VRC CHKVLP059 00 VP
Alternative Names: Alum-adjuvanted chikungunya virus-like particle vaccine; Chikungunya virus virus-like particle vaccine; Chikungunya-virus-vaccine-VRC; CHIKV-VLP; PXVX 0317; VRC-CHKVLP059-00-VPLatest Information Update: 28 Feb 2024
At a glance
- Originator National Institute of Allergy and Infectious Diseases
- Developer Bavarian Nordic; Emergent BioSolutions; National Institute of Allergy and Infectious Diseases; Walter Reed Army Institute of Research
- Class Viral vaccines; Virus-like particle vaccines
- Mechanism of Action Immunostimulants
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Phase III Chikungunya virus infections
Most Recent Events
- 23 Feb 2024 Bavarian Nordic announces intention to submit Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Chikungunya virus infections in the first half of 2024
- 23 Feb 2024 The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) grants accelerated assessment for the upcoming Marketing Authorization Application (MAA) for VRC CHKVLP059 00 VP
- 30 Aug 2023 Emergent BioSolutions initiates a phase III trial in Chikungunya virus infections (Prevention) in USA (NCT06007183)
Development Overview
Introduction
VRC CHKVLP059 00 VP is a chikungunya virus-like particle (VLP) vaccine, being developed by the National Institutes of Health (NIH), in collaboration with PaxVax (a subsidiary of Emergent BioSolutions) and United States Department of Defense (DoD), for the prevention of the chikungunya virus infections. VRC CHKVLP059 00 VP was a VLP vaccine consisting of chikungunya virus-like particles composed of E1, E2 and capsid proteins, and is developed by National Institute of Allergy and Infectious Diseases (NIAID), a part of NIH. Clinical development is ongoing in Dominican Republic, Guadeloupe, Haiti, Martinique, France, Puerto Rico and the US.
As of May 2023, Bavarian Nordic acquired Emergent Biosolutions [1]
In October 2018, PaxVax was acquired by Emergent BioSolutions [2] .
Company Agreements
In May 2023, Bavarian Nordic completed the acquisition of travel vaccine portfolio from Emergent BioSolutions. Upon closing of the acquisition, Emergent Biosolutions will be eligible to receive additional future payments of up to $US110 million conditioned upon the achievement of milestones related to the successful development of the Chikungunya vaccine ($US80 million) and sales performance of the marketed vaccines ($US30 million). Earlier in February 2023, Bavarian Nordic entered into an agreement with Emergent BioSolutions to acquire two marketed travel vaccines, Vivotif® and Vaxchora® against cholera as well as a phase III vaccine candidate (VRC CHKVLP059 00 VP) for the prevention of chikungunya virus for a total consideration of up to $US380 million, including $US270 million in an upfront payment and up to $US110 million in future conditional milestone payments. Bavarian Nordic will also take over a manufacturing site in Switzerland, an R&D centre in the US, and a smaller speciality sales staff in both the EU and the US as part of the acquisition. The acquisition also includes facilities and key personnel related to the acquired assets. Bavarian Nordic has also obtained the global rights and R&D know-how to the vaccine candidate against chikungunya. [3] [1]
In January 2017, PaxVax entered into an agreement with the National Institutes of Health (NIH) and United States Department of Defense (DoD), to develop a vaccine program for chikungunya virus infections. PaxVax in-licensed the virus-like particle (VLP) vaccine technology from NIH, for developing and commercialising the chikungunya virus vaccine. PaxVax will work with the Walter Reed Army Institute of Research (WRAIR), a DoD biomedical research laboratory, to conduct an additional clinical trials assessing an alum adjuvant in the vaccine formulation and its advantages [4] .
Key Development Milestones
In October 2020, Emergent BioSolutions received Breakthrough Therapy designation from the US FDA for VRC CHKVLP059 00 VP [5] .
