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PreHevbrio™ Vaccine Clinical Trials, Dosage, Efficacy, Side Effects, Usage

PreHevbrio™ (PreHevbri®, Sci-B-Vac) is a third-generation hepatitis B trivalent vaccine that mimics all three surface antigens, pre-S1, pre-S2, and S of the hepatitis B virus ("HBV"). PreHevbrio has demonstrated safety and efficacy in over 500,000 patients. As of April 2024, PreHevbri is the only 3-antigen hepatitis B vaccine, comprised of the three hepatitis B surface antigens of the hepatitis B virus, administered in three doses over six months, approved for use in the United States, European Union/European Economic Area, United Kingdom, Canada, and Israel.

In December 2017, VBI Vaccines Inc.(VBI) initiated patient dosing in a global Phase 3 clinical program with two concurrent pivotal studies: PROTECT, a safety and immunogenicity study, and CONSTANT, a lot-to-lot consistency study. Data from both the PROTECT study and the CONSTANT study. During an August 2020 presentation, Adam Finn, M.D., Ph.D., Professor of Paediatrics at the University of Bristol, UK, and principal investigator of the CONSTANT Phase 3 clinical study discussed the successfully met primary endpoint of CONSTANT – demonstration of the consistency of immune response as measured by the geometric mean concentration (GMC) of hepatitis B antibodies (anti-HBs titers) across three consecutively-manufactured lots of vaccine. Additional data highlighted included: High anti-HBs titers: GMC of anti-HBs for Sci-B-Vac was more than 7.5x compared to Engerix-B after two vaccinations (day 168) and more than 3x after three vaccinations (day 196); Rapid Onset of Seroprotection: After two vaccinations, Sci-B-Vac elicited a 90.4% seroprotection rate (SPR) compared to 51.6% with Engerix-B, increasing to 99.3% vs. 94.8% after the 3rd dose. On Oct. 12, 2021, the JAMA Network published an Original Investigation: Immunogenicity and Safety of a 3-Antigen Hepatitis B Vaccine vs. a Single-Antigen Hepatitis B Vaccine, phase 3 study. It found the 3-antigen HBV vaccine had higher seroprotection rates after the second and third vaccinations than the single-antigen HBV vaccine.

On Feb. 2, 2021, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) filing. On Dec. 1, 2021, the FDA approved PreHevbrio to prevent infection caused by all known subtypes of HBV in adults. On Jan. 12, 2022, Francisco Diaz-Mitoma, M.D., Ph.D. – Chief Medical Officer, VBI, presented 'The Safety & Immunogenicity of a 3-Antigen Hepatitis B Vaccine, PreHevbri, during the U.S. CDC's Advisory Committee on Immunization Practices meeting. Then, on Feb. 23, 2022, LCDR Mark K. Weng, MD MSc, CDC Hepatitis Vaccines Work Group, Advisory Committee on Immunization Practices, presented PreHevbrio for adult hepatitis B vaccination Evidence to Recommendation and GRADE. Following a positive vote, PreHevbrio is now recommended for prophylactic adult vaccination against HBV infection.

On May 2, 2022, the Company announced that the European Commission granted Marketing Authorisation for PreHevbri for active immunization against infection caused by all known subtypes of HBV in adults. On Sept. 8, 2022, Valneva SE and VBI Vaccines Inc. announced a partnership in select European markets for the marketing and distribution of PreHevbri®. The brand names for this vaccine are PreHevbri™ (EU/EEA/UK), PreHevbrio™ (US), and Sci-B-Vac® (Israel). In addition, on Dec. 8, 2022, Health Canada approved PreHevbrio™.

As of Mar. 22, 2024, Brii Bio secured exclusive development and commercialization rights for PreHevbri in Greater China and Asia Pacific (excluding Japan) and has submitted two pre-INDs to the CDE for PreHevbriTM's registration plan in China. A Market Authorization Application has also been filed in Hong Kong. In addition, VBI's enveloped virus-like particle (eVLP) platform technology enables the development of eVLPs that closely mimic the target virus to elicit a potent immune response.

