Travel Vaccine Breaking News

Travel vaccine breaking news brought to you by Vax Before Travel.

Mar 22, 2023 • 10:15 am CDT
by Gerd Altmann

Alzamend Neuro, Inc. today announced the completion of the clinical portion of its Phase IIA multiple ascending dose ("MAD") study for dementia related to Alzheimer's.

The topline data is expected to be disclosed in June 2023.

AL001 is a novel lithium-delivery system; it is a lithium-salicylate-L-proline engineered ionic cocrystal under development as an oral treatment for patients with dementia-related to mild, moderate, and severe cognitive impairment associated with Alzheimer's.

AL001 can potentially deliver the benefits of marketed lithium carbonate while mitigating or avoiding current toxicities associated with lithium.

"We strongly believe that AL001's patented ionic cocrystal technology could potentially provide clinicians with a major improvement over current lithium-based treatments and may constitute a means of treating over 40 million American suffering from Alzheimer's, bipolar disorder, MDD, and PTSD," said Stephan Jackman, Chief Executive Officer of Alzamend, in a press release on March 22, 2023.

"We look forward to reporting topline data in June 2023 and further advancing clinical development of this promising potential therapeutic."

Having completed the clinical portion of the MAD study, the resulting pharmacokinetic and statistical data are undergoing evaluation of the safety and tolerability of AL001 under multiple-dose, steady‑state conditions.

This characterizes the maximum tolerated dose in healthy young and elderly subjects and subjects diagnosed with mild to moderate Alzheimer's.

Potentially safe and effective doses will be determined for deployment in planned subsequent Phase IIA clinical trials involving Alzheimer's, bipolar disorder, MDD, and PTSD subjects.

Lithium has been well-characterized for safety and is approved/marketed in multiple formulations for bipolar affective disorders.

AL001 lithium ascending dosing for the MAD cohorts tested incremental fractions of the usual lithium exposure for the treatment of bipolar affective disorder, with the target lithium dose for Alzheimer's treatment expected at a level that will not require therapeutic drug monitoring.

In each of the multiple healthy young/elderly and Alzheimer's cohorts, consisting of 6 active and 2 placebo patients each (as per randomization), multiple ascending doses were administered three times daily for 14 days under fasted conditions up to tolerability/safety limits that included the highest dose permitted per protocol.

As of March 22, 2023, there are no approved vaccines targeting Alzheimer's disease.

Mar 21, 2023 • 2:40 pm CDT
Needle-free Injection System March 2023

PharmaJet® today announced that its partner, Scancell, reported positive results from their Phase 1 COVIDITY clinical trial. The trial was conducted at the University of Cape Town Lung Institute in South Africa to assess the safety and immunogenicity of their COVID-19 DNA candidate vaccines, SCOV1 and SCOV2.

The results from the trial were highly encouraging, inducing neutralizing antibody and T cell responses with no safety concerns. Administration with PharmaJet's devices was well received by study participants.

This new set of human data adds to the growing evidence indicating that this modern needle-free administration technology is an increasingly viable option to enhance plasmid DNA vaccine immune response.

The vaccines were exclusively administered using the PharmaJet Tropis® and Stratis® needle-free precision delivery systems.

Professor Lindy Durrant, Chief Executive Officer, Scancell, commented in a press release on March 21, 2023, "We are encouraged by these results."

"The trial validates that AvidiMab®-modified immunotherapies boost immune responses and PharmaJet's Needle-free Injection Systems are effective in delivering our ImmunoBody®-generated drug candidate."

"Our plans are to include PharmaJet Needle-free precision delivery systems in future trials with our immuno-oncology projects."

PharmaJet Needle-free precision delivery Systems provide increased vaccine effectiveness, a preferred patient and caregiver experience, and a proven path to commercialization.

The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously.

The Tropis® System has CE Mark and WHO PQS certification for intradermal injections.

They are both commercially available for global immunization programs.

Note: This news article is not paid content.

Mar 21, 2023 • 2:29 pm CDT
by Shane Gaughan

Vaxxinity, Inc. today announced that the first subjects had been dosed in a randomized, double-blind, placebo-controlled Phase 1 clinical trial of VXX-401, an investigational vaccine designed to lower low-density lipoprotein (LDL) cholesterol, a known factor contributing to heart disease.

Heart disease remains the leading cause of death globally, claiming over 18 million deaths yearly.

VXX-401 is designed to induce robust, long-acting antibodies against PCSK9 to lower LDL cholesterol.

