Chikungunya VirusPhase 3NCT05349617

Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years

A Phase 3 study testing CHIKV VLP/adjuvant in people with Chikungunya Virus, run by Bavarian Nordic at 10 sites 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 purpose of this phase 3, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity to PXVX0317 in adults ≥65 years of age. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Chikungunya Virus
What is being tested?: CHIKV VLP/adjuvant
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 413 participants
Where: 10 sitesUnited States
Study dates: 12 May 2022to 8 Aug 2023
Phase: Phase 3
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 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Able and willing to provide informed consent voluntarily signed by participant. Must verbalize understanding of the general procedures of, and reason for the study.
Males or females, ≥65 years of age.
Able to complete all scheduled visits and comply with all study procedures.
Women who are not of childbearing potential (CBP): surgically sterile (at least six weeks post bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or postmenopausal (defined as a history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous post menopausal sex-hormonal treatment).
Participants must be in stable health in the opinion of the investigator for at least 30 days prior to screening (eg, no hospital admission for acute illness in the last 30 days prior to screening).

Who cannot join

Participation or planned participation in an investigational clinical trial (eg, vaccine, drug, medical device, or medical procedure) within 30 days of Day 1 and for the duration of the study. Note: Participation in an observational trial or follow-up phase of a trial may be allowed; however, these instances should be discussed with the sponsor's medical monitor (MM) prior to enrollment.
Prior receipt of any CHIKV vaccine.
Positive laboratory evidence of current infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
Body mass index (BMI) ≥35 kg/m^2
History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product (IP).
History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to vaccination (eg, leukemia, lymphoma, malignancy, functional or anatomic asplenia, alcoholic cirrhosis). Note: History of basal cell and squamous cell carcinoma of the skin or carcinoma in situ of the cervix considered cured would not be exclusionary. History of a malignancy considered cured from over five years from the date of screening with minimal risk of recurrence is not exclusionary.

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Prior or anticipated use of systemic immunomodulatory or immunosuppressive medications from six months prior to screening through Day 22. Note: Systemic corticosteroid use at a dose or equivalent dose of 20 mg of prednisone daily for 14 days or more within 90 days of screening through Day 22 is exclusionary. The use of inhaled, intranasal, topical, or ocular steroids is allowed.
Bleeding disorder or receipt of anticoagulants in the 21 days prior to screening, contraindicating intramuscular (IM) vaccination, as judged by the investigator.
Moderate or severe acute illness with or without fever (oral temperature ≥100.4°F or 38.0°C).
Receipt or anticipated receipt of immunoglobulin from 180 days prior to screening through Day 22.
Medical condition (such as dementia) that, in the opinion of the investigator, could adversely impact the participant's participation in or conduct of the study.
Evidence of substance abuse that, in the opinion of the investigator, could adversely impact the participant's participation in or conduct of the study.
Identified as an investigator or employee of an Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse) of the investigator or employee with direct involvement in the proposed study.
Receipt or anticipated receipt of any vaccine from 30 days prior to Day 1 through Day 22.
Receipt or anticipated receipt of blood or blood-derived products from 90 days prior to screening through Day 22.
Any planned elective surgery that may interfere with study participation or conduct.
Any other medical condition that, in the opinion of the investigator, could adversely impact the participant's participation in or conduct of the study.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

DM Clinical Research CyFair
Houston, Texas, 77065
AMR Kansas City
Kansas City, Missouri, 64114
Suncoast Research Associates, LLC
Miami, Florida, 33173
Panax Clinical Research
Miami Lakes, Florida, 33014
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Rochester Clinical Research, Inc.
Rochester, New York, 14609
BHFC Research
San Antonio, Texas, 78249
Global Clinical Research Professionals (GCP)
St. Petersburg, Florida, 33705
DM Clinical Research Tomball
Tomball, Texas, 77375
Spaulding Clinical
West Bend, Wisconsin, 53095

Other trials in United States

About this study

Official title: A Phase 3 Safety and Immunogenicity Trial of the VLP-Based Chikungunya Virus Vaccine PXVX0317 in Adults ≥65 Years of Age

The purpose of this phase 3, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity to PXVX0317 in adults ≥65 years of age.

Read the detailed description

Co-primary Objectives:

To compare the anti-CHIKV serum neutralizing antibody (SNA) response to PXVX0317 and placebo at Day 22, as measured by geometric mean titer (GMT) and clinically relevant difference in seroresponse rate (PXVX0317 minus placebo) in adults ≥65 years of age.
To evaluate the safety of PXVX0317 in adults ≥65 years of age

Secondary Objectives:

To compare the anti-CHIKV SNA response to PXVX0317 and placebo at Day 15 and Day 183, as measured by GMT and seroresponse rate.
To compare the anti-CHIKV SNA response to PXVX0317 and placebo in participants ≥65 to <75 and ≥75 years of age as measured by GMT and seroresponse rate.