Massachusetts-based VBI Vaccines Inc. (Nasdaq: VBIV) is a commercial-stage biopharmaceutical company developing the next generation of vaccines to address unmet infectious disease and immuno-oncology needs. Through its innovative approach to VLPs, including a proprietary enveloped VLP platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system.

PreHevbrio Vaccine Revenues

As of May 16, 2024, PreHevbrio's global net revenue increased 105% year-over-year in the first quarter of 2024 compared to the first quarter of 2023. In the U.S., PreHevbrio sales continue to demonstrate substantial growth in early 2024, with over 80% of the 2023 full-year volume being sold in the first five months of 2024. VBI partners with Valneva SE to make PreHevbri available in certain European countries.

PreHevbrio Availability 2024

As of May 2024, PreHevbrio was available in the U.S., PreHevbri® is available in Europe (Netherlands, Belgium), the U.K., and Sci-B-Vac® in Israel. PreHevbri was approved by the European Commission and the United Kingdom Medicines and Healthcare Products Regulatory Agency in the second quarter of 2022. Valneva SE will lead marketing activities in the United Kingdom, Sweden, Norway, Denmark, Finland, Belgium, and the Netherlands. Valneva and VBI expect PreHevbri to be available in these countries in 2023. Brii Biosciences announced the development and commercialization of PreHevbri in the Asia Pacific region, excluding Japan. Availability is expected in Canada under the brand name PreHevbrio in 2024. In the U.S., PreHevbrio is available for purchase at retail pharmacy chains, including Costco, RiteAid, Walmart, and three of the top 10 regional retail pharmacy networks, as well as through the U.S. Department of Veterans Affairs, Federal Bureau of Prisons, and at certain military treatment facilities.

PreHevbrio Indication

Please visit www.PreHevbrio.com for U.S. Safety Information for PreHevbrio or U.S. Full Prescribing Information. In addition, a full European Summary of Product Characteristics for PreHevbri is available from the European Medicines Agency website. HBV infection is the leading cause of liver disease, and, with current treatments, it is challenging to cure, with many patients developing liver cancers. An estimated 900,000 people die each year from complications of chronic HBV, such as liver decompensation, cirrhosis, and hepatocellular carcinoma. The U.S. CDC. Sci-B-Vac is indicated to prevent hepatitis B in adults 18 and older. It can also be expected that hepatitis D will be controlled by immunization with PreHevbri, as hepatitis D does not occur without hepatitis B infection.

PreHevbrio Dosage

It is administered 10ug and intramuscular injection as a solution on Days 0, 28, and 168. Sci-B-Vac is currently in two Phase 3 clinical trials to support Sci-B-Vac licensure in the U.S., Europe, and Canada. In addition, it can be administered at lower doses than competing hepatitis B vaccines, says the Company.

PreHevbrio Side Effects

The safety and tolerability seen in a phase 3 study support the safety profile of VBI's 3-antigen vaccine candidate – with no safety signals observed in either study arm and no new safety risks identified. However, do not administer PreHevbrio to individuals with a history of a severe allergic reaction after a previous dose of any hepatitis B vaccine or any component of PreHevbrio. To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free), VAERS at 1-800-822-7967, or www.vaers.hhs.gov.

PreHevbrio Cost

On March 29, 2022, VBI Vaccines Inc. announced that PreHevbrio™ is now available in the U.S. at a Wholesale Acquisition Cost of $64.75/dose.

PreHevbrio News

April 16, 2024 - “Over the last 12 months, we’ve seen continued progress across all of our lead programs – with increased use of PreHevbrio and an ever-expanding access and distribution network in place, as well as positive clinical data announcements from all lead pipeline programs, we are helping to make great strides in the fight against GBM, hepatitis B, and coronaviruses,” said Jeff Baxter, VBI’s President and CEO. 

July 19, 2023 - Jeff Baxter, President and CEO of VBI, commented: "We are excited to announce the launch of PreHevbri in the Netherlands and Belgium through our partnership with Valneva.

December 8, 2022 - "We are excited to announce Health Canada's approval, a fourth regulatory approval for this vaccine," said Jeff Baxter, VBI's President and CEO. 

