Yellow fever

As GSK Discontinues HSV Vaccine, Opportunities Remain For Moderna And BioNTech

GSK recently announced the discontinuation of its herpes simplex virus (HSV) therapeutic vaccine candidate, GSK3943104, following the failure of a Phase I/II clinical trial to meet its primary efficacy goals.

The vaccine aimed to reduce lesions in patients with recurrent genital herpes - a high unmet medical need. Although deemed safe, its lack of efficacy led to GSK's decision not to advance the vaccine into Phase III trials. This effectively ends GSK's ambition to bring the first HSV vaccine to market, highlighting the significant challenges inherent in developing a vaccine against genital herpes.

HSV remains a highly prevalent infection worldwide, with millions affected by either HSV-1 or HSV-2. HSV-1 typically causes oral cold sores, while HSV-2 is the predominant cause of genital herpes, a sexually transmitted infection. According to GlobalData, in 2024 there are an estimated 52 million cases of HSV-2 and an additional 13 million cases of combined HSV-1 and HSV-2 infections across the 16 major markets (16MM: Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Russia, South Africa, South Korea, Spain, the UK and the US). Projections indicate that these numbers will continue to rise, further emphasising the urgency for effective therapeutic and prophylactic solutions. HSV-2 and combined HSV-1 and 2 cases in the 16MM are projected to reach 54 million and 14 million cases respectively by 2029.

Herpes symptoms can include blisters, fever, swollen lymph nodes and body aches. People infected usually have repeated outbreaks, known as recurrences, with recurrences being less severe than the initial outbreak. While the condition is not curable, antivirals can be used to reduce symptoms.

GSK3943104 was being investigated as a therapeutic vaccine, meaning that it was designed to induce antiviral immunity in individuals who had already contracted the virus, aiming to limit disease progression and reduce outbreaks. This contrasts with prophylactic vaccines, intended to prevent infection from taking hold in the first place. The failure of GSK's vaccine highlights the inherent difficulties in developing a therapeutic vaccine against a virus that can remain dormant and then reactivate periodically. However, GSK's trial remains ongoing for routine safety monitoring and to generate follow-up data that could provide valuable information on this infection and inform future research efforts.

While GSK's departure marks a setback, the focus now turns to companies such as Moderna and BioNTech, both of which are actively developing mRNA HSV vaccines. Moderna's therapeutic candidate mRNA-1608 is currently in Phase II development, while BioNTech's prophylactic candidate, BNT-163, is in Phase I development. The innovative use of mRNA technology, which gained global prominence during the Covid-19 pandemic, offers new hope for creating vaccines that could either prevent or mitigate the effects of HSV infections. These companies are now seen as the leading contenders in the effort to address this long-standing health issue.

"As GSK discontinues HSV vaccine, opportunities remain for Moderna and BioNTech " was originally created and published by Clinical Trials Arena, a GlobalData owned brand.

 

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GSK Halts Herpes Simplex Virus Vaccine Development, Clears Path For Other Contenders Like Moderna, BioNTech

GSK Plc GSK shelved on Wednesday its herpes simplex virus (HSV) vaccine development program.

The recombinant protein vaccine, dubbed GSK3943104, did not meet the study's primary efficacy objective.

GSK added that the vaccine candidate will not progress to phase three studies.

No safety concern was observed. The TH HSV REC-003 study will continue for routine safety monitoring and to generate follow-up.

"Given the unmet medical need and burden associated with genital herpes, innovation in this area is still needed," the company said. "GSK intends to evaluate the totality of all these data and other studies to progress future research and development of its HSV program."

There are no approved vaccines for HSV, and GSK's decision to stop developing GSK3943104 eliminates a key contender in the race to market.

Moderna Inc MRNA is developing mRNA-1608, an investigational vaccine for herpes simplex virus type 2. The candidate is currently in phase 1/2 trial that is fully enrolled with  300 participants in the U.S. Data is expected in June 2025.

Pfizer Inc. PFE partner BioNTech SE BNTX is developing BNT163, a prophylactic vaccine candidate being studied in a phase one clinical trial. 

The German company initiated the phase one trial in December 2022, with an estimated enrollment of 248 participants. Data is expected in 2025.

There are an estimated four billion people globally infected with HSV.

