Travel Vaccine Breaking News

While there are no herpes vaccines available in the United States, the government recently issued a substantive financial award to accelerate herpes research.

Massachusetts-based Rational Vaccines (RVx) announced on October 13, 2023, that the U.S. National Institute of Health (NIH) recently awarded it three grants totaling $2.8 million to help further its research to diagnose, treat, and prevent the spread of Herpes Simplex Virus (HSV).

These grants are essential since about half the human population harbors a life-long latent HSV infection, a sexually transmitted disease (STD).

The first grant is to help develop a new diagnostic test suitable for routine population-based screening. Current screening methods are limited to detecting active infections in people with high viral loads, often making them unreliable.

RVx is developing a novel HSV type-specific test that will provide improved sensitivity and reduce instances of false-negative diagnosis.

The second grant funds a live-attenuated herpes simplex virus 1 (HSV-1) strain, "VC2" to prevent and treat ocular herpes.

A live-attenuated virus is a weakened virus that can multiply within the host to a limited extent and is engineered to be unable to cause any disease.

This is a critical study because HSV-1 can result in irreparable cornea damage and is a significant cause of blindness worldwide.

The third undertaking is developing and manufacturing a prophylactic and therapeutic HSV vaccine that will be essential to curbing the spread of herpes.

Through an exclusive license with Louisiana State University (LSU), RVx is developing a novel immunomodulatory vaccine engineered to help the body recognize and eliminate the HSV without making the person sick.

A 2018 study by Brent Stanfield and colleagues at LSU examined the immune response generated by intramuscular injection of the VC2 vaccine in guinea pigs.

"We have always known how chronically debilitating herpetic diseases can be, especially for marginalized communities that are disproportionately affected. It is very encouraging that the U.S. National Institute of Allergy and Infectious Diseases is supporting our live attenuated approach to herpetic disease treatment and prevention," commented Agustin Fernandez, RVx Chief Executive Officer, in a press release.

"After many decades of failure with recombinant protein subunit-based vaccine approaches, we are convinced that our proprietary limited replication-competent mutants are the only way to defeat this virus."

"Our mission at Rational Vaccines remains the same as it has been since our inception — to rid the world of HSV. This brings us one step closer." 

To advance herpes vaccine research, the U.S. NIH established the Strategic Plan for Herpes Simplex Virus Research for 2023-2028.

Effective prevention of HSV requires a multi-pronged effort building upon advances in HSV research, says the NIH.

Promising HSV prevention strategies must be comprehensively tested in diverse populations and age groups and must be paired with enhanced strategies for diagnosis to target and treat high-risk groups.

This is particularly important for infected pregnant women at high risk for vertical transmission to the child.

This new plan aligns with ongoing national efforts, including the Sexually Transmitted Infections National Strategic Plan.

With the respiratory season arriving in the United States, a seldom-mentioned disease surpassed both COVID-19 and Influenza mortality last week.

According to the U.S. National Center for Health Statistics Mortality Surveillance reporting on October 13, 2023, there were 1,226 pneumonia deaths last week, exceeding 549 related to COVID-19 and 10 for influenza.

And no influenza-associated pediatric deaths occurred during the first week of the 2023-2024 flu season. Last flu season, there were 178 influenza-associated pediatric deaths.

Furthermore, the U.S. CDC reported outpatient respiratory illness was below baseline in all 10 HHS regions, and flu-related hospital admissions remained low nationally.

The good news is ample supplies of vaccines are available for the 2023-2024 respiratory season in the U.S. There are over 110 million flu shots and updated COVID-19 vaccines available today.

Regarding pneumonia, which is an infection of the lungs that can cause mild to severe illness in people of all ages, the CDC says various immunizations can help prevent disease by some of the bacteria and viruses that can cause pneumonia.

These immunizations include but are not limited to COVID-19, Influenza, Measles, Pertussis, Pneumococcal, Respiratory syncytial virus, and Varicella.

These immunizations are safe, but side effects can occur, most of which are mild, and dissipate on their own within a few days, says the CDC. These vaccines are generally available at health clinics and pharmacies in the U.S.

