A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Malaria

In brief

This is a randomized, dose-escalation Phase I/IIa trial to evaluate safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P. falciparum malaria in healthy malaria-naive adults. The multi-antigen malaria vaccine (designated BNT165e) is a combination of three distinct RNAs, BNT165c and BNT165d (composed of BNT165d1 and BNT165d2), encoding P. falciparum antigens encapsulated in lipid nanoparticles. The BNT165c RNA encodes the full Plasmodium falciparum circumsporozoite protein. The BNT165d1 and BNT165d2 RNAs both encode conserved, immunogenic segments of liver stage-expressed proteins.

Key facts

Study ID

NCT06069544

Run by

BioNTech SE

People needed

163

Starts

2023-11-13

Expected to finish

2026-03-20

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 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 IMP starting from Visit 0 and until 12 weeks after receiving Dose 3.
• Have not traveled and agree not to travel to a malaria-endemic region, as defined per Centers for Disease Control and Prevention (CDC) (https://www.cdc.gov/malaria/travelers/country_table/a.html) starting 6 months before Visit 0 and continuously until 28 days after receiving Dose 3.
• Negative human immunodeficiency virus -1 and -2 blood test result at Visit 0.
• Negative Hepatitis B surface antigen 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 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 VOCBP.
• VOCBP who agree to practice a highly effective form of contraception starting at Visit 0 and continuously until 90 days after receiving Dose 3.
• VOCBP who agree not to donate or cryopreserve 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 have not had a vasectomy and are sexually active with partners of childbearing potential and who agree to use condoms and to practice a highly effective form of contraception with their sexual partners of childbearing potential 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.

You may not qualify if…

• History of Plasmodium parasitemia (any species) based on volunteer-reported medical history.
• Prior residence for ≥6 months continuously in a malaria-endemic region as defined per CDC (https://www.cdc.gov/malaria/travelers/country_table/a.html) at any point during their lifetime.
• Breastfeeding or intending to become pregnant 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:
• 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 and 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.
• History of Diabetes mellitus type 1 or type 2, including cases controlled with diet alone or elevated hemoglobin A1C ≥6.5% at screening (not excluded: history of isolated gestational diabetes).
• Hypertension:
• If a person has a history of hypertension, or elevated blood pressure detected during screening, 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 screening and enrollment.
• Malignancy within 5 years of screening, excluding localized basal or squamous cell skin cancer.
• 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.
• An abnormal screening ECG (i.e., showing the corrected QT interval by Fridericia [QTcF] greater than 450 ms; significant ST-T wave changes suggestive of myocardial ischemia or of an acute or indeterminate-age myocardial infarction; left ventricular hypertrophy; any non-sinus rhythm including isolated premature ventricular contractions; complete right or left bundle branch block [QRS greater than 120 ms]; second-or third-degree atrioventricular block); or other clinically significant abnormalities on the ECG at the investigator's discretion.
• Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions).
• Seizure disorder: History of seizure(s) within the past 3 years or 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.

Where it is running

• AMR Tempe — Tempe, Arizona, United States
• University of Maryland, Center for Vaccine Development — Baltimore, Maryland, United States
• AMR Las Vegas — Las Vegas, Nevada, United States
• AMR Knoxville — Knoxville, Tennessee, United States
• Clinical Trials of Texas — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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