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

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ClinicalTrials.gov Identifier: NCT03382964
Recruitment Status : Active, not recruiting
First Posted : December 26, 2017
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH

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.


Condition or disease Intervention/treatment Phase
Chikungunya Biological: VLA1553 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Observer-Blinded, Dose-Escalation Phase 1 Study to Assess the Safety and Immunogenicity of Three Different Dose Levels of a Live-Attenuated Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers Aged 18 To 45 Years
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : July 13, 2018
Estimated Study Completion Date : June 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya

Arm Intervention/treatment
Active Comparator: VLA1553 low dose
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
I.M. vaccination with a live-attenuated Chikungunya virus (CHIKV) vaccine candidate

Active Comparator: VLA1553 medium dose
VLA1553 with 3.2x10^4 TCID50/ 1 mL Re-vaccination at Month 12 with VLA1553 with 3.2x10^5 TCID50/ 1 mL
Biological: VLA1553
I.M. vaccination with a live-attenuated Chikungunya virus (CHIKV) vaccine candidate

Active Comparator: VLA1553 high dose
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
I.M. vaccination with a live-attenuated Chikungunya virus (CHIKV) vaccine candidate




Primary Outcome Measures :
  1. Frequency of solicited injection site reactions [ Time Frame: up to Day 14 after single vaccination ]
    Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling.

  2. Severity of solicited injection site reactions [ Time Frame: up to Day 14 after single vaccination ]
    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)

  3. Frequency of solicited systemic reactions [ Time Frame: up to Day 14 after single vaccination ]
    Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner

  4. Severity of solicited systemic reactions [ Time Frame: up to Day 14 after single vaccination ]
    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


Secondary Outcome Measures :
  1. Frequency of any adverse event (AE) [ Time Frame: until Day 14, Day 28 and throughout the study period ]
  2. Severity of any adverse event (AE) [ Time Frame: until Day 14, Day 28 and throughout the study period ]
    The investigator will assess the severity of AEs using his/her clinical expertise and judgment based on the most appropriate description (mild, moderate, severe) as per study protocol

  3. Frequency of solicited injection site reactions [ Time Frame: until Day 14, Day 28 and throughout the study period ]
    Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling.

  4. Severity of solicited injection site reactions [ Time Frame: until Day 14, Day 28 and throughout the study period ]
    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)

  5. Frequency of solicited systemic reactions [ Time Frame: until Day 14, Day 28 and throughout the study period ]
    Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner

  6. Severity of solicited systemic reactions [ Time Frame: until Day 14, Day 28 and throughout the study period ]
    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

  7. Assessment of viremia after each vaccination [ Time Frame: on Days 3, 7, 14 and beyond Day 14 after re-vaccination ]
    Assessment of CHIKV viremia will be done by RT (real-time)-qPCR (quantitative polymerase chain reaction) in blood and urine

  8. Immune response as measured by CHIKV-specific neutralizing antibody titer as determined by micro-neutralization (μNT) assay. [ Time Frame: Day 28, Day 84, Month 6, Month 12, and 28 days after re-vaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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:

    1. 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;
    2. At least 5 years post-menopause (i.e., 6 years post last menstrual period), or menopause confirmed by follicle-stimulating hormone (FSH) testing.

Exclusion Criteria:

  • 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;
  • Blood donation within 30 days or receipt of blood-derived products (e.g. plasma) within 90 days prior to vaccination in this study or during the course of the study;
  • A rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating;
  • Known or suspected problem with alcohol or drug abuse as determined by the Investigator;
  • Any condition that, in the opinion of the Investigator, may compromise the subjects well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study;
  • Participation in another clinical study involving an investigational medicinal product within 30 days prior to study enrollment or during the course of this study;
  • Member of the team conducting the study or in a dependent relationship with one of the study team members. Dependent relationships include close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the Investigator or site personnel conducting the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382964


Locations
United States, Alabama
Optimal Research, LLC
Huntsville, Alabama, United States, 35802
United States, Illinois
Optimal Research, LLC
Peoria, Illinois, United States, 61614
United States, Maryland
Optimal Research, LLC
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
Study Chair: Nina Wressnigg Valneva Austria GmbH

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT03382964     History of Changes
Other Study ID Numbers: VLA1553-101
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Valneva Austria GmbH:
VLA1553
Chikungunya
CHIKV
Live-attenuated Chikungunya virus vaccine

Additional relevant MeSH terms:
Chikungunya Fever
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs