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CHIKV VLP/unadjuvanted · 1 trial · 1 indication
To assess the induction of anti-chikungunya virus (CHIKV) neutralizing antibody geometric mean titers by different formulations and schedules, as measured at 28 days after the last injection (Day 57) for Groups 2-8.
| Arm | Type | Description |
|---|---|---|
| Group 1: 20 mcg/unadjuvanted (Day 1 & 29) | EXPERIMENTAL | 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) |
| Group 2: 6 mcg/adjuvanted (Day 1 & 29) | EXPERIMENTAL | 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) |
| Group 3: 10 mcg/adjuvanted (Day 1 & 29) | EXPERIMENTAL | 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) |
| Group 4: 20mcg/adjuvanted (Day 1 & 29);40mcg/adjuvant (Day 547) | EXPERIMENTAL | 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) |
| Group 5: 6 mcg/adjuvanted (Day 15 & 29) | EXPERIMENTAL | Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) |
| Group 6: 10 mcg/adjuvanted (Day 15 & 29) | EXPERIMENTAL | Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) |
| Group 7: 20 mcg/adjuvanted (Day 15 & 29) | EXPERIMENTAL | Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) |
| Group 8: 40 mcg/adjuvanted (Day 29) | EXPERIMENTAL | Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) |
| Group 9: 20 mcg/adjuvanted (Day 1 & 29) | EXPERIMENTAL | 20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182 |
| Group 10: 40 mcg/adjuvanted (Day 1) | EXPERIMENTAL | 40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22. |
| Name | Type | Description |
|---|---|---|
| CHIKV VLP/unadjuvanted | BIOLOGICAL | Vaccine consists of virus-like particles of chikungunya virus antigens |
| CHIKV VLP/adjuvanted | BIOLOGICAL | Adjuvanted formulation includes Alhydrogel |
| Placebo | BIOLOGICAL | Placebo is vaccine diluent alone |
Inclusion Criteria: 1. Male or female 2. Age 18 to 45 years old (inclusive) 3. Using an acceptable method of contraception (if female of childbearing potential). 4. Able and willing to provide informed consent for study participation. Exclusion Criteria: 1. Current acute febrile illness. 2. Clini...
CHIKV VLP, adjuvanted is an investigational vaccine being developed for the prevention of Chikungunya virus infection. It is designed to protect against the Chikungunya virus, a mosquito-borne illness. The vaccine is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
CHIKV VLP, adjuvanted targets the Chikungunya virus by presenting virus-like particles to the immune system. These particles mimic the structure of the virus without causing disease, prompting an immune response that can neutralize the actual virus upon exposure.
CHIKV VLP, adjuvanted is being developed by Emergent BioSolutions Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol EBS. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.
CHIKV VLP, adjuvanted is in Phase 3 clinical development. It is an investigational vaccine and has not yet received regulatory approval. The Phase 3 program includes trials in healthy adults and older adults aged 65 years and above.
CHIKV VLP, adjuvanted has been studied in several completed clinical trials, including NCT03483961, NCT05065983, NCT05072080, and NCT05349617. These trials assessed the vaccine's safety and immunogenicity in healthy adults, including a large Phase 3 trial with 3,258 participants.
Yes, CHIKV VLP, adjuvanted is also known as PXVX0317. Clinical trial records refer to the vaccine as PXVX0317 CHIKV-VLP, and it is being evaluated for its ability to generate an immune response against the Chikungunya virus.