

Time frame: 7 days. Count of participants. Unit: Participants

Measure	LAIV H2N2 Vaccine n = 28	Placebo n = 10
Any solicited local or systemic reaction: Yes	9	2
Any solicited local or systemic reaction: No	19	8
Any solicited local reaction: Yes	0	0
Any solicited local reaction: No	28	10
Any solicited systemic reaction: Yes	9	2
Any solicited systemic reaction: No	19	8

Primary outcome: Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1

Time frame: 7 days following each vaccination. Count of participants. Unit: Participants

Measure	LAIV H2N2 Vaccine n = 28	Placebo n = 10
Unrelated to vaccination: Yes	15	7
Unrelated to vaccination: No	13	3
Related to vaccination: Yes	16	5
Related to vaccination: No	12	5

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LAIV H2N2 Vaccine	0 of 28 (0%)	26 of 28 (92.9%)	0 of 28
Placebo	0 of 10 (0%)	9 of 10 (90%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36146847Rak A, Donina S, Zabrodskaya Y, Rudenko L, Isakova-Sivak I. Cross-Reactivity of SARS-CoV-2 Nucleocapsid-Binding Antibodies and Its Implication for COVID-19 Serology Tests. Viruses. 2022 Sep 14;14(9):2041. doi: 10.3390/v14092041.
Derived from this study: PubMed 26432909Kiseleva I, Dubrovina I, Fedorova E, Larionova N, Isakova-Sivak I, Bazhenova E, Pisareva M, Kuznetsova V, Flores J, Rudenko L. Genetic stability of live attenuated vaccines against potentially pandemic influenza viruses. Vaccine. 2015 Dec 8;33(49):7008-14. doi: 10.1016/j.vaccine.2015.09.050. Epub 2015 Oct 2.

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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.

Oleg I Kiselev, Ph.D. principal investigator

Research Institute of Influenza

Jorge E Flores, MD, Ph.D. study director

PATH

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 LAIV H2N2 in people with Influenza, run by PATH at 1 site in Russia.

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 7 inclusion and 29 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 26 Feb 2019. 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 Russia. 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?

Yes. Results are posted in the registry (first posted 6 Feb 2019). 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?

Percentage of Participants With Immediate Reactions (time frame: 2 hours). The study lists 5 primary outcomes in all. 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 NCT01982331, which also lists 2 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 26 Feb 2019.