Travel Vaccine Breaking News

Alzamend Neuro, Inc. today announced receipt of a "Study May Proceed" letter from the U.S. Food and Drug Administration ("FDA") for the initiation of study AL001-MDD01, a Phase IIA clinical study of AL001 for the treatment of patients with major depressive disorder ("MDD"), also known simply as depression.

While a wide variety of medications have been used historically for augmentation of an antidepressant in MDD, lithium is one of the few agents that has demonstrated efficacy in multiple randomized controlled trials.

AL001 is a novel lithium-delivery system that can potentially deliver the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium.

Alzamend's goal is to revive the utility of lithium treatment by significantly improving the benefit-to-risk relationship of lithium treatment in clinical practice.

Stephan Jackman, Chief Executive Officer of Alzamend, commented in a press release on November 20, 2023, “If we can develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring, it would constitute a major improvement over current lithium-based treatments and positively impact the 21 million Americans afflicted with MDD."

"We are advancing the process and expect that the first patient will be dosed in the first quarter of 2024.”

Based on the favorable AL001 safety profile observed in the recently completed study and extensive safety data on the drug's constituent components, the AL001 development program may qualify for a Section 505(b)(2) New Drug Application pathway for FDA approval, which is available to new formulations of an approved drug.

As of November 21, 2023, the FDA has not approved a vaccine candidate targeting depression of Alzheimer's disease.

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.