NCT03992872 (WRAIR) is a Phase 2 clinical trial of Chikungunya in Chikungunya, sponsored by Bavarian Nordic.

Who is sponsoring NCT03992872?

NCT03992872 is sponsored by Bavarian Nordic.

What drugs are being tested in NCT03992872?

Interventions in NCT03992872: Chikungunya.

What condition does NCT03992872 study?

NCT03992872 studies Chikungunya.

Is NCT03992872 still recruiting?

NCT03992872 is currently completed. Last updated 16 October 2024.

Are results published for NCT03992872?

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

Last reviewed 2024-10-16 · How we verify

NCT03992872: WRAIR

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

Phase 2 Open-label Study of Alum-adjuvanted Chikungunya Virus-like Particle Vaccine (PXVX0317)

Completed Phase 2 Results posted Last updated 16 October 2024

What this trial tests

Phase 2 trial testing Chikungunya in Chikungunya in 60 participants. Completed in 19 January 2021.

Timeline

20 November 2019

Primary endpoint
19 January 2021

19 January 2021

Quick facts

Lead sponsor	Bavarian Nordic
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	60
Start date	20 November 2019
Primary completion	19 January 2021
Estimated completion	19 January 2021
Sites	2 locations across United States

Drugs / interventions tested

Chikungunya — full drug profile →

Conditions studied

Chikungunya — all drugs for Chikungunya →

Sponsor

Bavarian Nordic — full company profile →

Who can join

Adults 18 to 65, any sex, with Chikungunya. 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.

Percentage of Participants With 4-fold Rise in Anti-CHIKV Neutralizing Antibody Response Primary · 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.

Group	Value	95% CI
Experimental: Prior Alpha	100	88.6 – 100
Control: Naive Alpha	100	88.6 – 100

Geometric Mean Titer of Anti-CHIKV Neutralizing Antibody Response Secondary · Day 1, 8, 22, 29, 57, 182

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.

Day 1

Group	Value	95% CI
Experimental: Prior Alpha	9.21	7.80 – 10.87
Control: Naive Alpha	7.69	NA – NA

Day 8

Group	Value	95% CI
Experimental: Prior Alpha	271.88	163.72 – 451.49
Control: Naive Alpha	87.48	52.66 – 145.30

Day 22

Group	Value	95% CI
Experimental: Prior Alpha	2032.45	1412.95 – 2923.56
Control: Naive Alpha	2299.18	1598.09 – 3307.84

Day 29

Group	Value	95% CI
Experimental: Prior Alpha	1555.60	1081.46 – 2237.61
Control: Naive Alpha	1772.54	1118.75 – 2808.39

Day 57

Group	Value	95% CI
Experimental: Prior Alpha	727.91	540.94 – 979.52
Control: Naive Alpha	814.64	567.46 – 1169.49

Day 182

Group	Value	95% CI
Experimental: Prior Alpha	294.35	207.45 – 417.66
Control: Naive Alpha	328.89	231.75 – 466.74

Percentage of Participants With 4-fold Rise in Anti-CHIKV Neutralizing Antibody Response Secondary · Day 8, 29, 57, 182

Evaluation of seroconversion rate of Anti-CHIKV neutralizing antibodies, determined by luciferase-based assay (NT80), in prior alphavirus vaccine recipients versus alphavirus-naïve controls.

Day 8

Group	Value	95% CI
Experimental: Prior Alpha	93.3	78.7 – 98.2
Control: Naive Alpha	66.7	48.8 – 80.8

Day 29

Group	Value	95% CI
Experimental: Prior Alpha	100	88.6 – 100
Control: Naive Alpha	100	83.2 – 100

Day 57

Group	Value	95% CI
Experimental: Prior Alpha	100	88.6 – 100
Control: Naive Alpha	100	83.9 – 100

Day 182

Group	Value	95% CI
Experimental: Prior Alpha	86.7	70.3 – 94.7
Control: Naive Alpha	100	88.6 – 100

Percentage of Participants With Anti-CHIKV Neutralizing Antibody at or Above Selected Thresholds Secondary · Day 1, 8, 22, 29, 57, 182

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.

