| Eligibility |
Inclusion Criteria:
- Have given informed consent by signing and dating the informed consent form (ICF)
before initiation of any trial-specific procedures.
- Are willing and able to comply with scheduled visits, treatment schedule, laboratory
tests, lifestyle restrictions (e.g., to follow good practices to reduce their chances
of being infected or spreading Coronavirus Disease 2019 [COVID-19]), and other
requirements of the trial. This includes that they are able to understand and follow
trial-related instructions.
- Are aged 18 to 55 years, have a body mass index over 18.5 kg/m^2 and under 35 kg/m^2
and weigh at least 45 kg at Visit 0.
- Are healthy, in the clinical judgment of the investigator based on volunteer-reported
medical history data, and physical examination, 12-lead electrocardiogram (ECG), vital
signs, and clinical laboratory test outcomes at Visit 0.
- Note: Healthy volunteers with pre-existing stable disease (e.g., obesity,
hypertension), defined as disease not requiring significant change in therapy or
hospitalization for worsening disease during the 90 days before Visit 0, can be
included.
- Agree not to enroll in another trial with an investigational medicinal product (IMP)
starting from Visit 0 and until 12 weeks after receiving Dose 3.
- Agree not to travel to a malaria endemic region starting from Visit 0 and until 28
days after Dose 3, as defined per CDC (Centers for Disease Control and Prevention).
- Negative human immunodeficiency virus (HIV) -1 and -2 blood test result at Visit 0.
- Negative severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) antigen
test result at Visit 0.
- Negative hepatitis B surface antigen (HBsAg) test result at Visit 0 and negative anti
Hepatitis C virus (anti-HCV) antibodies, or negative HCV polymerase chain reaction
test result if the anti-HCV is positive at Visit 0.
- Volunteers of childbearing potential (VOCBP) that have a negative serum beta human
chorionic gonadotropin (ß-HCG) pregnancy test result at Visit 0 and negative urine
pregnancy test results before each IMP administration. Volunteers born female who are
postmenopausal or permanently sterilized will not be considered VOBCP.
- VOCBP who agree to practice a highly effective form of contraception and to require
their male sexual partners to use condoms with a spermicidal agent, starting at Visit
0 and continuously until 90 days after receiving Dose 3.
- VOCBP who agree not to donate eggs (ova, oocytes) for the purposes of assisted
reproduction during trial, starting at Visit 0 and continuously until 90 days after
receiving Dose 3.
- Men who are sexually active with partners of childbearing potential and who have not
had a vasectomy that agree to use condoms with a spermicidal agent and to practice a
highly effective form of contraception with their sexual partners born female during
the trial, starting at Visit 0 and continuously until 90 days after receiving Dose 3.
- Men who are willing to refrain from sperm donation, starting at Visit 0 and
continuously until 90 days after receiving Dose 3.
Exclusion Criteria:
- History of malaria infection (any species) based on volunteer-reported medical
history.
- Travel to a malaria endemic region starting 6 months before Visit 0 and continuously
until 28 days after receiving Dose 3, as defined per CDC.
- Prior residence for =6 months in a malaria endemic region.
- Breastfeeding or intending to become pregnant starting with Visit 0 and continuously
until 90 days after receiving Dose 3 or to father children starting with Visit 0 and
continuously until 90 days after receiving Dose 3.
- History of any serious adverse reactions to vaccines or to vaccine components such as
lipids, and including history of anaphylaxis and related symptoms such as hives,
respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from
participation: a volunteer who had an anaphylactic adverse reaction to pertussis
vaccine as a child).
- Current or history of the following medical conditions:
1. Uncontrolled or moderate or severe respiratory diseases (e.g., asthma, chronic
obstructive pulmonary disease); symptoms of asthma severity as defined in the US
National Asthma Education and Prevention Program Expert Panel report, 2020 -
e.g., exclude a volunteer who:
- Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
- Uses high dose inhaled corticosteroids (per American Academy of Allergy
Asthma & Immunology), or
- In the past year has either of the following:
- Greater than one exacerbation of symptoms treated with oral/parenteral
corticosteroids;
- Needed hospitalization, or intubation for asthma.
