Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates (NCT07703514)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Provision of signed and dated informed consent form before the initiation of any study procedures.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Non-pregnant healthy adults, aged 18 to 59 years of age, inclusive, at the time of enrollment.
4. In good general health as evidenced by medical history or diagnosed with stable chronic medical or psychiatric diagnoses or conditions.\* \*As determined by medical history, medications 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 study products. These medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, emergency room \[ER\] or urgent care for the condition \[excluding musculoskeletal conditions\], or invasive medical procedure and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication or dose 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 a 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. Participants may be on chronic or as-needed (prn) medications if, in the opinion of the site PI or appropriate sub-investigator, they pose no additional risk to participant safety or assessment of reactogenicity and immunogenicity, and do not indicate a worsening or treatment of continued symptoms of medical diagnosis or condition. Note: Low-dose topical corticosteroids as outlined in the Exclusion Criteria as well as herbals, vitamins, and supplements are permitted.
5. Oral temperature is less than 100.4 degrees Fahrenheit\*. \*Inclusion requirement at enrollment and prior to study product administration.
6. Heart rate (HR) is 55 to 100 beats per minute, inclusive\*. \*Screening heart rate 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.
7. 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.
8. 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.
9. BMI between 18 kilograms/square meter (kg/m\^2) (inclusive) and \<35 kg/m\^2 at screening
10. Females of childbearing potential\* must agree to true abstinence\*\* or use at least 1 acceptable primary form of contraception\*\*\*,\*\*\*\*
11. Not of childbearing potential - post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, salpingectomy, or Essure® placement with history of documented radiological confirmation test at least 90 days after the procedure). \*\*True abstinence is 100% of the time, no sexual intercourse (male's penis enters the female's vagina). (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods of contraception). \*\*\*Acceptable forms of primary contraception include monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the study product, tubal ligation, intrauterine devices, birth control pills, and injectable/implantable/insertable hormonal birth control products \*\*\*\*Must use at least one acceptable primary form of contraception for at least 30 days before screening and agreement to use such a method during study participation and for an additional 30 days after the end of last study product administration.
12. Females of reproductive potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours before the study product administration.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• University of Maryland, School of Medicine, Center for Vaccine Development and Global Health — Baltimore, Maryland

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.