September 8, 2022 - Jeff Baxter, President and CEO of VBI, commented: "This partnership is a significant milestone for PreHevbri, enabling us to hit the ground running in Europe. Valneva has substantial local knowledge, experience, and relationships in each of these European countries."

June 1, 2022 - VBI Vaccines Inc. announced that the UK Medicines and Healthcare Products Regulatory Agency granted marketing authorization for PreHevbri™.

May 2, 2022 - VBI Vaccines Inc. announced that the European Commission had granted Marketing Authorisation for PreHevbri™.

February 23, 2022 - VBI announced that, following a discussion at the U.S. CDC Advisory Committee meeting on Immunization Practices, PreHevbrio joined the recommended products for prophylactic adult vaccination against HBV infection.

December 1, 2021 - VBI announced that the U.S. FDA had approved PreHevbrio™.

October 26, 2020 - VBI Vaccines announced across the PROTECT and CONSTANT registrational Phase 3 studies, Sci-B-Vac safely elicited higher anti-HBs titers in all study subjects than Engerix-B, a single antigen HBV vaccine, regardless of age, gender, or underlying comorbidity.

January 9, 2020 - VBI Vaccines Announces Second Pivotal Phase 3 Study of Sci-B-Vac® Meets Primary and Secondary Endpoints; op-line data from CONSTANT, the second pivotal Phase 3 study, assessing lot-to-lot manufacturing consistency of Sci-B-Vac®.

December 2017 - VBI initiated patient dosing in a global, 15-month Phase 3 clinical program that, if successful, will allow the Company to seek marketing authorization in the U.S., Europe, and Canada.

Sci-B-Vac Vaccine Clinical Trials

Sci-B-Vac Vaccine has been tested in several clinical trials and a Phase 4 post-marketing clinical trial.

June 28, 2022 - Timo Vesikari, M.D., Ph.D., Professor Emeritus and Director of the Nordic Vaccine Research Network in Finland, and principal investigator of the PROTECT and CONSTANT Phase 3 clinical studies of VBI's 3-antigen HBV vaccine, highlighted data from his investigator-initiated analysis that evaluated the duration of immune response approximately 2.5 years after completion of vaccination. Immunogenicity was assessed using frozen sera samples from a subset of participants (n=465) enrolled at five clinical sites in Finland as part of PROTECT. In the follow-up analysis, participants in PROTECT who received VBI's 3-antigen HBV vaccine had 5.5-fold higher mean anti-HBs titers (GMC: 1382.9 mIU/mL vs. 251.4 mIU/mL) and a higher seroprotection rate (SPR: 88.1% vs. 72.4%) compared to those who received Engerix-B. Additionally, 72.9% of participants who received VBI's 3-antigen HBV vaccine retained anti-HBs titers ≥ 100 mIU/mL compared to 32.6% of those who received Engerix-B.

SurVaxM Vaccine Clinical Trials, Dosage, Indication, Side Effects

MimiVax Inc.'s SurVaxM is a first-in-class peptide mimic immunotherapeutic vaccine (immunotherapy) candidate targeting survivin, a cell-survival protein in 95% of glioblastoma and many other cancers. It is engineered to recognize survivin-expressing cancer cells as foreign and stimulate patients' immune response to control tumor growth and recurrence. SurVaxM is a brain cancer immunotherapy born in the labs of Roswell Park Comprehensive Cancer Center.

Positive Final Data from the Phase 2a Clinical Study of SurVaxM for nGBM, published in the Journal of Clinical Oncology, found that 51% of patients receiving SurVaxM survived at least two years, and 41% survived at least three years. The median Overall survival rate of 25.9 months with nGBM in this study is considerably higher than expected with standard therapy alone. A randomized, blinded, placebo-controlled Phase 2b clinical trial of SurVaxM for nGBM (SURVIVE) is recruiting at cancer centers across the USA. On October 12, 2023, MimiVax announced that the United States Food and Drug Administration granted Fast Track Designation to the SurVaxM vaccine candidate being studied for treatment for diagnosed glioblastoma. In June 2024, the U.S. Food and Drug Administration (FDA) expanded the orphan drug designation for SurVaxM. MimiVax first received orphan drug status for SurVaxM in August 2017. The supplemental FDA designation awarded to MimiVax Inc. now applies to SurVaxM as a treatment for not just adult glioblastoma but a broader category of cancerous brain tumors: any malignant glioma in children or adults. 

