Chikungunya VirusPhase 1NCT03325075

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

A Phase 1 study testing VAL-181388 in people with Chikungunya Virus, run by ModernaTX, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Chikungunya Virus
What is being tested?: VAL-181388
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 19 Jul 2017to 19 Mar 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 25Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Optimal Research
Rockville, Maryland, 20850

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of VAL-181388 in Healthy Adults in a Non-endemic Chikungunya Region

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

Conditions: Chikungunya Virus
Being tested: VAL-181388, Placebo
Keywords: VAL-181388, Chikungunya vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VAL-181388Biological
Escalating dose levels
PlaceboOther
Saline

Study groups in NCT03325075
Study group	Role	What they receive
VAL-181388	Experimental	Not described Receives: Biological: VAL-181388
Placebo	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through 1 year following the last vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jul 201719 Mar 2019

First posted30 Oct 2017
Study start19 Jul 2017
Primary completion19 Mar 2019
Study completion19 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chikungunya VirusStudies of the same condition, open and under way.
More trials run by ModernaTX, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03325075
Sponsor's protocol ID: VAL-181388-P101
Other IDs: W911NF-13-1-0417
Status last verified: Dec 2023
First submitted: 20 Oct 2017
Last updated: 10 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Shaw CA, August A, Bart S, Booth PJ, Knightly C, Brasel T, Weaver SC, Zhou H, Panther L. A phase 1, randomized, placebo-controlled, dose-ranging study to evaluate the safety and immunogenicity of an mRNA-based chikungunya virus vaccine in healthy adults. Vaccine. 2023 Jun 13;41(26):3898-3906. doi: 10.1016/j.vaccine.2023.04.064. Epub 2023 May 18.
PubMed 37210308

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chikungunya Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Immunogenicity of VAL-181388 in Healthy Adults in a Non-endemic Chikungunya Region
ClinicalTrials.gov ID: NCT03325075
Acronym / sponsor ID: VAL-181388-P101
Conditions: Chikungunya Virus
Keywords: VAL-181388, Chikungunya vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: ModernaTX, Inc.Industry (pharma, biotech, devices)
Collaborators: Defense Advanced Research Projects Agency
Study start: 19 Jul 2017 (actual)
Primary completion: 19 Mar 2019 (actual)
Study completion: 19 Mar 2019 (actual)
First posted: 30 Oct 2017 (actual)
Results: Posted 10 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
VAL-181388	Experimental	Biological: VAL-181388
Placebo	Placebo comparator	Other: Placebo

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (25 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VAL-181388Escalating dose levels	Biological	VAL-181388
PlaceboSaline	Other	Placebo

Primary outcome

Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events)
Time frame: 7 days following each vaccination
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.
Part A: Number of Participants With Unsolicited AEs
Time frame: 28 days following each vaccination
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.
Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest
Time frame: 28 days following each vaccination
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.
Part B: Number of Participants With SAEs and AEs of Special Interest
Time frame: Through 1 year following the last vaccination
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.

Results and safety

Results posted to the registry on 10 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VAL-181388 Dose A	15	15
VAL-181388 Dose B	15	15
VAL-181388 Dose C	15	15
Placebo	15	15

Primary outcome: Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events)

Time frame: 7 days following each vaccination. Count of participants. Unit: Participants

Measure	VAL-181388 Dose A: Vaccination 1 n = 15	VAL-181388 Dose A: Vaccination 2 n = 15	VAL-181388 Dose B: Vaccination 1 n = 14	VAL-181388 Dose B: Vaccination 2 n = 13	VAL-181388 Dose C: Vaccination 1 n = 15	VAL-181388 Dose C: Vaccination 2 n = 14	Placebo: Vaccination 1 n = 15	Placebo: Vaccination 2 n = 15
Value	11	10	11	10	13	12	7	5

Population analysed: The safety analysis set included all participants who received at least 1 dose of study drug (VAL-181388 or placebo). Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Primary outcome: Part A: Number of Participants With Unsolicited AEs

Time frame: 28 days following each vaccination. Count of participants. Unit: Participants

Measure	VAL-181388 Dose A: Vaccination 1 n = 15	VAL-181388 Dose A: Vaccination 2 n = 15	VAL-181388 Dose B: Vaccination 1 n = 15	VAL-181388 Dose B: Vaccination 2 n = 14	VAL-181388 Dose C: Vaccination 1 n = 15	VAL-181388 Dose C: Vaccination 2 n = 14	Placebo: Vaccination 1 n = 15	Placebo: Vaccination 2 n = 15
Value	4	3	6	3	3	6	8	6

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

Primary outcome: Part A: Number of Participants With Serious AEs (SAEs), Medically-Attended AEs, and AEs of Special Interest

Time frame: 28 days following each vaccination. Count of participants. Unit: Participants

Measure	VAL-181388 Dose A: Vaccination 1 n = 15	VAL-181388 Dose C: Vaccination 2 n = 14	Placebo: Vaccination 2 n = 15
SAEs	0	1	0
Medically-Attended AEs	1	0	1
AEs of Special Interest	0	0	0

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

Primary outcome: Part B: Number of Participants With SAEs and AEs of Special Interest

Time frame: Through 1 year following the last vaccination. Count of participants. Unit: Participants

Measure	VAL-181388 Dose A n = 15	VAL-181388 Dose B n = 15	VAL-181388 Dose C n = 15	Placebo n = 15
SAEs	0	0	1	0
AEs of Special Interest	0	0	0	0

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

Adverse events

Time frame: Through 1 year following the last vaccination. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A - VAL-181388 Dose A: Vaccination 1	0 of 15 (0%)	4 of 15 (26.7%)	0 of 15
Part A - VAL-181388 Dose A: Vaccination 2	0 of 15 (0%)	3 of 15 (20%)	0 of 15
Part A - VAL-181388 Dose B: Vaccination 1	0 of 15 (0%)	6 of 15 (40%)	0 of 15
Part A - VAL-181388 Dose B: Vaccination 2	0 of 14 (0%)	3 of 14 (21.4%)	0 of 14
Part A - VAL-181388 Dose C: Vaccination 1	0 of 15 (0%)	3 of 15 (20%)	0 of 15
Part A - VAL-181388 Dose C: Vaccination 2	1 of 14 (7.1%)	6 of 14 (42.9%)	0 of 14
Part A - Placebo: Vaccination 1	0 of 15 (0%)	8 of 15 (53.3%)	0 of 15
Part A - Placebo: Vaccination 2	0 of 15 (0%)	6 of 15 (40%)	0 of 15
Part B - VAL-181388 Dose A	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Part B - VAL-181388 Dose B	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Part B - VAL-181388 Dose C	1 of 15 (6.7%)	0 of 15 (0%)	0 of 15
Part B - Placebo	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37210308Shaw CA, August A, Bart S, Booth PJ, Knightly C, Brasel T, Weaver SC, Zhou H, Panther L. A phase 1, randomized, placebo-controlled, dose-ranging study to evaluate the safety and immunogenicity of an mRNA-based chikungunya virus vaccine in healthy adults. Vaccine. 2023 Jun 13;41(26):3898-3906. doi: 10.1016/j.vaccine.2023.04.064. Epub 2023 May 18.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VAL-181388 in people with Chikungunya Virus, run by ModernaTX, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Number of Participants With Any Solicited Adverse Events (AEs) (Local and Systemic Reactogenicity Events) (time frame: 7 days following each vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03325075, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2024.