Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CHIKV VLP/unadjuvanted · 4 trials · 2 indications
Incidence of solicited AEs through Day 8 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Incidence of unsolicited AEs through Day 29 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Incidence of AESIs, through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Incidence of MAAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Incidence of SAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Anti-CHIKV SNA seroresponse rates for PXVX0317 (CHIKV VLP vaccine) and placebo, difference (PXVX0317 minus placebo), and associated 95% confidence interval (CI) at Day 22 for the immunogenicity evaluable population (IEP), all age strata combined.
Anti-CHIKV SNA seroresponse rates and associated 95% confidence interval for PXVX0317 (CHIKV VLP vaccine) and placebo at Day 22 for the immunogenicity evaluable population (IEP), all age strata combined.
Anti-CHIKV SNA GMTs and associated 95% CIs at Day 22 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined.
Anti-CHIKV SNA GMTs and associated 95% CIs at Day 22 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined.
Anti-CHIKV SNA GMTs and associated 95% CIs between all three pairs of PXVX0317 (CHIKV VLP vaccine) lots (104:105, 104:106, 105:106) in adults 18 to \<46 years of age in the IEP at Day 22. Placebo group 4 is not relevant for this lot-to-lot consistency analysis. Reported GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.
Anti-CHIKV SNA GMTs and associated 95% CIs for PXVX0317 (CHIKV VLP vaccine) and placebo in adults 18 to \<46 years of age in the IEP at Day 22.
Difference in anti-CHIKV SNA titer (NT80) seroresponse rate (PXVX0317 minus placebo) and associated 95 percent confidence interval (CI) at Day 22.
Anti-CHIKV SNA titer (NT80) GMT and associated 95 percent CIs at Day 22 for PXVX0317 and placebo.
Incidence of SAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Incidence of MAAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
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.
CHIKV SNA Seroresponse Rate (Titer \>=40) and Associated 95% Confidence Interval (CI) at Day 22
CHIKV SNA GMT and Associated 95% CI at Day 22
CHIKV SNA Seroresponse Rates with Associated 95% CIs at Days 8, 15, and 57
CHIKV SNA GMTs with Associated 95% CIs at Days 8, 15, and 57
CHIKV ELISA IgG GMTs with Associated 95% CIs at Days 8, 15, 22, and 57
CHIKV ELISA IgM GMTs with Associated 95% CIs at Days 8, 15, 22, and 57
GMFI in CHIK SNA Titers from Day 1 to Days 8, 15, 22, and 57
GMFI in CHIK ELISA IgG from Day 1 to Days 8, 15, 22, and 57
GMFI in CHIK ELISA IgM from Day 1 to Days 8, 15, 22, and 57
Number and Percentage of Participants with a CHIKV SNA Titer ≥15, 40, 60, 80, 100, 160, 640, and 4-fold Rise Over Baseline Thresholds at Days 8, 15, 22, and 57
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | Group 1 - PXVX0317 lot A (Lot 104) |
| Group 2 | EXPERIMENTAL | Group 2 - PXVX0317 lot B (Lot 105) |
| Group 3 | EXPERIMENTAL | Group 3 - PXVX0317 lot C (Lot 106) |
| Group 4 | PLACEBO_COMPARATOR | Group 4 - Placebo |
| Group 1 - PXVX0317 | EXPERIMENTAL | PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant. |
| Group 2 - Placebo | PLACEBO_COMPARATOR | Placebo is comprised of formulation buffer. |
| 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. |
| PXVX0317 (CHIKV VLP, alum-adjuvanted) vaccine | EXPERIMENTAL | All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1). |
| Name | Type | Description |
|---|---|---|
| CHIKV VLP/adjuvant | BIOLOGICAL | CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2% |
| Placebo | BIOLOGICAL | Placebo is comprised of formulation buffer |
| CHIKV VLP/unadjuvanted | BIOLOGICAL | Vaccine consists of virus-like particles of chikungunya virus antigens |
| CHIKV VLP/adjuvanted | BIOLOGICAL | Adjuvanted formulation includes Alhydrogel |
| CHIKV VLP, adjuvanted | BIOLOGICAL | Adjuvanted formulation includes aluminum hydroxide |
Inclusion Criteria: * Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by participant (and guardian, as applicable). * Males or females, 12 to \<65 years of age. * Generally healthy, in the opinion of the investigator, based on medical history, physical ex...
CHIKV VLP/unadjuvanted is an investigational vaccine developed by Emergent BioSolutions Inc. (ticker: EBS) for the prevention of Chikungunya Virus and Chikungunya Virus Infection. It is a virus-like particle (VLP) vaccine candidate that has completed Phase 3 clinical development. The unadjuvanted formulation is one version of the CHIKV VLP vaccine platform.
CHIKV VLP/unadjuvanted is being developed for the prevention of Chikungunya Virus infection. Chikungunya is a mosquito-borne viral disease. The vaccine candidate targets healthy volunteers, including adults aged 65 years and older and individuals aged 12 years and older, across its completed clinical trials.
CHIKV VLP/unadjuvanted is developed by Emergent BioSolutions Inc., which trades under the ticker symbol EBS. The company is the sponsor of the clinical trials evaluating this Chikungunya virus-like particle vaccine candidate, including the Phase 3 studies conducted in the United States.
CHIKV VLP/unadjuvanted has completed Phase 3 clinical development. All three Phase 3 and Phase 2 trials listed for this vaccine candidate are marked as completed, with no active trials currently ongoing. It is an investigational vaccine and has not been approved by the FDA.
CHIKV VLP/unadjuvanted has been evaluated in completed trials including NCT05349617, a Phase 3 study in adults aged 65 years and older; NCT05072080, a Phase 3 trial enrolling 3,258 participants aged 12 years and older; NCT05065983, a Phase 2 study; and NCT03483961, a Phase 2 trial in healthy adults.