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Several recent studies provide valuable insight surrounding the appropriateness of transitioning from intravenous to oral therapy when treating bacteremic urinary tract infections.

Transition to Oral Therapy for the Treatment of Bacteremic Urinary Tract Infections

Along with a 1 reported case in Massachusetts, the

New Hampshire Department of Health and Human Services (DHHS) has confirmed a person infected with eastern equine encephalitis (EEE) has died. The public health agency said the person was hospitalized due to severe central nervous system disease. The last reported human EEEV infection in New Hampshire was in 2014, when DHHS identified 3 human infections, including 2 fatalities. In the same statement, DHHS mentions there has been 1 confirmed case in Vermont this summer.

On August 16, the Massachusetts Department of Public Health (MDPH) released a statement discussing the confirmation of the first human case of EEE in the state this year. The confirmed case was discovered in an 80 year old man who was exposed to the vector borne disease in Worcester County. As a result, the risk level in the local communities of Douglas, Oxford, Sutton, and Webster has been raised to critical, and in Dudley, Northbridge, and Uxbridge the risk is increased to high.

Additionally, the neighboring communities of Auburn, Charlton, Grafton, Leicester, Mendon, Millbury, Millville, Southbridge, and Upton are now considered at moderate risk according to MDPH.

“This is the first time we have seen a person infected with EEE in Massachusetts since 2020,” Public Health Commissioner Robbie Goldstein, MD, PhD, said in a statement. “EEE is a rare but serious disease and a public health concern. We want to remind residents of the need to protect themselves from mosquito bites, especially in areas of the state where we are seeing EEE activity.

Though very rare, EEE is serious and a potentially fatal disease that can affect people of all ages. EEE is generally spread to humans through the bite of an infected mosquito. There were 12 human cases of EEE in Massachusetts in 2019 with 6 deaths, and 5 human cases with 1 death in 2020. There were no human cases of EEE in Massachusetts in 2021, 2022, or 2023.

EEE has a fatality rate of 33% to 70%, with most deaths occurring 2–10 days after the onset of symptoms.

In addition to a high mortality rate, long-term physical and mental complications, including permanent neurological deficits have been identified in many people who survive EEE.

Plymouth is approximately 40 miles south of Boston along the coast, and Worcester County is in the middle of the state, so the 2 areas are not in close proximity, but due to the elevated risk locally, the town of Plymouth decided to take action in response to outdoor parks. As of last Friday, all town public parks and fields are close daily from dusk until dawn.

“As Mass DPH has now elevated Plymouth’s EEE risk status to high, it is important to take extra precautions when outdoors and follow state and local health guidelines to avoid unnecessary risk to exposure to EEE. The health and safety of our community, residents, and visitors remain our priority,” Plymouth’s Commissioner of Health and Human Services, Michelle Bratti, said in a statement.

According to the Centers for Disease Control and Prevention (CDC) most people who are infected with the virus do not develop symptoms; however, for those that do, the date from the bite to the onset of the illness is 4 to 10 days. EEE can also result in fever or neurologic disease. The type of illness will depend on the age of the person and other factors. Those who are infected can develop meningitis.

There are no FDA-approved treatments for EEE and for patients who develop severe cases, they can be hospitalized to receive supportive treatment.

Over the weekend, MDPH detailed plans of spraying for mosquitos including aerially in areas of Plymouth County, and truck-mounted spraying in parts of Worcester County. As of Saturday, 10 communities in Massachusetts were raised to high or critical risk for EEE virus.

“The risk from EEE is high in parts of Plymouth County and critical in parts of Worcester County,” State Epidemiologist Catherine M. Brown, DVM, said in a statement. “In addition to recommending that people use mosquito repellent with an EPA-registered active ingredient and clothing to reduce exposed skin, we also recommend that evening outdoor events be rescheduled to avoid the hours between dusk and dawn. The mosquitoes most likely to spread EEE are most active during the dusk to dawn hours.”

There are preventative strategies to avoid EEE, and the MDPH has listed such measures 

For those who live in Massachusetts and want more information on EEE, it can be found 

 or by calling the DPH Division of Epidemiology at 617-983-6800.

