CHIKV VLP Vaccine for Chikungunya
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new vaccine to protect against Chikungunya, a virus that causes fever and joint pain. The study aims to determine if this vaccine is safe and effective for children aged 2 to under 12. Participants will receive either the CHIKV VLP Vaccine or a placebo (a harmless substance with no effect) to compare results. Generally healthy children who haven't recently had Chikungunya might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking vaccine.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used certain immunosuppressive medications or received certain vaccines recently. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that the CHIKV VLP Vaccine is likely to be safe for children?
Research has shown that the CHIKV VLP vaccine is generally well-tolerated. In earlier studies, a single dose of this vaccine produced a strong immune response with minimal side effects. Most reported side effects were mild, such as soreness at the injection site or a slight fever, which are common for vaccines. Since the vaccine contains no live virus, it cannot cause chikungunya, enhancing its safety. Overall, evidence suggests that the CHIKV VLP vaccine is safe for use, even in children.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for chikungunya, which primarily focus on managing symptoms with pain relievers and anti-inflammatory drugs, the CHIKV VLP Vaccine offers a proactive approach by preventing the disease altogether. This vaccine is unique because it uses virus-like particles (VLPs) that mimic the chikungunya virus without causing infection, potentially stimulating a strong immune response. Researchers are excited about this vaccine as it represents a shift from merely treating symptoms to providing immunity, which could be a game-changer in areas affected by chikungunya outbreaks.
What evidence suggests that the CHIKV VLP Vaccine might be an effective treatment for Chikungunya?
Studies have shown that the CHIKV VLP vaccine effectively triggers a strong immune response against the chikungunya virus. Earlier research demonstrated that this vaccine quickly built up immunity within 15 days after vaccination, with effects lasting up to 183 days. Participants developed antibodies, proteins that help fight infections. Evidence suggests this vaccine works well in people aged 12 and older, providing high levels of protection. Initial findings in teenagers and adults indicate it might work similarly in younger children. Researchers will assign participants in this trial to receive either the CHIKV VLP vaccine or a placebo, allowing a comparison of the vaccine's effectiveness against the placebo.46789
Who Is on the Research Team?
Patrick Ajiboye, MD
Principal Investigator
Bavarian Nordic A/S
Are You a Good Fit for This Trial?
This trial is for children aged 2 to less than 12 years who are in good health. Specific details about what conditions might prevent participation (exclusion criteria) are not provided, but typically these would include having certain medical conditions or taking medications that could interfere with the vaccine's effects.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the CHIKV VLP vaccine or placebo
Initial Follow-up
Participants are monitored for safety and immunogenicity, with primary endpoints assessed at Day 8 and Day 22
Extended Follow-up
Participants are monitored for long-term safety and immunogenicity, with assessments at Day 183, Day 366, and Day 732
What Are the Treatments Tested in This Trial?
Interventions
- CHIKV VLP Vaccine
Trial Overview
The study is testing a CHIKV VLP vaccine against a placebo to see if it's safe and can create an immune response in young kids. It's conducted at multiple centers where participants are randomly assigned to receive either the vaccine or a placebo without knowing which one they get.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Cohort 2 Active Group
Cohort 1 Active Group
Cohort 1 Placebo Group
Cohort 2 Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bavarian Nordic
Lead Sponsor
Paul Chaplin
Bavarian Nordic
Chief Executive Officer since 2014
PhD in Immunology from Bristol University
Jean-Christophe May
Bavarian Nordic
Chief Medical Officer since 2020
PharmD and MBA
Citations
CHIKV VLP vaccine
* Seroresponse rate (considered the presumptive seroprotection rate) was defined as the percentage of participants who achieved an anti-CHIK ...
Statistical Review
Overall, the immunogenicity data appear to support the effectiveness of the CHIKV VLP vaccine in individuals 12 YOA and older. I defer to ...
Chikungunya Virus Vaccines: A Review of IXCHIQ and ...
CHIKV seropositive vaccinees more frequently reported vaccine injection site swelling (10%) compared to seronegative recipients (0.6%). These ...
Chikungunya vaccine development, challenges, and ...
The results up to day 22 after vaccination showed high immunogenicity in healthy adolescents and adults by the strong induction of chikungunya ...
Chikungunya Virus VLP Vaccine: Phase 3 Trial in ...
Conclusions CHIKV VLP vaccine induces a rapid and robust immune response by Day 15 that lasts through Day 183 postvaccination. These findings ...
Material Safety Data Sheet
The VLP is none infectious and thus does not represent a biological hazard. The product is an aqueous solution filled into syringes. The ...
Post-authorisation experience and reported adverse ...
The data presented here provide early insights on the use of the CHIKV VLP vaccine in a real-world setting. The frequency of reported AEs in ...
Safety and immunogenicity of an adjuvanted chikungunya ...
These data suggest that a single adjuvanted 40 μg dose of CHIKV VLP vaccine is well tolerated and immunogenic in previous recipients of ...
FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, ...
For most U.S. travelers, the risk of exposure to CHIKV is low. The Centers for Disease Control and Prevention provides resources for assessing ...
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