Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CHIKV VLP, adjuvanted · 3 trials · 1 indication
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 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 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).
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.
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 - 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 | 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 |
| 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 | PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant |
| Placebo | BIOLOGICAL | Placebo is comprised of formulation buffer |
| CHIKV VLP, adjuvanted | BIOLOGICAL | Adjuvanted formulation includes aluminum hydroxide |
Inclusion Criteria: * Able and willing to provide informed consent voluntarily signed by participant. Must verbalize understanding of the general procedures of, and reason for the study. * Males or females, ≥65 years of age. * Able to complete all scheduled visits and comply with all study procedur...
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.