Safety and Immunogenicity of CJCV2 With and Without ALFQ

Inclusion Criteria

• Provide informed consent prior to initiation of any study procedures.
• Able to understand and comply with planned study procedures and be available for all study visits/safety communications.
• Non-pregnant/non-lactating subjects 18-50 years of age inclusive upon enrollment.
• In general, good health* to be safely enrolled in this study as determined by medical history, medication use**, and physical exam.

*Good health is defined by the absence of any exclusionary medical conditions. If the subject has another current, ongoing medical condition, the condition cannot meet any of the following criteria; 1) first diagnosed within 3 months of enrollment; 2) is worsening in terms of clinical outcome in last 6 months; or 3) involves need for medication that may pose a risk to subject's safety or impede assessment of AEs or immunogenicity if they participate in the study.

**Topical, nasal, and inhaled medications (with the exception of inhaled corticosteroids as outlined in the Subject Exclusion #17). Herbals, vitamins, and supplements are permitted.

• Oral temperature is less than 100.4 degrees F.
• Pulse is 50 to 100 beats per minute (bpm), inclusive.
• Systolic blood pressure (BP) is 90 to 140 mmHg, inclusive.
• Diastolic BP is 55 to 90 mmHg, inclusive.
• Body Mass Index(BMI) less than 40.
• Females of childbearing potential* may enroll if subject has practiced adequate contraception** > 30 days prior to enrollment and agrees to continue adequate contraception for the entire study.

*Child-bearing potential 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 of the last menses if menopausal.

**Adequate contraception includes; non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the first study vaccination, barrier methods such as condoms or diaphragms with spermicide, effective intrauterine devices, NuvaRing (R), and licensed hormonal methods such as implants, injectables, or oral contraceptives ("the pill").

• Females of childbearing potential must have a negative urine pregnancy test within 24 hours prior to enrollment.
• Agree not to participate in another interventional clinical trial during the study period that may affect the analysis or endpoint assessment.
• Negative urine drug screen for opiates.

Exclusion Criteria

• Have any disease or medical condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation*.

*Including acute or chronic disease or medical condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.

These include:

History of inflammatory bowel disease (IBD) (including ulcerative colitis, Crohn's disease, indeterminate colitis, or celiac disease). Within the past 12 months, has any of the following: irritable bowel syndrome (IBS) or any active uncontrolled gastrointestinal disorders or diseases as assessed by the investigator, including symptoms or evidence of active gastritis or gastroesophageal reflux disease, gastric surgery or gastric acid hyper-secretory disorders (e.g., Zollinger-Ellison syndrome), gastrointestinal obstruction, ileus, gastric retention, bowel perforation, toxic colitis, persistent infectious gastroenteritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection. History of immunodeficiency due to congenital or hereditary causes, underlying illness or tr