In January 2020, Emergent BioSolutions received an agreement from the European Medicines Agency (EMA) and the US FDA on the proposed development plan to use Serum Neutralising Antibodies (SNA) as surrogate endpoint to predict likely clinical benefit of CHIKV VLP. The phase III safety and immunogenicity study anticipated in late 2020 [6] [7]
In October 2019, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a PRIoroty MEdicines (PRIME) designation to Chikungunya virus (CHIKV) virus-like particle (VLP) vaccine to prevent chikungunya virus infections [8] .
In May 2018, the US FDA granted fast track designation to Paxvax's chikungunya virus-like particle (VLP) vaccine [9] .
In February 2024, Bavarian Nordic announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assessment for the upcoming Marketing Authorisation Application (MAA) for VRC CHKVLP059 00 VP. The accelerated assessment, which is granted based upon CHMP’s decision that the vaccine candidate is of major interest for public health and therapeutic innovation, may reduce the timeframe for the review of the MAA from 210 days under the standard review procedure to 150 days, not counting clock stops when applicants must provide additional information [10] .
In February 2024, Bavarian Nordic announced its intention to submit Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for chikungunya virus infections in the first half of 2024 [10] .
In August 2023, VRC CHKVLP059 00 VP met all the co-primary endpoints of the trial and was highly immunogenic in the majority of subjects 22 days post a single vaccination. In April 2023, Emergent BioSolutions completed a phase III trial that evaluated the safety and immunogenicity of the VRC CHKVLP059 00 VP vaccine candidate in healthy individuals aged 12 to 64 as well as to demonstrated the consistency of the chikungunya virus (CHIKV) serum neutralizing antibody (SNA) response across three manufactured vaccine candidate lots (NCT05072080; EBSI-CV-317-004). The multi-center, randomised, double blind, placebo-controlled trial was initiated in In September 2021 and enrolled 3258 volunteers in the US. In the same month, the company announced dosing of the first volunteer in the trial [11] [12] . In August 2023, immunogenicity and adverse events data from a trial in Chikungunya virus infections released by Bavarian Nordic [13] .
In June 2023, Emergent Biosciences announced that a phase III trial of VRC CHKVLP059 00 VP in chikungunya virus infections, met its primary endpoints.In August 2023, Bavarian Nordic in collaboration with Emergent BioSolutions completed a phase III which was designed to evaluate the safety and immunogenicity of the VRC CHKVLP059 00 VP vaccine candidate in adults ≥65 years of age (NCT05349617; EBSI-CV-317-005). The double-blind, multicenter, placebo controlled trial, initiated in May 2022, enrolled 413 patients in the US. In June 2023, Bavarian Nordic released safety and immunogenicity data from the trial [14] [15] [16] .
In August 2023, Bavarian Nordic initiated a phase III trial to evaluate the safety and long-term immunogenicity of PXVX 0317 in adult and adolescent participants and to evaluate PXVX 0317 booster vaccine induced serum neutralizing antibody (SNA) response at 3, 4, or 5 years post-initial PXVX 0317 vaccination (NCT06007183; EBSI-CV-317-008). The randomized, double-blind, placebo-controlled trial intends to enroll 800 healthy adults and adolescents in US [17] .
In May 2022, Emergent BioSolutions completed a phase II trial that evaluated the safety and immunogenicity of VRC CHKVLP059 00 VP for the prevention of chikungunya virus infection (NCT05065983; EBSI-CV-317-010). The open-label trial initiated in October 2021 enrolled 25 participants, aged 18 to 45 years, in the US [18] .
In January 2021, Emergent BioSolutions in collaboration with Walter Reed Army Institute of Research completed a phase II trial that assessed the safety and immunogenicity of VRC CHKVLP059 00 VP, in prior recipients of other alphavirus vaccines versus alphavirus naïve controls, for the prevention of chikungunya virus infection (NCT03992872; EBSI-CV-317-002). The open-label trial was initiated in November 2019, and enrolled 60 volunteers in the US [19] . In November 2022, Emergent BioSolutions released results from the trial and were presented at the Annual Meeting of the American Society of Tropical Medicine and Hygiene (ASTMH-2022) [20] .
In September 2020, PaxVax in collaboration with Emergent BioSolutions completed a phase II trial designed to assess the safety and immunogenicity of VRC CHKVLP059 00 VP (PXVX-CV-317-001; NCT03483961). The primary endpoint of the trial is to determine anti-CHIKV neutralizing antibody response 28 days after the last injection in a time frame of 57 days from day 1 of vaccination. The randomised, double-blind trial, initiated in April 2018, enrolled 445 healthy volunteers in the US [21] [22] . In Novemver 2019 and April 2019, interim results from the trial were released by the company. In May 2021, Emergent BioSolutions released two-years persistent data from the trial [23] [24] [25] .
In March 2018, NIAID completed a phase II trial that evaluated the safety and immunogenicity of 20 mcg VRC CHKVLP059 00 VP, chikungunya virus vaccine, compared with VRC PBSPLA043 00 VP, a sterile phosphate buffered saline, in healthy volunteers in chikungunya endemic areas (VRC 704; NCT02562482). The randomised, placebo control trial was initiated in October 2015, and enrolled 400 patients in the Dominican Republic, Guadeloupe, France, Haiti, Martinique and Puerto Rico [4] [26] .
In April 2013, National Institute of Allergy and Infectious Diseases (NIAID) completed a phase I trial evaluating the safety and immunogenicity of VRC CHKVLP059 00 VP, chikungunya virus vaccine, in healthy volunteers (VRC 311; 120041; 12-I-0041; NCT01489358). The open label, dose-escalation study was initiated in December 2011 and enrolled a total of 25 volunteers, in the US [27] . In December 2014, the safety and tolerability results of this trial were published in The Lancet.
Financing Information:-
In May 2023, Emergent BioSolutions received cash payment of $US274 million from Bavarian Nordic upon closing of acquisition of the travel vaccine portfolio [1]
Drug Properties & Chemical Synopsis
- Route of administration IM
- Formulation Injection
- Class Viral vaccines, Virus-like particle vaccines
- Mechanism of Action Immunostimulants
-
WHO ATC code
J07B-X (Other viral vaccines)
-
EPhMRA code
J7E (Viral Vaccines)
Biomarkers Sourced From Trials
| Indication | Biomarker Function | Biomarker Name | Number of Trials |
|---|---|---|---|
|
Chikungunya virus infections |
Outcome Measure |
Snail |
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| VRC CHKVLP059 00 VP | prion protein (testis specific) | Outcome Measure |
| Snail | Outcome Measure |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| Chikungunya virus infections | - | In the elderly, Prevention | Phase III | USA | IM / Injection | Bavarian Nordic | 01 Aug 2022 |
| Chikungunya virus infections | - | In adolescents, In adults, Prevention | Phase III | USA (fast track) | IM / Injection | Emergent BioSolutions, Walter Reed Army Institute of Research | 15 Oct 2021 |
| Chikungunya virus infections | - | Prevention | Phase II | Dominican Republic, France, Guadeloupe, Haiti, Martinique, Puerto Rico | IM / Injection | National Institute of Allergy and Infectious Diseases | 01 Oct 2015 |
| Chikungunya virus infections | - | In adults, Prevention | Phase II | USA | IM / Injection | Emergent BioSolutions | 11 Oct 2021 |
Priority Development Status
| Type | Region | Indication |
|---|---|---|
| Fast Track | USA | Chikungunya virus infections |
| PRIME | European Union | Chikungunya virus infections |
| Breakthrough Therapy | USA | Chikungunya virus infections |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| National Institute of Allergy and Infectious Diseases | Originator | USA |
| National Institute of Allergy and Infectious Diseases | Owner | USA |
| Bavarian Nordic | Licensee | Denmark |
| Walter Reed Army Institute of Research | Collaborator | USA |
Scientific Summary
Adverse Events
Phase III:
CHIKV VLP was found to be well-tolerated in older adult population and with similar rates of adverse events observed between the active and the placebo group [14] [15]
In phase III trial (EBSI-CV-317-004) of adults and adolescents, CHIKV VLP was well-tolerated in adolescent and adult population and adverse events were mainly mild or moderate in nature [11] [13] .