Conditions: Chikungunya Virus
Being tested: CHIKV VLP/adjuvant, Placebo
Keywords: chikungunya, virus like particle (VLP), PXVX0317, vaccine, immunogenicity
Medical subject headings: Chikungunya Fever

What participants receive

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

CHIKV VLP/adjuvantBiological
PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
PlaceboBiological
Placebo is comprised of formulation buffer

Study groups in NCT05349617
Study group	Role	What they receive
Group 1 - PXVX0317	Experimental	PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant. Receives: Biological: CHIKV VLP/adjuvant
Group 2 - Placebo	Placebo comparator	Placebo is comprised of formulation buffer. Receives: Biological: Placebo

What is being measured

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

Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Day 22 in Baseline Seronegative Participants
Difference in anti-CHIKV SNA titer (NT80) seroresponse rate (PXVX0317 minus placebo) and associated 95 percent confidence interval (CI) at Day 22.
Measured: 21 days postvaccination
Anti-CHIKV SNA Titer (NT80) Geometric Mean Titers (GMT) at Day 22
Anti-CHIKV SNA titer (NT80) GMT and associated 95 percent CIs at Day 22 for PXVX0317 and placebo.
Measured: 21 days postvaccination
Incidence of Solicited Adverse Events (AE)
Incidence of solicited AEs through Day 8 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Measured: 7 days postvaccination
Incidence of Unsolicited AEs
Incidence of unsolicited AEs through Day 29 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Measured: 28 days postvaccination
Incidence of Serious Adverse Events (SAE)
Incidence of SAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Measured: 182 days postvaccination
Incidence of Medically Attended Adverse Events (MAAE)
Incidence of MAAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Measured: 182 days postvaccination
Incidence of Adverse Events of Special Interest (AESI)
Incidence of AESIs, through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Measured: 182 days postvaccination

Secondary outcomes (4)

Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Days 15 and 183
Difference in anti-CHIKV SNA titer (NT80) seroresponse rate (PXVX0317 minus placebo) with associated 95 percent CIs at Day 15 and Day 183.
Measured: Day 15 and 183 (14 and 182 days postvaccination, respectively)
Anti-CHIKV SNA GMTs at Days 15 and 183
Anti-CHIKV SNA GMTs with associated 95 percent CIs at Day 15, and Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined.
Measured: Day 15, and 183 (14 and 182 days postvaccination, respectively)
Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI)
Geometric mean fold increase (GMFI) in anti-CHIKV SNA titers from Day 1 to Day 15, Day 22, and Day 183 for the IEP for all age strata combined.
Measured: Day 15, 22, and 183 (14, 21 and 182 days postvaccination, respectively)
Subjects With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline
Number and percentage of participants with anti-CHIKV SNA titers ≥15 and 4-fold rise over baseline at Day 15, Day 22, and Day 183 for the IEP for all age strata combined.
Measured: Day 15, 22 and 183 (14, 21 and 182 days postvaccination, respectively)

Timeline

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

12 May 20228 Aug 2023

First posted27 Apr 2022
Study start12 May 2022
Primary completion19 Jun 2023
Study completion8 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chikungunya VirusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be randomized in a 1:1 ratio to receive PXVX0317 or placebo within each age stratum. Participants will be stratified in two age subgroups (≥65 to \<75 and ≥75 years of age). This study will be conducted in the US, using up to 10 sites.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 413 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05349617
Sponsor's protocol ID: EBSI-CV-317-005
Status last verified: Dec 2024
First submitted: 21 Apr 2022
Last updated: 13 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Tindale LC, Richardson JS, Anderson DM, Mendy J, Muhammad S, Loreth T, Tredo SR, Ramanathan R, Jenkins VA, Bedell L, Ajiboye P; EBSI-CV-317-005 Study Group. Chikungunya virus virus-like particle vaccine safety and immunogenicity in adults older than 65 years: a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2025 Apr 19;405(10487):1353-1361. doi: 10.1016/S0140-6736(25)00372-1. Epub 2025 Mar 27.
PubMed 40158524
Bennett SR, McCarty JM, Ramanathan R, Mendy J, Richardson JS, Smith J, Alexander J, Ledgerwood JE, de Lame PA, Royalty Tredo S, Warfield KL, Bedell L. Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial. Lancet Infect Dis. 2022 Sep;22(9):1343-1355. doi: 10.1016/S1473-3099(22)00226-2. Epub 2022 Jun 13.
PubMed 35709798