1.NH DHHS Identifies Person Infected with Eastern Equine Encephalitis Virus in New Hampshire.The New Hampshire Department of Health and Human Services. August 27, 2024. Accessed August 28, 2024.
https://www.dhhs.nh.gov/news-and-media/nh-dhhs-identifies-person-infected-eastern-equine-encephalitis-virus-new-hampshire
2. State health officials announce season’s first human case of Eastern Equine Encephalitis in Massachusetts. MDPH. August 16, 2024. Accessed August 27, 2024.
https://www.mass.gov/news/state-health-officials-announce-seasons-first-human-case-of-eastern-equine-encephalitis-in-massachusetts
3.Plymouth to Close all Public Parks and Fields from Dusk to Dawn. Town of Plymouth. August 23, 2024. Accessed August 27, 2024. PDF.
4. Eastern Equine Encephalitis: Symptoms, Diagnosis, and Treatment. CDC. May 15, 2024. Accessed August 27, 2024.
https://www.cdc.gov/eastern-equine-encephalitis/symptoms-diagnosis-treatment/index.html
5. State officials announce plans to spray for mosquitoes in sections of Worcester and Plymouth counties due to EEE. MDPH. August 24, 2024. Accessed August 27, 2024. 
https://www.mass.gov/news/state-officials-announce-plans-to-spray-for-mosquitoes-in-sections-of-worcester-and-plymouth-counties-due-to-eee



The town of Plymouth decided to prohibit people from using the parks from dusk to dawn due to concerns over eastern equine encephalitis after a man contracted the rare disease in the state.

Concerns Over Mosquito-Borne Illness Causes Massachusetts Town to Create Curfew for Parks, Spraying in Counties

Immunogenicity from a 40% fractional dose of 13-valent pneumococcal conjugate vaccine (PCV13, Pfizer) was found noninferior to full dose, in immunization of infants in a randomized trial1 in Kenya that also assessed a 10-valent vaccine (PCV10, GSK) and lower fractional doses of both.

Katherine Gallagher, PhD, faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, United Kingdom, and colleagues explain that even with the current, but transitory subsidy, the $2-3 cost per dose of pneumococcal vaccine (given in a 3-dose series) is the most expensive component of the routine immunization schedule in many of the 47 WHO-designated low- and lower-middle income countries.

"The sustainability of the pneumococcal vaccine program is in question in countries that are transitioning out of Gavi (the Vaccine Alliance) support and taking on the full cost of procuring the vaccine," Gallagher and colleagues indicate. "Furthermore, for middle-income countries that are ineligible for Gavi support, a reduction in the cost of the pneumococcal conjugate vaccine may enable vaccine introduction in areas where it is currently unaffordable."

The investigators compared the immunogenicity associated with full dose, 40% and 20% fractional doses of each vaccine, in a 2 primary and 1 booster series, to over 2,000 infants randomly assigned to the 6 treatment conditions; and to a 7th group, all of equal size, that received the PCV10 full dose as 3 primary doses without booster.

The principal measure of immunogenicity was serum IgG to vaccine-type capsular polysaccharides, from blood samples drawn 4 weeks after the 3rd dose, when the infants were approximately 10 months of age. ”The samples were analyzed for IgG to all vaccine serotypes; except for samples from the 3- full dose PCV10 series, which were assayed for 7 vaccine serotypes, due to study funding restraints. In addition, a subgroup of 50 randomly selected samples were tested for functional antibodies.

"Serum IgG has worked well as a correlate of protection for vaccine licensure purposes," Gallagher explained, in discussing the trial with 

. "The first trials of PCVs measured serum IgG and disease endpoints and the data from these trials are what generated a correlate of protection among infants—a threshold of IgG above which risk of IPD (invasive pneumococcal disease) was minimal."

The threshold value of IgG may not remain the index of vaccine effectiveness, however, as Gallagher pointed out that protection against pneumococcal carriage and invasion of pneumococci into sterile sites is a complex biological process.

"It is likely to be a surrogate marker for other immune actors that are active at the mucosa. As such, as newer PCVs are licensed and elicit lower IgG, but non-inferior responses, it is unclear whether these PCVs will be as protective or will have attenuated protection," Gallagher suggested.

