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Laboratory of Trials of Novel Remedies for Antiviral Protection

Laboratory Lead — Mariana K. Erofeeva, Dr.Med.Sci.

Phone: +7 (812) 234–60–32

E-mail: erofeeva@influenza.spb.ru









Laboratory of Trials of Novel for Antiviral Remedies has a accumulated years of experience in clinical trials of safety, reactogenicity, immunogenicity and efficacy of novel vaccines, antiviral and immune stimulating preparations and various techniques of their application in prevention and early treatment of influenza and other wide spread ARI in adults and children.

Primary Activities:

  • Clinical and epidemiological studies of novel influenza vaccines and immunization schemes
  • Efficacy studies of commercially available vaccines
  • Clinical and epidemiological studies of antiviral and immune–stimulating preparations
  • Studies of non–standard application of vaccines and preparations

Notable Achievements:

  • Domestic inactivated whole virion influenza vaccines for double intranasal immunization of children aged 3+ and adults
  • Live influenza vaccine for single intranasal immunization of children aged 3+ and adults
  • Live influenza vaccine with M2 stabilizer — 2005–2006
  • Endogenous Interferon Inductors — Amixin (1998), Cycloferon (1998), Kagocel (2000), Poludan (2006)
  • Recombinant alpha–interferon — liposomal Reaferon–ES Lipint (2002–2003, 2005), Ingaron (2006)
  • Immune corrective natural preparations — Immunal (1999–2003), Sodekor (2000), Phytogor (2003), Karmolis(2003–2004), Capilar(DKV AA; 2007)
  • Phase III randomized double blind placebo–controlled comparative parallel group study of safety and efficacy of Infagel, 10000 UI/g, for influenza and ARI prevention in adults, 2010
The lab conducted a number of joint trials with RII Clinical Department:
  • Live attenuated intranasal influenza vaccine VeroVac, a Vero cell-grown vaccine for intranasal administration
  • Controlled prospective randomized trials of Orniflu avian influenza vaccine, strains NIBRG-14, A(H5NI) (Phases I and II), 2006–2007
  • Controlled prospective randomized trials of Grifor split inactivated influenza vaccine (Phases II and III), 2007–2008
  • Placebo–controlled prospective randomized trials of pandemic A/H1N1 influenza vaccines (Phases I and II), 2009:
    • Influvir — live monovalent influenza vaccine in lyophilized state for soluble intranasal administration, A/17/California/2009/38(H1N1) strain
    • Pandeflu — inactivated subunit adsorbed monovalent influenza vaccine in suspension for intramuscular injection, A/California/7/2009 (HIN1)v strain
  • Phase I blind placebo–controlled randomized trial of dose–escalation single dose immunization with inactivated whole aluminum–adjuvanted influenza vaccine REFLUVAK, KAZFLUVAK in volunteers aged 18–60, 2010
  • Study of safety, reactogenicity and immunogenicity of influenza vaccines “Vaccine X” and “Vaccine Y” produced by NPO Microgen, Russia, in volunteers aged 18–60, Phase I–II
    • Phase I: simple blind randomized placebo–controlled prospective multicenter study
    • Phase II: simple blind randomized comparative prospective multicenter study
  • Controlled prospective randomized trial of split inactivated influenza vaccine Grifor in children aged 6–12, Phase III, 2010

The results acquired during the trials show safety, tolerability and low reactogenicity of the vaccines. All trials are conducted according to Russian Guidelines for Quality Clinical Research, Good Clinical Research Practice(GCP) rules and World Medical Association’s Declaration of Helsinki, with appropriate blinding and randomized study groups.

Interinstitutional and International Relations:

  • Rospotrebnadzor St. Petersburg and Leningradskaya Oblast’ branches
  • St. Petersburg Healthcare Committee
  • St. Petersburg RAMS Experimental Medicine Research Institute (IEM)
  • Tarasevich State Institute for Medical and Biological Standardization and Control (GISK)
  • Mechnikov Research Institute of Vaccines and Sera, Moscow
  • Leningrad Military District Medical Service
  • NPO Microgen, Moscow
  • Vector–Medica, Novosibirsk
  • NEARMEDIC
  • DIOD LLC, Moscow
  • Petrovax, Moscow

Grants and Projects:

  • FLUVACC — an Integrated Project (IP), research for vaccines against pandemic influenza. EU Sixth Framework Program. «Randomised, double-blind, placebo-controlled, Phase I dose–escalation study of two doses GHB04L1 in healthy adults»

Selected Publications:

