A Study to Assess the Safety and Immunogenicity of PXVX0317 Chikungunya Virus Virus-Like Particle Vaccine
Chikungunya Virus
Bottom Line
View on ClinicalTrials.gov: NCT05065983 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CHIKV VLP, adjuvanted (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bavarian Nordic
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CHIKV SNA (Serum Neutralizing Antibody) Seroresponse Rate at Day 22 |
100.0 | — |
| PRIMARY CHIKV SNA GMT (Geometric Mean Titer) at Day 22 |
2365.2 | — |
| PRIMARY CHIKV SNA Seroresponse Rates at Days 8, 15, and 57 |
76.0; 100.0; 100.0 | — |
| PRIMARY CHIKV SNA GMTs at Days 8, 15, and 57 |
117.4; 1397.1; 1069.7 | — |
| PRIMARY CHIKV ELISA (Enzyme-Linked Immunosorbent Assay) IgG GMTs at Days 8, 15, 22, and 57 |
0.71; 1.1; 1.5; 1.2 | — |
| PRIMARY CHIKV ELISA IgM GMTs at Days 8, 15, 22, and 57 |
1.2; 5.0; 6.2; 2.9 | — |
| PRIMARY Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57 |
15.6; 186.3; 315.4; 142.6 | — |
| PRIMARY GMFI in CHIK ELISA IgG at Days 8, 15, 22, and 57 |
0.93; 1.4; 2.0; 1.7 | — |
| PRIMARY GMFI in CHIK ELISA IgM at Days 8, 15, 22, and 57 |
3.1; 12.6; 15.6; 7.2 | — |
| PRIMARY Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 |
96.0; 76.0; 68.0; 56.0; 52.0; 48.0 | — |
| SECONDARY Incidence of Solicited Adverse Events (AE) Through Day 8 |
17; 12; 1; 1; 8; 7 | — |
| SECONDARY Incidence of Unsolicited AEs Through Day 29 |
8; 2; 2; 1; 1; 1 | — |
| SECONDARY Incidence of Adverse Events of Special Interest (AESI) Through Day 183 |
— | — |
| SECONDARY Incidence of Serious Adverse Events (SAEs) Through Day 183 |
— | — |
Summary
Eligibility Criteria
Inclusion Criteria
- Able and willing to provide informed consent voluntarily signed by participant.
- Any gender, 18 to 45 years of age (inclusive).
- Generally healthy, in the opinion of the Investigator, based on medical history, physical examination, and screening laboratory assessments.
- 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
- Currently pregnant, breastfeeding, or planning to become pregnant during the study.
- Body Mass Index (BMI) ≥35 kg/m2.
- Positive laboratory evidence of current infection with human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus (HCV) or hepatitis B virus (HBV).
- History of severe allergic reaction or anaphylaxis to any component of the investigational product (IP).
- 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).
- Prior or anticipated receipt of immunomodulatory or immunosuppressive therapy from six months prior to screening through Day 64.
- Receipt or anticipated receipt of blood or blood-derived products from 90 days prior to screening through Day 64.
- 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).
- 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.
- Enrollment in an interventional study and/or receipt of another investigational product from 30 days prior to screening through the duration of study participation.
- Receipt or anticipated receipt of any vaccine from 30 days prior to screening through Day 64.
- Prior receipt of an investigational CHIKV vaccine/product.
- Detectable baseline anti-CHIKV IgG antibody as determined by ELISA.
- 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.
- Restricted venous access that would prevent the collection of plasma and serum necessary for participation.
- Weight <110 pounds.
Data sourced from ClinicalTrials.gov (NCT05065983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.