Phase 2
N=445
Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults
Chikungunya Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT03483961 ↗Enrolled (actual)
445
Serious AEs
2.0%
Results posted
Nov 2021
Primary outcome: Primary: Anti-CHIKV Neutralizing Antibody Geometric Mean Titer 28 Days After the Last Injection for Groups 2-8. — 2057.0; 1116.2; 1465.3; 2023.8 titer — p=0.0015
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CHIKV VLP/unadjuvanted (Biological); CHIKV VLP/adjuvanted (Biological); Placebo (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bavarian Nordic
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-CHIKV Neutralizing Antibody Geometric Mean Titer 28 Days After the Last Injection for Groups 2-8. |
2057.0; 1116.2; 1465.3; 2023.8; 920.1; 1206.9 | 0.0015 sig |
| SECONDARY Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8. |
70.6; 34.3; 72.6; 117.6; 8.4; 7.5 | — |
| SECONDARY Differences in Persistence of Neutralizing Antibody Geometric Mean Titer for Groups 2-8. |
345.1; 209.0; 358.4; 486.6; 253.4; 303 | — |
| SECONDARY Boosting of Vaccine-induced Neutralizing Antibody Geometric Mean Titer by a Booster Dose of PXVX0317 for Group 4 Only. |
223.6; 12325.8; 5874.2 | — |
| SECONDARY Percentage of Participants With an Anti-CHIKV Neutralizing Antibody Titer Exceeding the Following Cutoff Values: ≥15, 40, 160, 640, and 4-fold Rise Over Baseline. |
47; 44; 44; 45; 48; 48 | — |
Summary
The goal of this Phase 2 trial is to evaluate the immune response to and safety profile of various doses/formulations/and schedules of administration of PXVX0317 in healthy adults.
Primary Objective:
To assess the immune response to the vaccine
Secondary Objectives:
To assess the kinetics of the immune response to different doses/formulations/schedules To assess the persistence of immune responses to different doses/formulations/schedules To assess the effect of a booster dose of the vaccine
Safety Objective:
To assess local and systemic reactions to the vaccine and to describe the safety profile of the vaccine
Eligibility Criteria
Inclusion Criteria
- Male or female
- Age 18 to 45 years old (inclusive)
- Using an acceptable method of contraception (if female of childbearing potential).
- Able and willing to provide informed consent for study participation.
Exclusion Criteria
- Current acute febrile illness.
- Clinically significant cardiac, respiratory, or rheumatologic disease, in the opinion of the Investigator.
- Pregnant or breast-feeding.
- Laboratory evidence of infection with Hepatitis B/C or HIV.
- History of chikungunya virus infection.
- Travel to a World Health Organization-designated chikungunya-endemic region within 30 days prior to Day 1.
- History of allergic reaction to any component of CHIKV-VLP vaccine, Diluent, or Alhydrogel®.
- Inability to discontinue systemic immunomodulatory or immunosuppressive medications 30 days prior to Day 1.
- Received or plans to receive any licensed vaccine from 30 days prior to Day 1 through Day 57.
- Received or plans to receive an investigational agent from 30 days prior to Day 1 through the duration of study participation.
- Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject.
- Any other condition that, in the opinion of the Investigator, may interfere with the conduct of the study or the validity of the data.
- Any other condition that, in the opinion of the Investigator, creates an unacceptable safety risk for apheresis (Group 9 & 10 only).
- Restricted venous access that would prevent the collection of PBMCs, plasma, and lymphocytes necessary for participation (Group 9 & 10 only).
- Weight < 110 pounds (Group 9 & 10 only)
Data sourced from ClinicalTrials.gov (NCT03483961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.