MimiVax Inc. is a NY-based, Delaware corporation, clinical-stage biotechnology company formed in 2012. The Company was initially formed as a spin-off from Roswell Park, supported by donations to Roswell Park. For more information on MimiVax, visit www.mimivax.com.

SurVaxM Vaccine Indication

Although SurVaxM was first tested in brain cancer, survivin is present in most cancers, including multiple myeloma, melanoma, ovarian, renal, lymphoma, prostate, and breast cancers. SurVaxM is an immunostimulant targeting survivin, a molecule in many cancers.

SurVaxM Vaccine Dosage

SurVaxM is delivered through a subcutaneous injection.

SurVaxM Vaccine News

June 21, 2024 - Roswell Park President and CEO Candace S. Johnson, PhD. “SurVaxM is one of the few treatment options for incurable brain cancer to reach late-stage clinical trials, and everyone who supports this work is helping to speed a highly promising cancer treatment to patients who may benefit from it.”

October 12, 2023 - "The receipt of Fast Track Designation affirms the importance of new clinical developments of novel therapies to improve the treatment and outcomes for patients with newly diagnosed glioblastoma," said Michael Ciesielski, CEO of MimiVax. "This designation is a key component in our journey to help patients with glioblastoma to live longer."

December 15, 2022 - “We are finally starting to see immunotherapy having an impact upon difficult-to-manage diseases like glioblastoma and are excited to be able to contribute in a meaningful way to cancer care to provide hope for glioblastoma patients” –Michael Ciesielski, Ph.D.; Chief Executive Officer, MimiVax

May 30, 2020 - MimiVax LLC announced a clinical collaboration to assess the combination of SurVaxM (MimiVax) and pembrolizumab (Keytruda; MERCK). SurVaxM is a patented peptide immunogen targeting survivin, a cell-survival protein in glioblastoma and many other cancers.

May 29, 2019 - MimiVax LLC, a clinical-stage biotechnology company developing immunotherapeutics for cancer and autoimmune diseases, announced upcoming presentations at leading scientific and industry events.

SurVaxM Vaccine Clinical Trial

A randomized, blinded, placebo-controlled Phase 2b clinical trial of SurVaxM for nGBM (SURVIVE) [NCT05163080] is now recruiting at 11 cancer centers. Results from the fully accrued phase 2b SURVIVE trial are expected in 2025, and a pilot study of the vaccine in children and adolescents with several forms of brain cancer is underway. SurVaxM is also being studied as a treatment for neuroendocrine tumors and multiple myeloma in adults.

Clinical Trial NCT02455557:  SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma. This phase II trial studies the side effects and how well vaccine therapy works when given with temozolomide to treat patients with newly diagnosed glioblastoma.

Typbar TCV® Typhoid Vaccine

Bharat Biotech International's Typbar TCV® is a vaccine containing a polysaccharide of Salmonella typhi Ty2 conjugated to Tetanus Toxoid. A human challenge study at the University of Oxford demonstrated that the vaccine is safe, 100% immunogenic, and prevents up to 87.1% of infections when using real-life definitions of typhoid fever. Vi Capsular polysaccharide of Salmonella typhi alone elicits B cell responses. In addition, the conjugation of bacterial polysaccharides to a protein carrier provides foreign peptide antigens presented to the immune system, eliciting antigen-specific CD4+ Th cells, referred to as T-dependent antibody responses. A hallmark of T-dependent responses elicited by toxoids is to induce higher-affinity antibodies and long-term immune memory.

A human challenge study at the University of Oxford demonstrated that the vaccine is safe, immunogenic, and prevents up to 87.1% of infections using real-life definitions of typhoid fever. A mathematical modeling study supported by Gavi published on February 3, 2022 - Estimating the effect of vaccination on antimicrobial-resistant typhoid fever in 73 countries - found the introduction of routine immunization with TCV at age nine months with a catch-up campaign up to age 15 years was predicted to avert 46–74% of all typhoid fever cases.

