A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.
ConditionChikungunya Virus
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-11
SponsorBavarian Nordic
About this trial
The goal of this multi-center, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity of CHIKV VLP Vaccine in children 1 to \<12 years of age.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males or females between 1 and <12 years of age at Day 1 (day of vaccination). Note: Screening should only occur in the active/open cohorts. Please see Section 6.1 for details
Body weight ≥6.5 kg.
In general good health, in the opinion of the investigator, based on medical history and physical examination.
Able and willing to provide informed assent for study participation and primary caregiver is able and willing to provide informed consent for study participation, in accordance with the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) determination and applicable federal and local regulations and guidelines.
Disqualifiers
Participation or planned participation in an investigational clinical study (eg, vaccine, drug) within 30 days before Day 1 and for the duration of the study. Note: Participation in an observational study or follow-up phase of a study may be allowed; these instances should be discussed with the sponsor's medical monitor and written agreement obtained prior to enrollment.
Current acute illness, with or without fever.
Current or recent CHIKV infection indicated by positive immunoglobulin M (IgM) and negative immunoglobulin G (IgG) rapid diagnostic test (RDT) results at screening in the Philippines only; participants in the US will not be tested using the RDT.
History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product.
Trial design
Design model
Parallel
Treatments tested in this trial
CHIKV VLP vaccine
Biological/VaccineCHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%
Placebo
Biological/VaccinePlacebo is comprised of formulation buffer
Treatment groups
720 Participants
are divided into 4 treatment groupsGroup A: Arm 1Experimental treatment 1 intervention
Group B: Arm 2Placebo comparator 1 intervention
Group C: Arm 3Experimental treatment 1 intervention
Group D: Arm 4Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety Endpoint 3: Incidence of AESI, MAAEs, and SAEs
Incidence of adverse events of special interest (AESIs; defined as new onset or worsening arthralgia that is medically attended), medically attended adverse events (MAAEs), and serious adverse events (SAEs) through end of the trial.
Time frame
From vaccination through the end of the trial, planned to be Day 732 for study completers.2
Primary Immunogenicity Endpoint: Day 22 anti-CHIKV SNA seroresponse rate in seronegative children
Day 22 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in baseline seronegative children 1 to \<12 years of age in the immunogenicity evaluable population.
Time frame
Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.3
Safety Endpoint 2: Incidence of unsolicited AEs through Day 29
Incidence of unsolicited adverse events (AEs) through Day 29.
Time frame
From vaccination on Day 1 through Day 29, 28 days after vaccination with CHIKV VLP vaccine or placebo.Secondary outcomes
1
Key Secondary Immunogenicity Endpoint 2: Day 22 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children
Day 22 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in both baseline seronegative and seropositive children 1 to \<12 years of age in the immunogenicity evaluable population.
Time frame
Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.2
Secondary Immunogenicity Endpoint 1: Day 15 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children
Day 15 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in both baseline seronegative and seropositive children 1 to \<12 years of age in the immunogenicity evaluable population.
Time frame
Study Day 15, 14 days after vaccination with CHIKV VLP vaccine or placebo.3
Safety Endpoint 1: Incidence of solicited adverse events through Day 8
Incidence of solicited adverse events through Day 8.
Time frame
From vaccination on study Day 1 through Day 8, 7 days after vaccination with CHIKV VLP vaccine or placebo.4
Key Secondary Immunogenicity Endpoint 1: Day 15 anti-CHIKV SNA seroresponse rate in seronegative children
Day 15 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in baseline seronegative children 1 to \<12 years of age in the immunogenicity evaluable population.
Time frame
Study Day 15, 14 days after vaccination with CHIKV VLP vaccine or placebo.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov