Emergent BioSolutions CHIKV-VLP (Chikungunya) Vaccine Description 2022
Emergent BioSolutions chikungunya CHIKV-VLP vaccine candidate (PXVX0317) is an aluminum hydroxide-adjuvanted chikungunya virus-like particle vaccine (VLP) with a multi-protein structure that mimics the organization and conformation of naturally occurring viruses without the viral genome, promoting a stronger immune response and increased antibody production.
There is currently no U.S. FDA Approved vaccine to prevent chikungunya virus infection.
The Lancet Infectious Diseases published a research article on June 13, 2022: Safety and immunogenicity of PXVX0317, an aluminum hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomized, double-blind, parallel-group, phase 2 trial. On June 21, 2022, Emergent announced the CHIKV VLP vaccine candidate was found in a phase 2 study to be well tolerated and induce a robust and durable serum neutralizing antibody immune response against the Chikungunya virus for up to two years.
The chikungunya CHKV-VLA vaccine candidate received the FDA Fast Track designation in May 2018 and EMA PRIME designation in January 2020. The chikungunya CHIKV VLP vaccine candidate is licensed from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.
Gaithersburg, Maryland-based Emergent BioSolutions is a global life science company whose mission is to protect and enhance life, providing solutions that target public health threats.
The CHIKV-VLP vaccine candidate is indicated to prevent the chikungunya virus. Chikungunya virus is spread to people through infected mosquitoes. Symptoms lasting 3-4 weeks include high-grade fever, joint pain, headache, muscle pain, joint swelling, or rash, while chronic arthritis occurs in a minority of patients. According to the U.S. CDC, Chikungunya outbreaks have occurred in North and South America, Africa, Asia, Europe, and the Indian and Pacific Oceans and can be found in over 70 countries. An updated map of chikungunya cases in the USA can be found at this CDC link.
Since 2014, the U.S. CDC has reported chikungunya virus disease cases among U.S. travelers returning from affected countries in the Americas, and local transmission was identified in Florida, Puerto Rico, and the U.S. Virgin Islands,
The CHIKV-VLP vaccine candidate is administered in clinical trials as a 40 µg dose intramuscular injection.
CHIKV-VLP Side Effects
The most common solicited adverse event in a phase 2 study was pain at the injection site, reported in 12 (23%) of 53 participants who received the unadjuvanted vaccine (group 1) and 111 (31%) of 356 who received the adjuvanted vaccine. No vaccine-related serious adverse events were reported.
Chikungunya studies have shown that Virus-like particle (VLP) vaccines are highly immunogenic, have a proven safety record, and typically elicit high titer neutralizing antibodies needed to protect against the chikungunya virus.
In November 2019, the Company presented updated results indicating that up to 98% of study participants produced a neutralizing antibody response against the chikungunya virus within seven days after vaccination after a single dose. Further, the immune response persisted for at least one year for subjects who received a single dose. The vaccine candidate was well-tolerated across all study arms, and no significant vaccine-related safety concerns have been identified in analyses to date. Solicited adverse event profiles were similar across groups and primarily mild or moderate.
On May 26, 2021, the Company announced phase 2 study results. "Emergent is pleased with the positive data from our Phase 2 CHIKV VLP study that demonstrated safety and immunogenicity two years post-vaccination with a single adjuvanted 40 µg dose of the CHIKV VLP vaccine, which we believe is an ideal candidate to evaluate in a Phase 3 study that we intend to initiate this year," said Karen L. Smith, M.D., Ph.D., EVP and CMO at Emergent BioSolutions.
CHIKV-VLP News For 2014 - 2022
July 27, 2022 - Vadodara, India continues to fight Vector-borne diseases as they make their presence felt in the city. In most months this year, the number of confirmed cases of these diseases remained higher as compared to the same months last year.
June 21, 2022 - Emergent BioSolutions Inc. announced two-year persistence data from its phase 2 clinical study evaluating the safety and immunogenicity of the CHIKV VLP vaccine candidate were published in The Lancet Infectious Diseases. The vaccine was well-tolerated and induced a robust and durable serum neutralizing antibody immune response against the Chikungunya virus up to two years.
May 12, 2022 - A cohort study examining the incidence of chikungunya virus infections among Kenyan children with neurological disease was reported in PLOS Medicine. This study observed that CHIKV infections are relatively more common than cerebral malaria and bacterial meningitis among children hospitalized with neurological disease in coastal Kenya.
