ChikungunyaPhase 2WRAIRNCT03992872
Phase 2 Open-label Study of Alum-adjuvanted Chikungunya Virus-like Particle Vaccine (PXVX0317)
A Phase 2 study testing Chikungunya in people with Chikungunya, run by Bavarian Nordic at 2 sites in United States.
Trial summary
This was a phase 2 parallel-group age- and gender-matched open label study in healthy adults 18-65 years of age to assess the safety and immunogenicity of an alum-adjuvanted chikungunya virus-like particle vaccine (PXVX0317; CHIKV VLP vaccine) in prior recipients of other alphavirus vaccines versus alphavirus naïve… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chikungunya
- What is being tested?
- Chikungunya
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Nov 2019to 19 Jan 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years old (inclusive)
- For women of childbearing potential, a negative pregnancy test at screening and on vaccination day, practicing highly effective contraception for at least 30 days prior to vaccination, and willing to use a highly effective method of contraception through study completion.
- Able and willing to provide informed consent for study participation prior to screening procedures.
- Free of obvious health problems as established by medical history and clinical examination at screening and enrollment.
- Available to participate for the duration of the study (approximately 8 months).
- For the cohort of prior alphavirus vaccine recipients, a documented history of prior alphavirus vaccination.
Who cannot join
- Acute disease or febrile illness at the time of screening or enrollment.
- Clinically significant cardiac, respiratory, rheumatologic or other medical or psychiatric condition that, in the opinion of the Investigator, places the subject at increased risk or affects their ability to understand and comply with study procedures.
- Abnormal screening lab test result that, in the opinion of the investigator, obscures interpretation of the safety data or suggests a clinically significant cardiac, respiratory, rheumatologic or other medical condition that places the subject at increased risk.
- Pregnant, lactating or planning to become pregnant during the study period.
- Laboratory evidence of infection with Hepatitis B, C or HIV.
- History of naturally (non-laboratory) acquired chikungunya or other alphavirus infection or travel to a WHO-designated chikungunya-endemic region within 30 days prior to Day 1.
Show all 16Show fewer
- History of acute allergic reaction to any component of CHIKV VLP vaccine or Alhydrogel®.
- Current (30 days prior to Day 1) or anticipated use of systemic immunomodulatory or immunosuppressive medications.
- History of splenectomy, immunosuppressive condition, autoimmune disease, or immunodeficient condition.
- Family history of congenital or hereditary immunodeficiency.
- Suspected or known current alcohol abuse that, in the opinion of the Investigator, would interfere with the subject's ability to understand and comply with study procedures.
- Current intravenous drug use.
- Prior receipt of an investigational chikungunya vaccine.
- Receipt or planned receipt of any licensed vaccine from 30 days prior to Day 1 through Day 29 study visit.
- Participation in another clinical trial during the study period in which an investigational product is administered.
- For the alphavirus naïve group, history of prior alphavirus vaccination is exclusionary.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
United States Army Medical Research Institute of Infectious Diseases
Fort Deterick, Maryland, 21702
Walter Reed Army Institute of Research
Silver Spring, Maryland, 20910
About this study
Official title: A Phase 2 Open-label Study to Assess the Safety and Immunogenicity of an Alum-adjuvanted Chikungunya Virus-like Particle Vaccine (PXVX0317) in Prior Recipients of Other Alphavirus Vaccines Versus Alphavirus Naïve Controls.
This was a phase 2 parallel-group age- and gender-matched open label study in healthy adults 18-65 years of age to assess the safety and immunogenicity of an alum-adjuvanted chikungunya virus-like particle vaccine (PXVX0317; CHIKV VLP vaccine) in prior recipients of other alphavirus vaccines versus alphavirus naïve controls.
Read the detailed description
It is currently unknown whether prior exposure to heterologous alphaviruses will enhance or interfere with immune responses to chikungunya virus (CHIKV) exposure or vaccination. The objective of this study was to evaluate the safety and immunogenicity of the chikungunya vaccine candidate PXVX0317 when administered to prior recipients of experimental alphavirus vaccines versus alphavirus naïve gender- and age-matched controls.