The multicenter Phase, 1 dose-escalation trial, aims to enroll 48 subjects aged 18 to 75 years with LDL cholesterol between 2.59 and 4.89 mmol/L.

The trial evaluates safety, tolerability, and immunogenicity (as measured by serum anti-PCSK9 antibody titers).

LDL cholesterol levels will measure the pharmacodynamics of the immune response, an established model of PCSK9 inhibition in hypercholesterolemia. This study was last updated on March 16, 2023.

VXX-401 was designed using Vaxxinity's proprietary synthetic peptide vaccine platform and is being developed to treat hypercholesterolemia.

The platform is designed to harness the immune system to convert the body into its own natural "drug factory," stimulating the production of antibodies.

"This is an exciting milestone for VXX-401 and Vaxxinity in our pursuit to vaccinate the world against heart disease with a preventative option that is convenient and accessible, addressing an unmet need to combat the leading global cause of death," said Mei Mei Hu, Chief Executive Officer of Vaxxinity, in a press release on March 20, 2023.

"PCSK9 antibody therapies are well-tolerated and effective, but huge, unmet patient need remains."

"In order to solve the problem of heart disease, the world needs a scalable, accessible technology that can reach the hundreds of millions, if not billions, of people at risk."

"With an LDL-lowering vaccine, we can offer an option that's cost-effective, safe, convenient, long-acting, and deployable."

Mar 21, 2023 • 12:22 pm CDT
by Muhammad Syafrani

Despite recent improvements in diagnostic tools, chikungunya outbreaks in Africa are probably underreported, stated a U.S. CDC Early Release Dispatch, Volume 29, Number 4—April 2023.

During 2019–2020, a large-scale chikungunya outbreak occurred in Djibouti City, the capital city of the Republic of Djibouti, located in the Horn of Africa.

Djibouti is a semi-arid country bordered by Eritrea, Somalia, and Ethiopia. In this region, the primary vector of the chikungunya virus (CHIKV) is the Aedes aegypti mosquito. 

The chikungunya outbreak remained limited (attack rate 2.1%) but was followed by a dengue outbreak.

These researchers found clinical features helpful but insufficient to discriminate between chikungunya and dengue viruses.

However, CHIKV blood samples on blotting paper have been described as a field method for detecting arboviruses, routinely used in the French Armed Forces when deployed in Africa.

In this study, the researchers used blood samples on blotting paper to detect the emergence of CHIKV and monitor the course of the outbreaks.

Blotting paper provided a robust method for blood sampling and transport to a reference laboratory, making it possible to confirm 90% of the arboviral diagnoses.

We recommend blotting paper as a field tool to detect and monitor arboviral epidemics remotely, wrote these researchers.

Various countries, like Paraguay, are reporting chikungunya outbreaks in remote areas.

As of March 21, 2023, no chikungunya vaccines are authorized in Africa, Europe, or the U.S.

Mar 21, 2023 • 9:37 am CDT
U.S. CDC Norovirus National Trends March 15, 2023

The National Center for Immunization and Respiratory Diseases recently reported data indicating cases of norovirus are spiking in the United States.

Norovirus is a very contagious virus that causes vomiting and diarrhea.

As of March 15, 2023, the 3-week moving average is reaching a new peak since the norovirus outbreak began in August 2022.

Each of the four regions has displayed similar trends, with the Northeast registering the steepest uptick.

In the U.S., cases of norovirus occur most frequently during late fall, winter, and early spring. 

According to the U.S. Centers for Disease Control and Prevention (CDC), people can get norovirus illness many times in their life because there are many different types of noroviruses.

Infection with one type of norovirus may not protect you against other types.

The CDC says it is possible to develop immunity to specific types. But, it is not known exactly how long immunity lasts.

This may explain why so many people of all ages get infected during norovirus outbreaks. About 80% of children will experience a norovirus infection within one year of birth.

As of March 21, 2023, there are no approved norovirus vaccines in the U.S., Europe, or the U.K.

Mar 21, 2023 • 4:40 am CDT
by R. Balouria

The peer review journal The Lancet Infectious Diseases published the results from a recent study examining prospective respiratory syncytial virus (RSV) surveillance data to assess the geotemporal prevalence of RSV A and B and functionally characterize the effect of the nirsevimab binding-site substitutions identified between 2015 and 2021.

Nirsevimab (Beyfortus®), an extended half-life monoclonal antibody (mAbs) to the RSV fusion protein, has been developed to protect infants for an entire RSV season. 

