Pivotal Study to Evaluate Safety and Immunogenicity of a Live-Attenuated Chikungunya Virus Vaccine Candidate in Adults
Condition: Chikungunya Virus Infection
MeSH terms: Virus Diseases; Chikungunya Fever
Intervention: VLA1553; Placebo
Intervention description: Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose; Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: VLA1553; Chikungunya Virus Infection; CHIKV; Live-attenuated Chikungunya virus vaccine

Summary:

      This was a prospective, randomized, double-blinded, multicenter, pivotal clinical study
      evaluating the final dose of VLA1553 (1 x10E4 TCID50 per dose) in comparison to a placebo
      control. The final dose of VLA1553 or control was administered as single immunization on Day
      1. Overall, 4.128 male and female subjects aged 18 years and above were randomized into the
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or above on the Day of screening

          2. able to provide informed consent

          3. generally healthy as determined by the Investigator's clinical judgement based on
             medical history, physical examination and screening laboratory tests

          4. for women of childbearing potential:

               1. practiced an adequate method of contraception during 30 days before screening

               2. negative serum or urine pregnancy test at screening

               3. agreed to employ adequate birth control measures for the first three months
                  post-vaccination.

        Main Exclusion Criteria:

          1. CHIKV infection in the past, including suspected CHIKV infection; was taking
             medication or other treatment for unresolved symptoms attributed to a previous CHIKV
             infection; or had participated in a clinical study involving an investigational CHIKV
             vaccine

          2. acute or recent infection

          3. Subject tested positive for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HBsAg) or hepatitis C virus (HCV);

          4. live virus vaccine within 28 days or inactivated vaccine within 14 days prior to
             vaccination in this study or planned to receive a vaccine within 28 days or 14 days
             after vaccination, respectively

          5. abnormal findings in any required study investigations (including medical history,
             physical examination, and clinical laboratory) considered clinically relevant by the
             Investigator which pose a risk for participation in the study

          6. medical history of or currently had acute or progressive, unstable or uncontrolled
             clinical conditions that posed a risk for participation in the study

          7. history of immune-mediated or clinically relevant arthritis / arthralgia

          8. history of malignancy in the past 5 years other than squamous cell or basal cell skin
             cancer. If there had been surgical excision or treatment more than 5 years ago that
             was considered to have achieved a cure, the subject could be enrolled.

          9. known or suspected defect of the immune system, such as subjects with congenital or
             acquired immunodeficiency, including infection with HIV, status post organ
             transplantation or immuno-suppressive therapy within 4 weeks prior to vaccination.

         10. history of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to
             components of the candidate vaccine, other known contraindications)

         11. with clinical conditions representing a contraindication to intramuscular vaccination
             and blood draws

         12. pregnant or lactating at the time of enrollment

         13. Donation of blood, blood fractions or plasma within 30 days or received blood-derived
             products (e.g. plasma) within 90 days prior to vaccination in this study or planned to
             donate blood or used blood products until Day 180 of the study

         14. rash, dermatological condition or tattoos that would, in the opinion of the
             Investigator, interfere with injection site reaction rating

         15. known or suspected problem with alcohol or drug abuse as determined by the
             Investigator

         16. any condition that, in the opinion of the Investigator, could compromise the subjects
             well-being, interfere with evaluation of study endpoints, or would limit the subject's
             ability to complete the study;

         17. committed to an institution (by virtue of an order issued either by the judicial or
             the administrative authorities)

         18. Participation in another clinical study involving an investigational medicinal product
             (IMP) or device within 30 days prior to study enrollment or is scheduled to
             participate in another clinical study involving an IMP, or device during the course of
             this study

         19. 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.