InfluenzaPhase 2NCT02468115
Influenza Challenge Study of VIS410 in Healthy Volunteers
A Phase 2 study testing VIS410 in people with Influenza, run by Visterra, Inc. at 1 site in Belgium.
Trial summary
A phase 2 a study to assess the safety profile and the effect of VIS410 in healthy subjects after inoculation with influenza A virus (H1N1). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- VIS410
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteBelgium
- Study dates
- May 2015to Feb 2016
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects of age 18-45 years, inclusive, at the time of informed consent.
- Women should fulfill one of the following criteria:
- Post-menopausal; either amenorrhea ≥ 12 months or follicle stimulating hormone > 40 mIU/mL.
- Surgically sterile; bilateral oophorectomy, hysterectomy, or tubal ligation.
- Women of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception until the end of the study.
- Must be sexually inactive by abstinence which is consistent with the preferred and usual lifestyle of the subject.
Show all 9Show fewer
- Women of childbearing potential must have a negative pregnancy test at screening (serum) and on Day -2 (urine).
- Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects must use an effective birth control method (see Inclusion Criterion 2).
- Seronegative for the challenge virus (HAI ≤ 10).
Who cannot join
- Known or suspected intolerance or hypersensitivity to the investigational study drug or virus.
- Has an acute or chronic medical condition that would render the investigational study drug unsafe or would interfere with the evaluation of the responses.
- Subjects receiving medications that affect the immune system.
- Significant adulthood history of seasonal hay fever or a seasonal allergic rhinitis or perennial allergic rhinitis or chronic or nasal or sinus condition.
- Subjects who have received any vaccination within the last 3 months or influenza vaccine within the last 6 months.
- Subjects with a confirmed diagnosis of influenza A within the last 6 months prior to screening.
Show all 21Show fewer
- Subjects with abnormal nasal structure (including septal deviation and nasal polyps), chronic sinusitis, or reason (i.e., intolerance) that complicates nasopharyngeal swabbing.
- Presence of lung disease, asthma, or chronic obstructive pulmonary disease.
- Has a history of alcohol or drug abuse.
- A positive HIV antibody screen, HBsAg, HBcAb or hepatitis C antibody screen.
- Cancer or treatment for cancer, within 3 years, excluding basal cell carcinoma of the skin, which is allowed.
- Presence of immunosuppression or any medical condition that may be associated with impaired immune responsiveness.
- Anticipated presence of a household contact with potential immunosuppression.
- History of Guillain-Barré syndrome.
- Current professional activity as a healthcare worker who will return to work within 2 weeks following challenge.
- Anticipated presence of a pregnant household contact, within 2 weeks following challenge.
- Women who are pregnant or breast-feeding, or consider becoming pregnant.
- Acute disease within 2 weeks prior to challenge.
- Elevated white blood cell count above 10.90 x 109/L or an absolute neutrophil count above 7.5 x 109/L.
- Current enrollment in any other investigational drug study or disease study or participation in an investigational drug study.
- Any other reasons for which the investigator considers the subject unfit for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Antiviral Activity of a Single Intravenous Dose of VIS410 in Healthy Subjects After a Viral Inoculation With Influenza A (H1N1)
A phase 2 a study to assess the safety profile and the effect of VIS410 in healthy subjects after inoculation with influenza A virus (H1N1).
Read the detailed description
This is a phase 2a randomized, double-blind, placebo-controlled study to be conducted in healthy volunteers. The study is designed to compare an infusion of a single dose of VIS410 against placebo. Eligible volunteers will be admitted to the clinical center and will receive a single intranasal administration of influenza A (H1N1). One day (24h) after inoculation, subjects will receive a single administration of VIS410 or placebo. Subjects will be confined in the clinical center for 10 days after virus administration.
Assessment of safety will be determined from vital sign measurements, physical examinations, hematology, chemistry and urinalysis laboratory testing, 12-lead electrocardiograms (ECGs), pulmonary function, use of concomitant medications, and review of adverse events (AEs) should they occur. During confinement in the clinical center a symptom score card of influenza symptoms will be completed three times a day; nasopharyngeal swabs will be obtained three times a day and assayed for the presence of influenza virus and VIS410 concentration; serum samples will be assayed for VIS410 and the presence of cytokines. Upon release from the clinical center subjects will return for follow-up visits on days 14, 28 and either 56 or 84.
- Conditions
- Influenza
- Being tested
- VIS410, 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.
VIS410Drug
Single fixed IV dose of VIS410
PlaceboDrug
Single IV dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| VIS410 | Experimental | Single intravenous fixed dose of VIS410 Receives: Drug: VIS410 |
| Placebo | Placebo comparator | Single intravenous infusion of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of VIS410 on the area under the curve of viral shedding over time.
The viral AUC will be measured, qRT-PCR, and compared between treatment groups
Measured: 56-84 days
To assess the safety profile of VIS410
The proportion of subjects with post-infusion adverse events will be compared between treatment groups.