The peer-reviewed journal The Lancet published an early-release (September 1, 2022) phase 3 study funded by the Gates Foundation - Safety and immunogenicity of a typhoid conjugate vaccine among children aged nine months to 12 years in Malawi: a nested substudy of a double-blind, randomized controlled trial. This study provides evidence of TCV vaccination safety, tolerability, and immunogenicity up to 730–1,035 days in Malawian children aged nine months to 12 years. On January 25, 2024, updated results from the phase 3 clinical study were published today in The Lancet. The research team enrolled more than 28,000 healthy children in Malawi. It randomly assigned about half the group to receive the TCV and the other half to receive a meningococcal capsular group A conjugate (MenA) control vaccine. During the more than four years of follow-up, 24 children in the TCV group and 110 in the MenA group developed typhoid fever, which was confirmed via blood culture. That resulted in an efficacy of 78.3 percent in the TCV group, with one case of Typhoid prevented for every 163 children vaccinated. TCV was effective in all age groups, and over the study period – which ended in 2022 – vaccine efficacy remained strong, decreasing by only 1.3 percent per year.

Typbar TCV is the only U.S. FDA-approved vaccine for children less than two years of age. Typhoid fever caused by multidrug-resistant H58 Salmonella Typhi is an increasing public health threat in sub-Saharan Africa. In addition, Typbar TCV has been recommended by the experts at the WHO-Strategic Advisory Group for routine immunizations and is WHO-prequalified.

Bharat Biotech is a pioneering biotechnology company known for its world-class R&D and manufacturing capabilities. The Bill & Melinda Gates Foundation funds TyVAC.

Typbar TCV Indication

Vaccination can help prevent typhoid fever, an acute enteric disease caused by Salmonella enterica serovar Typhi (S Typhi). S Typhi is a rod-shaped, gram-negative, anaerobic bacterium expressing surface polysaccharide capsule (Vi antigen), a critical virulence determinant. The UU.S.CDC recommends vaccination for people traveling to places with common typhoid fever, says the UU.S.CDC. Typhoid fever remains a significant cause of morbidity and mortality in low-income and middle-income countries, says the WHO. Typhoid fever, a systemic febrile illness caused by Salmonella enterica serovar Typhi, is responsible for more than 9 million infections and more than 110,000 deaths globally annually. The highest disease burden was observed among children.

The Typbar TCV vaccine is indicated as a preventative vaccine against Typhoid, which Salmonella Typhi and Paratyphi cause. If it is not treated, it can kill up to 30% of people who get it. Some people who get Typhoid become "carriers," who can spread the disease to others. Curbing typhoid transmission can also prevent resistant plasmid transfer to other bacterial pathogens. Our results can help inform country-level decision-making and prioritize TCV introduction in countries with a high incidence of antimicrobial-resistant typhoid fever.

Typbar TCV Dosage

The WHO recently recommended that routine childhood immunization programs include Typbar TCV as a single intramuscular dose for primary vaccination of infants and children from 6 months of age. It is also recommended for adults ≤45 years of age and in catch-up campaigns in typhoid-endemic regions in children ≤15 years of age.

According to the U.S., two typhoid fever vaccines are available in the USA. However, typhoid vaccines are not 100% effective. Oral vaccine: Can be given to people at least six years old. It consists of four pills taken every other day and should be finished at least one week before travel. An injectable vaccine that can be given to people at least two years old should be given at least two weeks before travel.

The Typbar-TCV is a WHO-prequalified tetanus-toxoid conjugated Vi-TCV containing 25 μg of Vi polysaccharide per 0.5-ml dose. 

Typbar TCV News

January 25, 2024 - "The newly published study supports the long-lasting impacts of a single shot of TCV, even in the youngest children, and offers hope of preventing typhoid in the most vulnerable children," said Kathleen Neuzil, MD, MPH.

August 10, 2022 - A new study finds the Typbar TCV® vaccine provides immunity for up to three years in children as young as nine months old and is safe and well tolerated. INotably, the vaccine can be given to nine-month-old infants at the same time as routine measles-rubella vaccinations without reducing the immune response to either vaccine.

