Zika Breaking News

The journal Scientific Reports recently published a meta-analysis that confirmed cardiovascular events remain a substantial global health concern and that common influenza vaccines may benefit older people during flu outbreaks.

These researchers found compelling evidence that influenza vaccination is associated with a decreased risk of major cardiovascular events, particularly myocardial infarction (MI) and cardiovascular death.

This study shows a 26% decreased risk of heart attacks in people who received an influenza vaccination and a 33% reduction in cardiovascular deaths.

On November 19, 2023, the study revealed Pooled relative risks (RR), and their 95% confidence intervals (CI) were calculated to evaluate the associations.

A notable reduction in major cardiovascular events was observed among patients who received the influenza vaccine, with 517 cases compared to 621 cases in the placebo group (RR 0.70; 95% CI 0.55–0.91).

The stratified analysis revealed a decreased risk of MI in vaccinated patients (RR 0.74; 95% CI 0.56–0.97).

And a significant reduction in cardiovascular death events (RR 0.67; 95% CI 0.45–0.98).

These findings highlight the potential of influenza vaccination as an adjunctive strategy in cardiovascular disease prevention.

As of November 20, 2023, the U.S. CDC recommends that most people six months of age and older get one dose of any approved influenza vaccine before the flu season arrives in their community. Annual flu shots are generally available at clinics and pharmacies in the U.S.

One of the world’s most formidable public health challenges, human immunodeficiency virus (HIV), is impacting more than 38 million people worldwide.

While there are no U.S. Food and Drug Administration (FDA) approved HIV vaccines in 2023, a novel arenaviral therapeutic vaccine candidate is being evaluated as a potential curative regimen for HIV.

HOOKIPA Pharma Inc. today announced that it has received clearance from the FDA for its Investigational New Drug (IND) application for HB-500, a novel arenaviral therapeutic vaccine for the treatment of HIV.

HB-500 is an alternating, 2-vector arenaviral therapeutic vaccine for the treatment of HIV.

One vector is based on the lymphocytic choriomeningitis virus as its arenaviral backbone; another vector is based on the Pichinde virus.

Both encode the same HIV antigens. The alternating 2-vector approach is designed to further focus the immune response against the target antigen.

HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial.

And Gilead Sciences, Inc. has the exclusive right to assume further program development afterward.

Joern Aldag, Chief Executive Officer at HOOKIPA, commented in a press release on November 20, 2023, “The ability to generate a potent and broad T cell response that can clear infected cells is critical for HIV control. Our novel arenaviral therapeutic vaccine (candidate) offers promise in helping to address the unmet need for a functional HIV cure.”

In November 2023, Nature Partner Journals Vaccines published the joint-preclinical research by HOOKIPA and Gilead, which served as the foundation for the IND submission.

The data show that arenaviral therapeutic vaccination was well tolerated and generated robust, high-quality, and durable immune responses (antigen-specific T cells and antibodies) in non-human primates.

Additionally, arenaviral therapeutic vaccination significantly reduced SIV viral load and clinical illness in those animals compared to placebo.

HIV, a sexually transmitted disease, is one of the world’s most formidable public health challenges.

The virus infects and kills immune cells and, without effective ongoing treatment, leaves the individual increasingly immunocompromised over time. While effective treatments have significantly extended the lives of people living with HIV and reduced the transmission of the virus, there is no cure for HIV or AIDS in 2023.

Since the launch of the World Health Organization's (WHO) global strategy to accelerate the elimination of cervical cancer three years ago, a further 30 countries, including Bangladesh, Indonesia, and Nigeria, have introduced a Human papillomavirus (HPV) vaccine into their vacation schedules.

As of November 17, 2023, 140 countries have now introduced HPV vaccinations into national programs.

Governments and communities are leading the way by declaring commitment and developing strategies to eliminate HPV cervical cancer, a sexually transmitted disease.

On Cervical Cancer Elimination Day of Action, Member States have a renewed commitment to eliminate this vaccine-preventable cancer.

"In the last three years, we have witnessed significant progress, but women in poorer countries and poor and marginalized women in richer countries still suffer disproportionately from cervical cancer," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General, in a press release.

"With enhanced strategies to increase access to vaccination, screening, and treatment, strong political and financial commitment from countries, and increased support from partners, we can realize our vision for eliminating cervical cancer."

There are effective HPV vaccines that protect males and females against cancers caused by HPV. 

According to the U.S. Centers for Disease Control and Prevention (CDC), these vaccines include 9vHPV, 4vHPV, and 2vHPV. In the U.S., HPV vaccination has been recommended for women since 2006 and for men since 2011. 

As of August 2023, the CDC reported that in 2022, 76% of people aged 13–17 had received one or more HPV vaccine doses.

HPV vaccines are generally available at health clinics and pharmacies in the U.S.

While the global flu season has not been very severe, recent data indicates the southern United States is experiencing a sudden spike in influenza cases.

According to the U.S. Centers for Disease Control and Prevention (CDC), during week #45, 3.5% of patient visits reported were due to respiratory illness that included fever plus a cough or sore throat. 

As of November 17, 2023, the regions with the highest percentage of respiratory specimens testing positive for influenza were Regions 8 (7.4%), 4 (7.0%), 6 (6.5%) and 9 (5.3%).

For regional and state-level data and age group distribution, please visit FluView Interactive. 

From a severity perspective, the National Center for Health Statistics Mortality Surveillance confirmed that during week #44, 21 people died from influenza. 

Previously, influenza deaths were reported during weeks #43 (32) and #42 (43).

Furthermore, one influenza-associated pediatric death occurring during the 2023-2024 season has been reported to the CDC.

The CDC continues recommending most people over six months of age get an annual flu vaccine.

