A Study to Assess the Safety and Immunogenicity of PXVX0317 Chikungunya Virus Virus-Like Particle Vaccine (CHIKV VLP)

A Phase 2 Open-Label Study to Assess the Safety and Immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV VLP], Aluminum Hydroxide Adjuvanted)

The objective of this study is to assess the safety and immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV VLP], aluminum hydroxide adjuvanted).

Study Overview

• Status: Completed
• Conditions: Chikungunya Virus
• Intervention / Treatment: Biological: CHIKV VLP, adjuvanted

Detailed Description

Primary Objectives:

1. To assess the induction of anti-CHIKV neutralizing antibody responses following a single adjuvanted dose of PXVX0317 (40 µg CHIKV VLP, alum-adjuvanted) as measured 21 days (Day 22) after vaccination.
2. To assess the induction of anti-CHIKV neutralizing antibody responses following a single adjuvanted dose of PXVX0317 as measured 7 days (Day 8), 14 days (Day 15), and 56 days (Day 57) after vaccination.

Secondary Objectives:

1. To assess safety of a single adjuvanted dose of PXVX0317 in healthy adults.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Johnson County ClinTrials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Able and willing to provide informed consent voluntarily signed by participant.
2. Any gender, 18 to 45 years of age (inclusive).
3. Generally healthy, in the opinion of the Investigator, based on medical history, physical examination, and screening laboratory assessments.

4. Women who are either:

   (i). Not of childbearing potential (CBP): pre-menarche, anatomically sterile, or post-menopausal (defined as ≥12 months without menses) or (ii). Meeting all the following criteria: Negative urine pregnancy test at screening visit; and Negative urine pregnancy test immediately prior to dosing at Day 1; and using an acceptable method of contraception (if female of childbearing potential) for the duration of participation, such as: Hormonal contraceptives (e.g., implants, pills, patches) initiated ≥ 30 days prior to dosing or; Intrauterine device (IUD) inserted ≥30 days prior to dosing or; double barrier type of birth control (male condom with female diaphragm, male condom with cervical cap).

Exclusion Criteria:

1. Currently pregnant, breastfeeding, or planning to become pregnant during the study.
2. Body Mass Index (BMI) ≥35 kg/m2.
3. Positive laboratory evidence of current infection with human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus (HCV) or hepatitis B virus (HBV).
4. History of severe allergic reaction or anaphylaxis to any component of the investigational product (IP).
5. History of known congenital or acquired immunodeficiency that could impact response to vaccination (e.g., leukemia, lymphoma, generalized malignancy, functional or anatomic asplenia, alcoholic cirrhosis).
6. Prior or anticipated receipt of immunomodulatory or immunosuppressive therapy from six months prior to screening through Day 64.
7. Receipt or anticipated receipt of blood or blood-derived products from 90 days prior to screening through Day 64.
8. Acute disease within the last 14 days (participants with an acute mild febrile illness can be considered for a deferral of vaccination two weeks after the illness has resolved and treatment has been completed).
9. Clinically significant cardiac, pulmonary, respiratory, rheumatologic, or other chronic disease, in the opinion of the Investigator. This may include chronic illness requiring hospitalization in the last one month prior to screening.
10. Enrollment in an interventional study and/or receipt of another investigational product from 30 days prior to screening through the duration of study participation.
11. Receipt or anticipated receipt of any vaccine from 30 days prior to screening through Day 64.
12. Prior receipt of an investigational CHIKV vaccine/product.
13. Detectable baseline anti-CHIKV IgG antibody as determined by ELISA.
14. Any other condition that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study, creates an unacceptable risk to the participant, or may interfere with the conduct of the study or validity of the data.
15. Restricted venous access that would prevent the collection of plasma and serum necessary for participation.
16. Weight <110 pounds.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PXVX0317 (CHIKV VLP, alum-adjuvanted) vaccine; All study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).	Biological: CHIKV VLP, adjuvanted; Adjuvanted formulation includes aluminum hydroxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GMFI in CHIK ELISA IgG at Days 8, 15, 22, and 57	GMFI in CHIK ELISA IgG from Day 1 to Days 8, 15, 22, and 57	56 days post vaccination
GMFI in CHIK ELISA IgM at Days 8, 15, 22, and 57	GMFI in CHIK ELISA IgM from Day 1 to Days 8, 15, 22, and 57	56 days post vaccination
CHIKV SNA (Serum Neutralizing Antibody) Seroresponse Rate at Day 22	CHIKV SNA Seroresponse Rate (Titer >=40) and Associated 95% Confidence Interval (CI) at Day 22	21 days post vaccination
CHIKV SNA GMT (Geometric Mean Titer) at Day 22	CHIKV SNA GMT and Associated 95% CI at Day 22	21 days post vaccination
CHIKV SNA Seroresponse Rates at Days 8, 15, and 57	CHIKV SNA Seroresponse Rates with Associated 95% CIs at Days 8, 15, and 57	56 days post vaccination
CHIKV SNA GMTs at Days 8, 15, and 57	CHIKV SNA GMTs with Associated 95% CIs at Days 8, 15, and 57	56 days post vaccination
CHIKV ELISA (Enzyme-Linked Immunosorbent Assay) IgG GMTs at Days 8, 15, 22, and 57	CHIKV ELISA IgG GMTs with Associated 95% CIs at Days 8, 15, 22, and 57	56 days post vaccination
CHIKV ELISA IgM GMTs at Days 8, 15, 22, and 57	CHIKV ELISA IgM GMTs with Associated 95% CIs at Days 8, 15, 22, and 57	56 days post vaccination
Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57	GMFI in CHIK SNA Titers from Day 1 to Days 8, 15, 22, and 57	56 days post vaccination
Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57	Number and Percentage of Participants with a CHIKV SNA Titer ≥15, 40, 60, 80, 100, 160, 640, and 4-fold Rise Over Baseline Thresholds at Days 8, 15, 22, and 57	56 days post vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Solicited Adverse Events (AE) Through Day 8	Incidence of Solicited AEs Through Day 8	7 days post vaccination
Incidence of Unsolicited AEs Through Day 29	Incidence of Unsolicited AEs Through Day 29	28 days post vaccination
Incidence of Adverse Events of Special Interest (AESI) Through Day 183	Incidence of AESIs Through Day 183	182 days post vaccination
Incidence of Serious Adverse Events (SAEs) Through Day 183	Incidence of SAEs Through Day 183	182 days post vaccination

Collaborators and Investigators

• Sponsor: Bavarian Nordic
• Collaborators: Emergent BioSolutions
• Investigators: Study Director: Patrick Ajiboye, Emergent BioSolutions

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2021
• Primary Completion (Actual): May 5, 2022
• Study Completion (Actual): May 5, 2022

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Alphavirus Infections; Togaviridae Infections; Chikungunya Fever
• Other Study ID Numbers: EBSI-CV-317-010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No