Phase 2
N=74
Evaluation of Anti-Hemagglutinin (Anti-HA) Antibodies as Protection From the Flu in Healthy People
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT01971255 ↗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
| Outcome | Result | p-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
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.