The investigators reported that the 40% fractional dose of PCV13 met the noninferiority criterion for 12 of 13 serotypes after the primary series, and for 13 of 13 after the booster. Neither the 20% dose of PCV13 nor the 40% or 20% fractional doses of PCV 10, however, met that threshold. Vaccine serotype-type carriage prevalence was similar across the PCV13 groups at 9 and 18 months of age.

The children found to have received subtherapeutic vaccine dosage were subsequently immunized, Gallagher noted. "The children who were allocated to receive doses that did not reach our non-inferiority criterion were traced and revaccinated with a full dose.We managed to trace 91% of these participants."

In addition, Gallagher pointed out, "the risk of vaccine type IPD in our community is low given the high coverage of the routine immunization program. Additionally, these children will have now aged-out of the highest risk period for IPD, which is infancy."

The trial findings support off-label use of the 40% fractional PCV13 dosing to help sustain pneumococcal vaccine immunization programs. In addition, Gallagher hopes that the findings, along with lower cost full dose products from alternative sources such as the Serum Institute of India (SII), prompt the principle vaccine manufacturers to further reduce their prices for under-resourced regions.

"This (price reduction) would be easier for them than changing their manufacturing volumes to meet the lower demand, if fractional doses were to be implemented across multiple countries," she said. "I doubt they will invest in re-labeling their product at this stage to re-license a lower dose."

1.Gallagher KE, Bottomley LC, Kaniu M, et al. Fractional doses of pneumococcal conjugate vaccine—A noninferioritytrial. 

2024; Published online September 26: DOI:10.1056/NEJMoa2314620. 

https://www.nejm.org/doi/full/10.1056/NEJMoa2314620 

Forty percent of the dose of the PCV 13 vaccine, but not of the PCV 10 or lower dose, was found noninferior to full doses when immunizing infants in Kenya.

Clinical Corner 

Fractional Doses of Pneumococcal Vaccine Could Bolster Supply in Under-Resourced Regions

Carter Keller discusses the company's recent $19.6 million contract with BARDA to develop recombinant polyclonal antibody therapies targeting botulinum neurotoxins and another unspecified biothreat, highlighting their innovative approach to rapidly address emerging health threats.

GigaGen's New Contract with BARDA for Polyclonal Antibody Development

GigaGen Inc, a biotechnology company focused on innovative antibody therapies, has been awarded a significant contract by the Biomedical Advanced Research and Development Authority (BARDA), a Department of Health and Human Services, to develop recombinant polyclonal antibody therapies targeting botulinum neurotoxins (BoNT) and an additional biothreat yet to be determined. The contract starts with an initial commitment of $19.6 million, with the potential to reach up to $135.2 million over a six-year period.

In our interview with Carter Keller, senior vice president of Grifols and head of GigaGen, he expressed enthusiasm about the collaboration: “We were excited to announce we were awarded a contract with BARDA to create two therapeutics together. One is a therapeutic to protect US citizens against botulinum toxin poisoning, which could be used as a bioweapon or a biothreat. The US government is worried about that and wants to replace current options, and then one additional potential biothreat or pandemic, and we're working with BARDA to figure out what that one will be.”

The funding will support drug manufacturing and Phase 1 clinical trials for these programs. BoNT, produced by the bacterium 

, is one of the most toxic biological substances known, capable of causing progressive muscle paralysis and potentially fatal outcomes if untreated.

Keller also noted that GigaGen sees exciting opportunities soon for developing polyclonal antibody therapies and plans to leverage them strategically, “We believe that we have the ideal platform for a rapid response to any type of biothreat or pandemic. We have a platform that can take an immune response from a human that's been exposed to a biothreat or an animal that's been immunized with a biothreat and recreate a great immune system response as a drug very quickly. You can imagine this could be used against any type of future biothreat. This is our chance to prove that to the world, show the potential and further show the promise of this recombinant antibody platform to quickly protect people against any future threat that might arise.”

