Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT04206332
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Able and willing to complete the informed consent process
2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
3. Available for clinical follow-up through the last study visit
4. 18 to 50 years of age
5. In good general health without clinically significant medical history
6. Physical examination without clinically significant findings within the 56 days prior to enrollment
7. Weight \<= 115 kg (for all groups except Groups 5, 10, and 16) and \< 100 kg for Group 15
8. Adequate venous access if assigned to an IV group or adequate subcutaneous tissue if assigned to an SC group
9. Willing to have blood samples collected, stored indefinitely, and used for research purposes
10. Agrees to participate in a controlled human malaria infection (CHMI) and to comply with post-CHMI follow-up requirements (except Group 4B)
11. Agrees to refrain from blood donation to blood banks for 3 years following participation in CHMI (except Group 4B)
12. Agrees not to travel to a malaria endemic region during the entire course of study participation
Laboratory Criteria within 56 days prior to enrollment:
13. White Blood Cell (WBC) 2,500-12,000/mm\^3
14. WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval
15. Platelets = 125,000 - 500,000/mm\^3
16. Hemoglobin within institutional normal range or accompanied by the PI or designee approval
17. Creatinine \<= 1.1 x upper limit of normal (ULN)
18. Alanine aminotransferase (ALT) \<= 1.25 x ULN
19. Negative for HIV infection by an FDA approved method of detection
Laboratory Criteria documented any time prior to enrollment:
20. Negative sickle cell screening test
21. Negative troponin test (except Group 4B)
22. Electrocardiogram (ECG) without clinically significant abnormalities (examples may include: pathologic Q waves, significant ST-T wave changes, left ventricular hypertrophy, any non-sinus rhythm excluding isolated premature atrial contractions, right or left bundle branch block, advanced A-V heart block). ECG abnormalities determined by a cardiologist to be clinically insignificant as related to study participation do not preclude study enrollment (except Group 4B)
23. No evidence of increased cardiovascular disease risk; defined as \>10% five-year risk by the non-laboratory method (except Group 4B)
Criteria Specific to Women:
24. Postmenopausal for at least 1 year, post-hysterectomy or bilateral oophorectomy, or if of childbearing potential:
1. Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on day of enrollment, and prior to product administration and CHMI, and
2. Agrees to use an effective means of birth control through the duration of study participation
* EXCLUSION CRITERIA:
1. Woman who is breast-feeding or planning to become pregnant during study participation
2. Previous receipt of a malaria vaccine
3. History of malaria infection
4. History of severe infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) defined per FDA guidance
5. Active SARS-CoV-2 infection
6. Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the study
7. Hypertension that is not well controlled
8. Receipt of any investigational study product within 28 days prior to enrollment (note: Emergency Use Authorization Coronavirus Disease 2019 (COVID-19) vaccine is not exclusionary)
9. Receipt of any live attenuated vaccines within 28 days prior to enrollment
10. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with intramuscular injections or blood draws
11. History of a splenectomy, sickle cell disease or sickle cell trait
12. History of skeeter syndrome or anaphylactic response to mosquito-bites (except Group 4B)
13. Known intolerance to chloroquine phosphate, atovaquone or proguanil (except Group 4B)
14. Use or planned use of any drug, including antibiotics, with antimalarial activity within 4 weeks prior to CHMI
15. History of psoriasis or porphyria, which may be exacerbated after treatment with chloroquine (except Group 4B)
16. Anticipated use of medications known to cause drug reactions with chloroquine or atovaquone-proguanil (Malarone) such as cimetidine, metoclopramide, antacids, and kaolin (except Group 4B)
17. Any other chronic or clinically significant medical condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer, including but not limited to: diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of: drug or alcohol abuse, asthma, autoimmune disease, psychiatric disorders, heart disease, or cancer
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04206332
Study Brief:
Protocol Section:
NCT04206332