NCT03483961

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
445

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

April 18, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 9, 2021

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

2.4 years

First QC Date

March 16, 2018

Results QC Date

September 14, 2021

Last Update Submit

June 29, 2023

Conditions

Chikungunya Virus Infection

Outcome Measures

Primary Outcomes (1)

  • Anti-CHIKV Neutralizing Antibody Geometric Mean Titer 28 Days After the Last Injection for Groups 2-8.

    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.

    Day 57 (from Day 1 vaccination), 28 days after the last injection.

Secondary Outcomes (4)

  • Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8.

    At Days 8, 15, 22, 29, 36, and 57.

  • Differences in Persistence of Neutralizing Antibody Geometric Mean Titer for Groups 2-8.

    At Days 182, 365, 547, and 760.

  • Boosting of Vaccine-induced Neutralizing Antibody Geometric Mean Titer by a Booster Dose of PXVX0317 for Group 4 Only.

    Antibody levels will be measured at Day 547 prior to the booster dose and again 28 days later on Day 575 and then at Day 760.

  • 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.

    Day 57 (from Day 1 vaccination), 28 days after the last injection.

Study Arms (10)

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)

Biological: CHIKV VLP/unadjuvantedBiological: Placebo

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)

Biological: CHIKV VLP/adjuvantedBiological: Placebo

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)

Biological: CHIKV VLP/adjuvantedBiological: Placebo

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)

Biological: CHIKV VLP/adjuvantedBiological: Placebo

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)

Biological: CHIKV VLP/adjuvantedBiological: Placebo

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)

Biological: CHIKV VLP/adjuvantedBiological: Placebo

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)

Biological: CHIKV VLP/adjuvantedBiological: Placebo

Group 8: 40 mcg/adjuvanted (Day 29)

EXPERIMENTAL

Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29)

Biological: CHIKV VLP/adjuvantedBiological: Placebo

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

Biological: CHIKV VLP/adjuvanted

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.

Biological: CHIKV VLP/adjuvanted

Interventions

CHIKV VLP/unadjuvantedBIOLOGICAL

Vaccine consists of virus-like particles of chikungunya virus antigens

Group 1: 20 mcg/unadjuvanted (Day 1 & 29)
CHIKV VLP/adjuvantedBIOLOGICAL

Adjuvanted formulation includes Alhydrogel

Group 10: 40 mcg/adjuvanted (Day 1)Group 2: 6 mcg/adjuvanted (Day 1 & 29)Group 3: 10 mcg/adjuvanted (Day 1 & 29)Group 4: 20mcg/adjuvanted (Day 1 & 29);40mcg/adjuvant (Day 547)Group 5: 6 mcg/adjuvanted (Day 15 & 29)Group 6: 10 mcg/adjuvanted (Day 15 & 29)Group 7: 20 mcg/adjuvanted (Day 15 & 29)Group 8: 40 mcg/adjuvanted (Day 29)Group 9: 20 mcg/adjuvanted (Day 1 & 29)
PlaceboBIOLOGICAL

Placebo is vaccine diluent alone

Group 1: 20 mcg/unadjuvanted (Day 1 & 29)Group 2: 6 mcg/adjuvanted (Day 1 & 29)Group 3: 10 mcg/adjuvanted (Day 1 & 29)Group 4: 20mcg/adjuvanted (Day 1 & 29);40mcg/adjuvant (Day 547)Group 5: 6 mcg/adjuvanted (Day 15 & 29)Group 6: 10 mcg/adjuvanted (Day 15 & 29)Group 7: 20 mcg/adjuvanted (Day 15 & 29)Group 8: 40 mcg/adjuvanted (Day 29)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

The Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Related Publications (1)

  • Bennett SR, McCarty JM, Ramanathan R, Mendy J, Richardson JS, Smith J, Alexander J, Ledgerwood JE, de Lame PA, Royalty Tredo S, Warfield KL, Bedell L. Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial. Lancet Infect Dis. 2022 Sep;22(9):1343-1355. doi: 10.1016/S1473-3099(22)00226-2. Epub 2022 Jun 13.

    PMID: 35709798DERIVED

MeSH Terms

Conditions

Chikungunya Fever

Condition Hierarchy (Ancestors)

Alphavirus InfectionsArbovirus InfectionsVector Borne DiseasesInfectionsMosquito-Borne DiseasesVirus DiseasesTogaviridae InfectionsRNA Virus Infections

Results Point of Contact

Title
Sharmila Rajendran
Organization
Emergent BioSolutions
rajendras@ebsi.com
650-486-0244

Study Officials

  • James McCarty, MD

    Emergent BioSolutions

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2018

First Posted

March 30, 2018

Study Start

April 18, 2018

Primary Completion

September 14, 2020

Study Completion

September 21, 2020

Last Updated

July 3, 2023

Results First Posted

November 9, 2021

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(3)