Phase II:
In the phase II trial, CHIKV-VLP was well-tolerated across all study arms and no significant vaccine-related safety concerns were identified. Adverse event (AE) profiles were mild or moderate and similar across groups. The most frequent AE was local injection site pain [24] [25] [21] .
Results from the phase II trial demonstrated that, the vaccine candidate was well-tolerated with no notable difference in the incidence of adverse events between the groups. The majority of solicited adverse events were mild or moderate. The most common adverse event was local injection site pain [20] [19] .
Phase I
All VRC CHKVLP059 00 VP injections were well tolerated and no serious adverse events were observed. Twenty-five volunteers were enrolled, out of which 23 completed the trial and non-completions were unrelated to adverse events. The results were reported from a dose-escalation, open-label, phase I trial in healthy volunteers [28] [27] .
Immunogenicity
Summary
Phase III:
The initial safety and immunogenicity data from Phase III trial in Chikungunya virus infections demonstrated that CHIKV VLP was immunogenic in healthy adults (upto 65 years of age), as showed by a strong induction of CHIKV neutralizing antibodies in 87% of vaccines, with neutralizing antibody titres exceeding the threshold agreed upon with authorities as a marker of seroprotection, which met the primary endpoints. Seroprotective neutralizing antibodies were detected in the majority of the subjects (82%) at day 15 following the single vaccination [14] [15] .
In phase III trial of adults and adolescents, VRC CHKVLP059 00 VP met all the co-primary endpoints and it was highly immunogenic in the majority of subjects 22 days post a single vaccination. A fast and durable response was confirmed with high levels of immunity at both 2 weeks and 6 months post a single vaccination. The results up to day 22 post vaccination showed that vaccine was highly immunogenic in healthy adolescents and adults, as demonstrated by the strong induction of chikungunya neutralizing antibodies in 98% of vaccinees in the active group. The strong neutralizing antibody titres were equal to, or exceeded the threshold. CHIKV VLP induced significant neutralizing antibodies in 47% and 97% of the subjects at 8 days and 15 days post vaccination, confirming a rapid onset of protective levels of immunity. These responses were robust and durable, as 86% of the subjects had seroprotective levels of neutralizing antibodies 6 months post vaccination [11] [13] .
Phase II
Updated data from a phase II trial showed active immunisation with VRC CHKVLP059 00 VP generated a dose-related increase in neutralising antibody response against the chikungunya virus. Two years post-vaccination, SNA responses were 19 times higher than pre-vaccination titers following a single adjuvanted 40 µg dose of the vaccine, supporting the persistence of the immune response. All patinets in the single-dose regimen remained seropositive at their one-year and two-year visits. Previously reported results demonstrated that administration of single dose of CHIKV-VLP produced a neutralising antibody response against the chikungunya virus (CHIKV) by day 7 in about 98% of study participants. In one-dose regimen, the immune response was persistent through the 12-month visits. By 28 days after the last dose, seroconversion was reported in 74% to 98% of patients within 7 days after one dose. This treatment arm had the highest Geometric Mean Titer at Days 7, 182, and 365 compared to the other arms, suggesting a durability of inducing high serum neutralising titers with just a single dose. The randomised, double-blind, dose-finding trial enrolled 415 healthy volunteers [23] [24] [25] [21] .
Results from the phase II trial demonstrated that, the CHIKV VLP vaccine candidate was immunogenic in both alphavirus vaccine-naïve participants and participants previously vaccinated against the Venezuelan equine encephalitis virus. The seroconversion rate 21 days post-vaccination was 100% in both groups. A higher percentage of prior alphavirus vaccine candidate recipients had a four-fold rise on study day 8 than the alphavirus vaccine-naïve group [20] [19] .
