Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

800

Participants

Timeline

Start Date

August 30, 2023

Primary Completion Date

April 30, 2028

Study Completion Date

August 31, 2028

Conditions
Chikungunya Virus Infection
Interventions
BIOLOGICAL

CHIKV VLP vaccine booster

CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP) 40mg, aluminum hydroxide 2% adjuvant, and formulation buffer supplied as a single dose of 0.8 mL in a pre-filled syringe, to be administered via intramuscular (IM) injection in the deltoid muscle.

BIOLOGICAL

Placebo booster

Placebo is comprised of formulation buffer supplied as a single dose of 0.8 mL in a pre-filled syringe administered via IM injection in the deltoid muscle.

Trial Locations (24)

14609

Rochester Clinical Research, LLC, Rochester

23502

Alliance for Multispecialty Research, LLC, Norfolk

27612

M3 Wake Research Inc., Raleigh

32934

Optimal Research, LLC, Melbourne

33173

Suncoast Research Associates, LLC, Miami

36608

Alliance for Multispecialty Research, LLC, Mobile

40509

Alliance for Multispecialty Research, LLC, Lexington

44122

Velocity Clinical Research, Cleveland, Cleveland

60602

Synexus Clinical Research US, Inc., Chicago

61614

Optimal Research, LLC, Peoria

64114

Alliance for Multispecialty Research, LLC, Kansas City

67114

Alliance for Multispecialty Research, LLC, Newton

67207

Alliance for Multispecialty Research, LLC, Wichita

73072

Lynn Institute of Norman, Norman

77081

DM Clinical Research, Houston

77375

DM Clinical Research, Tomball

78249

BFHC Research, LLC, San Antonio

78613

Velocity Clinical Research, Austin, Cedar Park

84088

Velocity Clinical Research, Salt Lake City, West Jordan

85281

Alliance for Multispecialty Research, LLC, Tempe

89106

Wr-Crcn, Llc, Las Vegas

89119

Alliance for Multispecialty Research, LLC, Las Vegas

97504

Velocity Clinical Research, Medford, Medford

02818

Velocity Clinical Research, Providence, East Greenwich

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bavarian Nordic

INDUSTRY