VLA1553 Vaccine for Chikungunya

Recruiting at 10 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

363 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the VLA1553 treatment for Chikungunya?

Research shows that the VLA1553 vaccine, when tested in animals using human blood samples from vaccinated people, provided complete protection against the chikungunya virus, preventing symptoms like fever and virus presence in the blood. ^{1 2 3 4 5}

How does the VLA1553 vaccine for chikungunya differ from other treatments?

The VLA1553 vaccine is unique because it is a live-attenuated vaccine, meaning it uses a weakened form of the chikungunya virus to stimulate an immune response without causing the disease. This approach is different from other treatments, as there are currently no commercially available vaccines for chikungunya, making VLA1553 a novel option for prevention. ^{6 7 8 9 10}

What is the purpose of this trial?

In this open-label Phase 3b, single arm trial, persistence of antibodies and long term safety will be evaluated in up to 375 participants rolled over from trial VLA1553-301 (NCT number: NCT04546724).

Research Team

Valneva Clinical Development

Principal Investigator

Valneva Austria GmbH

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: VLA1553 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Valneva Austria GmbH

Lead Sponsor

Trials

46

Recruited

59,100+

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of a single-shot live-attenuated chikungunya vaccine: a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A randomized, double-blinded phase 3 study to demonstrate lot-to-lot consistency and to confirm immunogenicity and safety of the live-attenuated chikungunya virus vaccine candidate VLA1553 in healthy adults. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of CHIKV vaccine VLA1553 demonstrated by passive transfer of human sera. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Chikungunya vaccines in development. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Chikungunya as a paradigm for emerging viral diseases: Evaluating disease impact and hurdles to vaccine development. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Acanthocheilonema viteae: vaccination of jirds with irradiation-attenuated stage-3 larvae and with exported larval antigens. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Brugia malayi: vaccination of jirds with 60cobalt-attenuated infective stage larvae protects against homologous challenge. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Co-Administration of Adjuvanted Recombinant Ov-103 and Ov-RAL-2 Vaccines Confer Protection against Natural Challenge in A Bovine Onchocerca ochengi Infection Model of Human Onchocerciasis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of recombinant chitinase and SXP1 antigens as antimicrofilarial vaccines. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Mutating chikungunya virus non-structural protein produces potent live-attenuated vaccine candidate. [2020]