Phase I
All VRC CHKVLP059 00 VP injections showed good chikungunya virus-specific immunogenic responses. After the second vaccination, neutralising antibodies were detected in all doses (10 μg, 20 μg, and 40 μg) groups, geometric mean titres of the half maximum inhibitory concentration was 2688 in the 10 μg group, 1775 in the 20 μg group, and 7246 in the 40 μg group. After the third vaccination, a significant boost occurred in all dose groups (10 μg group p=0 0197, 20 μg group p<0 0001, and 40 μg group p<0 0001). The results were reported from a dose-escalation, open-label, phase I trial in healthy volunteers [28] [27] .
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2025 | Regulatory Status | Bavarian Nordic announces intention to launch VRC CHKVLP059 00 VP for Chikungunya virus infections in USA and Europe in 2025 [13] | 11 Mar 2024 |
| 31 Dec 2024 | Regulatory Status | Bavarian Nordic announces intention to submit Biologics License Application (BLA) to the US FDA for Chikungunya virus infections in 2024 [13] | 28 Feb 2024 |
| 30 Jun 2024 | Regulatory Status | Bavarian Nordic announces intention to submit Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Chikungunya virus infections in the first half of 2024 [10] | 28 Feb 2024 |
| 30 Apr 2022 | Trial Update | Emergent BioSolutions plans a phase III safety and immunogenicity trial in Chikungunya virus infections (In the elderly, Prevention) in USA (Parenteral) in April 2022 (NCT05349617) (700351552) | 05 Aug 2022 |
| 31 Dec 2021 | Trial Update | Emergent BioSolutions plans a phase III safety and immunogenicity trial in Chikungunya virus infections (Prevention) in 2021 (Emergent Biosolutions pipeline, June 2021) (700315407) (NCT05072080) [12] | 19 Oct 2021 |
| 15 Oct 2019 | Trial Update | PaxVax plans a pivotal phase II trial for Chikungunya virus infection (Prevention) in October 2019 (IM) (700306506) (NCT03992872) [25] | 30 Jun 2020 |
| 30 Apr 2018 | Trial Update | PaxVax plans a phase II trial for Chikungunya Virus Infection in April 2018 (700294557), (NCT03483961) | 03 May 2018 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 23 Feb 2024 | Regulatory Status | Bavarian Nordic announces intention to submit Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Chikungunya virus infections in the first half of 2024 [10] Updated 28 Feb 2024 |
| 23 Feb 2024 | Regulatory Status | The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) grants accelerated assessment for the upcoming Marketing Authorization Application (MAA) for VRC CHKVLP059 00 VP [10] Updated 28 Feb 2024 |
| 30 Aug 2023 | Trial Update | Emergent BioSolutions initiates a phase III trial in Chikungunya virus infections (Prevention) in USA (NCT06007183) Updated 09 Oct 2023 |
| 08 Aug 2023 | Trial Update | Bavarian Nordic completes a phase III trial in Chikungunya virus infections (In the elderly, Prevention) in USA (IM) (NCT05349617) Updated 26 Sep 2023 |
| 06 Aug 2023 | Regulatory Status | Bavarian Nordic announces intention to launch VRC CHKVLP059 00 VP for Chikungunya virus infections in USA and Europe in 2025 [13] Updated 11 Mar 2024 |
| 06 Aug 2023 | Regulatory Status | Bavarian Nordic announces intention to submit Biologics License Application (BLA) to the US FDA for Chikungunya virus infections in 2024 [13] Updated 28 Feb 2024 |
| 06 Aug 2023 | Scientific Update | Immunogenicity and adverse events data from a phase III EBSI-CV-317-004 trial in Chikungunya virus infections released by Bavarian Nordic [13] Updated 08 Aug 2023 |
| 20 Jun 2023 | Scientific Update | Immunogenicity and adverse events data from a phase III trial in Chikungunya virus infection released by Emergent BioSolutions [14] Updated 22 Jun 2023 |
