Travel Vaccine Breaking News

IAVI announced today that the initial participants had been vaccinated with a Sudan virus (SUDV) vaccine candidate in a first-in-human Phase I clinical trial in the U.S.

As of June 27, 2023, the IAVI C108 IAVI-sponsored trial is funded by the Biomedical Advanced Research and Development Authority (BARDA).

IAVI C108 will occur at two U.S.-based clinical trial sites, where the vaccine candidate will be administered intramuscularly at three dosage levels. 

This is essential news since there are no SUDV vaccines available.

Furthermore, like the Zaire Ebolavirus (ZEBOV), SUDV is responsible for recurring viral hemorrhagic fever outbreaks across sub-Saharan Africa.

In past Ebola outbreaks, the estimated case fatality ratios of SUDV disease have varied from 41% to 100%.

This study evaluates the safety and immunogenicity of an investigational SUDV vaccine candidate previously donated to IAVI by Merck. This investigational SUDV vaccine candidate was produced for IAVI from an existing investigational bulk drug substance previously manufactured by Merck.

IAVI is responsible for all aspects of the candidate’s future development, including demonstrating equivalence between this SUDV vaccine candidate and IAVI’s other SUDV vaccine candidate, which utilizes the same viral vector but is manufactured using a new production platform.

The SUDV vaccine candidate being evaluated in IAVI C108 uses the same recombinant vesicular stomatitis virus (rVSV) viral vector platform as ERVEBO®, Merck’s single-dose ZEBOV vaccine, which is licensed in the U.S., U.K., European Union, Canada, Switzerland, and 10 African countries.

“IAVI C108 represents an important first step toward generating the data needed for eventual licensure of an rVSV-SUDV vaccine. The development and licensure of ERVEBO® have resulted in an important tool in Ebola Zaire outbreak responses. If proven effective, we’re hopeful that a vaccine candidate built on the same viral platform will be similarly important in future SUDV outbreaks,” said Swati Gupta, Ph.D., vice president and head of emerging infectious diseases and epidemiology at IAVI, in a related press release.

The rVSV platform has been used extensively in adults and children. The underlying vesicular stomatitis virus is a common animal virus that does not cause serious illness in humans and has been investigated extensively as a vaccine vector.

In the vaccine platform, it is engineered to encode a surface protein from a target pathogen, in this case, SUDV, to prompt the body to mount an immune response.

Much of the research and development on IAVI’s rVSV platform is performed at the IAVI Vaccine Design and Development Lab in Brooklyn, New York.

Sanofi - Aventis Groupe today announced positive topline Phase 2b clinical data in atopic dermatitis support amlitelimab as a potential first and best-in-class novel investigational anti-OX40-ligand monoclonal antibody.

The primary endpoint was met in the Phase 2b study (STREAM-AD) of amlitelimab in adults with moderate-to-severe atopic dermatitis whose disease cannot be adequately controlled with topical medications or for whom topical medications are not a recommended treatment approach.

Amlitelimab is a fully human non-depleting monoclonal antibody that binds to OX40-Ligand, a key immune regulator.

It can be a first-in-class treatment for various immune-mediated diseases and inflammatory disorders, including moderate-to-severe atopic dermatitis and asthma.

By targeting OX40-Ligand, amlitelimab aims to restore immune homeostasis between pro-inflammatory and regulatory T cells.

Naimish Patel, M.D., Head of Global Development, Immunology and Inflammation, Sanofi, commented in a press release on June 27, 2023, "While we have made significant strides in the treatment of atopic dermatitis, there are patients who are still in need of new options."

"We believe that the results from this Phase 2b study with amlitelimab support our perspective that targeting OX40-Ligand has the potential to provide a first and best-in-class treatment option that addresses type 2 and non-type 2 inflammation to meet the individual needs of people living with atopic dermatitis and other chronic inflammatory diseases."

"We look forward to advancing into a larger Phase 3 clinical development program and continuing to drive momentum in our Immunology pipeline to deliver first or best-in-class treatments."

In this dose-ranging study, treatment with amlitelimab resulted in statistically significant improvements in average Eczema Area and Severity Index score from baseline at 16 weeks compared to placebo for all four subcutaneous doses that were studied.

There were also improvements in key secondary outcome measures, and continued improvements were observed through week 24 in primary and key secondary outcomes.

Biomarker results support an effect on both type 2 and non-type 2 pathways.

Amlitelimab was well-tolerated in the study across all dose arms, and no new safety concerns were identified.

Furthermore, Amlitelimab is under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.

The U.S. NIH says atopic dermatitis, often referred to as eczema, is a chronic (long-lasting) disease that causes inflammation, redness, and irritation of the skin. It is a common condition that usually begins in childhood.

However, anyone can get the disease at any age.

And atopic dermatitis is not contagious, so it cannot be spread from person to person.

The journal Nature Communications recently published an article that concluded interim data from 2 parts of the phase 1/2 clinical trial support the continued development of mRNA-1010.

The mRNA-1010 vaccine candidate elicited either higher or comparable immune responses to a standard-dose, influenza quadrivalent inactivated vaccine. 

Overall, these first-in-human safety and immunogenicity findings highlight, on June 19, 2023, the potential of the mRNA platform to improve the effectiveness of influenza vaccines.