Ultimovacs ASA today announced encouraging overall survival (OS) data from cohort 1 in the UV1-103 Phase I clinical trial in malignant melanoma.

Among the patients in cohort 1 who were alive at the 3-year follow-up, no further deaths have been reported, reaffirming an encouraging trend of durable overall survival benefit from UV1 vaccination.   

The 4-year survival across both cohorts is expected to be announced in Q2 2024.

Ultimovacs has previously reported data showing a complete response rate in the UV1-103 study of 33% (complete disappearance of tumors) and an objective response rate of 57% (complete or partial disappearance of tumors).

Biomarker analyses reported in October 2022 showed robust clinical responses in patients treated with the combination of UV1 and pembrolizumab, regardless of patients' PD-L1 status. The safety profile of UV1 in combination with pembrolizumab is comparable to that of pembrolizumab alone.

UV1 is a peptide-based vaccine inducing a specific T-cell response against the universal cancer antigen telomerase.

"We are very encouraged to report a durable and long-term overall survival rate at the 4-year follow-up in the UV1-103 study. The data further strengthen the previously reported results from the study, including good safety for UV1 and the high number of complete responses in patients with metastatic malignant melanoma where surgery is not an option," said Jens Bjørheim, Chief Medical Officer at Ultimovacs, in a press release on October 12, 2023.

"The UV1-103 study treats the same patient population as our Phase II study INITIUM. As we await data from the first three randomized UV1 Phase II trials in the near-term, we are increasingly optimistic about UV1's potential to benefit cancer patients."

Ultimovacs is investigating UV1 in malignant melanoma in its randomized Phase II INITIUM trial of UV1 in combination with ipilimumab and nivolumab.

The top-line results will be disclosed after cancer progression has been verified in 70 patients, which has not yet occurred due to patients taking longer than estimated to experience cancer progression. The study's outcome is expected to be announced in the first half of 2024.

Throughout 2023, the Florida Health Department has been reporting travel-related and locally acquired dengue cases. Dengue is a vectorborne infectious disease spread by infected mosquitoes and endemic in about 125 countries.

During week #40, Florida reported 32 new dengue cases.

As of October 7, 2023, Florida's Arbovirus Surveillance report confirmed 17 new travel-associated Dengue cases. In 2023, there have been 351 dengue cases associated with international travelers, led by Miami-Dade County with 207.

Over sixty-two percent (220) of these dengue cases are related to visitors from Cuba.

Of more concern to health officials is the recent increase in locally acquired dengue cases.

Furthermore, there were 15 new cases of locally acquired dengue last week. This data increases 2023's total to 53 cases, with Miami-Dade County reporting 47 locally acquired cases.

According to the Centers for Disease Control and Prevention, there have been 1,289 dengue cases reported by 48 U.S. jurisdictions in 2023. In addition to Florida, New York has reported 90 dengue cases this year.

About 3.4 million dengue cases have been reported in the Region of the Americas so far this year.

As of October 11, 2023, two dengue vaccines are available globally, but only one is licensed in the U.S. Sanofi Pasteur's Dengvaxia® vaccine is available for certain people following a diagnostic test review.

During the 2023 Grand Challenges Annual Meeting, Bill Gates, Co-chair of the Bill & Melinda Gates Foundation, announced new $40 million investments to advance access to mRNA research and vaccine manufacturing technology that will support low- and middle-income countries (LMICs) capacity to develop high-quality, lifesaving vaccines.

Announced on October 9, 2023, this new funding builds on the Gates Foundation's previous $55 million investment in mRNA manufacturing technology.

"Expanding the availability of affordable, high-quality vaccines that meet the needs of local communities is one of the best ways to improve global health outcomes and reduce preventable deaths," commented Trevor Mundel, president of the Gates Foundation's Global Health Division, in a press release.

"By lowering barriers to access for LMICs, we can help ensure more people around the world benefit from lifesaving health innovation."

The foundation's funding advances access to Quantoom Biosciences' low-cost mRNA research and manufacturing platform, developed with an early-research Grand Challenges grant made to its parent company, Univercells.

The Institut Pasteur de Dakar and Biovac, research institutes with vaccine manufacturing experience based in Senegal and South Africa, respectively, will receive US$5 million each to acquire the technology and will be able to use it to develop locally relevant vaccines.