| 15 May 2023 | Licensing Status | Bavarian Nordic completes acquisition of VRC CHKVLP059 00 VP from Emergent BioSolutions [1] Updated 23 May 2023 |
| 03 Apr 2023 | Trial Update | Emergent BioSolutions completes a phase III CHIKV VLP trial in Chikungunya virus infections (Prevention) in USA (NCT05072080) Updated 24 Apr 2023 |
| 15 Feb 2023 | Licensing Status | Bavarian Nordic acquires VRC CHKVLP059 00 VP from Emergent BioSolutions [3] Updated 21 Feb 2023 |
| 25 Jan 2023 | Trial Update | Bavarian Nordic completes enrolment in phase III trial for Chikangunya virus infection in USA (IM) (NCT05349617) [14] Updated 17 Jul 2023 |
| 01 Nov 2022 | Scientific Update | Adverse events and immunogenicity data from a phase II trial in Chikungunya virus infection released by Emergent BioSolutions [20] Updated 07 Nov 2022 |
| 01 Aug 2022 | Phase Change - III | Phase-III clinical trials in Chikungunya virus infections (In the elderly, Prevention) in USA (IM) (NCT05349617) Updated 05 Aug 2022 |
| 05 May 2022 | Trial Update | Emergent BioSolutions completes a phase-II clinical trials in Chikungunya virus infections (In adults, Prevention) in USA (IM) (NCT05065983) Updated 28 Jul 2022 |
| 27 Apr 2022 | Trial Update | Emergent BioSolutions plans a phase III safety and immunogenicity trial in Chikungunya virus infections (In the elderly, Prevention) in USA (Parenteral) in April 2022 (NCT05349617) Updated 05 Aug 2022 |
| 15 Oct 2021 | Phase Change - III | Phase-III clinical trials in Chikungunya virus infections (Prevention, In adults, In adolescents) in USA (IM) Updated 19 Oct 2021 |
| 15 Oct 2021 | Trial Update | Emergent BioSolutions plans a phase III safety and immunogenicity trial in Chikungunya virus infections (Prevention) in 2021 (Emergent Biosolutions pipeline, June 2021) (NCT05072080) [12] Updated 19 Oct 2021 |
| 11 Oct 2021 | Phase Change - II | Phase-II clinical trials in Chikungunya virus infections (In adults, Prevention) in USA (IM) (NCT05065983) Updated 27 Oct 2021 |
| 04 Oct 2021 | Trial Update | Emergent BioSolutions plans a phase II trial for Chikungunya virus infections (Prevention) in USA (NCT05065983) Updated 07 Oct 2021 |
| 04 Oct 2021 | Biomarker Update | Biomarkers information updated Updated 06 Oct 2021 |
| 26 May 2021 | Scientific Update | Updated immunogenicity data from a phase II trial in Chikungunya virus infection released by Emergent BioSolutions [23] Updated 31 May 2021 |
| 19 Jan 2021 | Trial Update | Emergent BioSolutions and Walter Reed Army Institute of Research completes a phase II trial in Chikungunya virus infections (In adults, Prevention) in USA (IM) (NCT03992872) Updated 24 Aug 2021 |
| 31 Oct 2020 | Regulatory Status | VRC CHKVLP059 00 VP receives Breakthrough Therapy status for Chikungunya virus infections (Prevention) in USA [5] Updated 11 Mar 2022 |
| 14 Sep 2020 | Trial Update | PaxVax and Emergent BioSolutions complets a phase II trial for Chikungunya virus infections (Prevention) in USA (IM) (NCT03483961) Updated 20 Oct 2020 |
| 13 Jan 2020 | Regulatory Status | Emergent BioSolutions receives an agreement from the EMA and the US FDA on the proposed development plan to use serum neutralizing antibodies as surrogate endpoint [6] [7] Updated 07 May 2020 |
| 22 Nov 2019 | Scientific Update | Immunogenicity and adverse events data from a phase II trial in Chikungunya virus infection released by Emergent BioSolutions [24] Updated 03 Dec 2019 |
| 20 Nov 2019 | Trial Update | Phase-II clinical trials in Chikungunya virus infections (In adults, Prevention) in USA (IM) (NCT03992872) Updated 30 Jun 2020 |
| 10 Oct 2019 | Regulatory Status | VRC CHKVLP059 00 VP receives Priority Medicine (PRIME) status for Chikungunya virus infections in European Union [8] Updated 16 Oct 2019 |
