Efficacy and Safety of CR6261 in an H1N1 Influenza Healthy Volunteer Human Challenge Model

NCT02371668 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 15006915-I-0069
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Researchers want to see if a new drug reduces flu disease in people treated with this drug versus a placebo. The drug has an antibody that may help the immune system fight the flu. Placebo is only sugar and water. All participants will get the flu virus. They may or may not develop flu symptoms. Objective: \- To see if the drug CR6261 reduces flu disease in people treated with this drug versus a placebo. Eligibility: \- Healthy nonsmokers ages 18 45. Design:

• Participants will be screened under a separate protocol.
• Participants must use contraception or abstinence for several weeks before and after the study. They must have no alcohol for 1 day before each visit. Any medicine must be approved by the study doctor until after follow-up.
• Participants will stay in a hospital isolation unit for at least 10 days.
• They will have:
• Medical history
• Physical exam
• Blood and urine tests
• Heart and lung test
• Tests for drugs and alcohol
• Throughout their stay, participants will:
• Be closely watched by a medical team
• Have nasal washes and swabs several times a day
• Participants will have the flu virus sprayed in each nostril.
• The next day, participants will get either study drug or placebo through a soft plastic tube placed in a vein by needle. It will take 2 hours. They will not know which they get.
• Participants can go home after 10 days if they test negative for the flu 2 days in a row.
• Participants will have daily questionnaires at home and 2 follow-up visits over 2 months.

Conditions

H1N1 Influenza Healthy Volunteers

Keywords

Influenza A; H1N1; Challenge Model; Human Immunoglobulin and H1N1; Efficacy and Safety in H1N1

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve (AUC) of Viral Shedding

  Area under the curve (AUC) calculated from quantitative real-time RT-PCR for influenza A taken from 3 time per day nasal swab collection.

  3 times a day for 10 days

Secondary Outcomes (8)

• Confirmed Influenza Infection

  Evaluated daily for 10 days + 8 weeks convalescent follow up

• Days of Shedding

  Evaluated for up to 2 months

• Days of Symptoms

  Evaluated for up to 2 months

• Mild to Moderate Influenza Disease

  Evaluated daily for 10 days

• Number of Symptoms

  Evaluated for up to 2 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo, 5% dextrose (D-glucose) water

Biological: Placebo

CR6261

EXPERIMENTAL

CR6261, Investigational monoclonal antibody against influenza A viruses

Biological: CR6261

Interventions

CR6261 BIOLOGICAL

50 mg/kg administered as a single 2-hour intravenous infusion on Day 1 (24 hours after virus administration).

CR6261

Placebo BIOLOGICAL

Administered as a single 2-hour intravenous infusion on Day 1 (24 hours after virus administration).

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Greater than or equal to 18 and less than or equal to 45 years of age.
• Non-smoker.
• Willingness to remain in isolation for the duration of viral shedding (at a minimum 10 days) and to comply with all study requirements.
• A female participant is eligible for this study if she is not pregnant or breast feeding and 1 of the following:
• Of nonchildbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in greater than or equal to 1 year).
• Of childbearing potential but agrees to practice effective contraception or abstinence for 4 weeks prior to and 8 weeks after administration of the influenza challenge virus. Acceptable methods of contraception include a male partner who is sterile and is the sole sexual partner of the female participant or a male partner who uses a condom with spermicide plus 1 or more of the following: 1) implants of levonorgestrel; 2) injectable progestogen; 3) an intrauterine device with a documented failure rate of \<1%; 4) oral contraceptives; and 5) double barrier method including diaphragm.
• Willing to have samples stored for future research.
• Prechallenge serum HAI titer against the challenge virus less than or equal to 1:10 within 60 days of admission for the study.
• HIV uninfected confirmed by testing within 60 days of admission for the study.
• Agrees to abstain from alcohol intake 24 hours before admission on Day -1, during the inpatient period of the study, and 24 hours prior to all other outpatient clinic visits.
• Agrees to not use over-the-counter medications (including aspirin, decongestants, antihistamines, and other NSAIDs), and herbal medication (including, but not limited to, herbal tea, St. John s Wort), within 14 days prior to study drug administration through the final follow-up visit, unless approved by the investigator.

You may not qualify if:

• Presence of self-reported or medically documented significant medical condition including but not limited to:
• Chronic pulmonary disease (e.g., asthma, emphysema).
• Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
• Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., insulin dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
• Immunosuppression or ongoing malignancy.
• Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
• Postinfectious or postvaccine neurological sequelae.
• Hyperlipidemia requiring medical therapy per current American College of Cardiology (ACC) and American Heart Association (AHA) guidelines published in 2013.
• Have close or household (i.e., share the same apartment or house) high-risk contacts including but not limited to:
• Persons greater than or equal to 65 years of age.
• Children less than or equal to 5 years of age.
• Residents of nursing homes.
• Persons of any age with significant chronic medical conditions such as:
• Chronic pulmonary disease (e.g., severe asthma, COPD).
• Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Han A, Czajkowski L, Rosas LA, Cervantes-Medina A, Xiao Y, Gouzoulis M, Lumbard K, Hunsberger S, Reed S, Athota R, Baus HA, Lwin A, Sadoff J, Taubenberger JK, Memoli MJ. Safety and Efficacy of CR6261 in an Influenza A H1N1 Healthy Human Challenge Model. Clin Infect Dis. 2021 Dec 6;73(11):e4260-e4268. doi: 10.1093/cid/ciaa1725.

  PMID: 33211860 DERIVED

Results Point of Contact

• Title: Memoli, Matthew
• Organization: National Institute of Allergy and Infectious Diseases

mm982v@nih.gov

+1 301 443 5971

Study Officials

• Matthew J Memoli, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2015
• First Posted: February 26, 2015
• Study Start: February 25, 2015
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: March 17, 2020
• Results First Posted: February 17, 2020

Record last verified: 2018-11-30

Locations

US (1)