InfluenzaPhase 2NCT02989194

Study of an Investigational Monoclonal Antibody, VIS410, in Subjects With Uncomplicated Influenza A

A Phase 2 study testing VIS410 low dose and VIS410 high dose in people with Influenza, run by Visterra, Inc. at 54 sites in 7 countries.

Completed

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

Official record

Search all trials

Trial summary

This is a Phase 2a randomized, double-blind, placebo-controlled study designed to assess the safety and tolerability of an investigational monoclonal antibody, VIS410, in subjects with uncomplicated influenza. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Influenza
What is being tested?: VIS410 low dose and VIS410 high dose
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 54 sitesin 7 countries
Study dates: 6 Jan 2017to 27 Oct 2017
Phase: Phase 2
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female subjects aged ≥18 years and ˂65 years
Women should fulfill one of the following criteria:
Post-menopausal; either amenorrhea ≥12 months or follicle stimulating hormone >40 mIU/mL (milli-international units/milliliter) as documented in their medical history
Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation
Women of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception from screening until 60 days post infusion
Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects who have a female partner of childbearing potential must use an effective birth control method when having heterosexual intercourse, from screening until 60 days post infusion

Show all 9Show fewer

Test positive for influenza A by Rapid Antigen Test performed with a commercially available test on an adequate nasopharyngeal specimen in accordance with the manufacturer's instructions
Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of moderate to severe intensity, or presence of at least one constitutional symptom (myalgia [aches and pains], headache, feverishness, or fatigue) of moderate to severe intensity
Onset of symptoms (time when the temperature was first measured as elevated [temperature of ≥100.4°F or ≥38°C], OR the time when the subject experienced at least one respiratory symptom or at least one constitutional symptom) no more than 72 hours before the start of infusion

Who cannot join

Use of NSAIDs or antihistamines within 6 hours of study drug dosing with the exception of those used as part of the pretreatment regimen
History of intolerance or allergic response to monoclonal antibodies and/or pretreatment medications (diphenhydramine, ibuprofen and acetylsalicylic acid)
Subject weight less than (<) 45 kg
Subjects with clinical history that would lead to increased risk of influenza complications including but not limited to clinically significant cardiac disease, moderate to severe asthma, or other moderate to severe chronic obstructive pulmonary disease, metabolic syndrome including moderate to severe diabetes or active tuberculosis
History of chronic GI disease, including bleeding, ulceration, Irritable Bowel Syndrome, systemic mastocytosis or chronic diarrhea
Women who are pregnant, breast-feeding, or considering becoming pregnant

Show all 15Show fewer

Patients with hypoxemia requiring oxygen support
Clinical evidence of worsening of any chronic medical condition (temporally associated with the onset of symptoms of influenza) which, in the Investigator's opinion, indicates that such finding(s) could represent complications of influenza
Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy including systemic steroids
Presence of known Acquired Immune Deficiency Syndrome-defining illness, chronic hepatitis B or hepatitis C
Receipt of any dose of antiviral therapy such as, but not limited to, rimantadine, amantadine, peramivir, zanamivir, laninamivir or oseltamivir in the 7 days prior to screening
Enrollment in any other investigational drug or device study, any disease or vaccine study within 30 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer
Subjects unable to take oral predose medication
Known or suspected alcohol or drug abuse, that is, abuse of a level that would compromise the safety or cooperation of the subject in the opinion of the Investigator
Subjects on chronic medications where the dose has not been stable for at least 3 months

Trial locations and contacts

54 sites in 7 countries.