This project builds upon a prior contract awarded by the US Department of Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) in 2022, which confirmed the platform’s effectiveness against two BoNT variants. The new BARDA project will extend this research to develop treatments targeting all seven known BoNT variants.

Furthermore, GigaGen plans to utilize this platform for infectious and autoimmune diseases. Keller emphasized, “This is further validation that this is a great new way to treat patients. We're the only company that can make recombinant polyclonal antibody therapeutics. Everybody's aware of monoclonals. These are thousands of antibodies all directed towards the disease. We are excited to bring this new method of treating disease to patients in as many different ways as possible, and we'll be doing that with partnerships with the government, with partnerships with other pharmaceutical firms, and within Grifols and GigaGen for all of the opportunities that we see fit. This is one more step on the path to using this platform to transform human disease.”

 to this advancement, GigaGen recently received clearance from the US FDA for its Investigational New Drug (IND) application to begin a Phase 1 clinical trial evaluating GIGA-2339, its first recombinant polyclonal antibody for hepatitis B virus (HBV) infection. The trial is expected to commence in the fourth quarter of 2024.

GigaGen's next-generation recombinant polyclonal platform utilizes high-throughput, single-cell genomic, and protein engineering technologies to create a diverse array of synthetic polyclonal antibodies, more potent than traditional plasma-derived therapies. This innovative approach allows for continuous manufacturing of antibody products tailored to specific pathogens, providing a robust defense against evolving biological threats.

GigaGen Awarded U.S. BARDA Contract to Develop Recombinant Polyclonal Antibody Therapies for Botulinum Neurotoxins and an Additional Biothreat. 

. October 3, 2024. Accessed October 4, 2024. 

https://www.globenewswire.com/news-release/2024/10/03/2957651/0/en/GigaGen-Awarded-U-S-BARDA-Contract-to-Develop-Recombinant-Polyclonal-Antibody-Therapies-for-Botulinum-Neurotoxins-and-an-Additional-Biothreat.html

Carter Keller discusses the company's recent $135.2 million contract with BARDA to develop recombinant polyclonal antibody therapies targeting botulinum neurotoxins and an unspecified biothreat, highlighting their innovative approach to address emerging health threats.

Part 2 with James F Cummings, MD, as he discussed the need for a stronger response to emerging variants, the importance of protecting high-risk populations, and the potential to reduce vaccine hesitancy through easier administration.

Evaluating Safety and Efficacy of Vaxart's Oral Vaccine's Impact on COVID-19 Variants

Vaxart has announced the start of a sentinel cohort for its Phase 2b clinical trial, which will evaluate the safety, immunogenicity, and effectiveness of its oral COVID-19 vaccine candidate in comparison to an approved mRNA vaccine. This trial, valued at up to $456 million under Project NextGen, seeks to tackle ongoing challenges related to COVID-19. The study will examine various factors, including effectiveness against symptomatic and asymptomatic COVID-19, immune responses, and the occurrence of adverse events. The primary goal will be to assess the relative efficacy of Vaxart’s vaccine in preventing symptomatic disease, with results expected 12 months after vaccination.

In discussing the broader implications of the trial with James F. Cummings, MD, chief medical officer of Vaxart, he noted the initial successes in COVID-19 vaccine development, highlighting the role of significant investments in improving capabilities and technologies. He stated, “One key aspect of the response to COVID-19 has been the initial vaccine efforts, which were impressive given we started from scratch. This was made possible by significant investments from the government and various institutions in improving capabilities and technologies, along with effective biosurveillance to identify the issues and convert that data into actionable information for solutions. However, while it was a strong start, it wasn't the best approach moving forward. We know the virus mutates several times a year, so we need a more durable and broader response. For instance, if a vaccine is administered today, it should still be effective against strains that emerge six months later. This is where mucosal immunity comes into play.”

The first phase of the trial will enroll 400 participants, with 200 receiving Vaxart’s oral vaccine candidate and 200 receiving the approved mRNA vaccine. After a 30-day safety assessment by an independent Data and Safety Monitoring Board (DSMB) and the FDA, the trial will proceed to a second phase, which aims to enroll an additional 10,000 participants to ensure diverse demographic representation, including at least 25% of participants over the age of 65.

