US DoD Naval Medical Research Center Reports Positive Immunological Responses to Vaccine

▴ US DoD Naval Medical Research Center Reports Positive Immunological Responses to Vaccine
US DoD Naval Medical Research Center Reports Positive Immunological Responses to Vaccine

Immuron Limited, an Australian biopharmaceutical company focused on developing and commercializing oral immunotherapeutics for the prevention and treatment of gut mediated pathogens, today is pleased to announce that the Naval Medical Research Center (NMRC) has completed the characterization of the colostrum harvested from cows immunized with the experimental vaccine developed to target Campylobacter and Enterotoxigenic E.coli (ETEC).

The NMRC confirmed that the conjugated vaccine produced a robust immunological response in cows and reported that the new Hyper-immune therapeutic contains high levels of antibodies that specifically target Campylobacter jejuni capsule and Enterotoxigenic Escherichia coli (ETEC) colonization factor antigen 1 (CFA/1). These are key antigenic targets predicted to be protective against diarrhea induced by both pathogens. The US DoD noted that the colostrum contained high levels of specific immunoglobulins against the target antigens in the vaccine and furthermore, was shown to contain functional antibodies capable of inducing hemagglutination inhibition of the CFA/1 specific ETEC strain to be used in one of the two planned controlled human infection-model clinical trials scheduled for next year.

PCI Clinical Services has been contracted to manufacture the drug product against Campylobacter and ETEC for clinical evaluation by the US Department of Defense. The manufacturing campaign is scheduled to commence this month and be completed by the end of 2020.

Work on the Investigational New Drug (IND) application and the clinical protocols for evaluating the safety and efficacy of the product in moderate to severe campylobacteriosis and Enterotoxigenic Escherichia coli (ETEC) infections is progressing well. The NMRC plans to file the IND application with the U.S. Food and Drug Administration (FDA) in Q1 2021.

The ability of the new hyperimmune product to protect volunteers from moderate to severe campylobacteriosis and ETEC disease will be assessed during two inpatient clinical trials planned for Q2 and Q3 2021. A total of 60 volunteers divided into two inpatient cohorts will be enrolled in the study and randomly assigned to either Cohort 1 C. jejuni or Cohort 2 ETEC controlled human infection models.

Infectious diarrhea is the most common illness reported by military personnel deployed overseas and by travelers visiting developing countries. Diarrhea morbidity decreases daily performance, affects judgment, decreases morale, and declines operational readiness. In addition, travelers' diarrhea is now also recognized by the medical community to result in post-infectious sequalae, including post-infectious Irritable Bowel Syndrome and several post-infectious autoimmune diseases.

The US Department of Defense has recognized the burden of infectious diarrhea and has heavily invested in the development of effective vaccines for its prevention. However, despite robust research efforts made to develop vaccines against major enteric pathogens, there are currently no licensed vaccines available. Development of an effective, safe, and affordable prophylactic agent to control infectious diarrhea would offer a useful product for travelers and military personnel going to high-risk areas in Latin America, Africa, the Middle East, and Asia.

The major goal of this research effort is to lay the scientific foundation for the development of a multi-pathogen anti-diarrheal colostrum supplement that confers protection against Campylobacter jejuni and ETEC, the predominant causes of infectious diarrhea in travelers visiting developing countries and among military personnel deployed overseas. Ultimately, the data resulting from these studies will provide military policymakers with information needed to make decisions on product acquisition and stocking.

This release has been authorized by the directors of Immuron Limited.

Tags : #UnitedStates #DoDNaval #MedicalResearchCenter #NMRC #Campylobacter #Enterotoxigenic

Related Stories

Loading Please wait...


Trending Now

SARV Events & Celebrations Shines at "Edu-Bizz Leadership Summit & Awards 24July 18, 2024
UAE launches global initiative to build 10 hospitals to address critical healthcare gaps as part of Zayed Humanitarian Legacy InitiativeJuly 18, 2024
Geetanjali Homestate Expands Global Presence with the Launch of Geetanjali GlobalJuly 18, 2024
Changes projected in marine fish communities due to climate changeJuly 18, 2024
Understanding the Chandipura Virus Outbreak in Gujarat: A Critical OverviewJuly 18, 2024
Landmark Study Links Severe Endometriosis to Increased Risk of Ovarian CancerJuly 18, 2024
Equipping Healthcare Professionals for Global Opportunities: GIMS Partners with NSDCJuly 18, 2024
Hormone Modulating Therapy for Breast Cancer and Its Link to Lower Alzheimer’s RiskJuly 18, 2024
Multipl Secures $1.5 Million in Additional Funds, Led by Blume Ventures and MIXI Global Investments, JapanJuly 17, 2024
FedEx to empower youth with digital skilling programJuly 17, 2024
Putting people first means following Gandhi's TalismanJuly 17, 2024
American Oncology Institute (AOI) Launches #BreaktheHabit Campaign to Raise Awareness on Head & Neck cancerJuly 17, 2024
Chamraj Tea Estate Launches New Nilgiri Tea Blends: ‘Master Blend,’ ‘Master Blend Ginger Tea,’ and ‘Master Blend Lemon Tea’July 16, 2024
How a Fiber-Rich Diet and Gut Parasites Can Improve Your HealthJuly 16, 2024
LinkedIn: A Double-Edged Sword for Professional GrowthJuly 16, 2024
Food Safety and Drug Administration (FDA), Uttarakhand, National Association of Street Vendors of India (NASVI) and Nestlé India expand Project ‘Serve Safe Food’ in Uttarakhand July 16, 2024
IIT Kharagpur and University of Leeds Sign MoU for Joint Supervision of PhD ProgramsJuly 16, 2024
Puja Curtains go up with KHUTI PUJA at Hazra Park DurgotsabJuly 16, 2024
Algorand and SEWA Join Forces to Launch Digital Health Passport Initiative for Women's EmpowermentJuly 15, 2024
The Debate Over Menstrual Leave: Balancing Needs and Workplace EqualityJuly 15, 2024