Country

City, postcode or hospital

54 sites in 7 countries

South Africa15 sites

Study site
Benoni, Gauteng, 1500
Study site
Cape Town, Western Cape, 7570
Study site
Centurion, Gauteng, 1692
Study site
Durban, KwaZulu-Natal, 4092
Study site
Johannesburg, Gauteng, 2113
Study site
Kempton Park, Gauteng, 1619
Study site
Middelburg, Mpumalanga, 1055
Study site
Pretoria, Gauteng, 0121
Study site
Pretoria West, Gauteng, 0183
Study site
Soshanguve, Gauteng, 0152
Study site
Soweto, Gauteng, 2013
Study site
Thabazimbi, Limpopo, 0380
Study site
Welkom, Free State, 9460
Study site
Witbank, Mpumalanga, 1035
Study site
Worcester, Western Cape, 6850

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United States11 sites

Study site
Coral Gables, Florida, 33134
Study site
Eunice, Louisiana, 70535
Study site
Homestead, Florida, 33033
Study site
Houston, Texas, 77058
Study site
Huntsville, Alabama, 35801
Study site
McAllen, Texas, 78504
Study site
Miami, Florida, 33165
Study site
Miami, Florida, 33185
Study site
New Orleans, Louisiana, 70115
Study site
Orlando, Florida, 32811
Study site
Shelby, North Carolina, 28150

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Ukraine9 sites

Study site
Kharkiv, 61064
Study site
Kharkiv, 61106
Study site
Kiev, 03049
Study site
Kiev, 03110
Study site
Kiev, 04050
Study site
Odesa, 65023
Study site
Sumy, 40021
Study site
Vinnytsia, 21001
Study site
Vinnytsia, 21029

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Bulgaria6 sites

Study site
Asenovgrad, 4230
Study site
Lom, 3600
Study site
Rousse, 7002
Study site
Sofia, 1202
Study site
Sofia, 1407
Study site
Velingrad, 4600

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Latvia6 sites

Study site
Daugavpils, LV-5417
Study site
Liepāja, LV-3414
Study site
Rēzekne, LV-4600
Study site
Riga, LV-1010
Study site
Valmiera, LV-4201
Study site
Ventspils, LV-3601

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Estonia4 sites

Study site
Paide, 72713
Study site
Tallinn, 10617
Study site
Tallinn, 11615
Study site
Tallinn, 13415

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Serbia3 sites

Study site
Kragujevac, 34000
Study site
Niš, 18000
Study site
Novi Sad, 21000

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About this study

Official title: A Phase 2a Double-blind, Placebo-controlled Study to Assess the Safety and Tolerability of a Single Intravenous Dose of an Investigational Monoclonal Antibody With Code Name VIS410 in Subjects With Uncomplicated Influenza A Infection

Read the detailed description

Subjects will be admitted to an infusion unit for drug administration and observation following infusion. The study is designed to compare an infusion of a single high or low IV dose of VIS410 against placebo. Subjects will be followed for 100 (±7 days).

Conditions: Influenza
Being tested: VIS410 low dose, VIS410 high dose, Placebo
Medical subject headings: Influenza, Human

What participants receive

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

VIS410 low doseDrug
Single intravenous fixed low dose of VIS410
VIS410 high doseDrug
Single intravenous fixed high dose of VIS410
PlaceboDrug
Single intravenous infusion of placebo

Study groups in NCT02989194
Study group	Role	What they receive
VIS410 low dose	Experimental	Single intravenous fixed low dose of VIS410 Receives: Drug: VIS410 low dose
VIS410 high dose	Experimental	Single intravenous fixed high dose of VIS410 Receives: Drug: VIS410 high dose
Placebo	Placebo comparator	Single intravenous placebo infusion Receives: Drug: Placebo

What is being measured

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

Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection
The percentage of participants with adverse events (AEs) and serious adverse events (SAEs) following administration of a single dose of IV VIS410.
Measured: 100 days
Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest
Percentage of participants experiencing any TEAE, TEAEs considered related to study treatment and the number of participants experiencing adverse events of special interest (AESI). A TEAE is defined as an adverse event that starts on or after the date of study drug IV infusion. AESIs included hypersensitivity reaction, anaphylactic reaction, or injection site adverse event.
Measured: 100 days

Secondary outcomes (16)

