New malaria vaccine vivaxin enters first human tests

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Non-pregnant women and men aged between 18 and 59 years; 2. Willingness to participate in the study and undergo all study procedures, as demonstrated by signing the informed consent form (ICF); 3. In good general health, as determined by medical examination; 4. Women of childbearing potential must agree to use an acceptable\* contraceptive method for at least 30 days prior to the first vaccination and for at least 6 months following administration of the first dose of the investigational product, ensuring at least 3 months after the final vaccine dose have elapsed; 5. Agreement not to donate blood during the course of study participation. * Acceptable contraceptive methods: * Barrier methods, including condom or cervical cap; * Surgically sterile partner/participant (including those who have undergone vasectomy, hysterectomy, bilateral oophorectomy, and/or tubal ligation) who is the sole sexual partner; * Intrauterine device (with or without hormones); * Hormonal birth control methods (oral, topical, injectable, or implantable); * True sexual abstinence that is consistent with the participant's preferred and usual lifestyle. Note: Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) or withdrawal (coitus interruptus) will not be considered acceptable methods. Exclusion Criteria: 1. Prior history of malaria infection confirmed by serological testing; 2. Prior history of malaria vaccination; 3. Intention to travel to a malaria-endemic area during the study period; 4. Pregnant or breastfeeding women, or those intending to become pregnant or breastfeed within the first 6 months of the study; 5. Evidence of clinically active disease, such as but not limited to: neurological, renal, cardiovascular, endocrine, pulmonary, hepatic, hematological, immunological, neoplastic, or infectious diseases; 6. Use of concomitant medication for control of an underlying medical condition; 7. Positive serological test for HBV, HCV, or HIV; 8. Any condition that, in the opinion of the study investigator, could pose a risk to the participant or confound the study results, including clinically stable chronic conditions such as diabetes, hypertension, or neuralgias, among others; 9. Psychiatric illness or cognitive impairment that, in the opinion of the investigator, may affect the participant's ability to comply with the clinical study schedule; 10. History of alcohol or substance abuse within 12 months prior to enrollment that resulted in family, medical, or occupational problems; 11. History of severe allergic reaction or anaphylaxis to any component of the vaccine; 12. History of asplenia; 13. Participation in any other investigational clinical trial within 12 months prior to inclusion in this study; 14. Plans to participate in other clinical trials concurrently with this study; 15. Use of any immunosuppressive therapy within 3 months prior to enrollment or plans to use such therapy within 3 months after vaccination, including corticosteroids or other immunosuppressive drugs. An immunosuppressive dose of corticosteroid is defined as the equivalent of 20 mg/day of prednisone for more than one week. Topical or nasal corticosteroids are not considered immunosuppressive; 16. Use of blood products (including blood or immunoglobulins) within 3 months prior to enrollment in this study, or plans to use them during the study period; 17. Suspected or confirmed fever (axillary temperature ≥ 37.8 °C) within 72 hours prior to study enrollment. Enrollment should be postponed until the participant has been afebrile for at least 72 hours; 18. Receipt of any live attenuated or inactivated vaccine within 28 or 14 days, respectively, prior to administration of the investigational product, or plans for immunization within 28 days after enrollment in the study.