A booster dose of Sanofi’s Dengvaxia tetravalent dengue vaccine “does not elicit a consistent, meaningful booster effect” against all dengue serotypes in people previously exposed to the virus, according to a Phase 2 non-inferiority study published Tuesday in The Lancet Infectious Diseases.
The Sanofi-funded study—conducted in Colombia and the Philippines—tested an additional dose of the live attenuated shot administered one or two years after a two- or three-dose primary series in…
The U.S. FDA cleared the Investigational New Drug (IND) application for the intranasal RSV vaccine candidate (BLB-201) from Georgia-based CyanVac and its Californian subsidiary, Blue Lake Biotechnology, the companies announced Monday.
The move paves the way for Phase 1 trials, which will test BLB-201 in healthy adults ages 18-75, the press release said.
In other RSV news, Pfizer’s candidate shot (RSVpreF) won U.S. FDA Breakthrough Therapy designation for prevention of RSV in…
Bavarian Nordic has entered into a licensing and supply agreement with Shanghai-based Nuance Pharma to develop and commercialize Bavarian’s RSV vaccine candidate (MVA-BN RSV) for adults in China and other Asian markets, the Danish company announced Monday. Under the deal, Nuance Pharma will pay $12.5 million upfront and up to $212.5 million in milestones.
Nuance will run Phase 1 and 3 trials in China and push Asian regulatory approval for the vaccine, according to the press release.
The University of Oxford has started recruiting for a Phase 1/2 human challenge trial of a paratyphoid vaccine candidate, the university announced last week. The University of Maryland School of Medicine developed the oral candidate (CVD 1902) to protect against Salmonella Paratyphi infection, per the press release.
An Oxford researcher commented that a licensed paratyphoid vaccine is “desperately needed” due to “increasing antibiotic resistance.”
The University of Oxford and Ifakara Health Institute have dosed the first participants in a Tanzania-based Phase 1b/2 trial of Oxford’s single-dose rabies vaccine candidate, the university announced earlier this month.
The ChAdOx2 RabG vaccine uses the same adenovirus vector platform as the AstraZeneca/Oxford Covid-19 shot and would be a “game changer” if successful, according to Oxford’s chief trial investigator. The investigator noted that current rabies regimens are effective but “…
Venatorx Pharmaceuticals’ cefepime-taniborbactam was superior to standard of care meropenem for treating complicated urinary tract infections in Phase 3 trials, the Pennsylvania-based company announced last week.
The investigational antibiotic—which targets carbapenem-resistant Enterobacterales and P. aeruginosa—generated bacterial eradication in 70% of participants compared to 58% treated with meropene, and cefepime-taniborbactam’s superiority was maintained through a late follow-up,…
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…
Pfizer’s C. difficile vaccine candidate (PF-06425090) failed to meet the primary endpoint in a Phase 3 trial, the company announced Tuesday. At final analysis, the shot showed just 31% efficacy at preventing infection after three doses, according to a Pfizer press release. Nonetheless, the jab’s 100% efficacy at preventing “medically attended” infection—a secondary endpoint—suggested a possible future direction for the product, Endpoints News reported.
In more promising news, Pfizer’s…
A consortium seeking to optimize existing cryptococcal meningitis therapy flucytosine has launched a South African Phase 1 trial to evaluate a new formulation of the antifungal, the Drugs for Neglected Diseases Initiative (DNDI) announced last week.
With funding from the European & Developing Countries Clinical Trials Partnership, DNDI and other members of the 5FC HIV-Crypto consortium will assess three sustained-release formulations that can be taken orally or via nasogastric tube…
Gilead last week offered new clinical data on the sustained efficacy of lenacapavir in heavily treatment-experienced people living with multidrug-resistant HIV. At 52 weeks, 83% of participants receiving the investigational, long-acting HIV-1 capsid inhibitor (in combination with an optimized background regimen) achieved an undetectable viral load, according to the California-based company's press release. Gilead presented the data at the 29th Conference on Retroviruses and Opportunistic…