Percentage Change From Baseline in Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410
The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. These data were summarized at each visit by treatment group. The data below show the percent change in mean total symptom scores over time by treatment arm.
Measured: 10 days
Hospitalization for Influenza-related Complications
Number of participants requiring hospitalization for influenza-related complications
Measured: 100 days
Duration of Hospitalization for Complications of Influenza
Duration of hospitalization for participants with at least 1 complication of influenza. There were no participants hospitalized for complications of influenza.
Measured: 100 days
Count of Participants With Complications of Influenza
Count of participants with at least 1 complication of influenza
Measured: 100 days
Influenza A Relapse/Reinfection
Number of participants with influenza A relapse/reinfection
Measured: 100 days
VIS410 Maximum Plasma Concentration
The maximum observed concentration of VIS410 in serum (Cmax).
Measured: 1, 3, 5, 7, 14, 28, 56, 100 days
Pharmacokinetics of VIS410 Concentration in Serum
Time corresponding to the maximum serum concentration of VIS410.
Measured: 1, 3, 5, 7, 14, 28, 56, 100 days
VIS410 Plasma Concentration ( AUC 0-infinity)
VIS410 area under the plasma concentration time curve in serum. AUC 0-infinity is from the time of dosing extrapolated to infinity.
Measured: 1, 3, 5, 7, 14, 28, 56, 100 days
VIS410 Plasma Concentration (AUC 0-last)
VIS410 area under the plasma concentration time curve in serum. AUC 0-last is the area under the plasma concentration time curve from time 0 to the last measurable concentration.
Measured: 1, 3, 5, 7, 14, 28, 56, 100 days
Half-life of VIS410 in Serum.
Terminal elimination half-life of VIS410 in serum (t1/2) in serum.
Measured: 1, 3, 5, 7, 14, 28, 56, 100 days
Clearance (CL) of VIS410 in Serum.
Summary of VIS410 total clearance (CL) in serum.
Measured: 1, 3, 5, 7, 14, 28, 56, 100 days
Area Under the Viral Load-Time Curve (VL AUC) From Nasopharyngeal Swab Day 7.
The difference between VIS410 and placebo treatment groups in viral AUC based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.
Measured: 7 days
Peak Viral Load by TCID50
The difference between VIS410 and placebo treatment groups in peak viral load based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.
Measured: 7 days
Time to Resolution of Peak Viral Load From Nasopharyngeal Samples by TCID50.
The number of days for the median time to resolution of peak viral load from end of infusion by nasopharyngeal swabs collected from the first 50 participants and tested by half maximal tissue culture infective dose (TCID50)
Measured: 7 days
Summary of Anti-VIS410 Antibody (ADA) Titers.
Count of subjects testing positive for anti-VIS410 antibodies on days 1, 14, 56 and 100. A positive result includes samples confirmed positive and above titer cut point factor (and titer ≥ 1). Negative results include screened or confirmed negative or confirmed positive but below titer cut point factor (titer < 1). For participants receiving placebo, only samples from two participants were tested at Days 14 and 56.
Measured: 100 days
Duration of Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410
The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. Data below show the time to symptom resolution for Total Symptom Score.
Measured: 10 days

Timeline

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

6 Jan 201727 Oct 2017

First posted12 Dec 2016 (estimated)
Study start6 Jan 2017
Primary completion27 Oct 2017
Study completion27 Oct 2017

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 (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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02989194
Sponsor's protocol ID: VIS410-202
Status last verified: Aug 2022
First submitted: 5 Dec 2016
Last updated: 15 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: No plans to share IPD

Publications

Hershberger E, Sloan S, Narayan K, Hay CA, Smith P, Engler F, Jeeninga R, Smits S, Trevejo J, Shriver Z, Oldach D. Safety and efficacy of monoclonal antibody VIS410 in adults with uncomplicated influenza A infection: Results from a randomized, double-blind, phase-2, placebo-controlled study. EBioMedicine. 2019 Feb;40:574-582. doi: 10.1016/j.ebiom.2018.12.051. Epub 2019 Jan 9.
PubMed 30638863

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 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a Double-blind, Placebo-controlled Study to Assess the Safety and Tolerability of a Single Intravenous Dose of an Investigational Monoclonal Antibody With Code Name VIS410 in Subjects With Uncomplicated Influenza A Infection
ClinicalTrials.gov ID: NCT02989194
Acronym / sponsor ID: VIS410-202
Conditions: Influenza
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Visterra, Inc.Industry (pharma, biotech, devices)
Collaborators: Biomedical Advanced Research and Development Authority
Study start: 6 Jan 2017 (actual)
Primary completion: 27 Oct 2017 (actual)
Study completion: 27 Oct 2017 (actual)
First posted: 12 Dec 2016 (estimated)
Results: Posted 15 Aug 2022

