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Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults

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ClinicalTrials.gov Identifier: NCT03483961
Recruitment Status : Active, not recruiting
First Posted : March 30, 2018
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
PaxVax, Inc.

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


Condition or disease Intervention/treatment Phase
Chikungunya Virus Infection Biological: CHIKV VLP/unadjuvanted Biological: CHIKV VLP/adjuvanted Biological: Placebo Phase 2

Detailed Description:
The trial will explore 8 formulation/schedule combinations of CHIKV VLP vaccine with or without Alhydrogel adjuvant, and will also explore different dose schedules of Day 1 and 15 or Day 1 and 29 or Day 29 only.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 415 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2 Parallel-Group, Randomized, Double-Blind Study to Assess the Safety and Immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV-VLP], Unadjuvanted or Alum-adjuvanted)
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya

Arm Intervention/treatment
Experimental: Arm 1
20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29)
Biological: CHIKV VLP/unadjuvanted
Vaccine consists of virus-like particles of chikungunya virus antigens

Biological: Placebo
Placebo is vaccine diluent alone

Experimental: Arm 2
6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel

Biological: Placebo
Placebo is vaccine diluent alone

Experimental: Arm 3
10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)
Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel

Biological: Placebo
Placebo is vaccine diluent alone

Experimental: Arm 4
20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29)
Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel

Biological: Placebo
Placebo is vaccine diluent alone

Experimental: Arm 5
Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel

Biological: Placebo
Placebo is vaccine diluent alone

Experimental: Arm 6
Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)
Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel

Biological: Placebo
Placebo is vaccine diluent alone

Experimental: Arm 7
Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29)
Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel

Biological: Placebo
Placebo is vaccine diluent alone

Experimental: Arm 8
Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29)
Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel

Biological: Placebo
Placebo is vaccine diluent alone

Experimental: Arm 9
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
Adjuvanted formulation includes Alhydrogel




Primary Outcome Measures :
  1. Anti-CHIKV neutralizing antibody response 28 days after the last injection [ Time Frame: 57 days (From day 1 vaccination) ]
    To assess the induction of anti-chikungunya virus (CHIKV) neutralizing antibody responses by different formulations and schedules, as measured at 28 days after the last injection (Day 57).


Secondary Outcome Measures :
  1. Kinetics of anti-chikungunya virus (CHIKV) neutralizing antibody response [ Time Frame: Kinetics will be measured from 7 days after the first injection (Day 8) to 28 days after the last injection (Day 57). ]
    To describe the kinetics of induction of anti-CHIKV neutralizing antibody responses by different formulations and schedules

  2. To assess the difference in persistence of neutralizing antibody responses [ Time Frame: Neutralizing antibody levels will be measured up to Day 547 ]
    To assess the difference in persistence of neutralizing antibody responses induced by different formulations and schedules, as measured up to 518 days after the last injection (Day 547) relative to earlier time points.

  3. Boosting of vaccine-induced neutralizing antibody responses by a booster dose of PXVX0317 [ Time Frame: Antibody levels will be measured at Days 547 prior to the booster dose and again 28 days later on Day 575. ]
    To assess the effect of a booster dose of PXVX0317 on neutralizing antibody levels when given at Day 547. Antibody levels will be measured at Days 547 prior to the booster dose and again 28 days later on Day 575.


Other Outcome Measures:
  1. Incidence of vaccine-related reactions and adverse events [ Time Frame: Local and systemic reactions will be assessed for 7 days following each injection. Adverse events will be followed for 730 days. ]
    Local and systemic solicited adverse events will be recorded following each vaccination. Unsolicited adverse events will be collected for 28 days after each vaccination, and serious adverse events will be collected throughout the study. The frequencies and percentages of subjects in each study group (of the 8 formulations/schedules being studied) experiencing each solicited adverse event will be analyzed. Treatment-emergent adverse events will be analyzed by group.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female
  2. Age 18 to 45 years old (inclusive)
  3. Using an acceptable method of contraception (if female of childbearing potential).
  4. Able and willing to provide informed consent for study participation.

Exclusion Criteria:

  1. Current acute febrile illness.
  2. Clinically significant cardiac, respiratory, or rheumatologic disease, in the opinion of the Investigator.
  3. Pregnant or breast-feeding.
  4. Laboratory evidence of infection with Hepatitis B/C or HIV.
  5. History of chikungunya virus infection.
  6. Travel to a World Health Organization-designated chikungunya-endemic region within 30 days prior to Day 1.
  7. History of allergic reaction to any component of CHIKV-VLP vaccine, Diluent, or Alhydrogel®.
  8. Inability to discontinue systemic immunomodulatory or immunosuppressive medications 30 days prior to Day 1.
  9. Received or plans to receive any licensed vaccine from 30 days prior to Day 1 through Day 57.
  10. Received or plans to receive an investigational agent from 30 days prior to Day 1 through the duration of study participation.
  11. Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject.
  12. Any other condition that, in the opinion of the Investigator, may interfere with the conduct of the study or the validity of the data.
  13. Any other condition that, in the opinion of the Investigator, creates an unacceptable safety risk for apheresis (Group 9 only).
  14. Restricted venous access that would prevent the collection of PBMCs, plasma, and lymphocytes necessary for participation (Group 9 only).
  15. Weight < 110 pounds (Group 9 only)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483961


Locations
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United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, Utah
Advanced Clinical Research
West Jordan, Utah, United States, 84088
Sponsors and Collaborators
PaxVax, Inc.
Investigators
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Study Director: Sean Bennett, MD PhD PaxVax, Inc.

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Responsible Party: PaxVax, Inc.
ClinicalTrials.gov Identifier: NCT03483961     History of Changes
Other Study ID Numbers: PXVX-CV-317-001
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chikungunya Fever
Virus Diseases
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs