Healthy Volunteers 18-45 - Experimental Malaria Vaccine - Baltimore MD

Summary:

The purpose of the study is to assess the safety and immune response to an experimental malaria vaccine given with or without an adjuvant (a substance that helps the vaccine work better). Presently, there are no malaria vaccines licensed in the U.S. Additionally, in a smaller group of participants, we will see if the vaccine is protective against malaria after participants are bitten by mosquitoes infected with malaria.  This includes 2 weeks of daily clinic visits to occur sometime next year. If malaria develops, you will be treated with a medication right away to cure the malaria. Another even smaller group (control group) will just receive the challenge and no vaccinations.

1.      You must be between the ages of 18 and 45.

2.      You must be in good health.

3.      You must be able and willing to provide written informed consent.

4.      You must be able to provide informed consent before any study procedures, correctly answers > 70 % on the post consent quiz and be available for all study visits.

5.      Females of childbearing potential and males must agree to practice highly effective contraception. Contraception must be practiced from 30 days before the time of enrollment until at least 30 days following either the third vaccine dose for those only receiving vaccinations or following the malaria challenge event for those participating in the mosquito challenge. Acceptable birth control methods include double barrier methods (condoms plus foam or spermicide, diaphragm plus foam or spermicide), licensed intrauterine devices (IUDs), intravaginal or intra/transdermal or oral hormonal methods initiated at least 30 days before inoculation or challenge, documented surgical sterilization via tubal ligation the essure procedure or hysterectomy, abstinence or a vasectomized partner). The contraceptive method should remain unchanged throughout the study participation.

1. You must agree not to travel to a malaria endemic region during the entire course of the trial.
2. You must be willing to avoid non-study related blood donation for the duration of participation in the study or until at least 1 year after receiving the last investigational vaccine, whichever is longer. 
3. You must be willing to avoid non-study related blood donation for 3 years following the challenge if in that group.  This is a Red Cross requirement.

9.      You must not have any history of malaria infection, or have traveled to a malaria endemic   region within 6 months before first vaccination.  

10.  You must not have a history of long-term residence (≥5 years) in an area known to have significant transmission of malaria.

1. You must not have a positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B surface antigen (HBsAg).
2. You must not have a positive sickle cell screening test or known hemoglobinopathy if you are in the groups being challenged with malaria-infected mosquitoes.

13.  You must not be currently or recently (within the last four weeks) have treatment with medicines by vein or oral corticosteroids (intranasal or inhaled steroids are acceptable), or other immunosuppressive agents, or chemotherapy.

1. You must not have had your spleen removed.
2. You must not have had a vaccination with a live vaccine within the 30 days before vaccination or with a inactivated vaccine within the 14 days days before vaccination.
3. You must not have a history of acute or chronic medical conditions including, but not limited to, disorders of the liver, kidney, lung, heart, nervous system, or other metabolic or autoimmune/inflammatory conditions.
4. You must not have had a severe allergic reaction in the past including those to mosquito bites, any vaccinations, adjuvants (used to boost the immune response to vaccines), Coartem (artemether-lumefantrine) or Malarone (atovaquone-proguanil).
5. You must not have a history of Guillain-Barré syndrome
6. You must not have severe asthma, as defined by an emergency room visit or hospitalization within the last 12 months.
7. You must not be a pregnant or breastfeeding woman or plan to become pregnant before day 115 in the vaccination only group; or before 30 days post-malaria challenge for those participating in the mosquito challenge.
8. You must not be currently participating in other investigational protocols or have received an investigational product within the previous 30 days.
9. You must not plan to receive an investigational product within 28 days following the last vaccination dose or malaria challenge.
10. You must not plan surgery 30 days before or after vaccination or malaria challenge.
11. You must not have history of drug or alcohol abuse within the last five years.
12. You must not have received blood or blood products in the previous six months or donated a unit of blood within two months before screening.
13. You must not have a history of schizophrenia, bipolar disorder or other psychiatric condition that makes study compliance difficult. 
14. You must not have a history of diabetes mellitus with the exception of pregnancy-induced diabetes
15. Abnormal screening ECG if you in the malaria challenge group.
16. You must not have received any vaccines for malaria or vaccines containing GLA-LSQ (the adjuvant used in this study) in the past.
17. You must not be using or planning to use any drug that may be used to treat malaria (examples include, trimethoprim-sulfamethoxazole, azithromycin, erythromycin, tetracycline, doxycycline, minocycline, clindamycin, ciprofloxacin, levofloxacin, norfloxacin, and rifampin) for 30 days before or after the malaria challenge, if in the challenge group.
18. You must not be using medications known to interact with artemether/lumefantrine or atovaquone/proguanil in the 28 days after malaria challenge, such as cimetidine, metoclopramide, antacids, and kaolin.
19. You must not have previously participated in a CHMI study.

Qualified Participants May Receive:

Compensation for outpatient visits and study procedures per group: 

Volunteers of cohort 1, 2, and 3 will receive up to $1266.00

Volunteers of cohort 4 and 5 will receive up to $2696.00 

Volunteers of cohort 6 (Control Group) will receive up to $1710.00.