- |||||||||| gentamicin sulfate / Generic mfg.
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: The Immunostimulatory Effects of Gentamicin (clinicaltrials.gov) - May 15, 2024 P2, N=33, Terminated, N=50 --> 33 | Trial completion date: Jan 2023 --> May 2024 | Recruiting --> Terminated | Trial primary completion date: Jan 2023 --> May 2024; slow recruitment due to COVID19
- |||||||||| Stamaril (yellow fever vaccine) / Sanofi, YF-VAX (yellow fever vaccine) / Sanofi
IND, Journal: Enhanced safety surveillance of STAMARIL (Pubmed Central) - Nov 27, 2023 This study supports the utility of STAMARIL in the EAP as an alternative solution for the YF vaccine shortage in the USA. SAEs were very rare and consistent with the known safety profile of STAMARIL.
- |||||||||| Stamaril (yellow fever vaccine) / Sanofi
Enrollment open, Trial completion date, Trial primary completion date: CYF-8: Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination (clinicaltrials.gov) - May 10, 2023 P4, N=80, Enrolling by invitation, SAEs were very rare and consistent with the known safety profile of STAMARIL. Active, not recruiting --> Enrolling by invitation | Trial completion date: Feb 2022 --> Feb 2024 | Trial primary completion date: Nov 2021 --> Feb 2024
- |||||||||| Zyclara (imiquimod) / Mochida, Viatris, Bausch Health, Stamaril (yellow fever vaccine) / Sanofi
Enrollment open, Enrollment change, Trial completion date, Trial primary completion date: CoGA: Coadministration of GA2 Sporozoites With Adjuvants (clinicaltrials.gov) - Feb 10, 2023 P1, N=45, Recruiting, Active, not recruiting --> Enrolling by invitation | Trial completion date: Feb 2022 --> Feb 2024 | Trial primary completion date: Nov 2021 --> Feb 2024 Not yet recruiting --> Recruiting | N=25 --> 45 | Trial completion date: Nov 2023 --> Dec 2024 | Trial primary completion date: May 2023 --> Dec 2024
- |||||||||| Stamaril (yellow fever vaccine) / Sanofi
Journal: Neurovirulence, viscerotropism and immunogenicity of live attenuated yellow fever 17D vaccine virus in non-human primates. (Pubmed Central) - Dec 24, 2022 WHO reference virus 168-73 and Stamaril™ as a control vaccine was used for comparison...The SII seed virus and vaccine complies to the WHO requirement for neurovirulence, viscerotropism and immunogenicity, when tested in comparison to WHO reference seed virus 168/73. All challenged animals showed 100 % seroconversion as early as day 14 and neutralizing antibody titers were sustainable at day 30 in all animals.
- |||||||||| YF-VAX (yellow fever vaccine) / Sanofi
Journal: Absence of transmission of vYF next generation Yellow Fever vaccine in mosquitoes. (Pubmed Central) - Dec 16, 2022 Although comparison of vYF-247 to reference vaccines could not be completed to yield significant results, we showed that vYF-247 was not transmitted by both Aedes species, either laboratory strains or field-collected populations, compared to clinical strain S-79 at the highest inoculation dose. Combined with the undetectable to low level viremia detected in vaccinees, transmission of the vYF-247 vaccine by mosquitoes is highly unlikely.
- |||||||||| YF-VAX (yellow fever vaccine) / Sanofi
Low replication and absence of transmission of vYF next generation Yellow Fever Vaccine candidate in mosquitoes (Convention Center - Hall 4A (4th Floor); In-Person-Only) - Oct 9, 2022 - Abstract #ASTMH2022ASTMH_1846; These results were confirmed with field-collected mosquitoes from Asia, Latin America and Africa.Even if in some limited cases the vYF vaccine candidate could infect and to a very minor extent disseminate in mosquitoes, no transmission potential was detected. Together with the undetectable to low level viremia observed after vaccination of human volunteers, these data demonstrate that the dissemination of the vYF vaccine by mosquitoes is highly unlikely.
