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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05581641




Registration number
NCT05581641
Ethics application status
Date submitted
12/10/2022
Date registered
14/10/2022

Titles & IDs
Public title
Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
Scientific title
An Exploratory Phase I, Randomized, Observer-blind, Placebo-controlled Dose Escalation Trial Evaluating the Safety, Tolerability and Immunogenicity of an Investigational RNA-based Vaccine for Active Immunization Against Malaria
Secondary ID [1] 0 0
BNT165-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - BNT165b1
Other interventions - Placebo

Experimental: BNT165b1 - Escalating dose levels

Placebo comparator: Placebo -


Treatment: Other: BNT165b1
RNA vaccine for active immunization against malaria administered as intramuscular injection

Other interventions: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each dose
Timepoint [1] 0 0
Up to 7 days after each dose
Primary outcome [2] 0 0
Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever) recorded up to 7 days after each dose
Timepoint [2] 0 0
Up to 7 days after each dose
Primary outcome [3] 0 0
Proportion of participants with at least one adverse event (AE) occurring up to 28 days after each dose
Timepoint [3] 0 0
From Day 1 up to Day 211
Primary outcome [4] 0 0
Proportion of participants with at least one medically attended adverse event (MAAE) occurring up to 28 days after each dose
Timepoint [4] 0 0
From Day 1 up to Day 211
Primary outcome [5] 0 0
Proportion of participants in each cohort with at least one serious adverse event (SAE) occurring up to 24 weeks after Dose 3
Timepoint [5] 0 0
From Day 1 up to Day 351

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/09/2024
Sample size
Target
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Nevada
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BioNTech SE
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
BioNTech Responsible Person
Address 0 0
BioNTech SE
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05581641