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

NCT03325075 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: VAL-181388-P101W911NF-13-1-0417
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chikungunya Virus

Keywords

VAL-181388; Chikungunya vaccine

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Through 1 year following the last vaccination

Study Arms (2)

VAL-181388

EXPERIMENTAL

Biological: VAL-181388

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

VAL-181388 BIOLOGICAL

Escalating dose levels

VAL-181388

Placebo OTHER

Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ModernaTX, Inc.: lead
• Defense Advanced Research Projects Agency: collaborator

Study Sites (1)

Optimal Research

Rockville, Maryland, 20850, United States

Location

Related Publications (1)

• 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.

  PMID: 37210308 DERIVED

Results Point of Contact

• Title: Moderna Clinical Trials Support Center
• Organization: ModernaTX, Inc.

clinicaltrials@modernatx.com

1-877-777-7187

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 30, 2017
• Study Start: July 19, 2017
• Primary Completion: March 19, 2019
• Study Completion: March 19, 2019
• Last Updated: June 10, 2024
• Results First Posted: June 10, 2024

Record last verified: 2023-12

Locations

US (1)