Status:
COMPLETED
Study to Assess the Safety and Immunogenicity of a Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers
Lead Sponsor:
Valneva Austria GmbH
Conditions:
Chikungunya
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03382964
Start Date
March 5 2018
End Date
July 28 2019
Last Update
August 29 2019
Active Locations (2)
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1
Optimal Research, LLC
Huntsville, Alabama, United States, 35802
2
Optimal Research, LLC
Peoria, Illinois, United States, 61614