Phase 2 Open-label Study of Alum-adjuvanted Chikungunya V... | NCT03992872

NCT03992872

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Walter Reed Army Institute of Research (WRAIR)	FED
Emergent BioSolutions	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prior Alpha	Experimental	All study participants received the same Investigational Product according to the same schedule. Participants were prior recipients of experimental alphavirus vaccines.	Biological: Chikungunya
Control: Naïve Alpha	Active Comparator	All study participants received the same Investigational Product according to the same schedule. The alphavirus vaccine naïve participants will serve as controls for determining the effect of pre-existing alphavirus immunity on vaccine safety and immunogenicity.	Biological: Chikungunya

Name	Type	Description	Arm Group Labels	Other Names
Chikungunya	Biological	Virus Like Particle	Control: Naïve Alpha Prior Alpha

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With 4-fold Rise in Anti-CHIKV Neutralizing Antibody Response	Seroconversion, defined as a 4-fold or greater rise in neutralizing antibody against chikungunya virus, as determined by luciferase-based assay (NT80), induced by PXVX0317. PXVX0317 was administered to prior alphavirus vaccine recipients versus gender- and age-matched controls.	Day 22 (21 days after vaccination)

Secondary Outcomes

Measure	Description	Time Frame
Geometric Mean Titer of Anti-CHIKV Neutralizing Antibody Response	Evaluation of Geometric Mean Titer of Anti-CHIKV neutralizing antibodies, determined by luciferase-based assay (NT80), in prior alphavirus vaccine recipients versus alphavirus-naïve controls.	Day 1, 8, 22, 29, 57, 182
Percentage of Participants With 4-fold Rise in Anti-CHIKV Neutralizing Antibody Response

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 to 65 years old (inclusive)
For women of childbearing potential, a negative pregnancy test at screening and on vaccination day, practicing highly effective contraception for at least 30 days prior to vaccination, and willing to use a highly effective method of contraception through study completion.
Able and willing to provide informed consent for study participation prior to screening procedures.
Free of obvious health problems as established by medical history and clinical examination at screening and enrollment.
Available to participate for the duration of the study (approximately 8 months).
For the cohort of prior alphavirus vaccine recipients, a documented history of prior alphavirus vaccination.

Exclusion Criteria:

Acute disease or febrile illness at the time of screening or enrollment.
Clinically significant cardiac, respiratory, rheumatologic or other medical or psychiatric condition that, in the opinion of the Investigator, places the subject at increased risk or affects their ability to understand and comply with study procedures.
Abnormal screening lab test result that, in the opinion of the investigator, obscures interpretation of the safety data or suggests a clinically significant cardiac, respiratory, rheumatologic or other medical condition that places the subject at increased risk.
Pregnant, lactating or planning to become pregnant during the study period.
Laboratory evidence of infection with Hepatitis B, C or HIV.
History of naturally (non-laboratory) acquired chikungunya or other alphavirus infection or travel to a WHO-designated chikungunya-endemic region within 30 days prior to Day 1.
History of acute allergic reaction to any component of CHIKV VLP vaccine or Alhydrogel®.
Current (30 days prior to Day 1) or anticipated use of systemic immunomodulatory or immunosuppressive medications.
History of splenectomy, immunosuppressive condition, autoimmune disease, or immunodeficient condition.
Family history of congenital or hereditary immunodeficiency.
Suspected or known current alcohol abuse that, in the opinion of the Investigator, would interfere with the subject's ability to understand and comply with study procedures.
Current intravenous drug use.
Prior receipt of an investigational chikungunya vaccine.
Receipt or planned receipt of any licensed vaccine from 30 days prior to Day 1 through Day 29 study visit.
Participation in another clinical trial during the study period in which an investigational product is administered.
For the alphavirus naïve group, history of prior alphavirus vaccination is exclusionary.

Name	Affiliation	Role
James McCarty, MD	Emergent BioSolutions	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
United States Army Medical Research Institute of Infectious Diseases		Fort Deterick	Maryland	21702	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39954701	Derived	Hamer MJ, McCarty JM, Pierson BC, Regules JA, Mendy J, Sanborn AD, Gardner CL, Haller JM, Gregory MK, Liggett DL, Glass PJ, Ghosh N, Royalty Tredo S, Warfield KL, Burke CW, Lee C, Saunders D, Bedell L, Richardson JS. Safety and immunogenicity of an adjuvanted chikungunya virus virus-like particle (CHIKV VLP) vaccine in previous recipients of other alphavirus vaccines versus alphavirus vaccine-naive controls: an open-label, parallel-group, age-matched, sex-matched, phase 2 randomised controlled study. Lancet Microbe. 2025 Apr;6(4):101000. doi: 10.1016/j.lanmic.2024.101000. Epub 2025 Feb 12.

ID	Title	Description
FG000	Experimental : Prior Alpha	All study participants received the same Investigational Product according to the same schedule. Subjects were prior recipients of experimental alphavirus vaccines.
FG001	Control: Naive Alpha	All study participants received the same Investigational Product according to the same schedule. The alphavirus vaccine naïve subjects served as controls.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00030 subjects FG00130 subjects
Exposed	Screened subjects who received study vaccination.	FG00030 subjects FG00130 subjects
Safety	Subjects who received study vaccination and provided safety assessment data.	FG00030 subjects FG00130 subjects
mITT	Exposed subjects who had evaluable results from both Day 1 and at least one later on-study sample.	FG00030 subjects FG00130 subjects
Immunogenicity Evaluable	Exposed subjects who met the IEP criteria as detailed in the SAP.	FG00030 subjects FG00130 subjects
COMPLETED		FG00030 subjects FG00130 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Experimental : Prior Alpha	All study participants received the same Investigational Product according to the same schedule. Subjects were prior recipients of experimental alphavirus vaccines.
BG001	Control: Naive Alpha

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With 4-fold Rise in Anti-CHIKV Neutralizing Antibody Response

Seroconversion, defined as a 4-fold or greater rise in neutralizing antibody against chikungunya virus, as determined by luciferase-based assay (NT80), induced by PXVX0317.

PXVX0317 was administered to prior alphavirus vaccine recipients versus gender- and age-matched controls.

Immunogenicity evaluable population

Posted

Number

95% Confidence Interval

percentage of participants

Day 22 (21 days after vaccination)

ID	Title	Description
OG000	Experimental: Prior Alpha	All study participants received the same Investigational Product according to the same schedule. Participants were prior recipients of experimental alphavirus vaccines.
OG001	Control: Naive Alpha

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Experimental : Prior Alpha	All study participants received the same Investigational Product according to the same schedule. Subjects were prior recipients of experimental alphavirus vaccines.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 25, 2021	Aug 6, 2024	Prot_002.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Mar 1, 2021	Aug 6, 2024	SAP_003.pdf
ICF	No	No	Yes	Informed Consent Form	Oct 10, 2019	Jan 4, 2022	ICF_001.pdf

ID	Term
D018354	Alphavirus Infections
D001102	Arbovirus Infections
D000079426	Vector Borne Diseases
D007239	Infections