- Conditions
- Chikungunya
- Being tested
- Chikungunya
- Medical subject headings
- Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChikungunyaBiological
Virus Like Particle
| Study group | Role | What they receive |
|---|---|---|
| Prior Alpha | Experimental | All study participants received the same Investigational Product according to the same schedule. Participants were prior recipients of experimental alphavirus vaccines. Receives: Biological: Chikungunya |
| Control: Naïve Alpha | Active comparator | All study participants received the same Investigational Product according to the same schedule. The alphavirus vaccine naïve participants will serve as controls for determining the effect of pre-existing alphavirus immunity on vaccine safety and immunogenicity. Receives: Biological: Chikungunya |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With 4-fold Rise in Anti-CHIKV Neutralizing Antibody Response
Seroconversion, defined as a 4-fold or greater rise in neutralizing antibody against chikungunya virus, as determined by luciferase-based assay (NT80), induced by PXVX0317.
PXVX0317 was administered to prior alphavirus vaccine recipients versus gender- and age-matched controls.
Measured: Day 22 (21 days after vaccination)
Secondary outcomes (12)
Geometric Mean Titer of Anti-CHIKV Neutralizing Antibody Response
Evaluation of Geometric Mean Titer of Anti-CHIKV neutralizing antibodies, determined by luciferase-based assay (NT80), in prior alphavirus vaccine recipients versus alphavirus-naïve controls.
Measured: Day 1, 8, 22, 29, 57, 182
Percentage of Participants With 4-fold Rise in Anti-CHIKV Neutralizing Antibody Response
Evaluation of seroconversion rate of Anti-CHIKV neutralizing antibodies, determined by luciferase-based assay (NT80), in prior alphavirus vaccine recipients versus alphavirus-naïve controls.
Measured: Day 8, 29, 57, 182
Percentage of Participants With Anti-CHIKV Neutralizing Antibody at or Above Selected Thresholds
Evaluation of Anti-CHIKV neutralizing antibody response, as determined by luciferase-based assay (NT80), via proportion of participants with titers of at least 40, 160 or 640 on Days 1, 8, 22, 29, 57 and 182.
Measured: Day 1, 8, 22, 29, 57, 182
Geometric Mean Titer of Anti-CHIKV Total Antibody Response
Evaluation of Geometric Mean Titer of Anti-CHIKV total antibodies, determined by immunoassay (ELISA), in prior alphavirus vaccine recipients versus alphavirus-naïve controls.
Measured: Day 1, 22, 29
Percentage of Participants With 4-fold Rise in Anti-CHIKV Total Antibody Response
Evaluation of seroconversion rate of Anti-CHIKV total antibodies, determined by immunoassay, on Days 22 and 29, where seroconversion was a 4-fold rise in titer over baseline.
Measured: Day 22, 29
Geometric Mean Titer of Anti-VEEV Neutralizing Antibody Response
Evaluation of Geometric Mean Titer of Anti-VEEV neutralizing antibodies, determined by Plaque-Reduction Neutralization Test (PRNT80), in prior alphavirus vaccine recipients versus alphavirus-naïve controls
Measured: Day 1, 22, 29
Number of Participants With Anti-CHIKV Total Antibody Titers of at Least 40,160 or 640
Evaluation of Anti-CHIKV total antibody titer, as determined by immunoassay (ELISA), via proportion of participants with titers of at least 40, 160 or 640 on Days 1, 22, and 29.
Measured: Days 1, 22, and 29
Percentage of Participants With 4-fold Rise in Anti-VEEV Neutralizing Antibody Response
Evaluation of seroconversion rate of anti-VEEV neutralizing antibodies on Days 22 and 29 as determined by Plaque-Reduction Neutralization Test (PRNT80), where seroconversion is a 4-fold rise in titer over baseline.
Measured: Day 22 and 29
Percentage of Participants With Anti-VEEV PRNT Neutralizing Activity at or Above Selected Thresholds
Evaluation of Anti-VEEV neutralizing antibody response, as determined by Plaque-Reduction Neutralization Test (PRNT80), via proportion of participants with titers of at least 40, 160 or 640 on Days 1, 22 and 29.
Measured: Day 1, 22, 29
Geometric Mean Titer of Anti-VEEV Total Antibody Response
Evaluation of Geometric Mean Titer of Anti-VEEV total antibody as determined by an immunoassay (ELISA) in prior alphavirus vaccine recipients versus alphavirus-naïve controls.
