InfluenzaPhase 2NCT01938352
Evaluation of the Protective Efficacy and Safety of CR8020 in an Influenza Challenge
A Phase 2 study testing CR8020 in people with Influenza, run by Crucell Holland BV at 1 site in United Kingdom.
Trial summary
After prophylactic vaccination with CR8020, a monoclonal antibody, subjects will be challenged with the H3N2 virus. The protective efficacy, safety, tolerability, pharmacokinetics, and potential immunogenicity will be assessed. 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?
- CR8020
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Oct 2013to 22 Jan 2014
- 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 and female subjects ≥ 18 and ≤ 45 years of age.
- In good health, with no major medical conditions from medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation.
- A total body weight ≥50 kg and a BMI of >18. If the BMI is above 28 the subject may be included if the waist measurement is less than 94 cm (male), or less than 80 cm (female).
- (a) Male subjects must use highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at entry to Quarantine until after the Day 96 (± 5 days) Follow-up Visit.
- In addition, male subjects must not donate sperm following discharge from Quarantine until after the Day 96 (± 5 days) Follow-up Visit.
- Female subjects must be either:
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- Documented status as surgically sterile or post hysterectomy or-
- If of childbearing potential, must have a negative serum and urine pregnancy test at study specific screening and Day -4/-3 and must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at entry to Quarantine and continue until the Day 96 (± 5 days) Follow-up Visit.
- Acceptable forms of effective contraception include:
- Established use of oral, injected or implanted hormonal methods of contraception
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- Male sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). [For female subjects on the study, the vasectomised male partner should be the sole partner for that subject].
- True abstinence: When this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
- An informed consent document signed and dated by the subject and Investigator.
- Sero-suitable for challenge virus.
Who cannot join
- Subjects who have a significant history of tobacco use at any time (≥ total 10 pack year history, e.g. one pack a day for 10 years)
- (a) Females who are pregnant or have been pregnant within six months prior to the study, or who have been breastfeeding within three months prior to screening. Females who have a positive pregnancy test at any point in the study will be withdrawn immediately.
- Females intending to become pregnant within three months of administration of CR8020 or placebo or males with female partners intending to become pregnant within three months of administration of CR8020 or placebo
- Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease or malignancy, as judged by the Investigator
- Eczema/Atopic Dermatitis: (Subjects with clinically mild eczema/atopic dermatitis may be included at the Investigator's discretion e.g. if there is no regular use of topical steroids, no eczema in cubital fossa)
- Psoriasis:(Subjects with active psoriasis affecting less than 5% of the body's surface area for the past five years can be included at the Investigator's discretion- (1% of the body area is roughly equivalent to the palm of the subject's hand). Patients with a history of completely resolved guttate psoriasis can be included)
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- Psychiatric: (Subjects with a diagnosis of a single mild or moderate depressive episode two or more years ago, with good evidence of preceding stressors and which resolved within approximately three months (i.e. reactive depression), may be included at the Investigator's discretion)
- Abnormal pulmonary function in the opinion of the Investigator as evidenced by clinically significant abnormalities on spirometry
- History or evidence of autoimmune disease or known immunodeficiency of any cause
- Subjects with any history of asthma, chronic obstructive pulmonary disease (COPD), pulmonary hypertension, reactive airway disease, or chronic lung condition of any aetiology (See No. 7 for asthma)
- Asthma (A history of childhood asthma before the age of 12 is acceptable provided the subject is asymptomatic without treatment. Patients with a single episode of wheezing after age 12 (lasting less than eight weeks) can be included at the Investigator's discretion)
- Positive human immunodeficiency virus (HIV), Hepatitis A (HAV), B (HBV), or C (HCV) test
- Any significant abnormality altering the anatomy of the nose or nasopharynx
- Any clinically significant history of epistaxis
- Any nasal or sinus surgery within six months of Viral Challenge
- Recurrent history of clinically significant autonomic dysfunction
- Any abnormal laboratory test or ECG which is deemed by the Investigator to be clinically significant
- Confirmed positive test for drugs of abuse deemed by the Investigator to be clinically significant
- Venous access deemed inadequate for the phlebotomy and cannulation demands of the study
- Known allergy to any of the following:
- excipients in the Challenge Virus inoculum
- any CR8020 excipients (sucrose, L-histidine L-histidine monohydrochloride, polysorbate 20)
- oseltamivir or other influenza treatments
- Health care workers (e.g. doctors, nurses, medical students and allied healthcare professionals) who work in units with severely immuno-compromised patients (e.g. bone marrow transplant units)
- Presence of household member or close contact(s) (for an additional two weeks after discharge from the isolation facility) who:
- has known immunodeficiency
- is receiving immunosuppressant medication
- is undergoing or soon to undergo cancer chemotherapy within 28 days of Viral Challenge
- has been diagnosed with emphysema, COPD, or other severe lung disease and resides in a nursing home
- has received a bone marrow or solid organ transplant
- Evidence of vaccinations within the four weeks prior to Human Viral Challenge. Intention to receive travel vaccination(s) before the Day 96 (± 5 days) Follow Up Visit
- Those employed or immediate relatives of those employed at Retroscreen Virology Limited or the Sponsor
- Receipt of blood or blood products, or loss (including blood donations) of 450 mL or more of blood, during the three months prior to Viral Challenge or planned donation/receipt throughout the course of the study
- Use of nasal steroids within 28 days prior to Viral Challenge Use of any other medication or product (prescription or over-the-counter), for symptoms of hay fever, rhinitis, nasal congestion or respiratory tract infection within seven days of Viral Challenge
- Receipt of any investigational drug within three months prior to Viral Challenge Prior participation in a clinical trial with the same strain of respiratory virus Participation in any other Human Viral Challenge study with a respiratory virus within one year prior to the day of Viral Challenge
- Receipt of systemic glucocorticoids, antiviral drugs, or immunoglobulins (Igs) or any other cytotoxic or immunosuppressive drug within six months prior to dosing, or receipt or any systemic chemotherapeutic agent at any time
- Previous receipt of monoclonal antibodies or monoclonal antibody fragments at any time
- Presence of significant respiratory symptoms existing on the day of challenge or between admission to the unit and inoculation with the Challenge Virus History suggestive of respiratory infection within 14 days prior to admission to the Quarantine Unit
- Any other finding that, in the opinion of the Investigator or Sponsor, deems the subject unsuitable for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Double-Blind, Placebo-Controlled, Phase IIa Study in Healthy Volunteers to Evaluate the Protective Efficacy and Safety of CR8020 in an Influenza Challenge Model
After prophylactic vaccination with CR8020, a monoclonal antibody, subjects will be challenged with the H3N2 virus. The protective efficacy, safety, tolerability, pharmacokinetics, and potential immunogenicity will be assessed.
