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JN-International Medical Corporation

JN-International Medical Corporation is a U.S.-based biopharmaceutical corporation which since 1998 has been focused on developing vaccines and diagnostics for infectious disease for developing countries. This private corporation (formerly known as Jeeri Neotech International, Inc) was founded in 1998 by Dr. Jeeri R. Reddy with the help of Dr. Kelly F. Lechtenberg in a small rural town, Oakland, Nebraska. From there it grew and expanded until in the year 2000 the corporation moved to Omaha, Nebraska.

JNIMC has overseas business offices and clinical trial centers located in Abidjan, Ivory Coast in Africa with vaccine cold chain facilities in Burkina Faso. JNIMC partners with Global Health Organizations such as the Clinton Global Initiative, the Global Business Coalition, New York President's Malaria Initiative and PEPFAR. JNI also partners with several other non-profit global health organizations, NGOs, local governments and communities in developing countries to address the health issues related to HIV-AIDS, Malaria, Tuberculosis and Bacterial Meningitis that scourges the underserved communities in West Africa, South East Asia and Latin America.

HISTORY

VACCINE DEVELOPMENT

VACCINE FACILITIES

HISTORY

Early in its existence JNIMC developed rapid and western blot diagnostic test kits for Malaria TB and HIV. JNI was the first company to screen about 2 million pregnant women for the presence of HIV in South East Asia from 1999 – 2002. This resulted in many HIV-free births because the hospitals were able to treat the HIV positive pregnant women with Antiretroviral drugs. A rapid Tuberculosis test was developed by the company and demonstrated its diagnostic potential by screening 400 TB positive and negative serum samples from various hospitals in India. The results showed that the combination of Mycobacterium tuberculosis antigens improved the diagnostic specificity and sensitivity of the tests.[9] The diagnostic products of the company have been used in more than 30 countries for screening infectious diseases.

VACCINE DEVELOPMENT

Meningococcal meningitis disease, also referred to as cerebrospinal meningitis is a contagious bacterial disease caused by Neisseria meningitidis bacteria. Meningococcal infections occur worldwide and are the only bacterial agents associated with epidemic meningitis in the meningitis belt of sub-Saharan Africa. With the culmination of several years of research, JN-International developed its vaccine for Meningococcal meningitis serogroups A, C, Y and W-135 (NmVac4-A/C/Y/W-135). The efficacy of the vaccine was tested in sub-Saharan Africa (Niger and Burkina Faso) using 750 people for a period of 56 months. Protective sero-conversion occurred and was tested and recorded in vaccinated individuals during a spontaneous disease outbreak. However, it is well known that this type of vaccine gives disease protection for no more than 18 months. To better serve the market the company worked on and developed a Meningococcal meningitis serogroups A, C, Y and W-135 Diphtheria toxoid conjugate vaccine (NmVac4-A/C/Y/W-135 - DT), by using a Diphtheria Toxoid as the protein carrier. This method has been shown to provide a minimum of 3 years protection. JNIMC’s conjugate meningococcal vaccine was tested in the Ivory Coast using 100 sero-negative male and female children and adults. Protective sero-conversion was recorded in 98% of the individuals as tested and recorded by the Pasteur Institute Côte d'Ivoire. JNIMC is working to produce these vaccines in the United States. Production with regulatory approval for U.S. export is in process and will probably take a few years.

The research and development division of JNIMC is in various stages for the development of vaccines for the prevention and cure of Hepatitis C, Herpes, Tuberculosis and a preventive and therapeutic vaccine for stroke.

CLINICAL TRIALS
Meningococcal Meningitis Diphtheria Conjugate Vaccine
Seroconversion (hSBA) by Criteria used for Phase 2
% Seroconversion –PP Population – hSBA(Defined as for Phase 2)A (4 wk)A (8 wk)C (4 wk)C (8 wk)Y (4 wk)Y (8 wk)W-135 (4 wk)W-135 (8 wk)
NmVac4-DT5333738047478060
Menactra7769857792778562
Per Protocol subjects with hSBA titers ≥8
% Subjects with hSBATiter ≥8A (4 wk)A (8 wk)C (4 wk)C (8 wk)Y (4 wk)Y (8 wk)W-135 (4 wk)W-135 (8 wk)
NmVac4-DT8773808787878787
Menactra9277929292779277
>
% Seroconversion (PP Population)ACYW-135
NmVac4-DT70.766.563.166.2
Menactra70.172.564.165.9
Difference (95% CI)0.6 (-7.9, 9.1)-6.0 (-14.6, 2.6)-1.0 (-9.9, 7.9)0.3 (-8.5, 9.1)

Safety: Secondary safety outcome measures were based on local and systemic adverse event rates from Diary Cards filled by the participants from Day 0 to Day 7 after vaccination. Non-solicited adverse events were evaluated throughout the course of the study, based on laboratory test results, vital signs, examination and questioning the subjects up to 4 weeks after injection and at a 6 month follow-up call.Only expected adverse events associated with vaccination were observed. The overall prevalence of adverse events was similar between control and test vaccine groups. In the NmVac4-DT treated group, none of the subjects had any serious adverse events and in the Menactra treated group, 1 (0.4%) subject had a serious adverse event which was not related to vaccination. Additional information is available in National Library of Medicine clinical trial database (see clinicaltrials.gov) trial identifier NCT01897402.

VACCINE FACILITIES

JNIMC facility was designed for manufacture, research and development of human vaccines in compliance with FDA compliant cGMP (Current Good Manufacturing Practices) and European Union Good Manufacturing Practice standards. The facility has fermentation, formulation, vial, freeze drying bacterial facilities classified as Biosafety Level 2 (CDC-NIH BL2-LS) and ISO 9001. The facility includes both the upstream and downstream operations when the fermentation process is scaled up for bacterial polysaccharide product development. The facilities were designed for manufacture of vaccines in compliance with cGMP and European standards. The facility has fermentation, formulations and lyophilization and handling of bacterial polysaccharide products. Utilities include Water-For-Injection Grade Water (WFI) system, oil-free compressed air system (USP), clean steam system, process chilled system and Clean-in-Place systems. Processes include; seed bank, media preparation, fermentation, cell harvest, centrifugation and purification including ultra filtration. The facility operates with a SCADA (Supervisory Control and Data Acquisition) System, generally referred to as an Industrial Control System (ICS). JNIMC’s cGMP vaccine facility spans 33,000 ft2 and includes a fully automated vialing unit. The facility has a targeted production of 10 million doses of vaccine annually.