June 21, 2022 - The Lancet Microbe reported while multi-drug resistance to first-line antibiotics has generally declined in South Asia, strains resistant to macrolides and quinolones – two of the most important antibiotics for human health – have risen sharply and spread frequently to other countries.

April 7, 2022 - With support from Gavi, the Vaccine Alliance, WHO, UNICEF, and other partners, the Government of Nepal today launched a new vaccine campaign introducing Typhoid Conjugate Vaccine into the routine immunization program. The campaign aims to reach 95% coverage of nearly 7.5 million children.

February 3, 2022 - A meta-analysis of disease burdens in 73 countries eligible for support from Gavi, Birger, and colleagues has shown that the introduction of routine immunization of children from age nine months with typhoid conjugate vaccines, with a catch-up program up to age 15 years, would avert about 66 million cases and 826,000 deaths caused by typhoid fever over ten years. 

November 1, 2021 - The Lancet Global Health published the final results of the Phase 3 clinical trial. These results are from the 2-year follow-up of 20,019 children aged nine months to < 16 years of age. The final results are similar to the interim results. There is no evidence of waning protection over the two years. These results support the WHO recommendations to vaccinate children in endemic typhoid settings. 

September 16, 2021 - The New England Journal of Medicine published a study that found a single dose of Typhoid conjugate vaccine is safe and 84 percent effective in protecting against Typhoid in Blantyre, Malawi. An intention-to-treat analysis comparing this incidence with that in the Vi-TCV group yielded a protective efficacy of Vi-TCV of 80.7%. The effectiveness of Vi-TCV was similar in children younger than five years of age and children who were five years of age or older at the time of vaccination, and this efficacy remained consistent throughout the observation period.

August 21, 2021 - Recent data confirmed Bangladesh has one of the highest typhoid burdens in the world. A study conducted in Mirpur, Dhaka, with typhoid conjugate vaccine (TCV), has found that the vaccine prevents 85% of cases among vaccinated children aged nine months to 15 years.

August 9, 2021 - A new study conducted in Mirpur, Dhaka, with typhoid conjugate vaccine (TCV) and published by The Lancet found that the vaccine prevents 85% of cases among vaccinated children aged nine months to 15 years.

July 1, 2021 - UNICEF, Gavi, the Vaccine Alliance, and the WHO have partnered with the Ministry of Health and Child Care to launch a new vaccine campaign introducing TCV into the routine immunization schedule across Zimbabwe, which is the third country in the world to introduce the typhoid conjugate vaccine into the regular immunization program showing Zimbabwe's leadership in immunization in the Africa region and globally. In 2019, Pakistan introduced the vaccine into routine immunization schedules, and Liberia followed suit in April 2021.

April 5, 2021 - Liberia became the first country in Africa to introduce the typhoid conjugate vaccine (TCV) with a weeklong campaign to reach more than 1.9 million children aged nine months to younger than 15 years old with TCV. After the campaign concludes, TCV will become a routine immunization for all children at nine months old.

February 12, 2021 - U.S. reports extensive drug-resistant salmonella typhi infections among residents without international travel.

February 1, 2021 - The next step: Lifesaving typhoid conjugate vaccines reach Punjab province, Pakistan. For the next two weeks, vaccination teams will be in Islamabad and 12 districts of Punjab province to vaccinate nearly 12.7 million children between 9 months to 15 years against Typhoid. Keeping children protected against typhoid diseases, we help keep children in school and spare families the economic hardship of typhoid diagnosis and treatment. 

January 4, 2021- How a scientist's return kickstarted Bharat Biotech's journey. The company also developed and launched Typbar TCV, the world's first clinically proven and WHO-prequalified TCV, which can be administered to even a six-month-old.

September 30, 2020 - Travel Alert: EExtensive drug-resistant typhoid fever in Pakistan. The CDC recommends that all travelers (even short-term travelers) to South Asia, including Pakistan, be vaccinated against typhoid fever before travel.

November 18, 2019 - Pakistan became the first to introduce TCV into the routine immunization system, and the world watched. Nearly 10 million children were vaccinated in just three weeks in Sindh province, protecting them against a potentially deadly disease and sparing their families the economic hardship that so often comes with a case of Typhoid.