This AstraZeneca and Sanofi-funded observational analysis concluded on March 17, 2023, nirsevimab binding site was highly conserved, and escape variants were rare and have not increased over time.

The U.S. Food and Drug Administration (FDA) initially approved an injectable mAbs therapy for children in 1998.

Beyfortus has been granted various regulatory approvals.

As of March 21, 2023, neither the FDA nor the European Medicines Agency approved an RSV vaccine candidate for children or older adults.

However, various authorizations are expected in 2023.

Mar 21, 2023 • 4:14 am CDT
by Gerd Altmann

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Commission (EC) had approved Dupixent® in the European Union to treat severe atopic dermatitis in children aged six months to 5 years old who are candidates for systemic therapy.

With this approval on March 21, 2023, Dupixent is the first and only targeted medicine indicated to treat these children in Europe and the U.S.

Dupixent is a fully human monoclonal antibody injection administered under the skin at different injection sites.

Atopic dermatitis is a chronic type 2 inflammatory skin disease. Between 85% and 90% of patients first develop symptoms before five years of age, which can often continue through adulthood.

“Watching an infant or young child grapple with the debilitating and wide-reaching impacts of severe atopic dermatitis is heartbreaking,” said Korey Capozza, MPH, Founder and Executive Director of Global Parents for Eczema Research, in a press release.

“I’ve personally witnessed how this chronic skin disease can disrupt the lives of entire families when left uncontrolled. However, intervening with effective treatments during infancy and early childhood can help manage the challenging impact this disease has on children and their families during such formative years.”

Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers. Treatment options in this age group are primarily topical corticosteroids, which can be associated with safety risks and may impair growth when used long-term.

The approval is based on data from a Phase 3 trial evaluating Dupixent every four weeks (200 mg or 300 mg based on body weight) plus low-potency primarily topical corticosteroids (TCS) or TCS alone (placebo) in 162 children aged six months to 5 years with moderate-to-severe atopic dermatitis.

At 16 weeks, Dupixent improved skin clearance and reduced overall disease severity and itch compared to placebo in the overall enrolled population. However, in a subset of those with severe atopic dermatitis, patients randomized to Dupixent (n=63) experienced the following compared to placebo (n=62) at 16 weeks:

  • In addition, 46% of patients achieved 75% or greater improvement in overall disease severity compared to 7% treated with placebo, a co-primary endpoint.
  • 14% of patients achieved clear or almost clear skin compared to 2% treated with placebo, a co-primary endpoint.
  • 55% average reduction in overall disease severity from baseline compared to 10% with placebo.
  • 42% average reduction in itch from baseline compared to a 1% increase with placebo.

Dupixent also improved sleep quality, skin pain, and health-related quality of life compared to placebo in both the overall and severe populations. In addition, long-term efficacy data showed the clinical benefit at 16 weeks was sustained through 52 weeks.

The most common side effects across indications include injection site reactions, conjunctivitis, conjunctivitis allergic, arthralgia, oral herpes, and eosinophilia. 

Dupixent is currently approved for one or more indications in more than 60 countries, including Europe, the U.S., and Japan. More than 600,000 patients are being treated with Dupixent globally.

Mar 20, 2023 • 4:23 pm CDT
from Pixabay

Sweden's Public Health Agency recently reported several severe influenza cases have occurred in Orebro County, located west of Stockholm. Complications can occur in connection with influenza infection, but this outbreak is unusual. 

The spread of influenza A and B is estimated to continue throughout the country as of March 17, 2023.

During week #10, there was roughly the same number of cases of influenza A (385 cases) as influenza B (364 cases). 

So far, eleven newly admitted patients with laboratory-confirmed influenza have been reported in intensive care during week 10, of which six with influenza A and five with influenza B. 

The current investigation aims to assess whether there are more influenza B cases with serious complications than expected and whether there is any common contributing cause. Therefore, the Public Health Authority has asked other infection control units to investigate whether there are similar cases in other regions.

Of the 21 countries that reported sentinel primary care specimen influenza virus positivity above the 10% epidemic threshold, France, Hungary, Romania, and Slovenia reported activity above 40%.

So far, sequencing of clinical specimens from severe cases in Sweden has identified B/Victoria viruses belonging to subgroup V1A.3a.2, which is the dominant influenza type B virus circulating across Europe and the northern hemisphere 2022-23 and 2023-24 influenza vaccine strain (B/Austria/1359417/2021-like virus).

When traveling abroad, the U.S. Centers for Disease Control and Prevention suggests getting a second flu shot if visiting an area with influenza activity.

