Study to Assess the Safety and Immunogenicity of a Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers

NCT03382964 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: VLA1553-101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Randomized, observer-blinded, multicenter, dose-escalation Phase 1 clinical study investigating three dose levels of VLA1553 after a single immunization. 120 study participants will be enrolled into the study to receive three different doses (30 subjects in the low and medium and 60 subjects in the high dose group). Vaccination will be given intramuscularly on Day 0. As safety precaution, the study will begin with enrolment of 20 sentinel subjects in an open-label fashion. Thereafter, subjects will be enrolled in a blinded, randomized manner in the three study arms. A re-vaccination will be given at Month 6 or Month 12 to confirm that a single vaccination will be sufficient to induce high titer neutralizing antibodies and protect subjects from CHIKV viremia. Study participants will be followed up until 13 months after initial vaccination.

Conditions

Chikungunya

Keywords

VLA1553; Chikungunya; CHIKV; Live-attenuated Chikungunya virus vaccine

Outcome Measures

Primary Outcomes (4)

• Frequency of solicited injection site reactions

  Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling.

  up to Day 14 after single vaccination

• Severity of solicited injection site reactions

  Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling. They will be rated according to the Severity Grading Scale of Injection Site Reactions (FDA Guidance on Toxicity Grading Scales for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA 2007)

  up to Day 14 after single vaccination

• Frequency of solicited systemic reactions

  Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner

  up to Day 14 after single vaccination

• Severity of solicited systemic reactions

  Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner. They will be rated according to the FDA Guidance on Toxicity Grading Scales

  up to Day 14 after single vaccination

Secondary Outcomes (8)

• Frequency of any adverse event (AE)

  until Day 14, Day 28 and throughout the study period

• Severity of any adverse event (AE)

  until Day 14, Day 28 and throughout the study period

• Frequency of solicited injection site reactions

  until Day 14, Day 28 and throughout the study period

• Severity of solicited injection site reactions

  until Day 14, Day 28 and throughout the study period

• Frequency of solicited systemic reactions

  until Day 14, Day 28 and throughout the study period

Study Arms (3)

VLA1553 low dose

ACTIVE COMPARATOR

VLA1553 with 3.2x10\^3 TCID50/ 100 µL (microliter). Re-vaccination at Month 12 with VLA1553 with 3.2x10\^5 TCID50/ 1 mL (milliliter)

Biological: VLA1553

VLA1553 medium dose

ACTIVE COMPARATOR

VLA1553 with 3.2x10\^4 TCID50/ 1 mL Re-vaccination at Month 12 with VLA1553 with 3.2x10\^5 TCID50/ 1 mL

Biological: VLA1553

VLA1553 high dose

ACTIVE COMPARATOR

VLA1553 with 3.2x10\^5 TCID50/ 1 mL Re-vaccination at Month 6 or Month 12 with VLA1553 with 3.2x10\^5 TCID50/ 1 mL

Biological: VLA1553

Interventions

VLA1553 BIOLOGICAL

I.M. vaccination with a live-attenuated Chikungunya virus (CHIKV) vaccine candidate

VLA1553 high dose; VLA1553 low dose; VLA1553 medium dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 45 years on the Day of screening;
• Has a BMI of ≥ 18.5 and \< 30 kg/m2 on the Day of screening;
• Understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures;
• Generally healthy as determined by the Investigator's clinical judgement based on medical history, physical examination and screening laboratory tests;
• If female, subject is of non-childbearing potential. The definition of non-childbearing potential includes the following:
• Surgically sterile (e.g., hysterectomy with or without oophorectomy; fallopian tube ligation; endometrial ablation), at least 30 days prior to signature of the Informed Consent form;
• At least 5 years post-menopause (i.e., 6 years post last menstrual period), or menopause confirmed by follicle-stimulating hormone (FSH) testing.

You may not qualify if:

• History of known CHIKV infection;
• Plans to travel to areas with active CHIKV transmission during the course of the study or history of travel to an endemic CHIKV area within 4 weeks prior to study enrollment;
• Participation in a clinical study involving an investigational CHIKV vaccine;
• Receipt of an inactivated vaccine within 4 weeks or live vaccine within 8 weeks prior to vaccination in this study;
• Positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV);
• (1) Abnormal laboratory liver function values (≥ grade 1), (2) any grade 1 abnormal lab values deemed clinically relevant by the Investigator, and (3) any ≥ grade 2 abnormal lab values irrespective of clinical significance at screening;
• Clinically significant abnormal ECG at screening;
• History of significant cardiovascular, respiratory (including asthma), metabolic, neurological, hepatic, rheumatic, autoimmune, hematological, gastrointestinal or renal disorder;
• History of immune-mediated or clinically significant arthritis/arthralgia;
• History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved a cure;
• Disease or recent or current treatment that can be expected to influence immune response as specified in the protocol;
• History of severe hypersensitivity reactions or anaphylaxis;
• History of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to components of the candidate vaccine, other known contraindications);
• Acute febrile infections within two weeks prior to vaccination;
• Subject is of childbearing potential or lactating at the time of enrollment;

Sponsors & Collaborators

• Valneva Austria GmbH: lead

Study Sites (2)

Optimal Research, LLC

Huntsville, Alabama, 35802, United States

Location

Optimal Research, LLC

Peoria, Illinois, 61614, United States

Location

Related Publications (1)

• Wressnigg N, Hochreiter R, Zoihsl O, Fritzer A, Bezay N, Klingler A, Lingnau K, Schneider M, Lundberg U, Meinke A, Larcher-Senn J, Corbic-Ramljak I, Eder-Lingelbach S, Dubischar K, Bender W. Single-shot live-attenuated chikungunya vaccine in healthy adults: a phase 1, randomised controlled trial. Lancet Infect Dis. 2020 Oct;20(10):1193-1203. doi: 10.1016/S1473-3099(20)30238-3. Epub 2020 Jun 1.

  PMID: 32497524 DERIVED

MeSH Terms

Conditions

Chikungunya Fever

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Study Officials

• Nina Wressnigg

  Valneva Austria GmbH

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 26, 2017
• Study Start: March 5, 2018
• Primary Completion: July 13, 2018
• Study Completion: July 28, 2019
• Last Updated: August 29, 2019

Record last verified: 2019-08

Locations

US (2)