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Chikungunya VirusPhase 2CHIKV VLPNCT05065983

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

A Phase 2 study testing CHIKV VLP, adjuvanted in people with Chikungunya Virus, run by Bavarian Nordic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Chikungunya Virus
What is being tested?
CHIKV VLP, adjuvanted
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
11 Oct 2021to 5 May 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johnson County ClinTrials

    Lenexa, Kansas, 66219

Other trials in United States

About this study

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)

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).

Read the 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.
Being tested
CHIKV VLP, adjuvanted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHIKV VLP, adjuvantedBiological

    Adjuvanted formulation includes aluminum hydroxide

Study groups in NCT05065983
Study groupRoleWhat they receive
PXVX0317 (CHIKV VLP, alum-adjuvanted) vaccineExperimentalAll study participants will receive the same Investigational Product (40 µg CHIKV VLP, alum-adjuvanted according to the same single dose schedule on Day 1).
Receives: Biological: CHIKV VLP, adjuvanted

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 21 days post vaccination

  2. CHIKV SNA GMT (Geometric Mean Titer) at Day 22

    CHIKV SNA GMT and Associated 95% CI at Day 22

    Measured: 21 days post vaccination

  3. CHIKV SNA Seroresponse Rates at Days 8, 15, and 57

    CHIKV SNA Seroresponse Rates with Associated 95% CIs at Days 8, 15, and 57

    Measured: 56 days post vaccination

  4. CHIKV SNA GMTs at Days 8, 15, and 57

    CHIKV SNA GMTs with Associated 95% CIs at Days 8, 15, and 57

    Measured: 56 days post vaccination

  5. 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

    Measured: 56 days post vaccination

  6. 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

    Measured: 56 days post vaccination

  7. 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

    Measured: 56 days post vaccination

  8. 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

    Measured: 56 days post vaccination

  9. 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

    Measured: 56 days post vaccination

  10. 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

    Measured: 56 days post vaccination

Secondary outcomes (4)

  1. Incidence of Solicited Adverse Events (AE) Through Day 8

    Incidence of Solicited AEs Through Day 8

    Measured: 7 days post vaccination

  2. Incidence of Unsolicited AEs Through Day 29

    Incidence of Unsolicited AEs Through Day 29

    Measured: 28 days post vaccination

  3. Incidence of Adverse Events of Special Interest (AESI) Through Day 183

    Incidence of AESIs Through Day 183

    Measured: 182 days post vaccination

  4. Incidence of Serious Adverse Events (SAEs) Through Day 183

    Incidence of SAEs Through Day 183

    Measured: 182 days post vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2021
  2. Study start11 Oct 2021
  3. Primary completion5 May 2022
  4. Study completion5 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Open Label Safety and Immunogenicity
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05065983
Sponsor's protocol ID
EBSI-CV-317-010
Acronym
CHIKV VLP
Status last verified
Jun 2023
First submitted
23 Sep 2021
Last updated
3 Jul 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CHIKV VLP, adjuvanted in people with Chikungunya Virus, run by Bavarian Nordic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CHIKV SNA (Serum Neutralizing Antibody) Seroresponse Rate at Day 22 (time frame: 21 days post vaccination). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05065983.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.

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