Measured: Day 1, 22, 29
Percentage of Participants With 4-fold Rise in Total ELISA IgG Antibody Against VEEV
Evaluation of seroconversion rate of Anti-VEEV total antibody, as determined by immunoassay (ELISA), on Days 22 and 29, where seroconversion is a 4-fold rise in titer over baseline.
Measured: Day 22, 29
Number of Participants With Anti-VEEV Total Antibody Titers of at Least 40,160 or 640
Evaluation of Anti-VEEV total antibody titer, as determined by immunoassay (ELISA), via proportion of participants with titers of at least 40, 160, or 640 on Days 1, 22, and 29.
Measured: Days 1, 22, and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start20 Nov 2019
- Primary completion19 Jan 2021
- Study completion19 Jan 2021
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 (1)Papers the sponsor has linked to this study.
- Other trials for ChikungunyaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Open Label Safety and Immunogenicity
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Walter Reed Army Institute of Research (WRAIR), Emergent BioSolutions
- Responsible party
- Sponsor
- Investigators
- James McCarty, MD, Study director, Emergent BioSolutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992872
- Sponsor's protocol ID
- EBSI-CV-317-002
- Acronym
- WRAIR
- Status last verified
- Sep 2024
- First submitted
- 18 Jun 2019
- Last updated
- 16 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamer MJ, McCarty JM, Pierson BC, Regules JA, Mendy J, Sanborn AD, Gardner CL, Haller JM, Gregory MK, Liggett DL, Glass PJ, Ghosh N, Royalty Tredo S, Warfield KL, Burke CW, Lee C, Saunders D, Bedell L, Richardson JS. Safety and immunogenicity of an adjuvanted chikungunya virus virus-like particle (CHIKV VLP) vaccine in previous recipients of other alphavirus vaccines versus alphavirus vaccine-naive controls: an open-label, parallel-group, age-matched, sex-matched, phase 2 randomised controlled study. Lancet Microbe. 2025 Apr;6(4):101000. doi: 10.1016/j.lanmic.2024.101000. Epub 2025 Feb 12.
PubMed 39954701
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Open-label Study to Assess the Safety and Immunogenicity of an Alum-adjuvanted Chikungunya Virus-like Particle Vaccine (PXVX0317) in Prior Recipients of Other Alphavirus Vaccines Versus Alphavirus Naïve Controls.
- ClinicalTrials.gov ID
- NCT03992872
- Acronym / sponsor ID
- WRAIR / EBSI-CV-317-002
- Conditions
- Chikungunya
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Collaborators
- Walter Reed Army Institute of Research (WRAIR), Emergent BioSolutions
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 19 Jan 2021 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Posted 16 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a phase 2 parallel-group age- and gender-matched open label study in healthy adults 18-65 years of age to assess the safety and immunogenicity of an alum-adjuvanted chikungunya virus-like particle vaccine (PXVX0317; CHIKV VLP vaccine) in prior recipients of other alphavirus vaccines versus alphavirus naïve controls.
Detailed description
It is currently unknown whether prior exposure to heterologous alphaviruses will enhance or interfere with immune responses to chikungunya virus (CHIKV) exposure or vaccination. The objective of this study was to evaluate the safety and immunogenicity of the chikungunya vaccine candidate PXVX0317 when administered to prior recipients of experimental alphavirus vaccines versus alphavirus naïve gender- and age-matched controls.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open Label Safety and Immunogenicity
| Arm | Type | Receives |
|---|---|---|
| Prior Alpha | Experimental | Biological: ChikungunyaAll study participants received the same Investigational Product according to the same schedule. Participants were prior recipients of experimental alphavirus vaccines. |
| Control: Naïve Alpha | Active comparator | Biological: ChikungunyaAll study participants received the same Investigational Product according to the same schedule. The alphavirus vaccine naïve participants will serve as controls for determining the effect of pre-existing alphavirus immunity on vaccine safety and immunogenicity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 65 years old (inclusive)
- For women of childbearing potential, a negative pregnancy test at screening and on vaccination day, practicing highly effective contraception for at least 30 days prior to vaccination, and willing to use a highly effective method of contraception through study completion.
- Able and willing to provide informed consent for study participation prior to screening procedures.