Cummings expressed enthusiasm about the next generation of vaccines, noting the logistical advantages of developing a vaccine that does not require complex refrigeration infrastructure. “We aim to create a vaccine for everyone, especially focusing on protecting those at highest risk. In our trial, 25% of participants will be over 65 or at higher risk for severe disease. Historical data from past COVID-19 infections shows that these individuals are at the greatest risk, so we want to assess how well the vaccine prevents symptomatic disease and infections, as well as how effectively it triggers a strong immune response.”

He added that their platform has demonstrated no immune decline in older adults, with similar immune responses observed in both older and younger participants. “This is encouraging because older adults often require higher doses or additional boosters to achieve a robust immune response, but our platform doesn’t show that age-related decline.”

Cummings also addressed the importance of making vaccines accessible and easy to administer. “One significant issue is vaccine hesitancy; many people, including some in my family, are hesitant because they don’t like needles. Our approach could eliminate that concern, as it may be suitable for home use, similar to some vaccines already approved for home administration.” One significant issue is vaccine hesitancy; many people, including some in my family, are hesitant because they don’t like needles. Our approach could eliminate that concern, as it may be suitable for home use, similar to some vaccines already approved for home administration.”

All in all, Vaxart's Phase 2b trial aims to develop an oral COVID-19 vaccine. The study will assess safety and efficacy by comparing its candidate to an approved mRNA vaccine. This effort could improve public health and address vaccine hesitancy in the fight against COVID-19.

Watch part 1 of Cummings interview here: 

https://www.contagionlive.com/view/vaxart-initiates-phase-2b-study-of-oral-covid-19-vaccine

Press Release. Vaxart Announces Initiation of Sentinel Cohort for Phase 2b Study Evaluating Its COVID-19 Oral Pill Vaccine Candidate. VAXART. September 30, 2024. Accessed October 4, 2024.

Part 2 with James F Cummings, MD, as he discusses the need for a stronger response to emerging variants, the importance of protecting high-risk populations, and the potential to reduce vaccine hesitancy through easier administration.

James F Cummings, MD, discussed the trial's goals, highlighting the vaccine's potential to generate mucosal immunity and its advantages in logistics and administration.

Vaxart Initiates Phase 2b Study of Oral COVID-19 Vaccine

Vaxart has announced the initiation of a sentinel cohort for its Phase 2b clinical trial, evaluating the safety, immunogenicity, and efficacy of its oral COVID-19 vaccine candidate compared to an approved mRNA vaccine. Valued at up to $456 million under Project NextGen, this trial aims to address ongoing challenges posed by COVID-19. The study will assess factors such as efficacy against symptomatic and asymptomatic COVID-19, immune responses, and the incidence of adverse events. The primary endpoint will focus on the relative efficacy of Vaxart’s vaccine for preventing symptomatic disease, with analysis expected 12 months post-vaccination.

James F Cummings, MD, chief medical officer of Vaxart, he highlighted the significance of this milestone, stating, “Initiating the sentinel cohort is a strong step toward Vaxart’s goal of developing a vaccine that may bring us closer to a sustainable solution to the persistent threat of COVID-19. We continue to progress toward our goal of conducting the Phase 2b study and look forward to the results of our mucosal technology’s first head-to-head comparison against an approved mRNA vaccine for this virus.”

The first phase will enroll 400 participants: 200 receiving Vaxart’s oral vaccine candidate and 200 receiving the approved mRNA vaccine. Following a 30-day safety review by an independent Data and Safety Monitoring Board (DSMB) and the FDA, the trial will advance to a second phase aiming to enroll an additional 10,000 participants, ensuring demographic representation, including at least 25% of those over 65 years of age.

In the first part of our two-part interview with Cummings, he discussed how the oral COVID-19 vaccine enhances immune response compared to traditional injections and shared insights on its potential benefits for public health. He noted, “Another one is the fact that the way our vaccine works, it exhibits a mucosal immune response as well as a serum response,” emphasizing the significance of mucosal immunity in providing a first line of defense against pathogens.

