NCT05065983 (CHIKV VLP) is a Phase 2 clinical trial of CHIKV VLP, adjuvanted in Chikungunya Virus, sponsored by Bavarian Nordic.

Who is sponsoring NCT05065983?

NCT05065983 is sponsored by Bavarian Nordic.

What drugs are being tested in NCT05065983?

Interventions in NCT05065983: CHIKV VLP, adjuvanted.

What condition does NCT05065983 study?

NCT05065983 studies Chikungunya Virus.

Is NCT05065983 still recruiting?

NCT05065983 is currently completed. Last updated 3 July 2023.

Are results published for NCT05065983?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-07-03 · How we verify

NCT05065983: CHIKV VLP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 3 July 2023

What this trial tests

Phase 2 trial testing CHIKV VLP, adjuvanted in Chikungunya Virus in 25 participants. Completed in 5 May 2022.

Timeline

11 October 2021

Primary endpoint
5 May 2022

5 May 2022

Quick facts

Lead sponsor	Bavarian Nordic
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	25
Start date	11 October 2021
Primary completion	5 May 2022
Estimated completion	5 May 2022
Sites	1 location across United States

Drugs / interventions tested

CHIKV VLP, adjuvanted — full drug profile →

Conditions studied

Chikungunya Virus — all drugs for Chikungunya Virus →

Sponsor

Bavarian Nordic — full company profile →

Who can join

Adults 18 to 45, any sex, with Chikungunya Virus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

CHIKV SNA (Serum Neutralizing Antibody) Seroresponse Rate at Day 22 Primary · 21 days post vaccination

CHIKV SNA Seroresponse Rate (Titer \>=40) and Associated 95% Confidence Interval (CI) at Day 22

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	100.0	86.7 – 100.0

CHIKV SNA GMT (Geometric Mean Titer) at Day 22 Primary · 21 days post vaccination

CHIKV SNA GMT and Associated 95% CI at Day 22

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	2365.2	1625.0 – 3442.4

CHIKV SNA Seroresponse Rates at Days 8, 15, and 57 Primary · 56 days post vaccination

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

Day 8 titer at or above 40

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	76.0	56.6 – 88.5

Day 15 titer at or above 40

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	100.0	86.7 – 100.0

Day 57 titer at or above 40

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	100.0	86.2 – 100.0

CHIKV SNA GMTs at Days 8, 15, and 57 Primary · 56 days post vaccination

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

Day 8

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	117.4	68.3 – 201.8

Day 15

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	1397.1	901.9 – 2164.2

Day 57

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	1069.7	720.2 – 1588.9

CHIKV ELISA (Enzyme-Linked Immunosorbent Assay) IgG GMTs at Days 8, 15, 22, and 57 Primary · 56 days post vaccination

CHIKV ELISA IgG GMTs with Associated 95% CIs at Days 8, 15, 22, and 57

Day 8

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	0.71	0.66 – 0.77

Day 15

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	1.1	0.88 – 1.4

Day 22

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	1.5	1.3 – 1.9

Day 57

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	1.2	1.0 – 1.4

CHIKV ELISA IgM GMTs at Days 8, 15, 22, and 57 Primary · 56 days post vaccination

CHIKV ELISA IgM GMTs with Associated 95% CIs at Days 8, 15, 22, and 57

Day 8

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	1.2	0.93 – 1.6

Day 15

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	5.0	4.0 – 6.3

Day 22

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	6.2	5.0 – 7.7

Day 57

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	2.9	2.1 – 3.8

Geometric Mean Fold Increase (GMFI) in CHIK SNA Titers at Days 8, 15, 22, and 57 Primary · 56 days post vaccination

GMFI in CHIK SNA Titers from Day 1 to Days 8, 15, 22, and 57

Day 8

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	15.6	9.1 – 26.9

Day 15

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	186.3	120.3 – 288.6

Day 22

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	315.4	216.7 – 459.0

Day 57

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	142.6	96.0 – 211.9

GMFI in CHIK ELISA IgG at Days 8, 15, 22, and 57 Primary · 56 days post vaccination

GMFI in CHIK ELISA IgG from Day 1 to Days 8, 15, 22, and 57

Day 8

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	0.93	0.77 – 1.1

Day 15

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	1.4	1.0 – 2.0

Day 22

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	2.0	1.5 – 2.6

Day 57

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	1.7	1.4 – 2.1

GMFI in CHIK ELISA IgM at Days 8, 15, 22, and 57 Primary · 56 days post vaccination

GMFI in CHIK ELISA IgM from Day 1 to Days 8, 15, 22, and 57

Day 8

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	3.1	2.3 – 4.1

Day 15

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	12.6	9.9 – 16.1

Day 22

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	15.6	12.6 – 19.4

Day 57

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	7.2	5.3 – 9.8

Number and Percentage of Participants With a CHIKV SNA Titer at or Above Threshold Values at Days 8, 15, 22, and 57 Primary · 56 days post vaccination