- Free of obvious health problems as established by medical history and clinical examination at screening and enrollment.
- Available to participate for the duration of the study (approximately 8 months).
Key exclusion criteria (16 listed)
- Acute disease or febrile illness at the time of screening or enrollment.
- Clinically significant cardiac, respiratory, rheumatologic or other medical or psychiatric condition that, in the opinion of the Investigator, places the subject at increased risk or affects their ability to understand and comply with study procedures.
- Abnormal screening lab test result that, in the opinion of the investigator, obscures interpretation of the safety data or suggests a clinically significant cardiac, respiratory, rheumatologic or other medical condition that places the subject at increased risk.
- Pregnant, lactating or planning to become pregnant during the study period.
- Laboratory evidence of infection with Hepatitis B, C or HIV.
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 |
|---|---|---|
| ChikungunyaVirus Like Particle | Biological | Control: Naïve Alpha, Prior Alpha |
Primary outcome
Percentage of Participants With 4-fold Rise in Anti-CHIKV Neutralizing Antibody Response
Time frame: Day 22 (21 days after vaccination)
Seroconversion, defined as a 4-fold or greater rise in neutralizing antibody against chikungunya virus, as determined by luciferase-based assay (NT80), induced by PXVX0317. PXVX0317 was administered to prior alphavirus vaccine recipients versus gender- and age-matched controls.
12 secondary outcomes
Geometric Mean Titer of Anti-CHIKV Neutralizing Antibody Response
Time frame: Day 1, 8, 22, 29, 57, 182
Percentage of Participants With 4-fold Rise in Anti-CHIKV Neutralizing Antibody Response
Time frame: Day 8, 29, 57, 182
Percentage of Participants With Anti-CHIKV Neutralizing Antibody at or Above Selected Thresholds
Time frame: Day 1, 8, 22, 29, 57, 182
Geometric Mean Titer of Anti-CHIKV Total Antibody Response
Time frame: Day 1, 22, 29
Percentage of Participants With 4-fold Rise in Anti-CHIKV Total Antibody Response
Time frame: Day 22, 29
Geometric Mean Titer of Anti-VEEV Neutralizing Antibody Response
Time frame: Day 1, 22, 29
Number of Participants With Anti-CHIKV Total Antibody Titers of at Least 40,160 or 640
Time frame: Days 1, 22, and 29
Percentage of Participants With 4-fold Rise in Anti-VEEV Neutralizing Antibody Response
Time frame: Day 22 and 29
Percentage of Participants With Anti-VEEV PRNT Neutralizing Activity at or Above Selected Thresholds
Time frame: Day 1, 22, 29
Geometric Mean Titer of Anti-VEEV Total Antibody Response
Time frame: Day 1, 22, 29
Percentage of Participants With 4-fold Rise in Total ELISA IgG Antibody Against VEEV
Time frame: Day 22, 29
Number of Participants With Anti-VEEV Total Antibody Titers of at Least 40,160 or 640
Time frame: Days 1, 22, and 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39954701Hamer MJ, McCarty JM, Pierson BC, Regules JA, Mendy J, Sanborn AD, Gardner CL, Haller JM, Gregory MK, Liggett DL, Glass PJ, Ghosh N, Royalty Tredo S, Warfield KL, Burke CW, Lee C, Saunders D, Bedell L, Richardson JS. Safety and immunogenicity of an adjuvanted chikungunya virus virus-like particle (CHIKV VLP) vaccine in previous recipients of other alphavirus vaccines versus alphavirus vaccine-naive controls: an open-label, parallel-group, age-matched, sex-matched, phase 2 randomised controlled study. Lancet Microbe. 2025 Apr;6(4):101000. doi: 10.1016/j.lanmic.2024.101000. Epub 2025 Feb 12.
- Individual participant dataSharing planned: No
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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.
James McCarty, MD study director
Emergent BioSolutions
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chikungunya in people with Chikungunya, run by Bavarian Nordic at 2 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 6 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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 16 Oct 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?
Percentage of Participants With 4-fold Rise in Anti-CHIKV Neutralizing Antibody Response (time frame: Day 22 (21 days after vaccination)). 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 NCT03992872, which also lists 1 linked publication.
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 16 Oct 2024.