A synthetic biology-based diagnostic using a low-cost portable reader matched the sensitivity and specificity of real-time quantitative PCR tests for Zika and chikungunya, according to research published Monday in Nature Biomedical Engineering.
The cell-free, paper-based test uses a “field-ready” companion device called PLUM (Portable, Low-cost, User-friendly, Multimode), according to a press release from the University of Toronto, whose researchers led the study.
A scientist…
Neutralizing antibody titers produced by Valneva’s live attenuated, single-dose chikungunya vaccine candidate (VLA1553) held up in over 96% of trial participants after six months, the company announced Tuesday, citing a final analysis of Phase 3 data.
Seroprotection levels at the one-month mark confirmed topline data the French biotech shared in 2021: the Coalition for Epidemic Preparedness Innovations-backed shot generated neutralizing antibodies in nearly 99% of participants, the…
Valneva has launched an additional Phase 3 trial in Brazil of its VLA1553 live attenuated, single-dose chikungunya vaccine, the French company announced Monday.
The announcement follows previous Phase 3 data showing the Coalition for Epidemic Preparedness Innovations (CEPI)-backed shot produced neutralizing antibodies in 98.5% of participants and was well-tolerated in adults.
The new study tests the jab in adolescents ages 12 to 17 and, if successful, will support licensure in…
Moderna “does not have plans” to advance its chikungunya antibody candidate to Phase 2, the company revealed last week in its third-quarter earnings press release. The Massachusetts-based mRNA specialist said it had completed a Phase 1 study of mRNA-1944 and would publish full results soon. Moderna also deprioritized a chikungunya vaccine candidate (mRNA-1388) in January 2020.
In other news, the New York Times reported Tuesday on an escalating dispute between Moderna and the U.S.…
Emergent BioSolutions has launched a U.S.-based Phase 3 trial of its CHIKV VLP single-dose chikungunya virus-like particle vaccine in healthy people ages 12-64, the Maryland-based company announced last week.
The announcement follows Phase 2 persistence data that showed people who received a dose of the adjuvanted candidate maintained neutralizing antibody titers for two years at levels 19 times higher than pre-vaccination.
Rivals including Bharat Biotech, Merck’s Themis…
Seoul’s International Vaccine Institute announced Tuesday that the first participant has been dosed with Bharat Biotech’s BBV87 two-dose, live-inactivated chikungunya vaccine in a Phase 2/3 trial in Costa Rica.
The trial is the first in a multicountry study—backed by the Coalition for Epidemic Preparedness Innovations (CEPI) and the Indian government’s Ind-CEPI initiative—to test the Hyderabad-based company’s shot in healthy adults in areas with endemic chikungunya, the press release…
Valneva reported positive Phase 3 results last week showing that its live attenuated, single-dose chikungunya shot produced neutralizing antibodies in 98.5% of subjects and was well-tolerated across age groups.
The company, which expects final results for VLA1553 within the next six months, is on course to be the first to win U.S. FDA approval and snag a Priority Review Voucher (PRV) for a chikungunya vaccine—ahead of rivals Emergent BioSolutions and Merck.
Meanwhile, Nature…
Valneva announced Wednesday that the U.S. FDA has granted its VLA1553 single-shot chikungunya vaccine candidate (currently in Phase 3) Breakthrough Therapy Designation—adding to the PRIority MEdicines (PRIME) designation the EMA awarded the French company’s jab in 2020 and the FDA Fast Track status it received in 2018.
Days after its CEO faced withering criticism from U.S. lawmakers over production mistakes with Covid-19 vaccines, Emergent BioSolutions had rosier news: two-year persistence data from a Phase 2 trial of the Maryland-based company’s chikungunya virus-like particle vaccine candidate (CHIKV-VLP) showed mean neutralizing antibody titers 19 times higher than pre-vaccination titers, according to a Wednesday press release.
Citing the lasting response to a single adjuvanted dose of the vaccine…
Vaccine makers Vaccitech and Valneva separately filed plans last week for initial public offerings on Nasdaq.
Oxford-based Vaccitech is the Jenner Institute spinout that owns the technology underlying the AstraZeneca/Oxford Covid-19 vaccine. Its pipeline includes a Phase 1 MERS vaccine and a preclinical zoster shot.
France’s Valneva, already listed on Euronext and proposing to list American depositary shares via a new offering, is seeking regulatory clearance to advance its…