To further advance the technology and lower costs for commercialization, the foundation will also provide US$20 million to Quantoom Biosciences, ensuring LMICs can benefit from the next-generation mRNA health tools.

The Gates Foundation will grant another US$10 million to other LMIC vaccine manufacturers to be named.

Pertussis vaccination during pregnancy has been implemented in many high-resource countries, and recent data from the United States, the United Kingdom, and South America demonstrate its effectiveness in reducing infant pertussis in the first two months of life.

What has not been well established is whether 'blunting' (maternal immunological interference) has clinical consequences.

Blunting of the infant’s subsequent response to primary immunization by maternally derived antibodies has been demonstrated for many antigens.

A new study published in the journal Pediatrics disclosed pertussis vaccination near 28 weeks' gestation was associated with a lower risk of infection among infants through 8 months of age.

These Australian researchers reviewed records from 2013 through 2017 to calculate the impact after infants received diphtheria, tetanus, and pertussis DTaP doses.

The vaccine effectiveness (VE) from maternal vaccination in infants younger than two months was 70.4% (95% confidence interval 50.5% to 82.3%). 

Published on October 9, 2023, these researchers observed slightly lower VE point estimates for the third dose of infant pertussis vaccine among maternally vaccinated compared with unvaccinated infants (76.5% vs. 92.9%, P = .002) and did not observe higher rates of pertussis infection (hazard ratio, 0.70; 95% CI, 0.61–3.39).

The vaccine was given usually between 28 to 31 weeks gestation.

A commentary by Kathryn Edwards, MD, professor of pediatrics at Vanderbilt University Medical Center, stated, 'The consequences of maternally derived antibody on infant responses will need to continue to be monitored, as was done in the carefully conducted study of pertussis reported in this issue of Pediatrics. It will be critical to assess the burden of vaccine-preventable diseases and affirm that blunting from maternal immunization has no material impact on disease control.'

LimmaTech Biologics AG announced today the closing of a USD 37 million Series A financing round that will empower its proprietary technology platform and accelerate its preclinical and clinical vaccine candidates against increasingly dangerous bacterial infections, including programs addressing shigellosis and gonorrhea. 

Antimicrobial Resistance is responsible for approximately 5 million deaths annually. Infections that were once easily treatable have now become difficult, if not impossible, to cure.

As a leading example of this threat to global health, half of the approximately 700,000 annual gonorrhea infections in the U.S. are already resistant to antibiotics, and there is a real threat of gonorrhea soon becoming untreatable.

While there are no gonorrhea vaccines available, off-label vaccines and treatments are in use.

Later-stage clinical development efforts will focus on the company's Shigella vaccine program, which LimmaTech developed with GSK. The company expects to announce preliminary results from the Shigella program's ongoing Phase 2 clinical trial in the second half of 2023.

Shigella cause an estimated 450,000 infections in the U.S. each year.

According to the U.S. CDC, people can get a Shigella infection (shigellosis) after putting something in their mouth or swallowing something that has come into contact with the stool of someone with a Shigella infection.

"Within the next decade, multiple bacterial infections will become untreatable due to antimicrobial Resistance, which is already a significant burden on global health. By advancing our innovative technology platform, LimmaTech has the potential to simultaneously provide vaccine-induced protection against bacterial infections, mitigate the increasing risk of antibiotic resistance, and move toward the control of several highly transmissible pathogens," commented Dr. Franz-Werner Haas, CEO of LimmaTech, in a press release on October 9, 2023.

".....With this support and our team of proven experts in bacterial vaccine development and manufacturing, we look forward to providing life-changing vaccines to address a major global medical need."

The Company is conducting a Phase I/II clinical trial in the Republic of Kenya of a 4-valent candidate vaccine to help prevent diarrheal disease caused by the Shigella bacteria in children and infants in low and middle-income regions. The Shigella study is conducted in collaboration with GSK and the Wellcome Trust.

LimmaTech is committed to translating novel scientific concepts into highly effective vaccines that benefit humanity. For more information, please visit www.lmtbio.com.