Measured: 56-84 days
Secondary outcomes (5)
Assess the effects of VIS410 on viral shedding
The peak viral load and time to cessation of shedding will be measured (qRT-PCR and TCID50)
Measured: 10 days
Assess the pharmacokinetics of VIS410 in serum
The following PK parameters will be calculated: Cmax, tmax, AUC, t1/2, Vd, Cl
Measured: 56-84 days
Assess the immunogenicity of VIS410
The development of anti-drug antibodies will be measured
Measured: 56-84 days
Assess the effect of VIS410 on clinical symptoms
The duration of symptoms will be compared between treatment groups
Measured: 10 days
Assess antibody to challenge strain
The HAI antibody titer will be measured
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visterra, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- M Petkova, Principal investigator, SGS Life Sciences, a division of SGS Belgium NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468115
- Sponsor's protocol ID
- VIS410-201
- Status last verified
- Apr 2016
- First submitted
- 1 Jun 2015
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sloan SE, Szretter KJ, Sundaresh B, Narayan KM, Smith PF, Skurnik D, Bedard S, Trevejo JM, Oldach D, Shriver Z. Clinical and virological responses to a broad-spectrum human monoclonal antibody in an influenza virus challenge study. Antiviral Res. 2020 Dec;184:104763. doi: 10.1016/j.antiviral.2020.104763. Epub 2020 Mar 7.
PubMed 32151645
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Antiviral Activity of a Single Intravenous Dose of VIS410 in Healthy Subjects After a Viral Inoculation With Influenza A (H1N1)
- ClinicalTrials.gov ID
- NCT02468115
- Acronym / sponsor ID
- VIS410-201
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Visterra, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 2 a study to assess the safety profile and the effect of VIS410 in healthy subjects after inoculation with influenza A virus (H1N1).
Detailed description
This is a phase 2a randomized, double-blind, placebo-controlled study to be conducted in healthy volunteers. The study is designed to compare an infusion of a single dose of VIS410 against placebo. Eligible volunteers will be admitted to the clinical center and will receive a single intranasal administration of influenza A (H1N1). One day (24h) after inoculation, subjects will receive a single administration of VIS410 or placebo. Subjects will be confined in the clinical center for 10 days after virus administration.
Assessment of safety will be determined from vital sign measurements, physical examinations, hematology, chemistry and urinalysis laboratory testing, 12-lead electrocardiograms (ECGs), pulmonary function, use of concomitant medications, and review of adverse events (AEs) should they occur. During confinement in the clinical center a symptom score card of influenza symptoms will be completed three times a day; nasopharyngeal swabs will be obtained three times a day and assayed for the presence of influenza virus and VIS410 concentration; serum samples will be assayed for VIS410 and the presence of cytokines. Upon release from the clinical center subjects will return for follow-up visits on days 14, 28 and either 56 or 84.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIS410 | Experimental | Drug: VIS410Single intravenous fixed dose of VIS410 |
| Placebo | Placebo comparator | Drug: PlaceboSingle intravenous infusion of placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female subjects of age 18-45 years, inclusive, at the time of informed consent.
- Women should fulfill one of the following criteria:
- Women of childbearing potential must have a negative pregnancy test at screening (serum) and on Day -2 (urine).
- Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects must use an effective birth control method (see Inclusion Criterion 2).
- Seronegative for the challenge virus (HAI ≤ 10).
Key exclusion criteria (21 listed)
- Known or suspected intolerance or hypersensitivity to the investigational study drug or virus.
- Has an acute or chronic medical condition that would render the investigational study drug unsafe or would interfere with the evaluation of the responses.
- Subjects receiving medications that affect the immune system.
- Significant adulthood history of seasonal hay fever or a seasonal allergic rhinitis or perennial allergic rhinitis or chronic or nasal or sinus condition.
- Subjects who have received any vaccination within the last 3 months or influenza vaccine within the last 6 months.
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 |
|---|---|---|
| VIS410Single fixed IV dose of VIS410 | Drug | VIS410 |
| PlaceboSingle IV dose of placebo | Drug | Placebo |
Primary outcome
To assess the effect of VIS410 on the area under the curve of viral shedding over time.
Time frame: 56-84 days
The viral AUC will be measured, qRT-PCR, and compared between treatment groups
To assess the safety profile of VIS410
Time frame: 56-84 days
The proportion of subjects with post-infusion adverse events will be compared between treatment groups.
5 secondary outcomes
Assess the effects of VIS410 on viral shedding
Time frame: 10 days
Assess the pharmacokinetics of VIS410 in serum
Time frame: 56-84 days
Assess the immunogenicity of VIS410
Time frame: 56-84 days
Assess the effect of VIS410 on clinical symptoms
Time frame: 10 days
Assess antibody to challenge strain
Time frame: 28 days
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 5 Apr 2016.
- Derived from this study: PubMed 32151645Sloan SE, Szretter KJ, Sundaresh B, Narayan KM, Smith PF, Skurnik D, Bedard S, Trevejo JM, Oldach D, Shriver Z. Clinical and virological responses to a broad-spectrum human monoclonal antibody in an influenza virus challenge study. Antiviral Res. 2020 Dec;184:104763. doi: 10.1016/j.antiviral.2020.104763. Epub 2020 Mar 7.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
M Petkova principal investigator
SGS Life Sciences, a division of SGS Belgium NV
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 VIS410 in people with Influenza, run by Visterra, Inc. at 1 site in Belgium.
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 21 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 5 Apr 2016. 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 Belgium. 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?
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?
To assess the effect of VIS410 on the area under the curve of viral shedding over time. (time frame: 56-84 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 NCT02468115, 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 5 Apr 2016.