Day 1 (Titer >=40)

Group	Value	95% CI
Experimental: Prior Alpha	3.3	0.6 – 16.7
Control: Naive Alpha	0	0.0 – 11.4

Day 1 (Titer >=160)

Group	Value	95% CI
Experimental: Prior Alpha	3.3	0.6 – 16.7
Control: Naive Alpha	0	0.0 – 11.4

Day 1 (Titer >=640)

Group	Value	95% CI
Experimental: Prior Alpha	0	0.0 – 11.4
Control: Naive Alpha	0	0.0 – 11.4

Day 8 (Titer >=40)

Group	Value	95% CI
Experimental: Prior Alpha	96.7	83.3 – 99.4
Control: Naive Alpha	73.3	55.6 – 85.8

Day 8 (Titer >=160)

Group	Value	95% CI
Experimental: Prior Alpha	70.0	52.1 – 83.3
Control: Naive Alpha	40	24.6 – 57.7

Day 8 (Titer >=640)

Group	Value	95% CI
Experimental: Prior Alpha	26.7	14.2 – 44.4
Control: Naive Alpha	10.0	3.5 – 25.6

Day 22 (Titer >=40)

Group	Value	95% CI
Experimental: Prior Alpha	100	88.6 – 100
Control: Naive Alpha	100	88.6 – 100

Day 22 (Titer >=160)

Group	Value	95% CI
Experimental: Prior Alpha	100	88.6 – 100
Control: Naive Alpha	100	88.6 – 100

Geometric Mean Titer of Anti-CHIKV Total Antibody Response Secondary · Day 1, 22, 29

Evaluation of Geometric Mean Titer of Anti-CHIKV total antibodies, determined by immunoassay (ELISA), in prior alphavirus vaccine recipients versus alphavirus-naïve controls.

Day 1

Group	Value	95% CI
Experimental: Prior Alpha	39.03	29.85 – 51.03
Control: Naive Alpha	25.77	19.71 – 33.70

Day 22

Group	Value	95% CI
Experimental: Prior Alpha	2451.60	1770.49 – 3394.72
Control: Naive Alpha	1338.90	966.77 – 1854.27

Day 29

Group	Value	95% CI
Experimental: Prior Alpha	2010.72	1444.72 – 2798.46
Control: Naive Alpha	1194.75	786.21 – 1815.57

Percentage of Participants With 4-fold Rise in Anti-CHIKV Total Antibody Response Secondary · Day 22, 29

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.

Day 22

Group	Value	95% CI
Experimental: Prior Alpha	100	88.6 – 100
Control: Naive Alpha	100	86.6 – 100

Day 29

Group	Value	95% CI
Experimental: Prior Alpha	100	88.6 – 100
Control: Naive Alpha	100	83.2 – 100

Geometric Mean Titer of Anti-VEEV Neutralizing Antibody Response Secondary · Day 1, 22, 29

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

Day 1

Group	Value	95% CI
Experimental: Prior Alpha	449.82	262.84 – 769.80
Control: Naive Alpha	9.96	NA – NA

Day 22

Group	Value	95% CI
Experimental: Prior Alpha	467.95	278.47 – 786.34
Control: Naive Alpha	9.89	NA – NA

Day 29

Group	Value	95% CI
Experimental: Prior Alpha	538.63	291.97 – 993.67
Control: Naive Alpha	9.66	NA – NA

Number of Participants With Anti-CHIKV Total Antibody Titers of at Least 40,160 or 640 Secondary · Days 1, 22, and 29

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.

Day 1 Titers >=40

Group	Value	95% CI
Experimental: Prior Alpha	15
Control: Naive Alpha	4

Day 1 Titers >=160

Group	Value	95% CI
Experimental: Prior Alpha	4
Control: Naive Alpha	1

Day 1 Titers >=640

Group	Value	95% CI
Experimental: Prior Alpha	0
Control: Naive Alpha	0

Day 22 Titers >=40

Group	Value	95% CI
Experimental: Prior Alpha	30
Control: Naive Alpha	30

Day 22 Titers >=160

Group	Value	95% CI
Experimental: Prior Alpha	30
Control: Naive Alpha	30

Day 22 Titers >=640

Group	Value	95% CI
Experimental: Prior Alpha	30
Control: Naive Alpha	26

Day 29 Titers >=40

Group	Value	95% CI
Experimental: Prior Alpha	30
Control: Naive Alpha	19

Day 29 Titers >=160

Group	Value	95% CI
Experimental: Prior Alpha	30
Control: Naive Alpha	19

Percentage of Participants With 4-fold Rise in Anti-VEEV Neutralizing Antibody Response Secondary · Day 22 and 29

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.

Day 22

Group	Value	95% CI
Experimental: Prior Alpha	0	0.0 – 11.4
Control: Naive Alpha	0	0.0 – 11.4

Day 29

Group	Value	95% CI
Experimental: Prior Alpha	0	0.0 – 11.4
Control: Naive Alpha	0	0.0 – 16.8

Percentage of Participants With Anti-VEEV PRNT Neutralizing Activity at or Above Selected Thresholds Secondary · Day 1, 22, 29

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.

