Clinical trial NCT05065983: A Study to Assess the Safety and Immunogenicity of PXVX0317 Chikungunya Virus Virus-Like Particle Vaccine
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chikungunya Virus
Lead sponsor: Bavarian Nordic
Sponsor class: INDUSTRY
Collaborators: name: Emergent BioSolutions
First posted: 2021-10-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label Safety and Immunogenicity
Primary purpose: PREVENTION

Brief summary: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: CHIKV SNA (Serum Neutralizing Antibody) Seroresponse Rate at Day 22
timeFrame: 21 days post vaccination
measure: CHIKV SNA GMT (Geometric Mean Titer) at Day 22
timeFrame: 21 days post vaccination
measure: CHIKV SNA Seroresponse Rates at Days 8, 15, and 57
timeFrame: 56 days post vaccination
measure: CHIKV SNA GMTs at Days 8, 15, and 57
timeFrame: 56 days post vaccination
measure: CHIKV ELISA (Enzyme-Linked Immunosorbent Assay) IgG GMTs at Days 8, 15, 22, and 57
timeFrame: 56 days post vaccination
measure: CHIKV ELISA IgM GMTs at Days 8, 15, 22, and 57
timeFrame: 56 days post vaccination
measure: Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57
timeFrame: 56 days post vaccination
measure: GMFI in CHIK ELISA IgG at Days 8, 15, 22, and 57
timeFrame: 56 days post vaccination
measure: GMFI in CHIK ELISA IgM at Days 8, 15, 22, and 57
timeFrame: 56 days post vaccination
measure: Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57
timeFrame: 56 days post vaccination
Secondary outcomes:
measure: Incidence of Solicited Adverse Events (AE) Through Day 8
timeFrame: 7 days post vaccination
measure: Incidence of Unsolicited AEs Through Day 29
timeFrame: 28 days post vaccination
measure: Incidence of Adverse Events of Special Interest (AESI) Through Day 183
timeFrame: 182 days post vaccination
measure: Incidence of Serious Adverse Events (SAEs) Through Day 183
timeFrame: 182 days post vaccination
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Johnson County ClinTrials
state: Kansas
Study officials:
affiliation: Emergent BioSolutions
name: Patrick Ajiboye
role: STUDY_DIRECTOR
References: