As partner of TRANSVAC, IRTA will provide access to their animal facilities (CReSA) to carry out safety and
immunogenicity studies of new candidate vaccines and / or of novel vaccination (administration) strategies in pigs, ferrets and other large animal species.
Optional: additional groups of ferrets for lung / tissues; virus neutralisation titres; histopathology;
immunogenicity studies.
Researchers seek to sustain or increase this effect, and these clinical trials will enable them to collect more data and samples for
immunogenicity studies.
Not exact matches
Although Tdap has an excellent safety record, future cohort or surveillance
studies must continue to assess safety and
immunogenicity of Tdap immunization during pregnancy, write Natalia Jimnez - Truque, M.S.C.I., Ph.D., and Kathryn M. Edwards, M.D., of Vanderbilt University Medical Center, Nashville, Tenn., in an accompanying editorial.
According to Dr Won Park, Inha University Hospital, Korea, and lead investigator of the PLANETAS
study, «the challenge for biosimilars is to demonstrate similarity in therapeutic effectiveness, safety and
immunogenicity to their reference product, not just biochemical and pharmacokinetic equivalence.»
The
study, which was published in the last issue of Science Translational Medicine, reports early plasma cytokine signatures that correlate with, and predict, the
immunogenicity and reactogenicity of the vaccine.
The European research collaboration behind this
study focuses on deep immunological analysis of the
immunogenicity and reactogenicity of the Ebola vaccine in healthy volunteers.
The next steps for this vaccine are to produce a clinical grade lot and conduct a phase 1
study of safety and
immunogenicity in infants, Moore says.
Next to this, WBVR offers the use of its infrastructure to perform
immunogenicity and efficacy
studies for newly developed vaccines.
A Phase Ia
Study to Assess the Safety and
Immunogenicity of New Malaria Vaccine Candidates ChAd63 CS Administered Alone and with MVA CS.
We produce live and inactivated viruses in our BSL2 and BSL3 facilities, and perform
immunogenicity and efficacy
studies in pigs (influenza) and sheep (RSV) with a focus on skin vaccination and extended monitoring of humoral and cellular immune responses in the blood and lung.
CAMBRIDGE, Mass., April 27, 2017 — Moderna Therapeutics, a clinical stage biotechnology company that is pioneering messenger RNA (mRNA) Therapeutics ™ to create a new generation of transformative medicines for patients, today announced positive interim data from an ongoing Phase 1
study of mRNA - 1440, an mRNA infectious disease vaccine against avian H10N8 influenza, demonstrating mRNA - 1440 induced high levels of
immunogenicity, and was safe and well tolerated.
One hundred children aged 1 to 6 years were sequentially assigned to 3 cohorts of 20, 40 and 40 participants with stratification for age by 2 - year increments (1 — 2 years, 3 — 4 years, and 5 — 6 years) to ensure that the
study groups were balanced by age in case of age - related differences in tolerability or
immunogenicity.
Vaccine
studies in infants < 6 mo with novel vaccine candidates have generally demonstrated poor
immunogenicity (90).
The development track will begin with a Phase I trial to test the vaccine regimen's safety and
immunogenicity and depending on those
study results, a larger efficacy
study will follow.
The randomized, double - blind, placebo - controlled
study will evaluate the safety and tolerability of multiple doses of NPT088, as well as pharmacokinetics,
immunogenicity and pharmacodynamic characteristics, as measured by Aβ and tau PET imaging.
MHRP, which led the RV144 trial with the Thai Ministry of Public Health, initiated follow - on clinical
studies to conduct intensive
immunogenicity research.
The overall objective of the current
study was to identify an optimal pediatric dose of FMP2.1 / AS02A that is safe, with high
immunogenicity and acceptable reactogenicity, for progression to efficacy testing.
Along with collaborators, the Weiner Lab was the first to move DNA vaccines to human clinical
studies, establishing their initial safety and
immunogenicity.
WRAIR and collaborators will share data related to assays designed to measure antibody responses following vaccination with ZPIV, biologic samples generated during the performance of animal
studies, and biologic samples generated during the performance of early human trials assessing the safety and
immunogenicity of ZPIV.
The results obtained by this service may be part of the documentation provided to other analytical services (TNA3), Adjuvants and delivery systems (TNA2) or
Immunogenicity and efficacy
studies (TNA8) as well as the Pre-clinical GLP production services (TNA4) and the GMP production services (TNA5).
Within the framework of TRANSVAC2, the HZI will offer access in the form of pre-clinical
studies in the murine system to assess the
immunogenicity, safety and efficacy of specific vaccine formulations.
Once recombinant vaccine antigens produced by this service are available, they could be forwarded to Analytical services (TNA3), Adjuvants and delivery systems (TNA2) or
Immunogenicity and efficacy
studies (TNA8), if applicable.
Immunogenicity and efficacy
studies in pig (influenza) and sheep (RSV) with a focus on skin vaccination and extended monitoring of humoral and cellular immune responses in the blood and lung.
PFIE will provide access to its facilities for
immunogenicity and efficacy
studies in pigs or sheep (as well as other species if needed), according to users» requirements.
Furthermore serum samples or immune Ig preparations generated in the context of
immunogenicity and challenge
studies performed under the umbrella of the «Animal Models» could be analysed.
As partner of TRANSVAC2, WBVR will provide access to their animal facilities (Lelystad) to carry out
immunogenicity and efficacy
studies of new candidate vaccines and / or of novel vaccination (administration) strategies in pigs, cattle, ferrets or other animal species.
Within the framework of TRANSVAC2, the HZI will offer access in the form of pre-clinical
studies in the murine system to assess the
immunogenicity, safety and efficacy of specific vaccine formulations containing a mucosal adjuvant.
SSI offers vaccination
studies in mice including 1 - 2 control groups and full
immunogenicity analysis including CMI and humoral
immunogenicity using Flow cytometry (B and T cells) and ELISA (cytokines and antibodies).