This was a prospective, randomized, double-blinded, multicenter Phase 3 clinical study investigating three Lots of VLA1553 at the final dose. Overall 409 healthy subjects aged 18 to 45 years were randomized into the study.
This was a prospective, randomized, double-blinded, multicenter Phase 3 clinical study investigating three Lots of VLA1553. Overall 409 healthy subjects aged 18 to 45 years were randomized into the study, approximately136 subjects per VLA1553 Lot. Subjects were block-randomized in a 1:1:1 ratio into the three study arms to receive one of three Lots of VLA1553 as a single i.m. vaccination. The primary objective was to demonstrate Lot-to-Lot manufacturing consistency of VLA1553 28 days following the single vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
409
Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
AMR Miami
Coral Gables, Florida, United States
AMR Fort Myers
Fort Myers, Florida, United States
St. Johns Center for Clinical Research
Ponte Vedra, Florida, United States
Geometric Mean Titer (GMT) of CHIKV-specific Neutralizing Antibodies as Determined by Microneutralization (μPRNT) Assay in Subjects Who Tested Negative for CHIKV Antibodies at Baseline
Time frame: On Day 29 after single vaccination
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers
Time frame: on Day 8, 85 and Month 6
Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects
Time frame: on Day 8, 29, 85 and Month 6
Proportion of Subjects With Seroconversion
Time frame: on Day 29, Day 85 and Month 6
Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Time frame: on Day 8, 29, 85 and Month 6
Proportion of Subjects Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold Increase in CHIKV-specific Neutralizing Antibody Titer Compared to Baseline
Time frame: up to Month 6
Frequency of Solicited Injection Site
Time frame: 10 days post vaccination
Frequency of Solicited Systemic Reactions
Time frame: 10 days post vaccination
Severity of Solicited Injection Site
Time frame: 10 days post vaccination
Severity of Solicited Systemic Reactions
Time frame: 10 days post vaccination
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AMR Wichita West
Wichita, Kansas, United States
AMR Lexington
Lexington, Kentucky, United States
Walter Reed Amy Institute of Research
Silver Spring, Maryland, United States
Alliance for Multispecialty Research (AMR)
Kansas City, Missouri, United States
Meridian Clinical Research
Omaha, Nebraska, United States
Wr-Crcn, Llc
Las Vegas, Nevada, United States
Rochester Clinical Research
Rochester, New York, United States
...and 2 more locations
Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination
Time frame: up to Day 29
Frequency of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination
Time frame: up to Day 29
Severity of Any Adverse Event During the Entire Study Period
Time frame: up to Month 6
Frequency of Any Adverse Event During the Entire Study Period
Time frame: up to Month 6
Frequency of Any Serious Adverse Event (SAE) During the Entire Study Period
Time frame: up to Month 6
Severity of Any Adverse Event of Special Interest (AESI)
AESI Definition: The following cluster of symptoms suggestive of CHIKV infection with or without remissions or exacerbations received particular consideration: 1. Fever (≥38.0°C \[100.4°F\] measured orally) and 2. Acute (poly)arthralgia/arthritis most frequently in the extremities (wrists, ankles, and phalanges, often symmetric), back pain and/or neurological symptoms (e.g. confusion, optic neuritis, meningoencephalitis, or polyneuropathy) and/or cardiac symptoms (e.g. myocarditis) or One or more of the following signs and symptoms: macular to maculopapular rash (sometimes with cutaneous pruritus \[foot plant\] and edema of the face and extremities), polyadenopathies; and 3. Onset of symptoms 2 to 21 days after vaccination and 4. Duration of event ≥3 days. Ongoing AESIs are monitored for entire study period
Time frame: within 2 to 21 days post-vaccination
Frequency of Any Adverse Event of Special Interest (AESI)
Time frame: Within 2 to 21 Days Post-vaccination