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
VIS410 low dose	Experimental	Drug: VIS410 low doseSingle intravenous fixed low dose of VIS410
VIS410 high dose	Experimental	Drug: VIS410 high doseSingle intravenous fixed high dose of VIS410
Placebo	Placebo comparator	Drug: PlaceboSingle intravenous placebo infusion

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male and female subjects aged ≥18 years and ˂65 years
Women should fulfill one of the following criteria:
Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects who have a female partner of childbearing potential must use an effective birth control method when having heterosexual intercourse, from screening until 60 days post infusion
Test positive for influenza A by Rapid Antigen Test performed with a commercially available test on an adequate nasopharyngeal specimen in accordance with the manufacturer's instructions
Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of moderate to severe intensity, or presence of at least one constitutional symptom (myalgia [aches and pains], headache, feverishness, or fatigue) of moderate to severe intensity

Key exclusion criteria (15 listed)

Use of NSAIDs or antihistamines within 6 hours of study drug dosing with the exception of those used as part of the pretreatment regimen
History of intolerance or allergic response to monoclonal antibodies and/or pretreatment medications (diphenhydramine, ibuprofen and acetylsalicylic acid)
Subject weight less than (<) 45 kg
Subjects with clinical history that would lead to increased risk of influenza complications including but not limited to clinically significant cardiac disease, moderate to severe asthma, or other moderate to severe chronic obstructive pulmonary disease, metabolic syndrome including moderate to severe diabetes or active tuberculosis
History of chronic GI disease, including bleeding, ulceration, Irritable Bowel Syndrome, systemic mastocytosis or chronic diarrhea

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
VIS410 low doseSingle intravenous fixed low dose of VIS410	Drug	VIS410 low dose
VIS410 high doseSingle intravenous fixed high dose of VIS410	Drug	VIS410 high dose
PlaceboSingle intravenous infusion of placebo	Drug	Placebo

Primary outcome

Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection
Time frame: 100 days
The percentage of participants with adverse events (AEs) and serious adverse events (SAEs) following administration of a single dose of IV VIS410.
Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest
Time frame: 100 days
Percentage of participants experiencing any TEAE, TEAEs considered related to study treatment and the number of participants experiencing adverse events of special interest (AESI). A TEAE is defined as an adverse event that starts on or after the date of study drug IV infusion. AESIs included hypersensitivity reaction, anaphylactic reaction, or injection site adverse event.

16 secondary outcomes

Percentage Change From Baseline in Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410
Time frame: 10 days
Hospitalization for Influenza-related Complications
Time frame: 100 days
Duration of Hospitalization for Complications of Influenza
Time frame: 100 days
Count of Participants With Complications of Influenza
Time frame: 100 days
Influenza A Relapse/Reinfection
Time frame: 100 days
VIS410 Maximum Plasma Concentration
Time frame: 1, 3, 5, 7, 14, 28, 56, 100 days
Pharmacokinetics of VIS410 Concentration in Serum
Time frame: 1, 3, 5, 7, 14, 28, 56, 100 days
VIS410 Plasma Concentration ( AUC 0-infinity)
Time frame: 1, 3, 5, 7, 14, 28, 56, 100 days
VIS410 Plasma Concentration (AUC 0-last)
Time frame: 1, 3, 5, 7, 14, 28, 56, 100 days
Half-life of VIS410 in Serum.
Time frame: 1, 3, 5, 7, 14, 28, 56, 100 days
Clearance (CL) of VIS410 in Serum.
Time frame: 1, 3, 5, 7, 14, 28, 56, 100 days
Area Under the Viral Load-Time Curve (VL AUC) From Nasopharyngeal Swab Day 7.
Time frame: 7 days
Peak Viral Load by TCID50
Time frame: 7 days
Time to Resolution of Peak Viral Load From Nasopharyngeal Samples by TCID50.
Time frame: 7 days
Summary of Anti-VIS410 Antibody (ADA) Titers.
Time frame: 100 days
Duration of Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410
Time frame: 10 days