| 16 Apr 2019 | Trial Update | PaxVax plans a pivotal phase II trial for Chikungunya virus infection (Prevention) in October 2019 (IM) (NCT03992872) [25] Updated 30 Jun 2020 |
| 16 Apr 2019 | Active Status Review | Phase II development is ongoing in USA Updated 22 Apr 2019 |
| 16 Apr 2019 | Scientific Update | Immunogenicity and adverse events data from a phase II trial in Chikungunya virus infection released by Emergent BioSolutions Updated 22 Apr 2019 |
| 04 Oct 2018 | Company Involvement | PaxVax has been acquired by Emergent BioSolutions Updated 11 Oct 2018 |
| 28 Aug 2018 | Phase Change - No development reported | No recent reports of development identified for phase-I development in Chikungunya-virus-infections(Prevention, In volunteers) in USA (IM, Injection) Updated 28 Aug 2018 |
| 04 May 2018 | Regulatory Status | VRC CHKVLP059 00 VP receives Fast Track designation for Chikungunya virus infections [IM,Injection] (In volunteers) in USA [9] Updated 07 May 2018 |
| 25 Apr 2018 | Trial Update | PaxVax initiates enrolment in a phase IIb trial for Chikungunya virus infections (IM) (NCT03483961) Updated 10 May 2018 |
| 18 Apr 2018 | Phase Change - II | Phase-II clinical trials in Chikungunya virus infections (Prevention) in USA (IM) Updated 22 Apr 2019 |
| 30 Mar 2018 | Trial Update | PaxVax plans a phase II trial for Chikungunya Virus Infection in April 2018 , (NCT03483961) Updated 03 May 2018 |
| 06 Mar 2018 | Trial Update | National Institute of Allergy and Infectious Diseases completes a phase II trial in Chikungunya virus infections (Prevention) in France, Dominican Republic, Guadeloupe, Haiti, Martinique and Puerto Rico (IM) (NCT02562482) Updated 21 May 2019 |
| 05 Jan 2017 | Licensing Status | PaxVax in-licenses virus-like particle (VLP) vaccine technology from National Institutes of Health (NIH) [4] Updated 17 Jan 2017 |
| 01 Oct 2015 | Phase Change - II | Phase-II clinical trials in Chikungunya virus infections (Prevention) in France (IM) (NCT02562482) Updated 21 May 2019 |
| 01 Oct 2015 | Phase Change - II | Phase-II clinical trials in Chikungunya virus infections (Prevention) in Puerto Rico, Martinique, Haiti, Guadeloupe, Dominican Republic (IM) (NCT02562482) Updated 18 Jan 2017 |
| 06 Dec 2014 | Scientific Update | Safety, tolerability, and immunogenicity data from a phase I trial in chikungunya virus infections released by National Institute of Allergy and Infectious Diseases [28] Updated 18 Jan 2017 |
| 30 Apr 2013 | Trial Update | National Institute of Allergy and Infectious Diseases completes the phase I trial in chikungunya virus infection in USA (NCT01489358) Updated 23 Jan 2017 |
| 01 Dec 2011 | Phase Change - I | Phase-I clinical trials in Chikungunya virus infections (Prevention) in USA (IM) (NCT01489358) Updated 17 Jan 2017 |
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Emergent BioSolutions Presents Positive Immunogenicity Results From Phase 2 Study of Its Investigational Chikungunya VLP Vaccine Candidate.
Media Release -
Emergent BioSolutions Announces Interim Results From Phase 2 Study Evaluating CHIKV-VLP, Chikungunya Virus Vaccine Candidate.
Media Release -
Phase 2 Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Chikungunya Virus-Like Particle Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults
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VRC 311: A Phase 1 Open Label, Dose-Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, in Healthy Adults.
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Safety and tolerability of chikungunya virus-like particle vaccine in healthy adults: a phase 1 dose-escalation trial
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