VLA1553 Vaccine for Chikungunya

Not currently recruiting at 16 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Valneva Austria GmbH

Must not be taking: Immunosuppressants, Investigational drugs

Disqualifiers: Blood conditions, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 12

Duration: Single event

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the long-term effects and safety of a new vaccine, VLA1553, designed to protect against chikungunya, a viral disease spread by mosquitoes. Researchers aim to determine if the vaccine remains effective and safe over time. The trial seeks participants from a previous study who had no antibodies (proteins that fight disease) at the start of that study. As a Phase 3 trial, this is the final step before FDA approval, giving participants the opportunity to contribute to the potential availability of a new vaccine.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've taken an active drug with potential immunosuppressive action within 30 days before a trial visit.

Is there any evidence suggesting that the VLA1553 vaccine is likely to be safe for humans?

Research shows that the VLA1553 chikungunya vaccine is generally safe and well tolerated. Studies have found that teenagers aged 12 to 17 responded well to the vaccine, and it was safe for them regardless of previous chikungunya infection. In these studies, most participants developed protective antibodies, indicating the vaccine's effectiveness without serious safety issues.

However, reports have noted some serious side effects in older adults after receiving the vaccine. Data collected in the United States after the vaccine's approval revealed these effects. While trials have demonstrated good safety, there are risks, particularly for older adults. These findings are important to consider when deciding to join a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The VLA1553 vaccine is unique because it aims to provide long-lasting immunity against chikungunya with just a single dose. Unlike current options, which primarily focus on symptom management, VLA1553 targets the chikungunya virus directly, potentially preventing the disease entirely. Researchers are excited because if successful, this vaccine could offer a more efficient and proactive solution to an illness for which there are currently no vaccines or specific antiviral treatments.

What evidence suggests that the VLA1553 vaccine might be an effective treatment for Chikungunya?

Research has shown that the VLA1553 vaccine for chikungunya is highly effective. In one study, 97.8% of participants developed immunity, indicating that almost everyone was protected after vaccination. Another study found that 96.5% of children maintained strong immune responses six months later. The vaccine has demonstrated a strong immune reaction in both adults and children, suggesting lasting protection against chikungunya. Clinical research has confirmed its effectiveness and safety, leading to its approval. ^{6 7 8 9 10}

Who Is on the Research Team?

Valneva Clinical Development

Principal Investigator

Valneva Austria GmbH

Are You a Good Fit for This Trial?

This trial is for individuals who previously participated in the VLA1553-301 study, testing a Chikungunya virus vaccine. Participants must have had no neutralizing antibodies at baseline and understand the study's procedures. Those with substance abuse issues, conditions preventing blood draws, recent immunosuppressive drugs or blood donations are excluded.

Inclusion Criteria

Subject participated in the VLA1553-301 clinical study

Subject has an understanding of the study and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any study-related procedures

I provided blood samples for a study and tested negative for neutralizing antibodies initially.

Exclusion Criteria

You have a known or suspected issue with alcohol or drug abuse, as determined by the person in charge of the study.

Subject is a 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.

Subject is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single immunization with the VLA1553 vaccine

Single event

Follow-up

Participants are monitored for antibody persistence and long-term safety

120 months

Annual visits at Months 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120

What Are the Treatments Tested in This Trial?

Interventions

• VLA1553

Trial Overview The trial is an open-label Phase 3b study focusing on long-term safety and persistence of antibodies from the Chikungunya virus vaccine candidate VLA1553. Up to 375 subjects from a prior study will be monitored to assess these outcomes.

How Is the Trial Designed?

Group I: VLA1553 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Valneva Austria GmbH

Lead Sponsor

Trials

46

Recruited

59,100+

Citations

1. thelancet.com thelancet.com/journals/laninf/article/PIIS1473-3099%2824%2900432-8/fulltext

Chikungunya vaccine VLA1553 induces sustained ... Severe adverse events were reported in 46 (1·5%) of 3082 participants in the vaccinated group and in eight (0·8%) of 1033 participants in the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10911060/

A randomized, double-blinded Phase 3 study to demonstrate ... Moreover, this study confirmed the high seroresponse rate observed in the pivotal trial for the VLA1553 vaccine candidate with a seroresponse in 97.8% of ...

3. valneva.com valneva.com/press-release/valneva-reports-positive-six-month-antibody-persistence-and-safety-phase-2-results-in-children-for-its-single-shot-chikungunya-vaccine-ixchiq/

Valneva Reports Positive Six-Month Antibody Persistence and ... The strong immune response was confirmed in CHIKV-naïve children with a 96.5% seroresponse rate (full dose) at Day 180. VLA1553 was well ...

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. academic.oup.com academic.oup.com/jtm/article/31/7/taae123/7754743

From bench to clinic: the development of VLA1553/IXCHIQ, a ... This review outlines the preclinical and clinical efficacy and safety data that led to the approval of VLA1553 (IXCHIQ®), a live-attenuated vaccine against ...

6. valneva.com valneva.com/press-release/valneva-reports-positive-initial-phase-3-safety-data-in-adolescents-for-its-single-shot-chikungunya-vaccine-candidate/

Valneva Reports Positive Initial Phase 3 Safety Data in ... VLA1553 was generally safe and well tolerated in adolescents aged 12 to 17 years, regardless of previous CHIKV infection.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39243794/

interim results of a double-blind, randomised, placebo ... VLA1553 was generally safe and induced seroprotective titres in almost all vaccinated adolescents with favourable safety data in adolescents who were ...

8. academic.oup.com academic.oup.com/ofid/article/12/9/ofaf550/8247336

Fatal Adverse Event After VLA1553 Chikungunya Vaccination ... Post-licensure surveillance data from the United States have since reported 6 serious adverse events in elderly individuals following VLA1553 ...

9. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-67362300641-4/fulltext

Safety and immunogenicity of a single-shot live-attenuated ... VLA1553 was generally safe in all dose groups, was well tolerated in the low and medium dose groups after a single vaccination, but showed ...

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1473309924004584

Safety and immunogenicity of a live-attenuated ... The data demonstrate that vaccination of adolescents with VLA1553 is generally well tolerated. Similar to the trials in adults, the robust immune response ...