Results and safety

Results posted to the registry on 15 Aug 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VIS410 High Dose	50	49
VIS410 Low Dose	50	48
Placebo	50	50

Primary outcome: Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection

Time frame: 100 days. Number (95% Confidence Interval). Unit: percentage of participants

Measure	VIS410 High Dose n = 49	VIS410 Low Dose n = 49	VIS410 Total n = 98	Placebo n = 50
Percentage of subjects with any adverse events	57.1 (42.21 to 71.18)	34.7 (21.67 to 49.64)	45.9 (35.80 to 56.29)	26.0 (14.63 to 40.34)
Percentage of subjects with any serious adverse events	0 (0.00 to 7.25)	0 (0.00 to 7.25)	0 (0.0 to 3.69)	4 (0.49 to 13.71)

Population analysed: Safety Population The safety population included all subjects randomized who received IV study drug. The safety population summaries were based on the actual treatment received.

Primary outcome: Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest

Time frame: 100 days. Number (95% Confidence Interval). Unit: percentage of participants

Measure	VIS410 High Dose n = 49	VIS410 Low Dose n = 49	Total VIS410 n = 98	Placebo n = 50
Percentage of subjects with any TEAE	55.1 (40.23 to 69.33)	34.7 (21.67 to 49.64)	44.9 (34.83 to 55.28)	24.0 (13.06 to 38.17)
Percentage of subjects with treatment related TEAEs	30.6 (18.25 to 45.42)	14.3 (5.94 to 27.24)	22.4 (14.64 to 31.99)	12.0 (4.53 to 24.31)
Percentage of subjects with any TEAEs of Special Interest	34.7 (21.67 to 49.64)	16.3 (7.32 to 29.66)	25.5 (17.24 to 35.31)	12 (4.53 to 24.31)
Percentage of Subjects with any hypersensitivity Reactions	0 (0.00 to 7.25)	0 (0.00 to 7.25)	0 (0.00 to 3.69)	0 (0.00 to 7.11)
Percentage of subjects with any anaphylactic reactions	0 (0.00 to 7.25)	0 (0.00 to 7.25)	0 (0.00 to 3.69)	0 (0.00 to 7.11)
Percentage of subjects with any injection site AEs.	2.0 (0.05 to 10.85)	0.0 (0.00 to 7.25)	1.0 (0.03 to 5.55)	0 (0.00 to 7.11)

Population analysed: Safety Population. The safety population included all participants randomized who received IV study drug. The safety population summaries were based on the actual treatment received.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored continuously from signing of informed consent until the last study related activity (100 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VIS410 High Dose	0 of 49 (0%)	16 of 49 (32.7%)	0 of 49
VIS410 Low Dose	0 of 49 (0%)	10 of 49 (20.4%)	0 of 49
Placebo	2 of 50 (4%)	7 of 50 (14%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30638863Hershberger E, Sloan S, Narayan K, Hay CA, Smith P, Engler F, Jeeninga R, Smits S, Trevejo J, Shriver Z, Oldach D. Safety and efficacy of monoclonal antibody VIS410 in adults with uncomplicated influenza A infection: Results from a randomized, double-blind, phase-2, placebo-controlled study. EBioMedicine. 2019 Feb;40:574-582. doi: 10.1016/j.ebiom.2018.12.051. Epub 2019 Jan 9.
Individual participant dataSharing planned: No. No plans to share IPD

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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.

Clinical Development study director

Visterra, Inc.

54 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VIS410 low dose and VIS410 high dose in people with Influenza, run by Visterra, Inc. at 54 sites in 7 countries.

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 9 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 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in South Africa, United States, Ukraine, Bulgaria, Latvia and 2 more countries. 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 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?

Yes. Results are posted in the registry (first posted 15 Aug 2022). 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?

Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection (time frame: 100 days). The study lists 2 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 NCT02989194, 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 15 Aug 2022.