NCT03382964

Study to Assess the Safety and Immunogenicity of a Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers

Completed Phase 1 Last updated 29 August 2019

What this trial tests

Phase 1 trial testing VLA1553 in Chikungunya in 120 participants. Completed in 28 July 2019.

Timeline

5 March 2018

Primary endpoint
13 July 2018

28 July 2019

Quick facts

Lead sponsor	Valneva Austria GmbH
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	120
Start date	5 March 2018
Primary completion	13 July 2018
Estimated completion	28 July 2019
Sites	2 locations across United States

Drugs / interventions tested

• VLA1553 — full drug profile →

Conditions studied

• Chikungunya — all drugs for Chikungunya →

Sponsor

Valneva Austria GmbH — full company profile →

Who can join

Adults 18 to 45, any sex, with Chikungunya. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Randomized, observer-blinded, multicenter, dose-escalation Phase 1 clinical study investigating three dose levels of VLA1553 after a single immunization.

120 study participants will be enrolled into the study to receive three different doses (30 subjects in the low and medium and 60 subjects in the high dose group). Vaccination will be given intramuscularly on Day 0. As safety precaution, the study will begin with enrolment of 20 sentinel subjects in an open-label fashion. Thereafter, subjects will be enrolled in a blinded, randomized manner in the three study arms.

A re-vaccination will be given at Month 6 or Month 12 to confirm that a single vaccination will be sufficient to induce high titer neutralizing antibodies and protect subjects from CHIKV viremia.

Study participants will be followed up until 13 months after initial vaccination.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Viral Emerging Diseases: Challenges in Developing Vaccination Strategies.
   Trovato M, Sartorius R, D'Apice L, Manco R, et al · · 2020 · cited 87× · PMID 33013898 · DOI 10.3389/fimmu.2020.02130
2. Single-shot live-attenuated chikungunya vaccine in healthy adults: a phase 1, randomised controlled trial.
   Wressnigg N, Hochreiter R, Zoihsl O, Fritzer A, et al · · 2020 · cited 82× · PMID 32497524 · DOI 10.1016/s1473-3099(20)30238-3
3. Chikungunya as a paradigm for emerging viral diseases: Evaluating disease impact and hurdles to vaccine development.
   Rezza G, Weaver SC. · · 2019 · cited 74× · PMID 30653504 · DOI 10.1371/journal.pntd.0006919
4. Effectiveness of CHIKV vaccine VLA1553 demonstrated by passive transfer of human sera.
   Roques P, Fritzer A, Dereuddre-Bosquet N, Wressnigg N, et al · · 2022 · cited 53× · PMID 35700051 · DOI 10.1172/jci.insight.160173
5. Current Efforts in the Development of Vaccines for the Prevention of Zika and Chikungunya Virus Infections.
   Schrauf S, Tschismarov R, Tauber E, Ramsauer K. · · 2020 · cited 37× · PMID 32373111 · DOI 10.3389/fimmu.2020.00592
6. Chikungunya Virus Vaccines: A Review of IXCHIQ and PXVX0317 from Pre-Clinical Evaluation to Licensure.
   Weber WC, Streblow DN, Coffey LL. · · 2024 · cited 29× · PMID 39292392 · DOI 10.1007/s40259-024-00677-y
7. From bench to clinic: the development of VLA1553/IXCHIQ, a live-attenuated chikungunya vaccine.
   Chen LH, Fritzer A, Hochreiter R, Dubischar K, et al · · 2024 · cited 23× · PMID 39255380 · DOI 10.1093/jtm/taae123
8. Chikungunya Vaccine Candidates: Current Landscape and Future Prospects.
   Schmidt C, Schnierle BS. · · 2022 · cited 22× · PMID 36277603 · DOI 10.2147/dddt.s366112