From an availability perspective, over 147 million flu vaccine doses have been distributed in the U.S. Various flu shots are available at clinics and pharmacies in the U.S.

PharmaJet® today announced the start of the first human clinical trial for a Venezuelan Equine Encephalitis (VEE) vaccine delivered with PharmaJet Precision Delivery Systems.

The Phase 1 study, sponsored by PharmaJet, aims to identify the optimal dose, vaccination schedule, and delivery system most suitable for use in subsequent broader clinical evaluations of the VEE DNA vaccine candidate.

VEEV is a mosquito-borne alphavirus that has caused sporadic outbreaks and epidemics in North Central and South America. Aerosolized VEEV is highly infectious with greater mortality rates than natural infection and is listed as a potential biothreat agent with no approved human vaccine or therapeutic.

Disease outbreaks frequently involve equines– horses, donkeys, mules, zebras – and humans.

DNA vaccination has proven particularly effective at eliciting protective immune responses against the alphavirus challenge.

As previously reported, the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and PharmaJet found, in a non-human primate challenge study, that a prime and single boost by either the intramuscular (Stratis) or intradermal route (Tropis) resulted in humoral and cellular immune responses that provided significant protection against VEEV disease and viremia.

These results paved the way for advancing the candidate vaccine into human trials and approval to proceed was recently granted by the Institutional Review Board (IRB), the Army's Office of Human Research Oversight, and the FDA.

President and CEO of PharmaJet, Chris Cappello, said in a press release, "The PharmaJet Precision Delivery Systems are optimized for field use and have also shown immunogenicity levels higher than with needle-syringe."

"We look forward to the clinical results from the human trial of this promising DNA vaccine candidate with our commercially available needle-free precision delivery systems."

The VEE DNA vaccine candidate is being evaluated as part of a multi-year agreement between PharmaJet and the Joint Science and Technology Office of the U.S. Defense Threat Reduction Agency.

The study, in collaboration with USAMRIID, aims to advance further the clinical assessment of the vaccine with the PharmaJet Precision Delivery Systems: Tropis Intradermal and Stratis Intramuscular.

PharmaJet Systems effectively delivers nucleic acid-based vaccines compatible with military operations and the warfighter environment, in addition to being preferred by end-users compared to other delivery technologies.

Longhorn Vaccines and Diagnostics today presented new data from an animal study of LHNVD-301, the company's lead tuberculosis (TB) vaccine candidate.

The data presented at The Union World Conference on Lung Health 2023 on November 15, 2023, showed that a mycobacterium tuberculosis (MTB) vaccine could generate broader protection against pathogens susceptible to antimicrobial resistance (AMR).

LHNVD-301 is an unconjugated, peptide-based vaccine that combines a MTB heat shock protein epitope and a peptidoglycan (PGN) epitope.

PGN is a cell wall component of bacteria that plays a vital role in infections.

The combination of heat shock protein and PGN generates broad reactive antibodies.

It represents a novel approach that combats AMR while targeting tuberculosis by combining multiple epitopes specific to MTB and common to gram-positive bacteria into a peptide vaccine.

Longhorn CEO Gerald W. Fischer, MD, commented in a press release, "We are developing LHNVD-301 to address MTB as a global threat and combat AMR."

"Unconjugated peptides targeting epitopes of multiple pathogens enable a cost-effective, easily scalable approach for vaccine development, which is crucial for covering those most at risk for TB."

While TB is an ancient disease, outbreaks caused an estimated 10.6 million infections and 1.3 million deaths in 192 countries and areas in 2022.

As of November 2023, 16 TB vaccines are available globally, and various BCG vaccine candidates are under development.

Nouscom recently announced the completion of its Series C equity financing, raising $72 million that will be used to continue advancing and expanding Nouscom's wholly-owned clinical pipeline to achieve multiple clinical value catalysts.

As of November 13, 2023, the funding proceeds will support the following initiatives:

Readout from Nouscom's ongoing randomized Phase 2 clinical trial for NOUS-209, an off-the-shelf vaccine targeting 209 shared neoantigens, in combination with pembrolizumab for the treatment of Mismatch Repair/Microsatellite Instable Metastatic Colorectal Cancer.

Final readout from the ongoing Phase 1b study and advancement of NOUS-209 monotherapy in Lynch Syndrome carriers investigating the potential to intercept, prevent, or delay cancer before it occurs. LS carriers have a genetic predisposition to and, consequently, a higher risk of developing certain cancers. Promising initial results from this study were reported on October 31, 2023.

Completion of a Phase 1b study evaluating NOUS-PEV, a personalized cancer immunotherapy, in combination with a checkpoint inhibitor in patients with advanced melanoma and entry into randomized Phase 2 trials in indications with high unmet medical needs.

Nouscom has also exclusively out-licensed VAC-85135, an off-the-shelf immunotherapy developed under a multi-project agreement, which is currently under evaluation in a Phase 1 clinical trial for the treatment of Myeloproliferative Neoplasms sponsored by Janssen Research & Development and Bristol Myers Squibb.

Dr. Marina Udier, Chief Executive Officer of Nouscom, commented in a press release, ".... This financing will allow us to further accelerate development across our wholly-owned clinical portfolio reporting multiple clinical trial readouts, including from our ongoing randomized Phase 2 clinical trial with NOUS-209."

"These Phase 2 data, if positive, have the potential to position Nouscom's neoantigen-based cancer vaccines amongst the most thrilling developments in the field."

According to a Review Article published by the journal Frontiers in Immunology in February 2023, Neoantigen vaccines are based on epitopes of antigenic parts of mutant proteins expressed in cancer cells. These highly immunogenic antigens may trigger the immune system to combat cancer cells.