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

Chikungunya Virus Infection Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483961
• Other study ID #: PXVX-CV-317-001
• Status: Completed
• Phase: Phase 2
• Start date: April 18, 2018
• Est. completion date: September 21, 2020

Study information

• Verified date: June 2023
• Source: Bavarian Nordic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: September 21, 2020
• Est. primary completion date: September 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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 & 10 only).

14. Restricted venous access that would prevent the collection of PBMCs, plasma, and lymphocytes necessary for participation (Group 9 & 10 only).

15. Weight < 110 pounds (Group 9 & 10 only)

Related Conditions & MeSH terms

• Chikungunya Fever
• Chikungunya Virus Infection

Intervention

Biological:
• CHIKV VLP/unadjuvanted
Vaccine consists of virus-like particles of chikungunya virus antigens
• CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
• Placebo
Placebo is vaccine diluent alone

Locations

Country	Name	City	State
United States	The Center for Pharmaceutical Research	Kansas City	Missouri
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Advanced Clinical Research	West Jordan	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Bavarian Nordic	Emergent BioSolutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8.	To describe the kinetics of induction of anti-CHIKV neutralizing antibody geometric mean titers by different formulations and schedules for Groups 2-8.	At Days 8, 15, 22, 29, 36, and 57.
Secondary	Differences in Persistence of Neutralizing Antibody Geometric Mean Titer for Groups 2-8.	To assess differences in persistence of neutralizing antibody geometric mean titers induced by different formulations and schedules, as measured up to 731 days after the last injection (Day 760) relative to earlier time points for Groups 2-8.	At Days 182, 365, 547, and 760.
Secondary	Boosting of Vaccine-induced Neutralizing Antibody Geometric Mean Titer by a Booster Dose of PXVX0317 for Group 4 Only.	To assess the effect of a booster dose of PXVX0317 on neutralizing antibody geometric mean titers when given at Day 547 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.	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.
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.	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.