Flu Vaccine Self-Scheduler

Basic Criteria 

• Age 12 or older. For ages 12-17, parents must bring proof of guardianship or status 

• BMI ≥ 18 kg/m2  

• Weight ≥ 40 kg (88 lbs) 

• Previous participation in a Cidara study is NOT allowed 

• Stratum A: People at higher risk for flu complications due to chronic such as conditions chronic lung disease (such as COPD, chronic bronchitis, cystic fibrosis), daily asthma medication use, heart disease (such as congestive heart failure, coronary artery disease), insulin dependent diabetes, or kidney disease.

OR 

• Stratum B: People with compromised immune systems (due to cancer treatment, organ transplant, or immune-suppressing medications)
  • Has a solid tumor cancer and is receiving immunosuppressive treatment
  • Has blood cancer. (Key examples include leukemia, lymphoma, and multiple myeloma)
  • Had a transplant with at least one of the following- 

• • • had a solid organ transplant or hematopoietic cell transplant at least 6 months ago but within the last 2 years 

• • Have stable chronic graft-versus-host disease 

• • Is receiving immunosuppressive medicines (eg corticosteroids at last 20 mg prednisone or equivalent per day, alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, tumor-necrosis blockers, or other immunosuppressive biological agents (like for rheumetic disease) 

• • Has received chimeric antigen receptor-modified T-cell therapy 
  • Has received B-cell depleting therapies (eg rituximab, ocrelizumab, ofatumumab, alemtuzumab) within 12 months prior to screening 

• • Has a moderate or severe primary or secondary immunodeficiency 

• • Has advance or untreated HIV infection manifested by CD4 cell counts <350/mm within last 6 months 

Answers Must be NO 

• If female, are you currently pregnant, breast-feeding or planning to become pregnant during the study? Patients are allowed to participate if they agree to stop breastfeeding throughout the study. 

• In the past 14 days, have you received the current seasonal inactivated influenza vaccine or live attenuated influenza vaccine? 

• In the past 7 days, have had a fever of a 100.4°F or higher? 

• In the past 7 days, have you been in close contact with anyone diagnosed with flu or COVID-19, or anyone who has been treated with antiviral therapies for flu or COVID-19? 

• Any lifetime history of drug or alcohol abuse? 

• In the past 6 months have you been diagnosed with or had symptoms of flu? 

• Do you have any unstable psychiatric disorder, or have you had any suicidal attempts/thoughts in the past year? 

• In the past 4 weeks, have you had any major surgery, or do you have any upcoming surgery planned for the duration of the study? 

• Do you have untreated stage 4 or 5 kidney disease? Patients on dialysis may be allowed to participate at the discretion of the study doctor. 

• In the past 90days, have you received any experimental drug, vaccine, or biologic agent? 

• Are you currently participating or do you plan to participate in another clinical trial for the duration of this study? 

• In the past 30 days, have you received any drug for the prevention or treatment of flu? 

• In the past 21 days, have you received any formulation of immunoglobulin? 

• Do you have any clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder) or medical history of significant bleeding or bruising following intramuscular or subcutaneous injections or venipuncture? 

• Exception: Participants receiving apixaban or warfarin may be enrolled at the discretion of the investigator 

• In the past 30days, have you donated ≥ 450 mL of blood product (1 unit)? 

• Are you a staff member or related to anyone working at Cidara or Flourish San Antonio? 

• Do you have any known or suspected allergy or history of anaphylaxis or other serious adverse reactions to ZA (zanamavir) , mAbs (Monoclonal antibodies)   (including Fc domains), or any of the components of CD388 or placebo? 

Answers Must be YES 

• If female and of childbearing potential, do you agree to use one highly effective method of birth control through out the study and until 32 weeks after dose? 

• • Combined hormonal contraception: Oral, intravaginal, or transdermal 

• • Progestogen-only hormonal contraception: Oral, injectable, or implantable 

• • Intrauterine device (IUD) 

• • Intrauterine hormone-releasing system (IUS) 

• • Bilateral tubal occlusion/ligation 

• • Vasectomized male partner 

• • Sexual abstinence from heterosexual intercourse 

• If female, do you agree not to donate or freeze eggs (ova, oocytes) for future use from Day 1 until 32 weeks after study drug administration? 

• If male, do you agree to wear condoms from Day 1 until 32 weeks after study drug administration?  

• • If you have a female partner of childbearing potential, do you agree to additionally use a highly effective method of contraception? 

• If male, do you agree not to donate sperm from Day 1 until 32 weeks after study drug administration? 

• Are you able to read and sign consent, or have a caregiver or legal representative capable of doing so? 

• Are you willing to comply with all requirements of the study including completing questionnaires in e-diary? 

• Are you willing to refrain from donating blood or blood products from Day 1 until 32 weeks after study drug administration? 

• Do you have a valid method of identification and stable means of contact? 

Compensation may be available for time and travel

Insurance is not required 

PLEASE NOTE: If you do not see an available appointment, please call 210-714-0067 for availability