This clinical study will evaluate the safety, tolerability and reactogenicity of mRNA-1893 Zika vaccines in flavivirus seronegative and flavivirus seropositive participants
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
120
Meridan Clinical Research
Omaha, Nebraska, United States
Benchmark Research
Austin, Texas, United States
Benchmark Research
Fort Worth, Texas, United States
Ponce School of Medicine - CAIMED Center
Ponce, Puerto Rico
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-First Vaccination
Solicited ARs (local and systemic) were collected in the daily diary. Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the first study vaccination only. A summary of all serious adverse events (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.
Time frame: Up to Day 7 after first vaccination (up to 8 days)
Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reaction (ARs)-Second Vaccination
Solicited ARs (local and systemic) were collected in the daily diary. Local ARs included: injection site pain, injection site erythema, and injection site induration/swelling. Systemic ARs included: body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, chills, and rash. Data for this outcome measure is reported up to 7 days after the second study vaccination only. A summary of all serious adverse events (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.
Time frame: Up to Day 7 after second vaccination (Day 29 to Day 36)
Number of Participants With Unsolicited Adverse Events (AEs)
An unsolicited AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent adverse event (TEAE) was as any AE not present before exposure to vaccine or any AE already present that worsened in intensity or frequency after exposure. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Time frame: Up to Day 392 (all AEs considered an SAE were collected till end of study [Day 392]; the Other AEs [non-SAE] were collected up to Day 57)
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Number of Participants With Adverse Event of Special Interest (AESI) and Serious Adverse Events (SAEs)
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions was a congenital anomaly/birth defect, or was an important medical event. AESIs included potentially immune-mediated medical conditions (autoimmune or autoinflammatory diseases) that may have the theoretical potential for association with novel vaccines. A summary of all SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Time frame: Day 1 to the end of study visit (up to Day 392)
Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Time frame: Day 1, 29, 57, Month 7 and 13
Geometric Mean Titer of Neutralizing Antibody in Initially Seronegative Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Time frame: Day 1, 29, 57, Month 7 and 13
Geometric Mean Titer of Neutralizing Antibody in Initially Seropositive Participants Against Zika Virus as Measured by Plaque Reduction Neutralization Test (PRNT50)
GMT 95% CI is calculated based on the t-distribution of the log-transformed values, then back transformed to the original scale for presentation.
Time frame: Day 1, 29, 57, Month 7 and 13
Percentage of Participants Who Seroconverted From Day 1 (Baseline) to Day 29, From Day 1 to Day 57, From Day 1 to Month 7, and From Day 1 to Month 13
Seroconversion is defined as a change of PRNT from below the lower limit of quantification (LLOQ) to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers.
Time frame: Day 1 (baseline) to Day 29, from Day 1 to Day 57, from Day 1 to Month 7, and from Day 1 to Month 13.
Number of Initially Seronegative Participants With a Seroresponse as Measured by Plaque Reduction Neutralization Test
Seroconversion is defined as a change of PRNT from below the LLOQ to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers.
Time frame: Day 29, Day 57, Month 7, and Month 13
Number of Initially Seropositive Participants With a 2-fold or 4-fold Increase in Neutralizing Antibody Titers as Compared With Baseline as Measured by Plaque Reduction Neutralization Test
Seroconversion is defined as a change of Plaque Reduction Neutralization Test from below the lower limit of quantification (LLOQ) to a PRNT equal to or above LLOQ for the assay, or a multiplication by at least 4 in participants with pre-existing PRNT titers.
Time frame: Day 29, Day 57, Month 7, and Month 13