2. Diabetes mellitus type 1 or type 2, including cases controlled with diet alone
(Not excluded: history of isolated gestational diabetes).
3. Hypertension:
- If a person has been found to have elevated blood pressure or hypertension
during screening or previously, exclude for blood pressure that is not well
controlled. Well controlled blood pressure is defined as consistently =140
mm Hg systolic and =90 mm Hg diastolic, with or without medication, with
only isolated, brief instances of higher readings, which must be =150 mm Hg
systolic and =100 mm Hg diastolic at enrollment.
- If a person does not have a history of elevated blood pressure or
hypertension previously or during screening, also exclude for systolic blood
pressure >150 mm Hg at enrollment or diastolic blood pressure =100 mm Hg at
enrollment.
4. Malignancy within 5 years of screening, excluding localized basal or squamous
cell cancer;
5. Any current or history of cardiovascular diseases, (e.g., myocarditis,
pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or
clinically significant arrhythmias), unless such disease is not considered
relevant for participation in this trial in the investigator's judgment;
6. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy,
or platelet disorder requiring special precautions);
7. Seizure disorder: History of seizure(s) within past 3 years. Also exclude if
volunteer has used medications in order to prevent or treat seizure(s) at any
time within the past 3 years.
- Documented major psychiatric illness, including bipolar disorder, major depressive
disorder, schizophrenia, autism, and attention deficit-hyperactivity disorder that at
the discretion of the investigator could interfere with participation and follow-up as
outlined by the trial.
- The following diseases associated with immune dysregulation:
- Primary immunodeficiencies.
- History of solid organ or bone marrow transplantation.
- Asplenia: any condition resulting in the absence of a functional spleen.
- Currently existing or history of autoimmune disease including and not limited to
thyroid autoimmune disease, multiple sclerosis, psoriasis, etc.
- Previous vaccination with an approved or investigational malaria vaccine at any time
or having taken part in a human malaria challenge study.
- Receipt of any investigational product within 28 days before Visit 0.
- Any planned non-trial vaccinations starting at Visit 0 and continuously until Visit 11
(28 days after Dose 3).
- Note: Seasonal influenza and COVID-19 vaccines are allowed; however, they should
be administered at least 14 days before or after any IMP injection.
- Received blood/plasma products or immunoglobulin within 120 days before Visit 1 or
planned administration starting at Visit 0 and continuously until Visit 12.
- Received allergy treatment with antigen injections within 28 days before first IMP
administration or that are scheduled within 14 days after Visits 1, 5 and 9.
- Current or planned treatment with immunosuppressive therapy, including systemic
corticosteroids (if systemic corticosteroids are administered for =14 days at a dose
of =20 mg/day of prednisone or equivalent) starting at Visit 0 and continuously until
Visit 11 (28 days after Dose 3). Intraarticular, intrabursal, or topical (skin or
eyes) corticosteroids are permitted.
- Have a history of alcohol abuse or drug addiction within 1 year before Visit 0 or have
a history (within the past 5 years) of substance abuse which in the opinion of the
investigator, could compromise their wellbeing if they participate as participants in
the trial, or that could prevent, limit, or confound the protocol-specified
assessments.
- Any existing condition which may affect vaccine injection and/or assessment of local
reactions assessment at the injection site, e.g., tattoos, severe scars, etc.
- Are vulnerable individuals as per International Council for Harmonization (ICH) E6
definition, i.e., are individuals whose willingness to volunteer in a clinical trial
may be unduly influenced by the expectation, whether justified or not, of benefits
associated with participation, or of a retaliatory response from senior members of a
hierarchy in case of refusal to participate.
- Any screening hematology and/or blood chemistry laboratory value that meets the
definition of a Grade =2 abnormality or of Grade 1 at the investigator's discretion at
Visit 0. Individuals with abnormal but not clinically significant parameters not
included in the toxicity guidance may be considered eligible at the discretion of the
investigator.
- Current febrile illness (body temperature =38.0°C/=100.4°F) or febrile illness within
48 hours of Visit 0.
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