Tags : Initiate

Moderna to Commence Late-stage COVID-19 Vaccine Trial on 27 July,

Shots: Moderna has reported the robust results of its ongoing P-I study that demonstrated mRNA-1273 at (25-, 100- & 250-mcg dose levels) induced anti–SARS-CoV-2 immune responses in all participants with no trial-limiting safety concerns. These results were published in NEJM All participants seroconverted by the 15-day mark. Post two vaccinations, @57day, geometric mean titers exceeded […]Read More

GSK and Medicago to Initiate P-I Trial of Plant-Based COVID-19

Shots: The two companies collaborated to develop a COVID-19 vaccine combining Medicago’s recombinant Coronavirus Virus-Like Particles (CoVLP) with GSK’s pandemic adjuvant system. The partners are planning to initiate P-I study in mid-July followed by pre-clinical results that showed combining the two platforms demonstrated a high level of neutralizing Abs following a single dose The study […]Read More

Bharat Biotech to Initiate Clinical Trials Evaluating Covaxin (India’s First

Shots: Bharat Biotech has received DCGI approval to conduct P-I & II clinical studies assessing Covaxin, developed in collaboration with ICMR and NIV. The company anticipate initiating the clinical studies in July’2020 The DCGI’s approval is based on preclinical data demonstrating safety and immune response. The SARS-CoV-2 strain was isolated in NIV & transferred to […]Read More

Gilead to Initiate P-II/III Study Evaluating Remdesivir in Pediatric Patients

Shots: Gilead will begin enrollment in P-II/III clinical trial assessing the safety, tolerability, PK and efficacy of remdesivir in ~50 pediatric patients with moderate-to-severe COVID-19, including newborns through adolescents The trial will be conducted at 30+ sites in the US and EU. Remdesivir is available to pediatric patients with severe COVID-19 under our compassionate use […]Read More

Moderna to Initiate P-III Study of its mRNA-1273 Against COVID-19

Shots: The P-III study will evaluate mRNA-1273 vs PBO in a ratio (1:1) and is expected to enroll ~30,000 patients in the US, to be conducted in collaboration with NIAID. The 1EP of P-III study will be the prevention of symptomatic COVID-19 while 2EP include prevention of severe COVID-19 The company has finalized 100 μg […]Read More

Johnson & Johnson to Initiate P-I/IIa Clinical Study of its

Shots: Janssen has accelerated the initiation of the P-I/IIa study of its investigational Ad26.COV2-S recombinant vaccine. Earlier, the company had scheduled the clinical trial to begin in Sept’2020, the trial is now expected to commence in the second half of July The P-I/IIa study will evaluate the safety, reactogenicity & immunogenicity Ad26.COV2-S, recombinant in 1045 […]Read More

Eli Lilly to Initiate P-I Study of its Second Antibody

Shots: Lilly’s partner Junshi has dosed the first healthy volunteer in a study evaluating JS016 to combat COVID-19. The study is being conducted by Junshi in China while Lilly to imminently initiate its P-I study in the US Both P-I studies aim to evaluate the safety, tolerability, PK and immunogenicity of JS016 in healthy participants […]Read More

Inovio to Initiate P-I/II Study of INO-4800 Against COVID-19 in

Shots: Inovio and IVI collaborate with Seoul National University Hospital to begin P-I/II clinical study of INO-4800 in South Korea The P-II study will assess the safety, tolerability, and immunogenicity of the INO-4800 vaccine in 40 adults aged 19-50 yrs. and will expand to enroll an additional 120 people aged 19-64 yrs. the companies expect […]Read More