Stamaril (yellow fever vaccine) / Sanofi - LARVOL DELTA

A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population (clinicaltrials.gov) - P3 | N=2440 | Recruiting | Sponsor: Sanofi | Trial completion date: Oct 2029 ➔ Mar 2030

Trial completion date • Pediatrics

A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population (clinicaltrials.gov) - P3 | N=2440 | Recruiting | Sponsor: Sanofi

New P3 trial • Pediatrics

A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL (clinicaltrials.gov) - P3 | N=1824 | Completed | Sponsor: Serum Institute of India Pvt. Ltd. | Recruiting ➔ Completed

Trial completion

Real-world evidence of yellow Fever vaccination data-driven study. (PubMed, Vaccine) - "This study investigates the potential of Real-World Evidence (RWE) to enhance vaccine surveillance by analyzing electronic health records (EHRs) from the TriNetX platform, which identified a total of 15,835 individuals who were vaccinated with the Stamaril® YF vaccine between 2017 and 2021 in the United States...Our findings were consistent with those published previously and suggest no significant increase in adverse medical outcomes post-vaccination across all age groups, particularly in long-term analysis. This proof-of-concept study underscores the value of RWE in monitoring vaccine safety and supports its potential to complement traditional surveillance methods, offering a robust tool for continuous post-marketing vaccine evaluation."

HEOR • Journal • Real-world evidence • Infectious Disease

CYF-8: Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination (clinicaltrials.gov) - P4 | N=60 | Active, not recruiting | Sponsor: University of Aarhus | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • CD8

Comparison Study of SIBP's MMR Vaccine Versus GSK MMR Vaccine in Children Aged 9-11 Months (clinicaltrials.gov) - P3 | N=1200 | Recruiting | Sponsor: Shanghai Institute Of Biological Products | Not yet recruiting ➔ Recruiting

Enrollment open • Head-to-Head • Infectious Disease • Measles • Mumps • Rubella

The Immunostimulatory Effects of Gentamicin (clinicaltrials.gov) - P2 | N=33 | Terminated | Sponsor: Singapore General Hospital | 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

Enrollment change • Trial completion date • Trial primary completion date • Trial termination

Comparison Study of SIBP's MMR Vaccine Versus GSK MMR Vaccine in Children Aged 9-11 Months (clinicaltrials.gov) - P3 | N=1200 | Not yet recruiting | Sponsor: Shanghai Institute Of Biological Products

Head-to-Head • New P3 trial • Infectious Disease • Measles • Mumps • Rubella

CYF-8: Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination (clinicaltrials.gov) - P4 | N=80 | Enrolling by invitation | Sponsor: University of Aarhus | Trial completion date: Feb 2024 ➔ Dec 2025 | Trial primary completion date: Feb 2024 ➔ Feb 2025

Trial completion date • Trial primary completion date • CD8

Study on an Investigational Yellow Fever Vaccine Compared With Stamaril in Adults in Europe and Asia (clinicaltrials.gov) - P2 | N=690 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Trial completion date: Apr 2028 ➔ Apr 2027

Trial completion date

A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants (clinicaltrials.gov) - P3 | N=2216 | Recruiting | Sponsor: Serum Institute of India Pvt. Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Aug 2024 ➔ Jan 2024

Enrollment open • Trial completion date

A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL (clinicaltrials.gov) - P3 | N=1824 | Recruiting | Sponsor: Serum Institute of India Pvt. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

Immunity to Yellow Fever in HIV-infected Patients 10 Years After a Primary Anti-yellow Fever Vaccination (clinicaltrials.gov) - P=N/A | N=60 | Not yet recruiting | Sponsor: ANRS, Emerging Infectious Diseases | Trial completion date: Jul 2022 ➔ Nov 2024 | Trial primary completion date: Jul 2022 ➔ Nov 2024

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • CD4

YF-INFECT: Yellow Fever Human Infection Model With YF-17D (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Leiden University Medical Center

