A Clinical Trial of COVAC-2 in Adults

Inclusion Criteria

• •1. Generally healthy male and female adults aged 18 years of age or older at the time of signing the informed consent form;
• •2. Good general health as determined by screening evaluation not greater than 30 days before injection of first dose;
• •Note: Participants who are overtly healthy as determined by medical evaluation or are considered medically stable according to the judgment of the investigator. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalisation for worsening disease during the 3 months prior to enrolment, and/or hospitalization within the entire study period is not anticipated. Also, the participant appears likely to be able to remain in follow-up through the end of protocol-specified period. Mild to moderate well-controlled comorbidities are allowed.
• •3. If female of child-bearing potential and heterosexually active, practice of adequate contraception for 30 days prior to injection, negative pregnancy test on the day of injection, and agreement to continue adequate contraception until 180 days after the second injection;
• •4. Male participants are eligible to participate in the study if they agree to the following requirements during the study period and for at least 28 days after the last injection of study dose, i.e.,
• •o Be abstinent from any heterosexual intercourse with a female of childbearing potential as their preferred and usual lifestyle.
• •OR
• •o Must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person. In addition to male condom use, a highly effective method of contraception should be considered in women of child-bearing potential partners of male participants.
• •AND
• •o Must refrain from donating sperm; and
• •5. Written informed consent, after review of the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee and pass the "Test of Understanding" (up to 3 attempts). For participants who cannot read or write, the consent must be witnessed by a literate third party not involved in study conduct.