A Phase 1 interventional study of VAL-181388 and Placebo in Chikungunya Virus, sponsored by ModernaTX, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-10.
Sponsored by ModernaTX, Inc. · Phase 1, Interventional, and Prevention
This clinical study will assess the safety, tolerability, and immunogenicity of VAL-181388 in healthy participants.
Exclusion Criteria:
Biological: VAL-181388
Other: Placebo
Escalating dose levels
Saline
Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events)
Solicited AEs, including local and systemic AEs were recorded by participants daily using the memory aid. Solicited local AEs include injection site induration/swelling, injection site tenderness, injection site erythema/redness, and injection site pain. Solicited systemic AEs include body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, and diarrhea. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Time frame: 7 days following each vaccination
Part A: Number of Participants With Unsolicited AEs
An 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 AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Time frame: 28 days following each vaccination
Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest
An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AEs of special interest were evaluated as defined in the protocol. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Time frame: 28 days following each vaccination
Part B: Number of Participants With SAEs and AEs of Special Interest
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AEs of special interest were evaluated as defined in the protocol. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Time frame: Through 1 year following the last vaccination
| Milestone | VAL-181388 Dose A | VAL-181388 Dose B | VAL-181388 Dose C | Placebo |
|---|---|---|---|---|
| Started | 15 | 15 | 15 | 15 |
| Received vaccination 1 | 15 | 15 | 15 | 15 |
| Received vaccination 2 | 15 | 14 | 14 | 15 |
| Completed | 15 | 15 | 15 | 15 |
| Not completed | 0 | 0 | 0 | 0 |
| Milestone | VAL-181388 Dose A | VAL-181388 Dose B | VAL-181388 Dose C | Placebo |
|---|---|---|---|---|
| Started | 15 | 15 | 15 | 15 |
| Completed | 13 | 13 | 15 | 13 |
| Not completed | 2 | 2 | 0 | 2 |
| Withdrew: Lost to follow-up | 2 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 |
| Withdrew: Other than specified | 0 | 1 | 0 | 2 |
Solicited AEs, including local and systemic AEs were recorded by participants daily using the memory aid. Solicited local AEs include injection site induration/swelling, injection site tenderness, injection site erythema/redness, and injection site pain. Solicited systemic AEs include body temperature (oral), generalized myalgia (muscle ache or pain), generalized arthralgia (joint ache or pain), headache, fatigue/malaise (unusual tiredness), nausea/vomiting, and diarrhea. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
| Participants | VAL-181388 Dose A: Vaccination 1 | VAL-181388 Dose A: Vaccination 2 | VAL-181388 Dose B: Vaccination 1 | VAL-181388 Dose B: Vaccination 2 | VAL-181388 Dose C: Vaccination 1 | VAL-181388 Dose C: Vaccination 2 | Placebo: Vaccination 1 | Placebo: Vaccination 2 |
|---|---|---|---|---|---|---|---|---|
| Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events) | 11 | 10 | 11 | 10 | 13 | 12 | 7 | 5 |
An 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 AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
| Participants | VAL-181388 Dose A: Vaccination 1 | VAL-181388 Dose A: Vaccination 2 | VAL-181388 Dose B: Vaccination 1 | VAL-181388 Dose B: Vaccination 2 | VAL-181388 Dose C: Vaccination 1 | VAL-181388 Dose C: Vaccination 2 | Placebo: Vaccination 1 | Placebo: Vaccination 2 |
|---|---|---|---|---|---|---|---|---|
| Part A: Number of Participants With Unsolicited AEs | 4 | 3 | 6 | 3 | 3 | 6 | 8 | 6 |
An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner (HCP). An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AEs of special interest were evaluated as defined in the protocol. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
| Participants | VAL-181388 Dose A: Vaccination 1 | VAL-181388 Dose A: Vaccination 2 | VAL-181388 Dose B: Vaccination 1 | VAL-181388 Dose B: Vaccination 2 | VAL-181388 Dose C: Vaccination 1 | VAL-181388 Dose C: Vaccination 2 | Placebo: Vaccination 1 | Placebo: Vaccination 2 |
|---|---|---|---|---|---|---|---|---|
| SAEs | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Medically-Attended AEs | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| AEs of Special Interest | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AEs of special interest were evaluated as defined in the protocol. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
| Participants | VAL-181388 Dose A | VAL-181388 Dose B | VAL-181388 Dose C | Placebo |
|---|---|---|---|---|
| SAEs | 0 | 0 | 1 | 0 |