Vaccines using mRNA technology are readily amenable to antigenic drift and shift in influenza strains, allowing for rapid deployment of vaccines. In addition, mRNA-based platforms allow for the expression of multiple antigens, raising the possibility for an increased breadth of protective responses against seasonal influenza or multiple respiratory diseases.

However, approved cell-based influenza vaccines, such as Flucelvax® Quadrivalent (QIVc), currently produce an exact antigenic match for circulating flu trains.

Further, based on findings with mRNA-1273, an mRNA-based vaccine against SARS-CoV-2, mRNA vaccines may also induce strong cellular immune responses and prolonged germinal center reactions that can improve protection in older adults, a population at particular risk for infection and severe outcomes. 

While mRNA-1010 had an acceptable safety profile in this trial, transient solicited adverse reactions were more common after mRNA-1010 than with the active comparator.

Additional clinical trials are ongoing to assess further this vaccine candidate's safety, efficacy, and immunogenicity and a licensed influenza vaccine comparator (NCT05566639 and NCT05415462).

Moderna, Inc. was involved in the study design, data collection and analysis, and the writing of this manuscript. Moderna funded this study.

Invivyd, Inc. today announced that it has reached general alignment with the U.S. Food and Drug Administration (FDA) on a pathway to potential emergency use authorization (EUA) for VYD222 and anticipated follow-on monoclonal antibody (mAb) candidates designed to prevent symptomatic COVID-19.

The company plans to leverage the pathway, which includes the use of serum-neutralizing titers as a correlate of protection in an immunobridging approach to a pivotal clinical trial of VYD222, to rapidly generate data to support a potential VYD222 EUA for the prevention of symptomatic COVID-19.

Based on FDA feedback, the use of a correlate of protection in an immunobridging approach to a pivotal EUA-directed clinical trial may be a reasonable approach for a new mAb candidate when clinical trial data from a "prototype" mAb is available, provided that the new mAb candidate:

1. Is similar to the prototype mAb such that it leverages a consistent manufacturing platform and has limited structural and functional differences, and,
2. Has supportive nonclinical data, such as favorable in vitro neutralization data against currently circulating SARS-CoV-2 variants.

"We are very encouraged by the recent feedback from the FDA and appreciate their commitment to exploring alternative strategies to expedite the development of mAbs for the prevention of symptomatic COVID-19, such as the use of a correlate of protection as the primary endpoint in a pivotal clinical trial, a strategy that we are pleased to see further advance following the joint EMA-FDA workshop last December where the approach was discussed," said Dave Hering, chief executive officer of Invivyd, in a press release on June 26, 2023.

"Given our previous work developing adintrevimab and our platform-based approach to rapid mAb discovery, we believe we are one of few companies positioned to rapidly and serially generate data for potential EUA submission for next-generation mAb candidates for the prevention of symptomatic COVID-19."

"This potential pathway supports the company's vision and strategy of establishing a platform and stream of optimized anti-SARS-CoV-2 mAb candidates that can be deployed to keep pace with viral evolution and protect the vulnerable."

COVID-19 antibody and antiviral news was updated on June 26, 2023. 

Pfizer Inc. recently announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) unanimously voted to recommend PREVNAR 20® (20-valent Pneumococcal Conjugate Vaccine) for routine use to help protect infants and children from invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae serotypes covered by the vaccine and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR®.

These provisional recommendations will be reviewed and finalized by the director of the CDC and the Department of Health and Human Services.

“We are thrilled with today’s ACIP decision as it recognizes the increased level of protection that PREVNAR 20 will provide to millions of infants and children against pneumococcal disease,” said  Luis Jodar, Ph.D., Chief Medical Affairs Officer, Vaccines/Antivirals and Evidence Generation, Pfizer, in a press release on June 22, 2023.

Previously, the European Medicines Agency approved the brand name Apexxnar in February 2022.

The Florida Department of Health (DOH) in Sarasota and Manatee Counties recently confirmed a second locally-acquired malaria case.

As of June 19, 2023, this patient was being treated for this mosquito-cause infection.

This case has been identified as the P. vivax malaria species, which is not as fatal as other species.

In response, a mosquito-borne illness alert was issued for Sarasota and Manatee counties.

On May 26, 2023, DOH released information on the first confirmed local malaria case, who was treated and recovered.

Effective treatment is readily available through Florida hospitals and other healthcare providers.

The Florida Department of Health confirmed aerial and ground mosquito spraying is being conducted in these counties to mitigate the risk of further transmission.

Malaria is not transmitted from person to person.

Only infected Anopheles mosquitoes can transmit malaria to humans.

Malaria infects approximately 219 million people each year, with an estimated 660,000 deaths, mostly children in Africa. 

The U.S. Centers for Disease Control and Prevention (CDC) recently stated the risk of locally acquired malaria in the U.S. is extremely low. 

About 2,000 malaria cases are diagnosed annually in the U.S., most in international travelers.

However, Florida has had malaria outbreaks in the past.

In 2003, eight locally acquired P. vivax malaria cases were reported in Palm Beach County, FL. 

From a prevention perspective, malaria vaccines have already been approved.

The World Health Organization recommended the Mosquirix™ malaria vaccine in 2021, and the R21/Matrix-M™ vaccine was approved for use in Africa in 2023.