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

Day 8 : Titer at or above 15

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	96.0	80.5 – 99.3

Day 8 : Titer at or above 40

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	76.0	56.6 – 88.5

Day 8 : Titer at or above 60

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	68.0	48.4 – 82.8

Day 8 : Titer at or above 80

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	56.0	37.1 – 73.3

Day 8 : Titer at or above 100

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	52.0	33.5 – 70.0

Day 8 : Titer at or above 160

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	48.0	30.0 – 66.5

Day 8 : Titer at or above 640

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	12.0	4.2 – 30.0

Day 8 : Titer at or above 4-fold rise over baseline

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	88.0	70.0 – 95.8

Incidence of Solicited Adverse Events (AE) Through Day 8 Secondary · 7 days post vaccination

Incidence of Solicited AEs Through Day 8

Any solicited AE

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	17

Any systemic solicited AE

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	12

Fever

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	1

Chills

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	1

Fatigue

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	8

Headache

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	7

Myalgia

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	5

Arthralgia

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	2

Incidence of Unsolicited AEs Through Day 29 Secondary · 28 days post vaccination

Incidence of Unsolicited AEs Through Day 29

Participants with any unsolicited AEs

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	8

General disorders and administration site conditions

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	2

Vessel puncture site bruise

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	2

Immune system disorders

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	1

Anaphylactic reaction

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	1

Infections and infestations

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	1

Sinusitis

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	1

Musculoskeletal and connective tissue disorders

Group	Value	95% CI
PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine	1

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs include solicited AEs collected through Day 8 and unsolicited AEs collected through Day 29. SAEs (reported separately) were collected through Day 183.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PXVX0317 (CHIKV VLP, Alum-adjuvanted) Vaccine

Serious: 0/25 (0%)

Deaths: 0/25

Other adverse events (17 terms — click to expand)

Reaction	System	PXVX0317 (CHIKV VLP, Alum-…
Injection site pain	General disorders	—
Fatigue	General disorders	—
Headache	Nervous system disorders	—
Myalgia	Musculoskeletal and connective tissue disorders	—
Presyncope	Nervous system disorders	—
Nausea	Gastrointestinal disorders	—
Vessel puncture site bruise	General disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Dizziness	Nervous system disorders	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—
Chills	General disorders	—
Pyrexia	General disorders	—
Anaphylactic reaction	Immune system disorders	—
Sinusitis	Infections and infestations	—
Anxiety	Psychiatric disorders	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—
Hot flush	Vascular disorders	—

Data from ClinicalTrials.gov NCT05065983 adverse events section.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Biological Nanoparticles in Vaccine Development.
Curley SM, Putnam D. · · 2022 · cited 43× · PMID 35402394 · DOI 10.3389/fbioe.2022.867119
A chikungunya virus-like particle vaccine induces broadly neutralizing and protective antibodies against alphaviruses in humans.
Raju S, Adams LJ, Earnest JT, Warfield K, et al · · 2023 · cited 33× · PMID 37196061 · DOI 10.1126/scitranslmed.ade8273
Chikungunya Vaccine Candidates: Current Landscape and Future Prospects.
Schmidt C, Schnierle BS. · · 2022 · cited 22× · PMID 36277603 · DOI 10.2147/dddt.s366112
Developing a Prototype Pathogen Plan and Research Priorities for the Alphaviruses.
Powers AM, Williamson LE, Carnahan RH, Crowe JE, et al · · 2023 · cited 12× · PMID 37849399 · DOI 10.1093/infdis/jiac326
Chikungunya virus vaccine: a decade of progress solving epidemiological dilemma, emerging concepts, and immunological interventions.
Shaikh MS, Faiyazuddin M, Khan MS, Pathan SK, et al · · 2024 · cited 7× · PMID 39104592 · DOI 10.3389/fmicb.2024.1413250
Immunogenicity and Safety of Chikungunya Vaccines: A Systematic Review and Meta-Analysis.
Rosso A, Flacco ME, Cioni G, Cioni G, et al · · 2024 · cited 4× · PMID 39340001 · DOI 10.3390/vaccines12090969
Vaccine development for zoonotic viral diseases caused by positive‑sense single‑stranded RNA viruses belonging to the <i>Coronaviridae</i> and <i>Togaviridae</i> families (Review).
Babaeimarzangou SS, Zaker H, Soleimannezhadbari E, Gamchi NS, et al · · 2023 · cited 1× · PMID 36569444 · DOI 10.3892/etm.2022.11741
Resurgence of Chikungunya virus: rising global threat and challenges in its mitigation.
Sahu PS, Pattnaik R, Alissa M, Abusalim GS, et al · · 2026 · PMID 42100311 · DOI 10.3389/fphar.2026.1757035

Verify or expand the search:

Other Bavarian Nordic trials

Trials by the same sponsor.

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NCT05349617 — Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years · Phase 3 · completed
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05065983 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bavarian Nordic
Last refreshed: 3 July 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05065983.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT05065983: CHIKV VLP

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other Bavarian Nordic trials

Verify against primary sources