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CompletedNCT03325075Updated Jun 10, 2024Results posted

Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Participants

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

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
All
01

Study summary

This clinical study will assess the safety, tolerability, and immunogenicity of VAL-181388 in healthy participants.

02

Conditions studied

  • Chikungunya Virus

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Keywords

  • VAL-181388
  • Chikungunya vaccine
03

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18 to 49 years of age
  • Body mass index between 18 and 35 kilograms (kg)/square meter (m\^2)
  • In good health as determined by medical history
  • Female participants must be non pregnant and non lactating and meet one of the following criteria: a) post menopausal b) surgically sterile, or c) of childbearing potential and agree to use an adequate contraception method
  • Male participants must use an acceptable method of birth control through 3 months after the final vaccination
  • Agrees to comply with the study procedures and provides written informed consent
  • Has access to a consistent and reliable means of telephone contact and agrees to stay in contact with the study site for the duration of the study

Exclusion criteria

Exclusion Criteria:

  • Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care
  • Female of childbearing potential and has a positive pregnancy test at screening or on the day of vaccination
  • Abnormal vital signs or screening safety laboratory test results including liver enzyme tests
  • Administration of an investigational product within 60 days, or 5 half-lives, whichever is longer
  • Administration of any live attenuated vaccines within 4 weeks before enrollment or inactive vaccines within 2 weeks before enrollment, or plans to receive any vaccine during the active vaccination period
  • Prior administration of a vaccine for chikungunya virus (CHIKV), dengue, Yellow Fever, tick-borne encephalitis, a history of confirmed or suspected CHIKV infection, or has lived in a CHIKV-endemic area greater than 1 year or cumulative stay of greater than 30 days in 5 years
  • Prior administration of investigational agent using formulations similar to VAL-181388
  • A history of hypersensitivity or serious reactions to previous vaccinations
  • Any known or suspected autoimmune disease or immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination
  • A history of inflammatory arthritis
  • Any neurologic disorder
  • Prior administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study drug or plans to receive such products at any time during the study
  • Any chronic administration of an immunosuppressant or other immune modifying drug
  • Daily or every other day administration of antipyretic or analgesic medication
  • Any acute illness at the time of enrollment
  • Any significant disorder of coagulation requiring ongoing or intermittent treatment
  • A history of idiopathic urticaria
  • A history of alcohol abuse or drug addiction
  • A positive test result for drugs of abuse
  • The participant has any abnormality or permanent body art (for example, tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site
  • Any condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the study drug or interpretation of study results
  • A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies
  • A history of active cancer (malignancy) in the last 10 years
  • Donation of blood or blood products >450 milliliters (mL) within 30 days of dosing
  • Is an employee or first degree relative of the Sponsor, clinical research organization (CRO), or study site personnel
04

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    VAL-181388

    Biological: VAL-181388

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • BiologicalVAL-181388

    Escalating dose levels

  • OtherPlacebo

    Saline

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

06

Results

Posted Jun 10, 2024

Participant flow

Part A: Dose Escalation (28 Days)
Participant flow — Part A: Dose Escalation (28 Days)
MilestoneVAL-181388 Dose AVAL-181388 Dose BVAL-181388 Dose CPlacebo
Started15151515
Received vaccination 115151515
Received vaccination 215141415
Completed15151515
Not completed0000
Part B: Follow-up (Up to 364 Days)
Participant flow — Part B: Follow-up (Up to 364 Days)
MilestoneVAL-181388 Dose AVAL-181388 Dose BVAL-181388 Dose CPlacebo
Started15151515
Completed13131513
Not completed2202
Withdrew: Lost to follow-up2000
Withdrew: Withdrawal by subject0100
Withdrew: Other than specified0102

Outcome measures

PrimaryPart 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
Reported as:
Count of participants · Participants
Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events)
ParticipantsVAL-181388 Dose A: Vaccination 1VAL-181388 Dose A: Vaccination 2VAL-181388 Dose B: Vaccination 1VAL-181388 Dose B: Vaccination 2VAL-181388 Dose C: Vaccination 1VAL-181388 Dose C: Vaccination 2Placebo: Vaccination 1Placebo: Vaccination 2
Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events)11101110131275
PrimaryPart 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
Reported as:
Count of participants · Participants
Part A: Number of Participants With Unsolicited AEs
ParticipantsVAL-181388 Dose A: Vaccination 1VAL-181388 Dose A: Vaccination 2VAL-181388 Dose B: Vaccination 1VAL-181388 Dose B: Vaccination 2VAL-181388 Dose C: Vaccination 1VAL-181388 Dose C: Vaccination 2Placebo: Vaccination 1Placebo: Vaccination 2
Part A: Number of Participants With Unsolicited AEs43633686
PrimaryPart 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
Reported as:
Count of participants · Participants
Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest
ParticipantsVAL-181388 Dose A: Vaccination 1VAL-181388 Dose A: Vaccination 2VAL-181388 Dose B: Vaccination 1VAL-181388 Dose B: Vaccination 2VAL-181388 Dose C: Vaccination 1VAL-181388 Dose C: Vaccination 2Placebo: Vaccination 1Placebo: Vaccination 2
SAEs00000100
Medically-Attended AEs10000001
AEs of Special Interest00000000
PrimaryPart 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
Reported as:
Count of participants · Participants
Part B: Number of Participants With SAEs and AEs of Special Interest
ParticipantsVAL-181388 Dose AVAL-181388 Dose BVAL-181388 Dose CPlacebo
SAEs0010
AEs of Special Interest0000