February 24, 2022 - Emergent BioSolutions Inc. reported Q4 2021 total revenues of $723M and Adjusted EBITDA of $348M resulting in F.Y. 2021 total revenues of $1,793M and Adjusted EBITDA of $518M, and pipeline progress is expected across the R&D portfolio with the ongoing advancement of the CHIKV VLP Phase 3 clinical trial.
October 15, 2021 - Emergent BioSolutions Inc. announced the first participant dosed in its pivotal phase 3 study evaluating the safety and immunogenicity of the Company's investigational chikungunya virus (CHIKV) virus-like particle (VLP) vaccine candidate, CHIKV VLP, in a single dose. CHIKV VLP is the only VLP-based vaccine currently in clinical development for active immunization against chikungunya disease.
May 26, 2021 - Emergent BioSolutions Inc. announced two-year persistence data from its Phase 2 clinical study evaluating the safety and immunogenicity of the Company's investigational chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate in 415 healthy adults. Two years post-vaccination, SNA responses were 19 times higher than pre-vaccination titers following a single adjuvanted 40 µg dose of the CHIKV VLP vaccine, supporting the persistence of the immune response. All subjects in the single-dose regimen remained seropositive at their one-year and two-year visits. The vaccine candidate was well-tolerated, and no significant vaccine-related safety concerns were identified. The majority of solicited adverse events were mild or moderate in severity, and the most frequent were local injection site pain.
March 23, 2021 - GAVI reported 'Deaths from chikungunya are about one in 1,000 and almost always related to existing health problems, or being a newborn or over 65 years. Although death is less common than in other mosquito-borne diseases, the chronic joint pain and other symptoms associated with chikungunya can persist for months or years.'
March 19, 2021 - The global chikungunya vaccine market is estimated to reach USD 1.98 billion by 2027.
February 18, 2021 - Emergent BioSolutions Inc. reported financial results for the quarter and year ended December 31, 2020. The Company also reaffirmed its full-year 2021 forecast.
September 30, 2020 - The U.S. CDC issued a Level 1 Travel Alert regarding chikungunya risks in many parts of Africa. There is currently an outbreak in Ethiopia. Travelers should protect themselves by preventing mosquito bites.
April 17, 2020 - The U.S. NIH announced, 'After analyzing the results, the researchers concluded that the vaccine was both safe and well-tolerated. None of the volunteers experienced serious adverse effects related to the vaccine. In addition, the volunteers who received the vaccine developed an immune response to the chikungunya virus that remained strong for the entire 72 weeks of the study. These results support the conclusions of an earlier, smaller trial of the vaccine. As a result, NIAID has granted nonexclusive rights to several organizations to develop and commercialize the CHIKV VLP vaccine.
January 13, 2020 - Emergent BioSolutions Inc. announced that it had received an agreement from the European Medicines Agency to pursue its proposed development plan for its chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate. The Company has proposed conducting a safety and immunogenicity Phase 3 trial using Serum Neutralizing Antibodies as an immune correlate of protection to predict the vaccine candidate's clinical benefit.
November 22, 2019 - Emergent BioSolutions announced updated results from the interim analysis of its Phase 2 clinical study evaluating its chikungunya virus-like particle (CHIKV VLP) vaccine candidate across a series of dosing regimens.
April 26, 2019 - Study published by PLOS: Vaccination with a chikungunya virus-like particle vaccine exacerbates disease in aged mice. Conclusions: Unadjuvanted CHIK VLP vaccination elicits immune responses that protect 100% of adult mice against CHIKV infection. However, an improved vaccine/adjuvant combination is still necessary to enhance the protective immunity against CHIKV in the aged.
April 16, 2019 - Emergent BioSolutions announced results from the interim analysis of its Phase 2 clinical study evaluating the safety and immunogenicity.
August 25, 2014 - The U.S. NIH issued a press statement: "The candidate vaccine prompted a robust immunological response in recipients and was very well tolerated," Ledgerwood says. "Notably, the levels of neutralizing antibody produced in response to the experimental vaccine were comparable to those seen in 2 patients who had recovered from a chikungunya virus infection acquired elsewhere."
CHIKV-VLP Clinical Trials
Emergent's CHIKV-VLP vaccine candidate, a single-dose, 40 μg injection of adjuvanted, is being further investigated in phase 3 clinical trials (clinicaltrials.gov identifiers NCT05072080 and NCT05349617).
The randomized, double-blind, parallel-group, phase 2 study was conducted at three U.S. sites with 415 participants. Eligible participants were healthy CHIKV-naïve adults aged 18–45 years. The primary endpoint was the geometric mean titer of the anti-CHIKV neutralizing antibody on day 57 (28 days after the last vaccination). Safety was also assessed.