๐ฌIn plain words
What the trial is, and whether it could suit you
This protocol describes a clinical trial to develop and validate a Controlled Human Infection Model (CHIM) for influenza A/Arkansas/08/2020 (pH1N1). The study is designed to determine the optimal infectious dose of the pH1N1 challenge strain for use in future clinical trials evaluating influenza countermeasures. The study will enroll and challenge adult volunteers with the pH1N1 influenza virus challenge or sham inoculations. Given the adaptive design of this trial, the potential number of participants can vary. Depending on the pathway recommended by the PSRT and followed in the Trial Schema, the study population can range from around 30 to 99. The anticipated final sample size will be approximately 90 receiving pH1N1 challenge product plus and 6 persons receiving a sham inoculation. Participants will be pre-screened for health and for serological HAI antibody titers of \</1:40 against
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Provides signed and dated informed consent form prior to the initiation of any trial procedures.
2. Able to understand and agrees to comply with all planned trial procedures and to be available for all study visits.
3. Age \>/= 18 and \</= 55 years at time of enrollment.
4. Must agree to collection of venous blood and nasal absorption specimens per protocol and enrollment in DMID 19-0025 biorepository protocol for use of residual/repository research blood specimens.
5. In good general health.\*
\*Good health, as determined by medical history, medication use and physical examination to evaluate ongoing chronic medical or psychiatric diagnoses or conditions, defined as those that have been present for at least 90 days, which would not affect the assessment of the safety of participants or the immunogenicity of challenge. These medical diagnoses or conditions should be stable for the last 90 days -- no hospitalizations, emergency room or urgent care for condition (excluding musculoskeletal conditions). If a participant has an ongoing symptomatic condition for which they have had or have ongoing medical investigations but have not yet received a diagnosis or treatment plan, they may not be in good health, as determined by the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572. Participants may be on a medical intervention (such as device or medication) only if the condition or disease being treated is stable and not deteriorating, the medications are not listed in the Exclusion Criteria and treatment poses no additional risk to participant safety or assessment of adverse events. This also includes no change in prescription medication, dose, or frequency as a result of new symptoms or deterioration of the condition or disease being treated in the 30 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this inclusion criterion. Any change in prescription medication due to improvement of a condition or disease outcome (e.g., lowering of the dosage or frequency), as determined by the site Principal Investigator (PI) or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572, will not be considered a deviation of this inclusion criterion.
6. Able to take oral medication and willing to receive oseltamivir phosphate and/or baloxavir marboxil as part of the study.
7. Participants of childbearing potential\* agree to the use of acceptable forms of contraception\*\* for at least 30 days prior to enrollment and agree to use such a method during study participation.
\*Childbearing potential in a participant is defined as not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure(R) placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or \<1 year since last menses if menopausal.
\*\*Acceptable forms of primary contraception include true abstinence (100% of time no insertional sexual intercourse), or, if heterosexual intercourse is anticipated, monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to enrollment, intrauterine devices, birth control pills, condoms, and injectable/implantable/insertable/transdermal hormonal birth control products. Must use at least one acceptable form of contraception for at least 30 days prior to enrollment and through study completion.
8. Non-smoker or non-habitual smoker\* of tobacco, e-cigarettes, or marijuana
\*A non-habitual smoker is a person who smokes no more than four cigarettes, other tobacco products, e-cigarettes (to include vaping and Juul products), and/or marijuana in a week.
9. No self-reported or known history of alcoholism within the 2 years prior to enrollment.
10. No self-reported or known history of illicit drug use for at least 30 days prior to enrollment.
11. Agrees not to use the listed prescription or over the counter medications\* within 7 days prior to confinement and through the confinement period\*\*.
\*Oseltamivir, zanamivir, peramivir, baloxavir marboxil, amantadine, rimantadine, aspirin, intranasal steroids, decongestants, antihistamines, and non-steroidal anti-inflammatory drugs (NSAIDs)
\*\*An exception can be made with the approval of the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572
12. Screening pulse is 55 to 100 beats per minute, inclusive\*
\*Screening pulse values in the normal range or with grade 1 abnormalities deemed not clinically significant by the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572 are considered acceptable.
13. Screening systolic blood pressure is 90 to 140 mmHg, inclusive\*
\*Screening systolic blood pressure values in the normal range or with grade 1 abnormalities deemed not clinically significant by the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572 are considered acceptable.
14. Screening diastolic blood pressure is 55 to 90 mmHg, inclusive\*
\*Screening diastolic blood pressure values in the normal range or with grade 1 abnormalities deemed not clinically significant by the site PI or designated clinician licensed to make medical diagnoses and listed on Form FDA 1572 are considered acceptable.
15. Screening SpO2 \>/= 95 percent
16. Screening respiratory rate is \</= 16
17. Screening oral temperature is \<100.4 degrees Fahrenheit
18. Screening body mass index (BMI) \>/=18.5 and \<40 kg/m\^2 at screening 19 Screening
19. Screening lab test results are within acceptable parameters:\*
* White blood cell (WBC), Absolute lymphocyte