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Safety and Immunogenicity Trial of the VLP-Based Chikungunya Virus Vaccine PXVX0317 in Adults ≥65 Years of Age
ClinicalTrials.gov ID: NCT05349617
Acronym / sponsor ID: EBSI-CV-317-005
Conditions: Chikungunya Virus
Keywords: chikungunya, virus like particle (VLP), PXVX0317, vaccine, immunogenicity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 413 participants (actual)
Lead sponsor: Bavarian NordicIndustry (pharma, biotech, devices)
Collaborators: Emergent BioSolutions
Study start: 12 May 2022 (actual)
Primary completion: 19 Jun 2023 (actual)
Study completion: 8 Aug 2023 (actual)
First posted: 27 Apr 2022 (actual)
Results: Posted 13 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this phase 3, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity to PXVX0317 in adults ≥65 years of age.

Detailed description

Co-primary Objectives:

To compare the anti-CHIKV serum neutralizing antibody (SNA) response to PXVX0317 and placebo at Day 22, as measured by geometric mean titer (GMT) and clinically relevant difference in seroresponse rate (PXVX0317 minus placebo) in adults ≥65 years of age.
To evaluate the safety of PXVX0317 in adults ≥65 years of age

Secondary Objectives:

To compare the anti-CHIKV SNA response to PXVX0317 and placebo at Day 15 and Day 183, as measured by GMT and seroresponse rate.
To compare the anti-CHIKV SNA response to PXVX0317 and placebo in participants ≥65 to <75 and ≥75 years of age as measured by GMT and seroresponse rate.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Participants will be randomized in a 1:1 ratio to receive PXVX0317 or placebo within each age stratum. Participants will be stratified in two age subgroups (≥65 to <75 and ≥75 years of age). This study will be conducted in the US, using up to 10 sites.

Arm	Type	Receives
Group 1 - PXVX0317	Experimental	Biological: CHIKV VLP/adjuvantPXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant.
Group 2 - Placebo	Placebo comparator	Biological: PlaceboPlacebo is comprised of formulation buffer.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

Able and willing to provide informed consent voluntarily signed by participant. Must verbalize understanding of the general procedures of, and reason for the study.
Males or females, ≥65 years of age.
Able to complete all scheduled visits and comply with all study procedures.
Women who are not of childbearing potential (CBP): surgically sterile (at least six weeks post bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or postmenopausal (defined as a history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous post menopausal sex-hormonal treatment).
Participants must be in stable health in the opinion of the investigator for at least 30 days prior to screening (eg, no hospital admission for acute illness in the last 30 days prior to screening).

Key exclusion criteria (17 listed)

Participation or planned participation in an investigational clinical trial (eg, vaccine, drug, medical device, or medical procedure) within 30 days of Day 1 and for the duration of the study. Note: Participation in an observational trial or follow-up phase of a trial may be allowed; however, these instances should be discussed with the sponsor's medical monitor (MM) prior to enrollment.
Prior receipt of any CHIKV vaccine.
Positive laboratory evidence of current infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
Body mass index (BMI) ≥35 kg/m^2
History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product (IP).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CHIKV VLP/adjuvantPXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant	Biological	Group 1 - PXVX0317
PlaceboPlacebo is comprised of formulation buffer	Biological	Group 2 - Placebo

Primary outcome

Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Day 22 in Baseline Seronegative Participants
Time frame: 21 days postvaccination
Difference in anti-CHIKV SNA titer (NT80) seroresponse rate (PXVX0317 minus placebo) and associated 95 percent confidence interval (CI) at Day 22.
Anti-CHIKV SNA Titer (NT80) Geometric Mean Titers (GMT) at Day 22
Time frame: 21 days postvaccination
Anti-CHIKV SNA titer (NT80) GMT and associated 95 percent CIs at Day 22 for PXVX0317 and placebo.
Incidence of Solicited Adverse Events (AE)
Time frame: 7 days postvaccination
Incidence of solicited AEs through Day 8 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Incidence of Unsolicited AEs
Time frame: 28 days postvaccination
Incidence of unsolicited AEs through Day 29 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Incidence of Serious Adverse Events (SAE)
Time frame: 182 days postvaccination
Incidence of SAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Incidence of Medically Attended Adverse Events (MAAE)
Time frame: 182 days postvaccination
Incidence of MAAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).
Incidence of Adverse Events of Special Interest (AESI)
Time frame: 182 days postvaccination
Incidence of AESIs, through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).

