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Cleveland Clinic: First Patient to Receive Breast Cancer Vaccine Shares Health Journey

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The vaccine targets a lactation protein called α-lactalbumin, which is no longer found after lactation in normal, aging tissues but is present in most triple-negative breast cancers. If breast cancer develops, the vaccine is designed to prompt the immune system to attack the tumor and keep it from growing. (Courtesy: Cleveland Clinic)

#USA, April 17, 2023 – During a typical day at work, Jennifer Davis received an unexpected call that changed her life. A nurse on the other end of the line delivered the news Jennifer had triple-negative breast cancer. The mother of three recalls feeling terrified. She didn’t know how she was going to tell her family. After receiving the diagnosis, Jennifer knew she wanted to take advantage of every treatment option available. Through her driven search for answers, she became the first person to participate in a novel study at Cleveland Clinic for a vaccine that aims to eventually prevent triple-negative breast cancer.

“When I found out I was the first person to receive the vaccine, I was excited. I was thrilled. The trial has given me a lot of hope,” says Jennifer, a registered nurse from Lisbon, Ohio.  

Jennifer’s health journey started in February 2018 when she felt a lump in her breast. She went to a local hospital for follow-up, and her first biopsy showed no evidence of cancer. Months went by, and Jennifer says the lump grew. She listened to her body and continued to get it checked. Jennifer eventually received another biopsy after doctors detected abnormalities during an ultrasound. Her diagnosis was confirmed about one week later, and she sought a second opinion for her treatment.  

“I knew I wanted to go to Cleveland Clinic, so I had my first appointment there shortly after. I met my entire care team within my first few appointments and had a complete treatment plan. I was very happy with my team and was anxious to get started,” says Jennifer.  

As part of the plan, she underwent multiple rounds of chemotherapy and radiation. She also had a double mastectomy performed by breast surgeon Zahraa AlHilli, MD.  

“After the double mastectomy, I was adamant while in recovery about wanting to know what they found and whether the cancer had spread. Dr. AlHilli was able to get clear margins, and there were no signs the cancer had spread anywhere else,” says Jennifer.  

After undergoing treatment, it was during her follow-up appointments with breast medical oncologist Megan Kruse, MD, she learned about the breast cancer vaccine clinical trial.  

The vaccine is based on pre-clinical research led by the late Vincent Tuohy, PhD, who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research at Cleveland Clinic’s Lerner Research Institute. The vaccine targets a lactation protein called α-lactalbumin, which is no longer found after lactation in normal, aging tissues but is present in most triple-negative breast cancers. If breast cancer develops, the vaccine is designed to prompt the immune system to attack the tumor and keep it from growing.  

Research nurse coordinator Donna Lach administers the third dose of the breast cancer vaccine to Jennifer. (Courtesy: Cleveland Clinic)

“Triple-negative breast cancer is the form of the disease for which we have the least effective treatments,” said G. Thomas Budd, MD, breast medical oncologist and principal investigator for the breast cancer vaccine trial. “Long term, we are hoping this can be a true preventive vaccine that would be administered to cancer-free individuals to prevent them from developing this highly aggressive disease.”  

Jennifer is involved in phase 1a of the study, which includes patients who completed treatment for early-stage, triple-negative breast cancer within the past three years and are currently tumor-free but at high risk for recurrence.  

“There is no medication I take to make sure there’s not a recurrence,” says Jennifer. “With every ache and pain, your mind goes to the worst-case scenario. So, I was very excited when I heard about the vaccine.”  

In October 2021, Jennifer became the first patient to enroll in the trial and receive the first dose of the vaccine. “I didn’t think twice about getting the vaccine and haven’t looked back since.”  

Dr. Kruse says, “For a long time with triple-negative breast cancer, the overarching theme patients talked about is how they’re going through all this treatment but still feeling like they’re destined to have the cancer return. I think having the hope of this vaccine study where we can potentially turn that around and have some optimism as we approach the future for these patients is the best part.”  

Over the course of the study, Jennifer and other participants received three doses of the vaccine. The vaccinations were each given two weeks apart, and the participants were closely monitored for side effects and immune response. She received her last dose in November 2021 and has not noted any major side effects.  

“My husband went with me for the first vaccine. Then my mom went with me for the second and third,” says Jennifer. “I don’t know if I ever went to an appointment at Cleveland Clinic by myself, and that support has meant a lot to me.”  

Jennifer is hopeful about the vaccine trial and encourages others to stay positive amid the ongoing research. (Courtesy: Cleveland Clinic)

In February 2023, Cleveland Clinic researchers launched the next step in their study of the vaccine. The phase 1b clinical trial, conducted in partnership with Anixa Biosciences, Inc., focuses on individuals who are cancer-free, at high risk for developing breast cancer and have decided to voluntarily undergo a prophylactic mastectomy to lower their risk.  

Meanwhile, Jennifer, now 46 years old, continues to follow up with Dr. Kruse as she nears her fifth year of being in remission. Although it will take years to fully understand the vaccine’s effectiveness, she’s eager for what’s to come and hopes her story can help others diagnosed with breast cancer.  

“Even though you’re going to have days where you’re not positive, where you feel terrible – keep moving forward. If the vaccine works the way they want, it could prevent triple-negative breast cancer one day,” says Jennifer.  

Editor’s note: Dr. Tuohy was inventor of the technology, which Cleveland Clinic exclusively licensed to Anixa Biosciences. He was entitled to a portion of the commercialization revenues received by Cleveland Clinic and also held equity in the company.

Related Institutes: Lerner Research InstituteCleveland Clinic Cancer Center

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Caribbean News

CARPHA Progresses to Eligibility for the First Disbursement of Pandemic Funding

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Following a landmark Public Signing Ceremony for the Pandemic Fund (PF) Technical Cooperation Agreement (“Reducing the Public Health Impact of Pandemics in the Caribbean through Prevention, Preparedness, and Response” [RG-T4387] Project) on December 14, 2023, in Trinidad, the Caribbean Public Health Agency (CARPHA) and the Inter-American Development Bank (IDB) continues to progress towards the start of implementation.

 CARPHA fulfilled the IDB’s nine conditions prior to first disbursement, achieving full eligibility on March 15, 2024, and is now eligible for the first disbursement. This milestone achievement in just 3 months after the signing speaks to the commitment of both CARPHA, the Executing Agency, and IDB, the Implementing Entity, toward the regional PF project with the objective of supporting the reduction of the public health impact of pandemics in the Caribbean by building pandemic prevention, preparedness and response (PPR) surveillance & early-warning systems (EWS), laboratory systems and workforce capacity, regionally at CARPHA and in countries.

Since the signing of the Technical Cooperation Agreement and as part of the conditions prior to first disbursement, CARPHA has achieved the following key outputs (i) the development of the PF Project Operations Manual, Multi-annual Execution Plan, Procurement Plan, Financial Plan, Procedure for CARPHA’s Financial Reporting System; (ii) vacancy announcements for two tranches of consultants with the subsequent hiring of five (Technical Coordinator, Financial Specialist, Procurement Specialist, Operations Officer and Project Operations Coordinator) and (iii) the establishment of the Project Execution Unit (PEU) and Project Execution Steering Committee (PESC). The dedicated PEU will be responsible for execution according to its planned timelines, which will be led by the Dr. Lisa Indar, the Project Director (CARPHA’s Director of Surveillance, Disease Prevention and Control Division).

 CARPHA, as the lead regional public health agency and an expression of Caribbean Cooperation in Health is mandated by its Inter-Governmental Agreement (IGA) to support its 26 CARPHA Member States (CMS) in bolstering national systems and coordinating regional response to public health threats. The Agency works closely with regional and international agencies and uses regional mechanisms, surveillance systems, and networks for coordinating its public health response work.