January 3, 2018 - Typbar TCV from Bharat Biotech, World's First Typhoid Conjugate Vaccine Prequalified by WHO. This enables the procurement and supply of this lifesaving vaccine to UNICEF, Pan-American Health Organization, and GAVI-supported countries. In addition, Typbar TCV® has been evaluated in Human Challenge Studies at Oxford University, and typhoid conjugate vaccines have been recommended by WHO's Strategic Advisory Group of Experts on Immunization.

Typbar TCV Typhoid Vaccine Clinical Trials

Clinical Trial NCT03299426: Among Malawian children nine months to 12 years of age, administration of Vi-TCV resulted in a lower incidence of blood culture-confirmed typhoid fever than the MenA vaccine. Last updated on 2023-02-08.

Clinical Trial NCT03933098: Immune Non-inferiority and Safety of a Vi-DT Typhoid Conjugate Vaccine. This is a multicenter, observer-blinded, randomized, active-controlled, Phase 3 study in healthy Nepalese aged six months to 45 years at the first vaccine dose.

Clinical Trial NCT03600025:  Cellular Immune Responses in Typhoid Fever Patients and Vaccinees (Recruiting). This Phase 1 clinical trial aims to understand further the role of mucosal-associated invariant T cell (MAIT) and natural killer (NN.K. cell responses in typhoid fever or following vaccination.

INO-4500 DNA Vaccine Description 2022

INO-4500 is a DNA vaccine candidate. On November 17, 2022, the company discontinued the development of product candidates targeting Lassa Fever (INO-4500) following initial analyses of data from studies conducted by INOVIO and funded by CEPI.

In addition, INOVIO is leveraging its optimized plasmid design and delivery technology to develop DNA medicines to treat and prevent infectious diseases. INO-4500 is the first vaccine candidate for Lassa fever to enter human trials, says the company.

INOVIO's DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using one of INOVIO's proprietary hand-held CELLECTRA smart devices. INOVIO's DNA medicines are made using a process called SynCon®. SynCon uses a proprietary computer algorithm designed to identify and optimize the DNA sequence of the target antigen, whether it is a virus or a tumor. Once this sequence has been determined, the DNA is synthesized or reorganized, and manufacturing can begin, says the company.

DNA medicines are composed of optimized DNA plasmids, which are small circles of double-stranded DNA synthesized or reorganized by computer sequencing technology and designed to produce a specific immune response in the body.

On February 23, 2021, INOVIO announced the first participant was dosed in a Phase 1B clinical trial for INO-4500 in Ghana, Africa. The Phase 1B clinical trial (LSV-002) is ongoing at the Noguchi Memorial Institute for Medical Research in Accra, Ghana. It is the first vaccine clinical trial for Lassa fever to be conducted in West Africa.

Plymouth Meeting, Pennsylvania-based INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases INOVIO has 15 DNA medicine clinical programs currently in development focused on HPV-associated diseases, cancer, and infectious diseases, including coronaviruses associated with MERS and COVID-19 diseases being developed under grants from the Coalition for Epidemic Preparedness Innovations and the U.S. Department of Defense.

INO-4500 Indication

The U.S. CDC says Lassa fever is an animal-borne, or zoonotic, acute viral illness. It is endemic in West Africa, including Sierra Leone, Liberia, Guinea, and Nigeria. Neighboring countries are also at risk, as the animal vector for the Lassa virus, the "multimammate rat" (Mastomys natalensis), is distributed throughout the region.

The illness was discovered in 1969 and is named after the town in Nigeria where the first cases occurred. An estimated 100,000 to 300,000 infections of Lassa fever occur annually, with approximately 5,000 deaths, says the CDC. Unfortunately, surveillance for Lassa fever is not standardized; therefore, these estimates are crude. However, in some areas of Sierra Leone and Liberia, it is known that 10-16% of people admitted to hospitals annually have Lassa fever, demonstrating the serious impact the disease has on the region.