Cummings also emphasized the advantages of their oral vaccine platform, “It's a pretty neat idea, and that we have a pill-based form that’s thermally stable. This is something that has stability at room temperature and doesn’t require a needle, syringe, or any medical professional to administer. From start to finish, it’s a very economical way of fielding a vaccine for global health,” he said.

Additionally, Cummings highlighted the logistical benefits, stating, “having something that could be as easy as sending them in the mail or ubering it to someone, or however you would want to deliver it, I think makes distribution, the logistics of vaccine delivery a lot easier. I think that's one of the benefits of the platform.”

Stay tuned for part two of our interview, where we will explore the key safety and effectiveness measures that will be evaluated in the trial, their relevance to current needs in the fight against COVID-19, and how the trial will ensure representation of various age groups and health conditions. We will also discuss what the results could imply for future vaccines.

Funding for this initiative is provided by Project NextGen, an effort led by BARDA and NIAID to accelerate the development of next-generation COVID-19 vaccines and therapeutics. Vaxart stands out as the first US company to complete a Phase 2 clinical trial for an oral COVID-19 vaccine, showcasing its leadership in oral vaccine development. The company is also advancing oral vaccines for norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus.

Press Release. Vaxart Announces Initiation of Sentinel Cohort for Phase 2b Study Evaluating Its COVID-19 Oral Pill Vaccine Candidate. VAXART. September 30, 2024. Accessed October 3, 2024.

Part 1 of James F Cummings, MD interview, discusses the trial's goals and highlights the vaccine's potential to generate mucosal immunity, its logistical advantages and ease of administration.





The benefits, challenges, and prospects of wastewater data in enhancing public health strategies against AMR.

Transformative Potential of Wastewater Surveillance in Monitoring Antimicrobial Resistance

Valerie Morley, PhD, senior scientist at Ginkgo Bioworks, recently delivered a presentation at the World AMR Congress on the role of wastewater surveillance in monitoring antimicrobial resistance (AMR) across diverse environments, including healthcare settings and agricultural sites. Her talk focused on drawing valuable public health insights from wastewater surveillance for AMR.

She highlighted the benefits of wastewater surveillance for obtaining population-level data, which complements cultured clinical isolates.“Wastewater surveillance is a cost-effective way to get population-level data that can be very targeted. We can look at wastewater coming from a single ward or unit in a hospital, or it can be very broad. We can look at municipal-level wastewater that's coming from an entire community, and importantly, wastewater allows us to get data from the community setting as well as healthcare settings.”

Morley identified technical challenges in associating resistance genes with bacterial organisms and the complexity of interpreting metagenomic data. “One of the big examples that comes to mind for me is that with metagenomic data, we often can't make associations between the resistance genes that we're detecting and the bacterial organisms that they're associated with.”

Morley noted that these challenges stem from limitations in current sequencing approaches but highlighted ongoing efforts to improve accuracy through new methodologies. “That's just kind of a limitation of most types of sequencing approaches, and that's a place where, if we can start to make those associations more accurately, that's really valuable. We're working on that both, there's new approaches coming out that help us to do that. On the wet lab side, they're expensive right now compared to other sequencing methods, and there's also ways to potentially get better at doing that bioinformatically and from a statistical perspective, to make those predictions.”

She underscored the importance of collaborating with end-users to extract meaningful insights and discussed the potential of wastewater surveillance to inform public health strategies. This includes reducing healthcare-associated infections and guiding antimicrobial stewardship through large-scale pilots and data correlation with electronic health records.

“We're really excited about the idea that wastewater surveillance could help hospitals to reduce healthcare-associated infections and to make decisions regarding antimicrobial stewardship. ... This could help to inform when hospitals might want to turn on heightened infection control procedures or more targeted surveillance methods like sequencing or testing swabs, for example.”

In conclusion, Morley highlights wastewater surveillance as a promising tool for monitoring AMR in both healthcare and community settings. While this approach provides valuable population-level data that complements traditional methods, it faces challenges in data interpretation and accuracy. Advances in technology and data integration are expected to enhance its effectiveness, potentially improving infection control and antimicrobial stewardship.

MARLEE A. MANGINO, PHARMD

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