A Randomized, Double‐Blind, Parallel Controlled, Single‐Dose Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of the Infliximab Biosimilar CMAB008 and the Reference Product in Healthy Chinese Male Subjects
Sign Up to like & getrecommendations! Published in 2022 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1135
Abstract: This study aimed to evaluate the pharmacokinetics (PK), safety, and immunogenicity of the infliximab biosimilar CMAB008 compared to the reference product (Remicade) in healthy Chinese male subjects to provide the basis for the similarity evaluation… read more here.
Keywords: safety immunogenicity; time; reference; concentration ... See more keywords
Safety and immunogenicity of a recombinant receptor‐binding domain‐based protein subunit vaccine (Noora vaccine™) against COVID‐19 in adults: A randomized, double‐blind, placebo‐controlled, Phase 1 trial
Sign Up to like & getrecommendations! Published in 2022 at "Journal of Medical Virology"
DOI: 10.1002/jmv.28097
Abstract: The development of a safe and effective vaccine is essential to protect populations against coronavirus disease 2019 (COVID‐19). There are several vaccine candidates under investigation with different mechanisms of action. In the present study, we… read more here.
Keywords: safety immunogenicity; safety; placebo; phase trial ... See more keywords
Safety and immunogenicity of Zika virus vaccine: A systematic review of clinical trials
Sign Up to like & getrecommendations! Published in 2022 at "Reviews in Medical Virology"
DOI: 10.1002/rmv.2385
Abstract: Several phase‐1 clinical trials have been performed to evaluate the safety and efficacy of candidate anti‐Zika vaccines. In this systematic review, we systematically evaluated the safety and immunogenicity of candidate vaccines, which would aid researchers… read more here.
Keywords: safety immunogenicity; safety; clinical trials; systematic review ... See more keywords
Safety and immunogenicity of SARS-CoV-2 vaccines in Chinese patients with cirrhosis: a prospective multicenter study
Sign Up to like & getrecommendations! Published in 2022 at "Hepatology International"
DOI: 10.1007/s12072-022-10332-9
Abstract: Data on safety and immunogenicity of coronavirus disease 2019 (COVID-19) vaccination in patients with compensated (C-cirrhosis) and decompensated cirrhosis (D-cirrhosis) are limited. In this prospective multicenter study, adult participants with C-cirrhosis and D-cirrhosis were enrolled… read more here.
Keywords: prospective multicenter; safety immunogenicity; cirrhosis cirrhosis; multicenter study ... See more keywords
Safety and immunogenicity of the measles vector-based SARS-CoV-2 vaccine candidate, V591, in adults: results from a phase 1/2 randomised, double-blind, placebo-controlled, dose-ranging trial
Sign Up to like & getrecommendations! Published in 2022 at "EBioMedicine"
DOI: 10.1016/j.ebiom.2021.103811
Abstract: Background We report on the safety and immunogenicity of V591, a measles vector-based SARS-CoV-2 vaccine candidate. Methods In this multicentre, randomised, placebo-controlled, double-blind, phase 1/2 trial, healthy adults with no history of COVID-19 disease were… read more here.
Keywords: safety immunogenicity; sars cov; v591; placebo ... See more keywords
Inactivated SARS-CoV-2 vaccine for people with HIV
Sign Up to like & getrecommendations! Published in 2022 at "EClinicalMedicine"
DOI: 10.1016/j.eclinm.2022.101327
Abstract: eClinicalMedicine 2022;45: 101327 Published online xxx https://doi.org/10.1016/j. eclinm.2022.101327 HIV patients are at increased risk of COVID-19 morbidity and mortality. Moreover, increased SARS-CoV-2 mutation development has been reported in (African) HIV-1 infected patients. Previous reports documented… read more here.
Keywords: hiv infected; cov vaccine; safety immunogenicity; sars cov ... See more keywords
Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants.
Sign Up to like & getrecommendations! Published in 2018 at "Vaccine"
DOI: 10.1016/j.vaccine.2018.02.113
Abstract: BACKGROUND Pediatric use of pneumococcal conjugate vaccines (PCV) has been associated with significant decrease in disease burden. However, disease caused by non-vaccine serotypes has increased. Safety and immunogenicity of 15-valent PCV (PCV15) containing serotypes included… read more here.
Keywords: safety; safety immunogenicity; pcv15; pcv13 ... See more keywords
Safety and immunogenicity of a Vi-DT typhoid conjugate vaccine: Phase I trial in Healthy Filipino adults and children
Sign Up to like & getrecommendations! Published in 2018 at "Vaccine"
DOI: 10.1016/j.vaccine.2018.05.038
Abstract: Highlights • Vi-DT is safe and well tolerated in participants aged 2–45 years.• Significantly higher immune responses post Vi-DT compared to Vi polysaccharide vaccine.• No further increase in GMT post second dose as compared to post… read more here.
Keywords: typhoid conjugate; conjugate vaccine; safety immunogenicity; immunogenicity typhoid ... See more keywords
Safety and immunogenicity of a recombinant vaccine against Trypanosoma cruzi in Rhesus macaques.
Sign Up to like & getrecommendations! Published in 2020 at "Vaccine"
DOI: 10.1016/j.vaccine.2020.05.010
Abstract: Chagas disease, caused by the protozoan parasite Trypanosoma cruzi is one of the most important neglected parasitic diseases in the Americas. Vaccines represent an attractive complementary strategy for the control of T. cruzi infection and… read more here.
Keywords: recombinant vaccine; safety immunogenicity; cruzi; vaccine ... See more keywords
Safety and immunogenicity of experimental stand-alone trivalent, inactivated Sabin-strain polio vaccine formulations in healthy infants: A randomized, observer-blind, controlled phase 1/2 trial
Sign Up to like & getrecommendations! Published in 2020 at "Vaccine"
DOI: 10.1016/j.vaccine.2020.05.081
Abstract: Highlights • A novel IPV vaccine was developed from attenuated Sabin poliovirus strains.• The vaccine was generally well tolerated in adults, toddlers and infants.• The vaccine was immunogenic as a booster in previously polio-vaccinated toddlers.•… read more here.
Keywords: stand alone; safety immunogenicity; sabin; immunogenicity experimental ... See more keywords
The safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in Chinese adults aged 18–59 years: A phase I randomized, double-blinded, controlled trial
Sign Up to like & getrecommendations! Published in 2021 at "Vaccine"
DOI: 10.1016/j.vaccine.2021.04.006
Abstract: Background This study examined the safety and immunogenicity of an inactivated SARS-CoV-2 vaccine. Method In a phase I randomized, double-blinded, placebo-controlled trial involving 192 healthy adults 18-59 years old, two injections of three doses (50… read more here.
Keywords: trial; cov vaccine; safety immunogenicity; sars cov ... See more keywords