  • M.K. Erofeeva, V.L. Maksakova, M.G. Pozdnyakova, I. Yu. Nikonorov, O.S. Kotova, I.V. Amosova, S.N. Targonsky, S.V. Usova. The possibilities of using Infagel preparation for prevention of influenza and other Acute respiratory Infections. J Polyclinic(Poliklinika), 2010 N4 In Russian
  • M.K. Erofeeva, I.Yu. Nikonorov, V.L. Maksakova et al. Evaluating the Effectiveness of Influenza Vaccine Grippol® Plus School­Aged Children During the Influenza Epidemic 2008–2009. Epidemiology & Vaccinal Prevention 2010;53(4):80–86 In Russian
  • M.K. Erofeeva, I.Yu. Nikonorov, S.M. Kharit, V.V Romanenko. Summary review of clinical studies of safety and immunogenicity of Grippol Neo vaccine. J Attending Physician(Lechashii Vrach) In Russian
  • M.K. Erofeeva, T.I. Krainova, I.Yu. Nikonorov, O.V. Parkov. Features of the Recent Influenza Epidemics in St. Petersburg. Research and Surveillance of Infectious Diseases. Proceedings of the International Conference, St. Petersburg, May 18–20, 2010
  • M.A Stukova. M.K. Erofeeva. Phase I Clinical Study of H5N1 delNS1 pandemic influenza vaccine. J Infectious Diseases(Infektsionnie Bolezni) 2010, V.8, App. 1
  • M.A Stukova. M.K. Erofeeva. Clinical Studies of Pandemic Influenza Vaccines in Russia. J Infectious Diseases(Infektsionnie Bolezni) 2010, V.8, App. 1
  • S.M.Kharit, M.K. Erofeeva, V.V. Romanenko. Safety data for cell-derived inactivated subunit adjuvanted influenza vaccine «Grippol Neo» in children 3-17 years old. Pediatrics Questions(Voprosi Sovremennoi Pediatrii). 2010;9(4):44–47 In Russian
  • E.P. Grigoreva, V.P. Drinevskij, å.í. Doroshenko et al. Efficacy of the Live Reassortant Influenza Vaccine During Circulation Drift Variants Of Influenza Virus. Epidemiology & Vaccinal Prevention 2009;44(1):45–52 In Russian
  • V.L. Maksakova, I.A. Vasilieva, M.K. Erofeeva. Use of Kagocel for Influenza and ARI Prevention and Treatment. Medline. 2009;1(201):42–45 In Russian
  • V.V. Zverev, A.V. Katlinskiĭ, M.P. Kostinov, S.N. Zhirova, M.K. Erofeeva, M.A. Stukova, S.A. Korovkin, S.Ia. Mel'nikov, A.V. Semchenko, A.N. Mironov. Comparative clinical trial of vaccines against avian influenza. Zh Mikrobiol Epidemiol Immunobiol. 2007 May–Jun;(3):10-6. In Russian
  • M.K. Erofeeva, M.A. Stukova, V.L. Maksakova, M.G. Pozdnjakova, E.A. Ohapkina, I.A. Vasilieva, V.D. Evgrafov, V.K. Pozdeev, V.Z. Krivitskaya, E.M. Voitsehovskaya, A.A. Sominina, O.I. Kiselev. «Safety and immunogenicity of an inactivated subunit influenza H5N1 vaccine: a phase 1 clinical trial». International Conference «Preparedness to the influenza pandemic-an international outlook», 2007, March 15–17, p.14–15
  • M.G. Pozdniakova, V.L. Maksakova, I.L. Kolyvanova, V.M. Nikolayeva. The Possibility of Application of Liposomal Alpha–2B Interferon for the Prevention of Flu and Other Acute Respiratory Infections among Children. Pediatrics Questions(Voprosi Sovremennoi Pediatrii). 2007;6(1):80–84 In Russian
  • M.G. Pozdniakova, V.L. Maksakova, I.L. Kolyvanova, V.M. Nikolayeva, T.I. Kraynova, S.V. Usova, M.K. Yerofeyeva. The Efficiency Assessment of the Extra Prevention against Flu and Other Respiratory Acute Viral Infections among Children Aided By Alfa–2b Interferon Medication. Pediatric Pharmacology(Pediatricheskaya Farmakologia) 2006;3(6):10–13 In Russian
  • M.K. Erofeeva, M.G. Pozdniakova, V.L. Maksakova, I.L. Kolyvanova. Comparative Evaluation of Organoleptic Properties and Immunogenic Activity of ULTRAVAC Vaccine and Live, Egg-derived Intranasal Influenza Vaccine. Epidemiology & Vaccinal Prevention. 2006:28(3):24–28 In Russian