| AEs of Special Interest | 0 | 0 | 0 | 0 |
Collected over Through 1 year following the last vaccination. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part A - VAL-181388 Dose A: Vaccination 1 | 0/15 (0%) | 0/15 (0%) | 4/15 (26.7%) |
| Part A - VAL-181388 Dose A: Vaccination 2 | 0/15 (0%) | 0/15 (0%) | 3/15 (20%) |
| Part A - VAL-181388 Dose B: Vaccination 1 | 0/15 (0%) | 0/15 (0%) | 6/15 (40%) |
| Part A - VAL-181388 Dose B: Vaccination 2 | 0/14 (0%) | 0/14 (0%) | 3/14 (21.4%) |
| Part A - VAL-181388 Dose C: Vaccination 1 | 0/15 (0%) | 0/15 (0%) | 3/15 (20%) |
| Part A - VAL-181388 Dose C: Vaccination 2 | 0/14 (0%) | 1/14 (7.1%) | 6/14 (42.9%) |
| Part A - Placebo: Vaccination 1 | 0/15 (0%) | 0/15 (0%) | 8/15 (53.3%) |
| Part A - Placebo: Vaccination 2 | 0/15 (0%) | 0/15 (0%) | 6/15 (40%) |
| Part B - VAL-181388 Dose A | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Part B - VAL-181388 Dose B | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Part B - VAL-181388 Dose C | 0/15 (0%) | 1/15 (6.7%) | 0/15 (0%) |
| Part B - Placebo | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Event | Part A - VAL-181388 Dose A: Vaccination 1 | Part A - VAL-181388 Dose A: Vaccination 2 | Part A - VAL-181388 Dose B: Vaccination 1 | Part A - VAL-181388 Dose B: Vaccination 2 | Part A - VAL-181388 Dose C: Vaccination 1 | Part A - VAL-181388 Dose C: Vaccination 2 | Part A - Placebo: Vaccination 1 | Part A - Placebo: Vaccination 2 | Part B - VAL-181388 Dose A | Part B - VAL-181388 Dose B | Part B - VAL-181388 Dose C | Part B - Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aspartate aminotransferase increasedInvestigations | 0/15 | 0/15 | 0/15 | 0/14 | 0/15 | 1/14 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 |
| Fibula fractureInjury, poisoning and procedural complications | 0/15 | 0/15 | 0/15 | 0/14 | 0/15 | 0/14 | 0/15 | 0/15 | 0/15 | 0/15 | 1/15 | 0/15 |
| Event | Part A - VAL-181388 Dose A: Vaccination 1 | Part A - VAL-181388 Dose A: Vaccination 2 | Part A - VAL-181388 Dose B: Vaccination 1 | Part A - VAL-181388 Dose B: Vaccination 2 | Part A - VAL-181388 Dose C: Vaccination 1 | Part A - VAL-181388 Dose C: Vaccination 2 | Part A - Placebo: Vaccination 1 | Part A - Placebo: Vaccination 2 | Part B - VAL-181388 Dose A | Part B - VAL-181388 Dose B | Part B - VAL-181388 Dose C | Part B - Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 2/15 | 0/15 | 3/15 | 0/14 | 1/15 | 0/14 | 1/15 | 1/15 | 0/15 | 0/15 | 0/15 | 0/15 |
| Injection site haemorrhageGeneral disorders | 0/15 | 0/15 | 1/15 | 0/14 | 0/15 | 0/14 | 2/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/15 | 0/15 | 0/15 | 0/14 | 0/15 | 0/14 | 2/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 |
| Injection site rashGeneral disorders | 0/15 | 0/15 | 0/15 | 0/14 | 0/15 | 1/14 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 |
| NauseaGastrointestinal disorders | 0/15 | 0/15 | 0/15 | 0/14 | 0/15 | 1/14 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 |
| Lipase increasedInvestigations | 0/15 | 0/15 | 1/15 | 0/14 | 0/15 | 1/14 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 |
| Alanine aminotransferase increasedInvestigations | 0/15 | 0/15 | 0/15 | 0/14 | 0/15 | 1/14 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 |
| Blood pressure diastolic increasedInvestigations | 0/15 | 0/15 | 0/15 | 1/14 | 0/15 | 0/14 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 |
| Blood pressure increasedInvestigations | 0/15 | 0/15 | 0/15 | 0/14 | 0/15 | 1/14 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 |
| Blood pressure systolic increasedInvestigations | 0/15 | 0/15 | 0/15 | 1/14 | 0/15 | 0/14 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 | 0/15 |
The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).
| Age, Continuous(years) | VAL-181388 Dose A | VAL-181388 Dose B | VAL-181388 Dose C | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 32.1 ± 8.45 | 33.0 ± 6.76 | 32.2 ± 8.46 | 29.1 ± 5.18 | 31.6 ± 7.30 |
| Sex: Female, Male(Participants) | VAL-181388 Dose A | VAL-181388 Dose B | VAL-181388 Dose C | Placebo | Total |
|---|---|---|---|---|---|
| Female | 7 | 9 | 10 | 8 | 34 |
| Male | 8 | 6 | 5 | 7 | 26 |
| Ethnicity (NIH/OMB)(Participants) | VAL-181388 Dose A | VAL-181388 Dose B | VAL-181388 Dose C | Placebo | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 1 | 1 | 7 |
| Not Hispanic or Latino | 12 | 13 | 14 | 14 | 53 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | VAL-181388 Dose A | VAL-181388 Dose B | VAL-181388 Dose C | Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 0 | 0 | 1 |
| Asian | 0 | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 1 | 1 |
| Black or African American | 7 | 6 | 7 | 6 | 26 |
| White | 7 | 7 | 7 | 7 | 28 |
| More than one race | 0 | 1 | 1 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 1 |
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ModernaTX, Inc.