- Conditions
- Influenza
- Being tested
- CR8020, Placebo
- Keywords
- Influenza, Virus, Monoclonal Antibody, Immunization, Treatment
- Medical subject headings
- Influenza, Human, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CR8020Biological
CR8020 15 mg/kg, administered by intravenous infusion
PlaceboBiological
Placebo (hydrous dextrose in water for injection), administered by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| CR8020 | Experimental | CR8020 administered as a single 2-hour intravenous infusion Receives: Biological: CR8020 |
| Placebo | Placebo comparator | Placebo administered as a single 2-hour intravenous infusion Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of viral load
Measured from the nasopharyngeal mucosa (by qPCR) post influenza virus challenge
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study start2 Oct 2013
- Primary completion22 Jan 2014
- Study completion22 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crucell Holland BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Retroscreen Virology Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938352
- Sponsor's protocol ID
- CR102595
- Other IDs
- CRU-CS-001, CR8020FLZ2002, 2013-002185-39
- Status last verified
- Mar 2019
- First submitted
- 5 Sep 2013
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-Blind, Placebo-Controlled, Phase IIa Study in Healthy Volunteers to Evaluate the Protective Efficacy and Safety of CR8020 in an Influenza Challenge Model
- ClinicalTrials.gov ID
- NCT01938352
- Acronym / sponsor ID
- CR102595
- Conditions
- Influenza
- Keywords
- Influenza, Virus, Monoclonal Antibody, Immunization, Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Crucell Holland BVIndustry (pharma, biotech, devices)
- Collaborators
- Retroscreen Virology Ltd.
- Study start
- 2 Oct 2013 (actual)
- Primary completion
- 22 Jan 2014 (actual)
- Study completion
- 22 Jan 2014 (actual)
- First posted
- 10 Sep 2013 (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.
After prophylactic vaccination with CR8020, a monoclonal antibody, subjects will be challenged with the H3N2 virus. The protective efficacy, safety, tolerability, pharmacokinetics, and potential immunogenicity will be assessed.
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 |
|---|---|---|
| CR8020 | Experimental | Biological: CR8020CR8020 administered as a single 2-hour intravenous infusion |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo administered as a single 2-hour intravenous infusion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Male and female subjects ≥ 18 and ≤ 45 years of age.
- In good health, with no major medical conditions from medical history, physical examination, and routine laboratory tests as determined by the Investigator at a screening evaluation.
- A total body weight ≥50 kg and a BMI of >18. If the BMI is above 28 the subject may be included if the waist measurement is less than 94 cm (male), or less than 80 cm (female).
- (a) Male subjects must use highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at entry to Quarantine until after the Day 96 (± 5 days) Follow-up Visit.
- True abstinence: When this is in line with the preferred and usual lifestyle of the subject. [Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
Key exclusion criteria (39 listed)
- Subjects who have a significant history of tobacco use at any time (≥ total 10 pack year history, e.g. one pack a day for 10 years)
- (a) Females who are pregnant or have been pregnant within six months prior to the study, or who have been breastfeeding within three months prior to screening. Females who have a positive pregnancy test at any point in the study will be withdrawn immediately.
- Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychiatric, renal, and/or other major disease or malignancy, as judged by the Investigator
- Abnormal pulmonary function in the opinion of the Investigator as evidenced by clinically significant abnormalities on spirometry
- History or evidence of autoimmune disease or known immunodeficiency of any cause
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 |
|---|---|---|
| CR8020CR8020 15 mg/kg, administered by intravenous infusion | Biological | CR8020 |
| PlaceboPlacebo (hydrous dextrose in water for injection), administered by intravenous infusion | Biological | Placebo |
Primary outcome
Area under the curve (AUC) of viral load
Time frame: Day 7
Measured from the nasopharyngeal mucosa (by qPCR) post influenza virus challenge
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 12 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 CR8020 in people with Influenza, run by Crucell Holland BV at 1 site in United Kingdom.
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 16 inclusion and 39 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 12 Apr 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 United Kingdom. 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?
Area under the curve (AUC) of viral load (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019; AzTrials last refreshed its copy on 8 Nov 2026.