CHIKV VLP Vaccine for Chikungunya

Recruiting at 8 trial locations

Overseen By Priya Uppin

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Bavarian Nordic

Must not be taking: Immunosuppressants, Anticoagulants, others

Disqualifiers: Immunodeficiency, CHIKV infection, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

720 Participants Needed

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. ^{1 2 3 4 5}

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. ^{4 6 7 8 9}

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

I can attend all visits and follow study rules.

In general good health, in the opinion of the investigator, based on medical history and physical examination

I am between 2 and 11 years old on the day of vaccination.

Exclusion Criteria

I have not received and do not plan to receive blood products from 3 months before the study starts until it ends.

Any other medical condition, including severe malnutrition, that, in the opinion of the investigator, could adversely impact the participant's participation or conduct of the study

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CHIKV VLP vaccine or placebo

1 day

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and immunogenicity, with primary endpoints assessed at Day 8 and Day 22

4 weeks

Multiple visits (in-person and virtual)

Extended Follow-up

Participants are monitored for long-term safety and immunogenicity, with assessments at Day 183, Day 366, and Day 732

24 months

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?

Group I: Arm 3 Experimental Treatment 1 Intervention

Cohort 2 Active Group

Group II: Arm 1 Experimental Treatment 1 Intervention

Cohort 1 Active Group

Group III: Arm 2 Placebo Group 1 Intervention

Cohort 1 Placebo Group

Group IV: Arm 4 Placebo Group 1 Intervention

Cohort 2 Placebo Group

Who Is Running the Clinical Trial?

Bavarian Nordic

Lead Sponsor

Trials

67

Recruited

50,900+

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

1. cdc.gov cdc.gov/acip/downloads/slides-2024-10-23-24/03-Chikungunya-Jenkins-508.pdf

CHIKV VLP vaccine * Seroresponse rate (considered the presumptive seroprotection rate) was defined as the percentage of participants who achieved an anti-CHIK ...

2. fda.gov fda.gov/media/185801/download?attachment

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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11530495/

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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X24011654

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 ...

5. medrxiv.org medrxiv.org/content/10.1101/2024.10.11.24315179v1.full-text

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 ...

6. medicomart.com medicomart.com/images/document/MSDS_Vimkunya_BN.pdf

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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12595291/

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 ...

8. thelancet.com thelancet.com/journals/lanmic/article/PIIS2666-5247(24)00268-4/fulltext

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 ...

9. fda.gov fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-update-safety-ixchiq-chikungunya-vaccine-live

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 ...