4 secondary outcomes

Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Days 15 and 183
Time frame: Day 15 and 183 (14 and 182 days postvaccination, respectively)
Anti-CHIKV SNA GMTs at Days 15 and 183
Time frame: Day 15, and 183 (14 and 182 days postvaccination, respectively)
Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI)
Time frame: Day 15, 22, and 183 (14, 21 and 182 days postvaccination, respectively)
Subjects With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline
Time frame: Day 15, 22 and 183 (14, 21 and 182 days postvaccination, respectively)

Results and safety

Results posted to the registry on 13 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 - PXVX0317	206	200
Group 2 - Placebo	207	188

Primary outcome: Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Day 22 in Baseline Seronegative Participants

Time frame: 21 days postvaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group 1 - PXVX0317 n = 189	Group 2 - Placebo n = 183
Value	87.3 (81.8 to 91.3)	1.1 (0.3 to 3.9)

Group 1 - PXVX0317 vs Group 2 - Placebo: Percent Difference: 86.2 (95% CI 80 to 90.3), p <0.0001, Chi-squared

Population analysed: Immunogenicity Evaluable Population (IEP): All participants in the modified intent-to-treat (mITT) population who provide evaluable serum sample results for Day 22 within the required time frame of Day 19 through Day 27, inclusive; have no measurable anti-CHIKV SNA at Day 1; and have no important protocol deviation or other reason to be excluded as defined prior to unblinding. IEP is the primary population for all immunogenicity analyses.

Primary outcome: Anti-CHIKV SNA Titer (NT80) Geometric Mean Titers (GMT) at Day 22

Time frame: 21 days postvaccination. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Group 1 - PXVX0317 n = 189	Group 2 - Placebo n = 183
Value	724 (584 to 897)	8 (7 to 10)

Group 1 - PXVX0317 vs Group 2 - Placebo: [GMT Ratio]: 90 (95% CI 69 to 117), p <0.0001, ANOVA

Population analysed: Immunogenicity evaluable population (all randomized and vaccinated participants who provided an evaluable Day 22 anti-CHIKV human SNA assay sample within the analysis window (Day 19 through 27, inclusive), had no measurable anti-CHIKV human SNA assay titer at Day 1 (i.e., seronegative at baseline; participants missing a Day 1 titer were excluded from IEP), and had no important exclusionary protocol deviation or other reason for exclusion as defined prior to unblinding).

Primary outcome: Incidence of Solicited Adverse Events (AE)

Time frame: 7 days postvaccination. Count of participants. Unit: Participants

Measure	Group 1 - PXVX0317 n = 205	Group 2 - Placebo n = 200
Value	25	28

Primary outcome: Incidence of Unsolicited AEs

Time frame: 28 days postvaccination. Count of participants. Unit: Participants

Measure	Group 1 - PXVX0317 n = 206	Group 2 - Placebo n = 207
Value	26	34

Population analysed: Safety population (vaccinated participants who provided safety assessment data), All ages pooled.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from Day 1 through to the Day 183 end of study visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 - PXVX0317	4 of 206 (1.9%)	46 of 206 (22.3%)	1 of 206
Group 2 - Placebo	3 of 207 (1.4%)	44 of 207 (21.3%)	1 of 207

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40158524Tindale LC, Richardson JS, Anderson DM, Mendy J, Muhammad S, Loreth T, Tredo SR, Ramanathan R, Jenkins VA, Bedell L, Ajiboye P; EBSI-CV-317-005 Study Group. Chikungunya virus virus-like particle vaccine safety and immunogenicity in adults older than 65 years: a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2025 Apr 19;405(10487):1353-1361. doi: 10.1016/S0140-6736(25)00372-1. Epub 2025 Mar 27.
Derived from this study: PubMed 35709798Bennett SR, McCarty JM, Ramanathan R, Mendy J, Richardson JS, Smith J, Alexander J, Ledgerwood JE, de Lame PA, Royalty Tredo S, Warfield KL, Bedell L. Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial. Lancet Infect Dis. 2022 Sep;22(9):1343-1355. doi: 10.1016/S1473-3099(22)00226-2. Epub 2022 Jun 13.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patrick Ajiboye, MD study director

Bavarian Nordic

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CHIKV VLP/adjuvant in people with Chikungunya Virus, run by Bavarian Nordic at 10 sites 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 17 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 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 13 Dec 2024). 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?

Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Day 22 in Baseline Seronegative Participants (time frame: 21 days postvaccination). The study lists 7 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 NCT05349617, which also lists 2 linked publications.

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 13 Dec 2024.