Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria

Completed · Phase 1 · Has a placebo group

Conditions studied: Malaria

In brief

This first-in-human clinical trial, was a dose escalation multi-center trial designed to assess the safety, tolerability, and immunogenicity of the vaccine component, BNT165b1, a ribonucleic acid (RNA)-lipid nanoparticle (LNP) encoding for part of the Plasmodium falciparum circumsporozoite protein (PfCSP). BNT165b1 was evaluated at three dose levels (DLs) to select a safe and tolerable dose in a 3-dose schedule.

Key facts

Study ID: NCT05581641
Run by: BioNTech SE
People needed: 60
Starts: 2022-12-15
Expected to finish: 2024-09-06
Last updated by the study team: 2025-09-03

Who can join

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

You may qualify if…

Had given informed consent by signing and dating the informed consent form (ICF) before initiation of any trial-specific procedures
Were 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 were able to understand and follow trial-related instructions
Were aged 18 to 55 years, had a body mass index over 18.5 kg/m\^2 and under 35 kg/m\^2 and weighed at least 45 kg at Visit 0
Were 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, were included
Agreed not to enroll in another trial with an investigational medicinal product (IMP) starting from Visit 0 and until 12 weeks after receiving Dose 3
Agreed 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 was positive at Visit 0
Volunteers of childbearing potential (VOCBP) who had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test result at Visit 0 and negative urine pregnancy test results before each IMP administration. Volunteers born female who were postmenopausal or permanently sterilized were not considered VOBCP
VOCBP who agreed to practice a highly effective form of contraception and required 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 agreed 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 were sexually active with partners of childbearing potential and who did not have a vasectomy that agreed 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 were 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 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 greater than or equal to (>=) 6 months in a malaria endemic region
Were breastfeeding or had intended to become pregnant starting with Visit 0 and continuously until 90 days after receiving Dose 3 or fathered 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:
Used a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
Used high dose inhaled corticosteroids (per American Academy of Allergy Asthma \& Immunology), or
In the past year has had either of the following:
Greater than one exacerbation of symptoms treated with oral/parenteral corticosteroids;
Needed hospitalization, or intubation for asthma.
Diabetes mellitus type 1 or type 2, including cases controlled with diet alone (Not excluded: history of isolated gestational diabetes).
Hypertension:
If a person had been found to have elevated blood pressure or hypertension during screening or previously, they were excluded for blood pressure that is not well controlled. Well controlled blood pressure was defined as consistently less than or equal to (<=)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 did not have a history of elevated blood pressure or hypertension previously or during screening, also excluded for systolic blood pressure greater than (>)150 mm Hg at enrollment or diastolic blood pressure ≥100 mm Hg at enrollment.
Malignancy within 5 years of screening, excluding localized basal or squamous cell 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 was not considered relevant for participation in this trial in the investigator's judgment;
Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions);
Seizure disorder: History of seizure(s) within past 3 years. Also excluded if volunteer had 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.

Where it is running

Alliance for Multispecialty Research, LLC — Tempe, Arizona, United States
University of Maryland, Center for Vaccine Development — Baltimore, Maryland, United States
Alliance for Multispecialty Research, LLC — Las Vegas, Nevada, United States
Alliance for Multispecialty Research, LLC — Knoxville, Tennessee, United States
Clinical Trials of Texas, Inc. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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