INO-4500 Dosage

The INO-4500 vaccine is conducting clinical tests for the prevention of Lassa Fever. Inovio's proprietary Cellectra electroporation device injects this vaccine into the muscle or skin. Injection of the DNA plasmid into a patient generates robust in vivo monoclonal antibody production. Thus, this approach can potentially generate in vivo production of therapeutic antibodies.

INOVIO's Phase 1B clinical trial, LSV-002, dosing regimen involves two vaccinations at 0 and 28 days with either 1.0 mg or 2.0 mg dosing levels. This trial will inform dose selection for subsequent Phase 2 studies in West Africa.

INO-4500 News 2018 - 2022

March 22, 2022 - The UK NHS confirmed a systematic review examining preclinical and human pharmacokinetic data and found that the clinical evidence for ribavirin as a treatment for Lassa fever was limited. 

March 15, 2022 - The U.S. CC confirmed an outbreak of Lassa fever in Nigeria in Ondo, Edo, Bauchi, Ebonyi, Kogi, Taraba, Enugu, Benue, Gombe, Nasarawa, and the Delta States.

February 21, 2022 - The WHO stated 'Considering the seasonal increases of cases between December and March, countries in West Africa that have endemic Lassa fever are encouraged to strengthen their related surveillance systems to enhance early detection and treatment of cases and to reduce the case fatality rate, as well as to strengthen cross border collaboration.'

February 9, 2022 - The UK Health Security Agency press office confirmed two people had been diagnosed with Lassa fever in the East of England. Before these cases, 8 cases of Lassa fever were imported to the UK since 1980. The last 2 cases occurred in 2009. There was no evidence of onward transmission from any of these cases.

November 7, 2021 - The WHO Africa reported through October 2021 that Nigeria had confirmed 403 cases. A total of 79 individuals have died among those who had confirmed results, yielding a 19.6% CFR this year. The CFR during the same period in 2020 was 20.7%

October 26, 2021 - INOVIO announced its Phase 1B clinical trial for INO-4500, its DNA vaccine candidate for Lassa fever, and completed full enrollment of 220 participants. This trial is ongoing at the Noguchi Memorial Institute for Medical Research in Accra, Ghana. It is the first vaccine clinical trial for Lassa fever conducted in West Africa, where the viral illness is endemic.

February 23, 2021 - INOVIO announced the first participant was dosed in a Phase 1B clinical trial for INO-4500, its DNA vaccine candidate for Lassa fever, in Ghana. The Phase 1B clinical trial (LSV-002), ongoing at the Noguchi Memorial Institute for Medical Research in Accra, Ghana, is the first vaccine clinical trial for Lassa fever to be conducted in West Africa, where the infection is endemic.

October 11, 2018 - According to new research published in Nature Communications, a novel vaccine designed to protect people from Lassa fever and rabies showed promise in preclinical testing. The investigational vaccine, called LASSARAB, was developed and tested by scientists at Thomas Jefferson University in Philadelphia; the University of Minho in Braga, Portugal; the University of California, San Diego; and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

April 11, 2018 -  Inovio Pharmaceuticals, Inc. (NASDAQ: INO) and the Coalition for Epidemic Preparedness Innovations announced a partnership under which Inovio will develop vaccine candidates against Lassa fever and Middle East Respiratory Syndrome.

INO-4500 Clinical Trials 

Clinical Trial NCT04093076: INOVIO's Phase 1B clinical trial, LSV-002, will enroll approximately 220 adult participants 18-50 years old, with the primary endpoint of evaluating safety and immunogenicity in an African population. The dosing regimen involves two vaccinations at 0 and 28 days with either 1.0 or 2.0 mg dosing levels. In addition to providing valuable insights on the INO-4500 safety and immunogenicity profile, this trial will inform dose selection for subsequent Phase 2 studies in West Africa. Last Update Posted: February 25, 2021. Estimated study completion date: September 2022.

Clinical Trial NCT03805984:  Safety, Tolerability, and Immunogenicity of INO-4500 in Healthy Volunteers. This Phase 1 trial is a randomized, double-blinded, placebo-controlled, placebo-controlled trial to evaluate the safety, tolerability, and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers. Last Update Posted: November 23, 2020. Actual completion date: October 21, 2020.