In July 2023, the PF Governing Board announced that CARPHA’s regional entity proposal, entitled ‘Reducing the Public Health Impact of Pandemics in the Caribbean through Strengthened Integrated Early Warning Surveillance, Laboratory Systems and Workforce Development’ was successfully selected for the first round of financing. It was one of only 19 proposals selected from over 300 submissions and the only regional project. The three priority areas in the proposal are: (i) Comprehensive disease surveillance and EWS, (ii) Laboratory systems and (iii) Human resources and public health and community workforce capacity.

This project is expected to begin implementation in March 2024, starting off with a blended onboarding session. A Stakeholder Meeting with countries is tentatively planned for July 2024.

CARPHA remains dedicated to working together with the IDB, CARPHA Member States and the Pandemic Fund to successfully implement the regional proposal geared toward reducing the public health impact of pandemics in the Caribbean.

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Health

Ministry of Health and Human Services Launched Electronic Patient Care Report (Ambpro)

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The Ministry of Health and Human Services proudly announces the successful launch of the Electronic Patient Care Report (ePCR), marking a historic milestone in emergency healthcare services. The official unveiling ceremony took place on March 12, 2024 at the Atrium conference room.

In attendance were distinguished dignitaries, including  Deputy Premier and Minister of Physical Planning and Infrastructure Development, Honourable Jamell Robinson; Minister of Health and Human Services, Honourable Shaun D. Malcolm; Minister of Tourism, Environment, Maritime, Culture, Heritage and Religious Affairs, Honourable Josephine Connolly; Minister of Education, Youth, Sports and Library Services, Honourable Rachel Taylor; the Minister of Immigration and Border Services, Honourable Arlington Musgrove; and the Permanent Secretary of Health, Mrs Desiree Lewis, who recognized the significance of the ePCR system in promoting public health and safety. Their presence underscored the government’s unwavering commitment to investing in healthcare infrastructure and technological advancements to better serve the needs of the population. Thus reaffirming their support for initiatives aimed at improving emergency healthcare services and strengthening the National Emergency Medical Service’s capabilities.

During the launch event, the Minister of Health and Human Services highlighted the transformative impact of the ePCR system on patient care and emergency response efforts. Emphasizing the importance of innovation in healthcare, the Minister expressed gratitude to the dedicated team of professionals who contributed to the development and implementation of the ground breaking technology. The Deputy Premier praised the collaborative efforts of all stakeholders involved in the development and implementation of the ePCR system, affirming its potential to revolutionize emergency medical services especially the pre-hospital management of citizens and visitors across the country.

The Director of Emergency Medical Services, Mr. Andy Brijmohansingh, spoke passionately about the importance of embracing technology to advance patient care. “The introduction of the Electronic Patient Care Report marks a new chapter in our commitment to providing high-quality emergency medical services,” said Mr Brijmohansingh. “This innovative system empowers our teams with the tools they need to deliver swift and effective care, while ensuring that patient information is accurately captured and securely shared.”

The Electronic Patient Care Report (ePCR) represents a significant advancement in the National Ambulance Service’s mission to deliver efficient and high-quality emergency medical care to citizens across the nation. Developed with cutting-edge technology and meticulous attention to detail, the ePCR system streamlines the documentation process, enhances communication, and ensures the seamless transfer of patient information between emergency responders and healthcare facilities.

The launch of the Electronic Patient Care Report marks a new chapter in the evolution of emergency medical services, promising enhanced efficiency, accuracy, and patient outcomes. With its implementation, the National Emergency Medical Services reaffirms its dedication to providing timely and effective care to individuals in their time of need.

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Caribbean News

Haiti Food Insecurity Rising

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Rashaed Esson

Staff Writer

 

#Haiti#FoodInsecurity, March 25th, 2024 Half of Haiti’s population or nearly 5 million people are classified as food insecure for the period March to June 2024, a projected 50 percent increase up from 45 percent from August 2023 to February 2024. This is according to the Haitian Government in a March 23rd report, as informed by an update from an IPC1 analysis. The factors contributing to the continued decrease in food security, the report says, include the increase of the food basket by 22 percent as of February 2024 and the worsening Violence which disrupts food supply chains.

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