Adverse events

Collected over Through 1 year following the last vaccination. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Part A - VAL-181388 Dose A: Vaccination 10/15 (0%)0/15 (0%)4/15 (26.7%)
Part A - VAL-181388 Dose A: Vaccination 20/15 (0%)0/15 (0%)3/15 (20%)
Part A - VAL-181388 Dose B: Vaccination 10/15 (0%)0/15 (0%)6/15 (40%)
Part A - VAL-181388 Dose B: Vaccination 20/14 (0%)0/14 (0%)3/14 (21.4%)
Part A - VAL-181388 Dose C: Vaccination 10/15 (0%)0/15 (0%)3/15 (20%)
Part A - VAL-181388 Dose C: Vaccination 20/14 (0%)1/14 (7.1%)6/14 (42.9%)
Part A - Placebo: Vaccination 10/15 (0%)0/15 (0%)8/15 (53.3%)
Part A - Placebo: Vaccination 20/15 (0%)0/15 (0%)6/15 (40%)
Part B - VAL-181388 Dose A0/15 (0%)0/15 (0%)0/15 (0%)
Part B - VAL-181388 Dose B0/15 (0%)0/15 (0%)0/15 (0%)
Part B - VAL-181388 Dose C0/15 (0%)1/15 (6.7%)0/15 (0%)
Part B - Placebo0/15 (0%)0/15 (0%)0/15 (0%)
Most frequent serious events
Most frequent serious events
EventPart A - VAL-181388 Dose A: Vaccination 1Part A - VAL-181388 Dose A: Vaccination 2Part A - VAL-181388 Dose B: Vaccination 1Part A - VAL-181388 Dose B: Vaccination 2Part A - VAL-181388 Dose C: Vaccination 1Part A - VAL-181388 Dose C: Vaccination 2Part A - Placebo: Vaccination 1Part A - Placebo: Vaccination 2Part B - VAL-181388 Dose APart B - VAL-181388 Dose BPart B - VAL-181388 Dose CPart B - Placebo
Aspartate aminotransferase increasedInvestigations0/150/150/150/140/151/140/150/150/150/150/150/15
Fibula fractureInjury, poisoning and procedural complications0/150/150/150/140/150/140/150/150/150/151/150/15
Most frequent other events
Showing 10 of 47
Most frequent other events
EventPart A - VAL-181388 Dose A: Vaccination 1Part A - VAL-181388 Dose A: Vaccination 2Part A - VAL-181388 Dose B: Vaccination 1Part A - VAL-181388 Dose B: Vaccination 2Part A - VAL-181388 Dose C: Vaccination 1Part A - VAL-181388 Dose C: Vaccination 2Part A - Placebo: Vaccination 1Part A - Placebo: Vaccination 2Part B - VAL-181388 Dose APart B - VAL-181388 Dose BPart B - VAL-181388 Dose CPart B - Placebo
Upper respiratory tract infectionInfections and infestations2/150/153/150/141/150/141/151/150/150/150/150/15
Injection site haemorrhageGeneral disorders0/150/151/150/140/150/142/150/150/150/150/150/15
ArthralgiaMusculoskeletal and connective tissue disorders0/150/150/150/140/150/142/150/150/150/150/150/15
Injection site rashGeneral disorders0/150/150/150/140/151/140/150/150/150/150/150/15
NauseaGastrointestinal disorders0/150/150/150/140/151/140/150/150/150/150/150/15
Lipase increasedInvestigations0/150/151/150/140/151/140/150/150/150/150/150/15
Alanine aminotransferase increasedInvestigations0/150/150/150/140/151/140/150/150/150/150/150/15
Blood pressure diastolic increasedInvestigations0/150/150/151/140/150/140/150/150/150/150/150/15
Blood pressure increasedInvestigations0/150/150/150/140/151/140/150/150/150/150/150/15
Blood pressure systolic increasedInvestigations0/150/150/151/140/150/140/150/150/150/150/150/15

Baseline characteristics

The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo).

Age, Continuous
Age, Continuous(years)VAL-181388 Dose AVAL-181388 Dose BVAL-181388 Dose CPlaceboTotal
Mean32.1 ± 8.4533.0 ± 6.7632.2 ± 8.4629.1 ± 5.1831.6 ± 7.30
Sex: Female, Male
Sex: Female, Male(Participants)VAL-181388 Dose AVAL-181388 Dose BVAL-181388 Dose CPlaceboTotal
Female7910834
Male865726
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)VAL-181388 Dose AVAL-181388 Dose BVAL-181388 Dose CPlaceboTotal
Hispanic or Latino32117
Not Hispanic or Latino1213141453
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)VAL-181388 Dose AVAL-181388 Dose BVAL-181388 Dose CPlaceboTotal
American Indian or Alaska Native10001
Asian01001
Native Hawaiian or Other Pacific Islander00011
Black or African American767626
White777728
More than one race01102
Unknown or Not Reported00011
07

Study locations

1 site
  • Optimal Research
    Rockville, Maryland 20850, United States
08

References and documents

Study documents

  • Study protocol · Aug 30, 2018
  • Statistical analysis plan · Sep 19, 2018
  • Informed consent form · Jun 21, 2017

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03325075
Lead sponsor
ModernaTX, Inc.
Collaborators
Defense Advanced Research Projects Agency
Responsible party
Sponsor
First posted
Oct 30, 2017
Start date
Jul 19, 2017
Primary completion
Mar 19, 2019
Completion
Mar 19, 2019
Results posted
Jun 10, 2024
Last update
Jun 10, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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