- |||||||||| YF-VAX (yellow fever vaccine) / Sanofi
Evaluation of safety and immuno-efficacy of the next generation live attenuated yellow fever vaccine in cynomolgus macaques (Convention Center - Hall 4A (4th Floor); In-Person-Only) - Oct 9, 2022 - Abstract #ASTMH2022ASTMH_928; Finally, vYF provided effective resistance to virulent challenge with wild-type YFV Asibi including complete protection against YFV-induced mortality, pathology, dysregulation of blood and liver soluble biomarkers and a significant reduction in viremia and viral load to the limit of detection. These data suggest that vYF is safe and would provide protection against YFV infection in clinical practice, at least similar to that achieved with currently marketed YF-17D vaccines.
- |||||||||| gentamicin sulfate / Generic mfg.
Enrollment open: The Immunostimulatory Effects of Gentamicin (clinicaltrials.gov) - May 17, 2022 P2, N=50, Recruiting, These data suggest that vYF is safe and would provide protection against YFV infection in clinical practice, at least similar to that achieved with currently marketed YF-17D vaccines. Not yet recruiting --> Recruiting
- |||||||||| Stamaril (yellow fever vaccine) / Sanofi
Developing a novel HIV cure strategy: retargeting potent cytotoxic T cells to kill HIV-infected cells () - May 12, 2022 - Abstract #AIDS2022AIDS_2536; We have developed a novel immunotherapy concept in which epitope-specific CTLs induced by vaccination can be redirected towards HIV-infected cells. This novel technology is highly specific and easily adaptable to recognize any target of interest while obviating the need for ex vivo modification and expansion, thus holding great potential for various diseases.
- |||||||||| Stamaril (yellow fever vaccine) / Sanofi, YF-VAX (yellow fever vaccine) / Sanofi
Enrollment closed: Study on an Investigational Yellow Fever Vaccine Compared With Stamaril in Adults in Europe and Asia (clinicaltrials.gov) - Apr 29, 2022 P2, N=690, Active, not recruiting, This novel technology is highly specific and easily adaptable to recognize any target of interest while obviating the need for ex vivo modification and expansion, thus holding great potential for various diseases. Recruiting --> Active, not recruiting
- |||||||||| Stamaril (yellow fever vaccine) / Sanofi
Enrollment closed, Trial completion date, Head-to-Head: Immunogenicity and Safety of Fractional Doses of Yellow Fever Vaccines (YEFE) (clinicaltrials.gov) - Dec 17, 2020 P4, N=1630, Active, not recruiting, Recruiting --> Active, not recruiting | Trial completion date: Sep 2021 --> Feb 2022 Recruiting --> Active, not recruiting | Trial completion date: Dec 2020 --> May 2021
- |||||||||| Stamaril (yellow fever vaccine) / Sanofi
Trial completion, Enrollment change: Yellow Fever Vaccine on Statin/ Non Statin Subjects (clinicaltrials.gov) - Mar 23, 2020 P2, N=37, Completed, Trial completion date: Sep 2020 --> Sep 2021 | Trial primary completion date: Sep 2020 --> Sep 2021 Recruiting --> Completed | N=70 --> 37
- |||||||||| Stamaril (yellow fever vaccine) / Sanofi
Enrollment change, Trial completion date, Head-to-Head: Immunogenicity and Safety of Fractional Doses of Yellow Fever Vaccines (YEFE) (clinicaltrials.gov) - Nov 28, 2018 P4, N=1630, Active, not recruiting, Active, not recruiting --> Completed | Trial completion date: Oct 2018 --> Dec 2017 | Trial primary completion date: Nov 2017 --> Feb 2017 N=960 --> 1630 | Trial completion date: Dec 2019 --> Dec 2020
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