Clinical Investigations

Since 1967, RII was charged with responsibilities for conducting clinical investigations of novel antiviral drugs and vaccines. Vast experience, gained in the trials, allowed for developing efficient approaches of preventing and treating viral infections. Many tested medications, such as Rimantadine, Arbidol, Ingaron, etc., live and inactivated influenza vaccines were successfully integrated into clinical practice.

Currently, RII is authorized by the Ministry of Health and Social Development of the Russian Federation, to carry out clinical trials of novel medical products and technologies. The investigations are organized and conducted within the two divisions of the Clinical Department — Specialized Clinic for Viral Infections and Division of Clinical and Experimental Investigations, the latter being a test ground for both preclinical and clinical evaluation of antiviral medications.

RII fully meets the requirements to maintain high quality phase I to IV clinical trials. State-of-the-art facilities and a team of professional physicians, clinical and laboratory investigators, nurses, epidemiologists, biostatisticians and IT—specialists, involved in the trials, ensures safety and efficiency of clinical research. All the investigations are carried out in close collaboration with RII research laboratories. To protect both volunteers and researchers, WHO guidelines and Good Clinical and Laboratory Practice (GCP and GLP) regulations are closely followed, while appropriate ethical and quality standards are guaranteed by an independent Ethics Committee.

Along with trials of RII—designed medicines, RII contributes to single— and multi—center national and international clinical research projects, provides expert services to various research institutions and pharmaceutical companies.

List of Vaccines Tested at RII

Research Period Vaccine
Since 1985,
annually
Vaccine candidates for production of live influenza vaccine based on WHO-recommended seasonal strains
1991–1993 Oral inactivated influenza vaccine
1989–1995 Purified live 3-valent influenza vaccine
1992–2001 Inactivated 3-valent influenza vaccine
1999–2003 Live influenza vaccine (two cold-adapted attenuation donors)
1999–2001 VeroVac — Live cultural intranasal influenza vaccine
 2005–2006  Ultravac — Live influenza vaccine
2006–2007 Orniflu — Inactivated subunit vaccine (H5N1)
2006–2008 Grifor — Inactivated virosomal split influenza vaccine
 2008–2009  Panvax — Live replication-defective influenza intranasal vaccine (H5N1)
2009  Live and inactivated pandemic influenza vaccines A(H1N1)v


 List of Drugs Tested at RII

Research Period Antiviral Drug
1967–1969  Antigrippin
1968–1975  Rimantadine
1978–1983  Adapromin
1983–1986 Reaferon
1984–1986  Deitiforin
1988–1990 Ribavirin
1988–1989  Mildronat
1989–1990 Olifen
1990 Polirem
1991–1995  Arbidol
1997–2000  Algirem
1998 Cycloferon
1999 Amixin
1999 Kagocel
2000–2004  Interferon-alpha (nasal spray)
2005–2007 Ingaron
2009 Triazavirin (Phase I)
2009 Amizon
2010 Kupol


Completed Clinical Trials

Study to Evaluate Safety, Tolerability and Pharmacokinetics of Triazavirin in Volunteers (Phase I)

Prospective, Simple Blind, Comparative Study to Evaluate Efficacy and Safety of Amizon (tablets; 250mg) in Patients with Influenza and ARI (Phase III)

Ongoing Clinical Trials

Prospective Simple Blind Placebo-Controlled Clinical Study to Evaluate Safety and Efficacy of Triazavirin (capsules; 250mg) in Volunteers Diagnosed with Influenza (Phase II)