CHIKV-VLP Vaccine Description
Emergent’s CHIKV-VLP vaccine candidate is a multi-protein structure that mimics the organization and conformation of naturally occurring viruses without the viral genome that could promote a stronger immune response and increased antibody production.
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. There is currently no vaccine, VLP or otherwise, to prevent chikungunya virus infection.
The CHIKV VLP vaccine candidate is licensed from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. It received the FDA Fast Track designation in May 2018 and EMA PRIME designation in September 2019.
Maryland-based Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life, we provide solutions that target public health threats.
CHIKV-VLP Vaccine History
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 mostly mild or moderate.
The CHIKV VLP vaccine candidate is licensed from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. It received the FDA Fast Track designation in May 2018 and EMA PRIME designation in January 2020.
“Emergent is encouraged by the concurrence we have received from EMA in paving the path for chikungunya vaccine development based on SNA as the surrogate endpoint,” said Abbey Jenkins, senior vice president, and vaccines business unit head at Emergent BioSolutions, in a press statement issued on January 13, 2020.
“As a leading provider of travel health vaccines, Emergent seeks to address the threat posed by this highly debilitating virus by defining a realistic and optimal path to bring to market a much-needed chikungunya vaccine that could potentially serve patients worldwide."
CHIKV-VLP Vaccine Indication
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. 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, says the U.S. CDC.
An updated map of chikungunya cases in the USA can be found at this CDC link.
'Although not a killer disease, high morbidity rates, and prolonged polyarthritis lead to considerable disability in a proportion of the affected population and can cause a substantial socioeconomic impact in affected countries, said the WHO on December 27, 2019.
CHIKV-VLP Vaccine Dosage
The CHIKV-VLP vaccine candidate is administered in the clinical trial as an intramuscular injection.
It received Fast Track designation from the U.S. Food and Drug Administration in May 2018.
CHIKV-VLP Vaccine Updates:
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. 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. NIAID has granted nonexclusive rights to develop and commercialize the CHIKV VLP vaccine to several organizations.'
January 13, 2020 - Emergent BioSolutions Inc. announced that it had received 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 (SNA) 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 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 Vaccine Clinical Trials:
Clinical Trial NCT03483961: Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults. The Phase 2 parallel-group, randomized, double-blind, dose-finding study involved 415 healthy adults in 3 U.S. sites. Participants were given a 1- or 2-dose series, with or without an adjuvant, over a 4-week period. Last Update Posted: October 9, 2020.
Clinical Trials NCT01489358: This is a Phase I, open-label, dose-escalation study to examine the safety, tolerability, and immune response to a Virus-Like Particle (VLP) Chikungunya Virus (CHIKV) vaccine in healthy adults ages 18 to 50 years old. The plan is for 25 subjects to receive 3 intramuscular vaccine injections at weeks 0, 4, and 20. The three groups will be enrolled sequentially, starting with the lowest dose of 10 micrograms per injection in Group 1. The hypothesis is that the vaccine is safe and induces immune responses to CHIKV. The primary objective is to evaluate the safety and tolerability of the investigational vaccine, VRC-CHKVLP059-00-VP, at three dosages, 10 micrograms (mcg), 20 mcg, and 40 mcg, in healthy adults. The secondary objective is to evaluate the antibody response against CHIKV VLPs four weeks after the third vaccine injection. The exploratory objectives relate to antigen-specific humoral and cellular immune responses throughout the study.