Various flu shots are available in the U.S. at health clinics and travel pharmacies.

Mar 20, 2023 • 2:56 pm CDT
Vietnam airports March 2023

The Socialist Republic of Vietnam's Health Ministry today announced it has requested for visitors arriving from African countries with Marburg virus disease outbreaks to be monitored for three weeks while in-country.

The ministry also requested samples be taken in suspected cases while at local airports.

"This is a highly dangerous disease," the ministry noted, according to local media on March 20, 2023.

The request was made as the highly contagious disease killed nine people in Equatorial Guinea and could spread further into other African regions and Spain.

As of March 20, 2023, no approved Marburg vaccines or antivirals exist.

Mar 20, 2023 • 8:00 am CDT
by Engin Akyurt

Vaccitech plc today announced topline interim data from the HPV001 Phase 1b/2 clinical trial of VTP-200 heterologous prime-boost immunotherapy in women with low-grade cervical human papillomavirus (HPV) lesions.

It is estimated that approximately 291 million women worldwide are carriers of HPV DNA.

Data from the first 58 women enrolled who reached their 6-month timepoint in the HPV001 placebo-controlled study were reviewed internally, and the trial will continue as planned to the 12-month primary endpoint. Immunogenicity results showed high responses, defined as an average greater than 1,000 spot-forming units per million peripheral blood mononuclear cells in an ELISPOT assay, especially to the E1, E2, and E6 antigens.

VTP-200 was generally well-tolerated with no product-related grade 3 unsolicited events and no product-related SAEs.

"These interim data are a promising step in the right direction, and we look forward to seeing the final data in early 2024," said Bill Enright, CEO of Vaccitech, in a press release on March 20, 2023.

"Currently, people with persistent HPV infections have no treatment options until they develop high-grade lesions. Being told to return for a repeat cervical screening every 6 to 12 months without a treatment option can be frustrating and anxiety-provoking."

"VTP-200 is intended to treat HPV infections, potentially before the virus causes these high-grade lesions."

VTP-200 is being developed as a potential non-invasive treatment for persistent high-risk HPV infections and associated pre-cancerous lesions.

Persistent genital HPV infection is responsible for almost all cases of cervical pre-cancerous lesions, which can lead to cervical carcinoma.

Over 95% of cervical cancers are caused by HPV infection.

The American Cancer Society predicts that in 2022, approximately 14,100 new cases of invasive cervical cancer were diagnosed in the U.S., with over 4,280 women dying from the disease.

In the U.S., various HPV vaccines are authorized for women and men and available at most clinics and clinical pharmacies in March 2023.

Mar 18, 2023 • 3:01 pm CDT
Miami International Airport March 2023

The Florida Health Department recently reported there had been 39 travel-associated dengue cases as of March 11, 2023. And in 2022, 903 travel-associated dengue cases were confirmed, primarily focusing on south Florida.

Since Miami, Florida is a significant destination for many southern hemisphere travelers, updated research is helping identify where these dengue-infected visitors originate.

In 2022, of the total of cases reported in the Pan American Health Region (PAHO) was 1,370,072.

The highest number of severe dengue cases reported by the PAHO was in Brazil, with 1,450 cases (31.5%), Colombia with 1,371 cases (29.8%), Honduras 436 cases (9.5%), Mexico with 410 cases (8.9%), and the Dominican Republic 279 with cases (6.1%).

With the increased access to dengue prevention vaccines such as Qdenga® in Brazil, an unanswered question is whether Miami should require proof of vaccination before visiting.

While the recent pandemic generated much debate about vaccination requirements, over 30 PAHO countries continue requiring yellow fever vaccination verification before visiting in March 2023.

With Miami International Airport's (MIA) record-breaking growth carrying into 2023, the airport is expecting its busiest spring break travel season.

Passenger totals at MIA in January and February 2023 were all-time highs for those months, with February bringing in a total of 4.1 million passengers. 

According to aviation analytics provider Cirium, MIA is the fastest-growing U.S. airport in airline seats compared to pre-pandemic levels.

Overall, the U.S. TSA recently reported a slight increase in air passenger screening at airports in the U.S. as compared with 2019 activity.

Mar 18, 2023 • 1:00 pm CDT
U.S. CDC Tanzania March 2023

AfricaNews recently reported the United Republic of Tanzania requested medical experts investigate a mysterious "communicable" disease that has already killed five people in the country in March 2023.

Outbreaks are not new in the east African country of Tanzania.

