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Phase 2 N=74 Basic Science

Evaluation of Anti-Hemagglutinin (Anti-HA) Antibodies as Protection From the Flu in Healthy People

Influenza

Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Number of Patients With Mild to Moderate Influenza Disease (MMID) — 6; 29 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Ca/04/2009/H1N1r Challenge Virus (Biological)
Age
Adult · 18+ yrs
Sex
All
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion
Sep 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Patients With Mild to Moderate Influenza Disease (MMID)
6; 29
SECONDARY
Clinical Disease Severity Score
18; 21
SECONDARY
Duration of Shedding (Days)
0; 2
SECONDARY
Duration of Symptoms (Days)
4; 5.5
SECONDARY
Number of Symptoms
2; 4.5
SECONDARY
Number of Participants With Influenza Symptoms
20; 35

Summary

Background: - Researchers want to know if a certain type of antibody in the blood affects whether people get influenza (the flu). They will study 2 different groups with different levels of anti-HA antibodies and expose them to the flu virus. They will study how the flu develops in a healthy person. This may lead to future studies to develop new vaccines and treatments for the flu. Objective: - To study how people can be protected from flu infection. Eligibility: - Healthy volunteers 18 to 50 years of age. Design: * Participants will be screened through the use of a medical history, physical exam, and laboratory tests. * Groups of 7 participants will stay in an isolation unit in a hospital for at least 9 days with no visitors. * Participants will be screened again upon admission. They will also have: * ECG: soft electrodes will be stuck to the skin. A machine will record the heart s electrical signals. * Echocardiogram: a small probe will be held to the chest to take pictures of the heart. * Lung tests: participants will blow into a machine. * They will also have nasal fluid collected. This will be done either with a swab or with a tube of water washing out the nose. This will be done once every day. * The flu virus will be sprayed into the participant s nose. This will be done only once. * Participants will complete a questionnaire on day 1 and twice a day after that for 14 days. * A medical team will watch participants 24 hours a day. They will go home after 2 days of negative flu tests. * Participants will have 4 follow-up visits over 8 weeks.

Eligibility Criteria

-INCLUSION CRITERIA:

  • Greater than or equal to 18 and less than or equal to 50 years of age.
  • Agrees to not use tobacco products during participation in this study.
  • Willingness to remain in isolation for the duration of viral shedding (at a minimum 9 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 1 or more of the following: 1) male partner who is sterile prior to the female participant s entry into the study and is the sole sexual partner for the female participant; 2) implants of levonorgestrel; 3) injectable progestogen; 4) an intrauterine device with a documented failure rate of < 1%; 5) oral contraceptives; and 6) double barrier methods including diaphragm or condom with a spermicide.
  • Willing to have samples stored for future research.
  • Prechallenge serum hemagglutination inhibition (HAI) titer against the challenge virus of greater than or equal to 1:40 or less than or equal to 1:10 during a screening visit in protocol #11-I-0183
  • HIV uninfected.

EXCLUSION CRITEIRA:

  • 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., 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.
  • 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., asthma).
  • Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
  • Contacts who required medical follow-up or hospitalization during the past 5 years because of chronic metabolic disease (e.g., diabetes mellitus, renal dysfunction, hemoglobinopathies).
  • Immunosuppression or cancer.
  • Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
  • Individuals who are receiving long-term aspirin therapy.
  • Women who are pregnant or who are trying to become pregnant.
  • Individual with body mass index (BMI) less than or equal to 18.5 and greater than or equal to 40.
  • Smokes more than 4 cigarettes or other tobacco products on weekly basis.
  • Complete blood count (CBC) with differential outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
  • Chemistries in the acute care, mineral, and/or hepatic panels, and/or any of the following: lactate dehydrogenase, uric acid, creatine kinase, and total protein outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
  • Neutropenia below 1, 500 cells/mm(3) (Grade 2 or greater)
  • Urinalysis outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
  • Clinically significant abnormality on electrocardiogram.
  • Clinically significant abn
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01971255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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