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.
The trial had enrolled participants into three cohorts by dose level who were randomized 4:1 to BNT165b1: placebo. The trial used a staggered dose escalation schema with sentinel participants for Dose 1 in all cohorts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
60
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
Number of Participants With Solicited Local Reactions
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) and pre-listed (that is, solicited) in the e-diary. Solicited local reactions included: pain at the injection site, erythema/redness, and induration/swelling. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.
Time frame: Up to 7 days post any vaccination, and up to 7 days post each vaccination dose (i.e., post Dose 1 [at Day 8], Dose 2 [at Day 64] and Dose 3 [at Day 190])
Number of Participants With Solicited Systemic Reactions
A solicited reaction was defined as an adverse reaction observed and reported under the conditions (symptom and onset) pre-listed (i.e., solicited) in the e-diary. Solicited systemic reactions included: vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, and fever. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the specified doses.
Time frame: Up to 7 days post any vaccination, and up to 7 days post each vaccination dose (i.e., post Dose 1 [at Day 8], Dose 2 [at Day 64] and Dose 3 [at Day 190])
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a participant administered with a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. The intensity of AEs was graded by the investigator. Grades were defined as: Grade 1 - Mild; does not interfere with the trial participant's usual function; Grade 2 - Moderate; interferes to some extent with the trial participant's usual function; Grade 3 - Severe; interferes significantly with the trial participant's usual function and Grade 4 - Potentially life-threatening; life-threatening consequences, urgent intervention required. Participants may have been counted more than once if they reported multiple episodes of the event for the different doses.
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Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Time frame: Up to 28 days post any vaccination, and up to 28 days post each vaccination dose (i.e., post Dose 1 [at Day 29], Dose 2 [at Day 85] and Dose 3 [at Day 211])
Number of Participants With Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death and was life-threatening. It also included any event requiring hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, caused a congenital anomaly or birth defect, or any other event determined as SAE as per medical or scientific judgment.
Time frame: From Day 1 up to 24 weeks after Dose 3 (i.e., up to Day 351)
Number of Participants With Medically Attended Adverse Events (MAAEs)
MAAE was defined as an AE for which the participants received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits. Participants may have been counted more than once if they reported multiple episodes of the event for the different doses.
Time frame: Up to 28 days post any vaccination, and up to 28 days post each vaccination dose (i.e., post Dose 1 [at Day 29], Dose 2 [at Day 85], Dose 3 [at Day 211])