In July 2022, a disease whose symptoms included nosebleeds, fever, headaches, and fatigue, was detected in the Lindi region. A total of 13 patients were detected then.

The World Health Organization later confirmed 20 cases of leptospirosis in two districts in the Lindi Region, including three deaths. The majority of these cases were men who were farmers as of August 8, 2022.

And in 2019, a disease with Ebola-like symptoms killed one woman who had visited Uganda, where an Ebola outbreak was detected.

Tanzania was formed as a sovereign state in 1964 through the combination of Tanganyika and Zanzibar, reports Britannica.  

No U.S. CDC health notices are in effect for Tanzania, including Zanzibar, as of March 18, 2023.

Mar 18, 2023 • 12:04 pm CDT
GPEI WPV1 and cVDPV polio cases March 14, 2023

The World Health Organization (WHO) today announced that after three decades, authorities in the Republic of Burundi declared an outbreak of circulating vaccine-derived polioviruses - type 2 (CVDPV 2) after confirming eight polioviruses.

Circulating poliovirus type 2 infection can occur when the weakened strain of the virus in the oral polio vaccine spreads among under-immunized populations for long periods.

Additionally, five samples from environmental surveillance of wastewater confirmed the presence of the circulating poliovirus type 2.

Dr. Matshidiso Moeti, WHO Regional Director for Africa, commented in a press release on March 17, 2023, "We are supporting the national efforts to ramp up polio vaccination to ensure that no child is missed and faces no risk of polio's debilitating impact."

Burundi's government declared the detection of the poliovirus a national public health emergency and planned to implement a vaccination campaign for eligible children.

Burundi is a landlocked African country, a historical kingdom, and one of the few countries whose borders were not determined by colonial rulers, reports Britannica

The WHO says polio is a vaccine-preventable disease.

Circulating poliovirus type 2 is the most prevalent form of polio in Africa.

More than 400 cases were reported in 14 countries in 2022.

International travelers were alerted to this and other polio outbreaks when the U.S. Centers for Disease Control and Prevention reissued its Global Polio travel alert in March 2023.

Mar 18, 2023 • 11:35 am CDT
by Andrew from Pixabay

The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced an early-stage antiviral candidate (JNJ-1802) provides strong protection against dengue in non-human primates and mice.

The new data indicate JNJ-1802 is effective against all four dengue serotypes in mouse models and provides strong protection against two tested serotypes (DENV-1 and -2) in non-human primates.

The first-in-class antiviral, which was shown to be safe and well tolerated in a first-in-human clinical study, is progressing into Phase 2 clinical studies for the prevention and treatment of dengue.

"The unprecedented rise in dengue outbreaks throughout the past years offers a glimpse of what lies ahead ....." said Ruxandra Draghia-Akli, M.D., Ph.D., Global Head, Global Public Health R&D at Janssen Research & Development, LLC, in a press release on March 15, 2023.

"We know an antiviral will be critical to addressing the unmet needs today and tomorrow."

The peer-review journal Nature published this study: Blocking NS3–NS4B interaction inhibits dengue virus in non-human primates. These findings support the further clinical development of JNJ-1802, a first-in-class antiviral agent against dengue, which is now progressing in clinical studies to prevent and treat dengue.

Mar 17, 2023 • 2:56 pm CDT
WHO measles outbreak Nepal November 10, 2023

Measles outbreaks increased by about 80% during 2022, and disease experts warned of increasing outbreaks in 2023.

For example, the World Health Organization (WHO) recently announced an outbreak of measles was confirmed in Nepalgunj sub-metropolitan city (SMC) in Banke district, Nepal, following a cluster of fever and rash cases.

Following the confirmation and through active case search as of March 14, 2023, the index case was identified, with the onset of symptoms on November 24, 2022. Between November 24, 2022, and March 10, 2023, 690 measles cases, including one associated death (case fatality ratio: 0.14 %), were reported from seven districts in western Nepal and three in eastern Nepal (Terai ecological region).

The majority of the cases (n=591; 86%) have been reported in children aged less than 15 years.

While measles is endemic in Nepal and is reported every year, the magnitude and extent of the current outbreak are unusually high compared to the previous years.

Only sporadic isolated measles cases had occurred since 2004 when a significant outbreak of over 12,000 cases was reported. 

The WHO says the risk of the spread of measles is assessed as high at the national level and moderate at the regional level.

Measles is a vaccine-preventable disease, with various vaccines offered at clinics and community pharmacies in the U.S. during 2023.