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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05065983
Other study ID # EBSI-CV-317-010
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 11, 2021
Est. completion date January 2022

Study information

Verified date October 2021
Source Emergent BioSolutions
Contact Sarah Butts
Phone 650-486-0257
Email buttss@ebsi.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to assess the Safety and Immunogenicity of PXVX0317 (Chikungunya Virus-Like Particle Vaccine [CHIKV VLP], alum-adjuvanted).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date January 2022
Est. primary completion date January 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: 1. Able and willing to provide informed consent voluntarily signed by subject. 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 (subjects 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 subject's participation or the conduct of the study, creates an unacceptable risk to the subject, 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
CHIKV VLP, adjuvanted
Adjuvanted formulation includes Alhydrogel

Locations

Country Name City State
United States Johnson County ClinTrials Lenexa Kansas

Sponsors (1)

Lead Sponsor Collaborator
Emergent BioSolutions

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary CHIKV SNA (Serum Neutralizing Antibody) seroresponse rate at Day 22 CHIKV SNA seroresponse rate and associated 95% Confidence Interval (CI) at Day 22. 21 days post vaccination
Primary CHIKV SNA GMT (Geometric Mean Titer) at Day 22 CHIKV SNA GMT and associated 95% CI at Day 22 21 days post vaccination
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Number and percentage of subjects with a CHIKV SNA titer at or above threshold values at Days 8, 15, 22, and 57 Number and percentage of subjects 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 Incidence of solicited Adverse Events (AE) through Day 8 Incidence of solicited AEs through Day 8 7 days post vaccination
Secondary Incidence of unsolicited AEs through Day 29 Incidence of unsolicited AEs through Day 29 28 days post vaccination
Secondary Incidence of Adverse Events of Special Interest (AESI) through Day 64 Incidence of AESIs through Day 64 63 days post vaccination
Secondary Incidence of Serious Adverse Events (SAEs) through Day 64 Incidence of SAEs through Day 64 63 days post vaccination
See also
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Recruiting NCT05072080 - A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 Phase 3
Terminated NCT00391313 - CuraChik : A Trial of the Efficacy and Safety of Chloroquine as Therapeutic Treatment of Chikungunya Disease Phase 3
Completed NCT02305732 - A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components
Completed NCT01489358 - Chikungunya Virus Vaccine Trial in Healthy Adults Phase 1
Completed NCT03325075 - Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Subjects Phase 1