Day 1 (Titer >=40)

Group	Value	95% CI
Experimental: Prior Alpha	90.0	74.4 – 96.5
Control: Naive Alpha	0	0.0 – 11.4

Day 1 (Titer >=160)

Group	Value	95% CI
Experimental: Prior Alpha	76.7	59.1 – 88.2
Control: Naive Alpha	0	0.0 – 11.4

Day 1 (Titer >=640)

Group	Value	95% CI
Experimental: Prior Alpha	53.3	36.1 – 69.8
Control: Naive Alpha	0.0	0.0 – 11.4

Day 22 (Titer >=40)

Group	Value	95% CI
Experimental: Prior Alpha	90.0	74.4 – 96.5
Control: Naive Alpha	0	0.0 – 11.4

Day 22 (Titer >=160)

Group	Value	95% CI
Experimental: Prior Alpha	80.0	62.7 – 90.5
Control: Naive Alpha	0	0.0 – 11.4

Day 22 (Titer >=640)

Group	Value	95% CI
Experimental: Prior Alpha	56.7	39.2 – 72.6
Control: Naive Alpha	0	0.0 – 11.4

Day 29 (Titer >=40)

Group	Value	95% CI
Experimental: Prior Alpha	90.0	74.4 – 96.5
Control: Naive Alpha	0	0.0 – 16.8

Day 29 (Titer >=160)

Group	Value	95% CI
Experimental: Prior Alpha	83.3	66.4 – 92.7
Control: Naive Alpha	0	0.0 – 16.8

Geometric Mean Titer of Anti-VEEV Total Antibody Response Secondary · Day 1, 22, 29

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.

Day 1

Group	Value	95% CI
Experimental: Prior Alpha	324.36	195.37 – 538.52
Control: Naive Alpha	14.03	8.45 – 23.30

Day 22

Group	Value	95% CI
Experimental: Prior Alpha	2574.16	1812.27 – 3656.35
Control: Naive Alpha	14.92	10.50 – 21.20

Day 29

Group	Value	95% CI
Experimental: Prior Alpha	2006.14	1320.28 – 3048.31
Control: Naive Alpha	16.94	9.97 – 28.76

Percentage of Participants With 4-fold Rise in Total ELISA IgG Antibody Against VEEV Secondary · Day 22, 29

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.

Day 22

Group	Value	95% CI
Experimental: Prior Alpha	86.7	70.3 – 94.7
Control: Naive Alpha	0	0.0 – 11.4

Day 29

Group	Value	95% CI
Experimental: Prior Alpha	80.0	62.7 – 90.5
Control: Naive Alpha	0	0.0 – 16.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Local and systemic post-injection solicited events were collected through Day 8. Unsolicited adverse events were collected through Day 29. Serious adverse events and adverse events leading to withdrawal were collected through Day 183 end of study visit.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Experimental : Prior Alpha

Serious: 0/30 (0%)

Deaths: 0/30

Control: Naive Alpha

Serious: 1/30 (3%)

Deaths: 0/30

Serious adverse events (1 terms)

Reaction	System	Experimental : Prior Alpha	Control: Naive Alpha
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Experimental : Prior Alpha	Control: Naive Alpha
Injection site pain	General disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Headache	Nervous system disorders	—	—
Fatigue	General disorders	—	—
Malaise	General disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Pain in extremity.

Data from ClinicalTrials.gov NCT03992872 adverse events section.

Sponsor's own description

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.

Publications & conference data

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

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
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
Pathogenesis and clinical management of arboviral diseases.
Cenci Dietrich V, Costa JMC, Oliveira MMGL, Aguiar CEO, et al · · 2025 · cited 6× · PMID 40134841 · DOI 10.5501/wjv.v14.i1.100489
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 controlle
Hamer MJ, McCarty JM, Pierson BC, Regules JA, et al · · 2025 · cited 6× · PMID 39954701 · DOI 10.1016/j.lanmic.2024.101000
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:

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Other Bavarian Nordic trials

Trials by the same sponsor.

NCT07199569 — Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells · Phase 2 · active not recruiting
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NCT05349617 — Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years · Phase 3 · completed
NCT05238025 — MVA-BN-RSV Vaccine Trial · Phase 3 · terminated

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 NCT03992872 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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: 16 October 2024

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/NCT03992872.

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

NCT03992872: WRAIR

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Chikungunya

Other Bavarian Nordic trials

Verify against primary sources