New trial • Infectious Disease

CYF-8: Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination (clinicaltrials.gov) - P4 | N=80 | Enrolling by invitation | Sponsor: University of Aarhus | Active, not recruiting ➔ Enrolling by invitation | Trial completion date: Feb 2022 ➔ Feb 2024 | Trial primary completion date: Nov 2021 ➔ Feb 2024

Enrollment open • Trial completion date • Trial primary completion date • CD8

An Experimental Medicine Decipher of a Minimum Correlate of Cellular Immunity (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Singapore General Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Infectious Disease

Enhanced safety surveillance of STAMARIL® yellow fever vaccine provided under the expanded access investigational new drug program in the United States. (PubMed, J Travel Med) - "This study supports the utility of STAMARIL in the EAP as an alternative solution for the yellow fever vaccine shortage in USA. SAEs were very rare and consistent with the known safety profile of STAMARIL."

IND • Journal

CoGA: Coadministration of GA2 Sporozoites With Adjuvants (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Leiden University Medical Center | Not yet recruiting ➔ Recruiting | N=25 ➔ 45 | Trial completion date: Nov 2023 ➔ Dec 2024 | Trial primary completion date: May 2023 ➔ Dec 2024

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Malaria

Study on an Investigational Yellow Fever Vaccine Compared With Stamaril in Adults in Europe and Asia (clinicaltrials.gov) - P2 | N=690 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Trial completion date: Apr 2027 ➔ Apr 2028

Trial completion date

Neurovirulence, viscerotropism and immunogenicity of live attenuated yellow fever 17D vaccine virus in non-human primates. (PubMed, Vaccine) - "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."

Journal

A phase I clinical study to assess safety and immunogenicity of yellow fever vaccine. (PubMed, NPJ Vaccines) - "This was a Phase I, open-label, randomized, controlled study where healthy adults received SII YFV intramuscularly (SII YFV IM), SII YFV subcutaneously (SII YFV SC) or STAMARIL (Sanofi-Pasteur) in 1:1:1 ratio. The new YFV was found safe and immunogenic by IM as well as SC routes. The vaccine can be tested in further phases of clinical studies."

Journal • P1 data • Infectious Disease

Absence of transmission of vYF next generation Yellow Fever vaccine in mosquitoes. (PubMed, PLoS Negl Trop Dis) - "Here we infected Aedes aegypti and Aedes albopictus mosquitoes with vYF-247 vaccine compared first to the YF-17D-204 reference Sanofi vaccines (Stamaril and YF-VAX) and a clinical human isolate S-79, provided in a blood meal at a titer of 6.5 Log ffu/mL and secondly, to the clinical isolate only at an increased titer of 7.5 Log ffu/mL. 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."

Journal • Infectious Disease

Low replication and absence of transmission of vYF next generation Yellow Fever Vaccine candidate in mosquitoes (ASTMH 2022) - "For the development of a new vaccine, WHO recommends to document infectivity and replication in mosquitoes in comparison with a current vaccine.Batches of 40 Aedes aegypti and Aedes albopictus mosquitoes were infected through a blood meal containing vYF vaccine in comparison with Stamaril, YF-VAX and wild type (wt) Dakar strain provided at 6.5 or 7.5 LogFFU/mL. 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."

Late-breaking abstract • Hematological Disorders • Infectious Disease

Evaluation of safety and immuno-efficacy of the next generation live attenuated yellow fever vaccine in cynomolgus macaques (ASTMH 2022) - "The protective activity upon virulent challenge with wild-type YF virus Asibi, 9 months after vaccination, was evaluated and compared to Stamaril and YF-VAX. 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."

Clinical • Late-breaking abstract • Infectious Disease

Bis(Benzofuran-1,3-N,N-heterocycle)s as Symmetric and Synthetic Drug Leads against Yellow Fever Virus. (PubMed, Int J Mol Sci) - "Among 23 new bis-conjugated compounds, 4 of them inhibited YFV strain 17D (Stamaril) on Huh-7 cells in the cytopathic effect reduction assays. These conjugates exhibited the most compelling efficacy and selectivity with an EC of <3.54 μM and SI of >15.3. The results are valuable for the development of novel antiviral drug leads against emerging diseases."

Journal • Hematological Disorders