GSK Price Action: GSK stock is down 1.12% at $43.61 at last check Wednesday.

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Incurable, 'highly Contagious' STD Affects Nearly 900 Million People Under Age 50

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The rise of sexually transmitted infections (STIs) continues to pose threats.

The prevalence of one uncurable STI in particular – genital herpes simplex virus (HSV) type 1 and 2 – is at a global high, according to a new study published in the BMJ Journals Sexually Transmitted Infections.

Approximately 846 million people between 15 and 49 years old (more than one in five) were living with a genital herpes infection as of 2020.

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The World Health Organization (WHO) confirmed that at least one person each second, amounting to 42 million people annually, is estimated to acquire the infection.

While HSV-2 is slowly declining, genital HSV-1 is increasing, although it does not cause as much burden, one expert said. (iStock)

The researchers at Weill Cornell Medicine, Qatar, noted that both types of HSV infections are lifelong and can cause symptomatic genital ulcer disease (GUC).

HSV-2 "almost always" causes sexually transmitted genital infection, the researchers said, while HSV-1 mainly causes oral infection, like cold sores, but can be sexually transmitted to cause a genital infection.

The infection can lead to painful genital sores and blisters that typically recur in random episodes throughout life. In 2020, more than 200 million people in the same age group suffered at least one painful symptomatic episode, data shows.

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Not every case of HSV is symptomatic, which makes transmission more likely.

The researchers concluded that the "high incidence and prevalence" of HSV worldwide requires new prevention and treatment measures, such as vaccines, to control the spread and reduce the disease burden.

Approximately 846 million people between 15 and 49 years old are living with a genital herpes infection as of 2020. (iStock)

Study co-author Laith Abu-Raddad, a health care policy and research professor at Weill Cornell Medical College in Qatar, emphasized the scale of HSV's impact.

"Symptomatic genital herpes imposes a substantial global burden, affecting 200 million people annually and incurring significant economic costs, estimated at $35 billion per year due to health care expenditures and productivity loss," he wrote in a statement to Fox News Digital. 

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"Addressing this pressing health challenge requires a fundamental solution," Abu-Raddad went on.

"Developing a vaccine capable of protecting against HSV-1 and HSV-2, the viruses responsible for genital herpes, represents a pivotal step toward controlling this infection on a global scale."

There is currently no cure for HSV, although there are treatments to help manage symptoms.

The STI can also lead to more serious complications like neonatal herpes, which can be transmitted from a mother to her baby during childbirth.

HSV-2 accounts for 90% of symptomatic episodes and is linked to a significantly higher risk of contracting HIV, according to the WHO.

HSV can cause painful sores and blisters that can occur in periodic episodes, according to experts. (iStock)

Dr. Gabe Gaviola, senior medical director at Everlywell in New York — an at-home STD testing and treatment platform — shared his concern about increased exposure.

"HSV is highly contagious and often asymptomatic, which means many people may unknowingly transmit the virus," Gaviola, who was not involved in the study, told Fox News Digital. "This makes prevention and early diagnosis more difficult." 

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"There's also a persistent stigma associated with genital herpes, which may discourage individuals from seeking treatment or disclosing their herpes status to partners, leading to further spread."

Gaviola reiterated how HSV infection can increase the risk of contracting other STIs due to the "sores and compromised skin barrier," which makes it "even more crucial to seek proper testing and treatment."

"New data in this study highlight just how widespread HSV-2 and HSV-1 are, with millions of new and existing cases each year," one doctor said. (iStock)

"High prevalence rates, especially in individuals aged 15 to 49 years old, are driven by a lack of public awareness, prevention efforts, and access to testing and treatment," he said.

For those experiencing symptoms, Gaviola recommends getting regular screenings and being open with sexual partners to reduce the spread.

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"Safer sex practices, including condom use and antiviral treatments for those who have HSV, can help reduce the transmission of HSV," he added.

While HSV outbreaks can be controlled and potentially become less frequently or severely over time, flare-ups can occur during times of stress or illness, according to Gaviola.

Experts explain that the nature of HSV make it difficult to pinpoint a cure. (iStock)

HSV remains dormant in nerve cells after initial infection, which makes it "extremely difficult to completely eradicate from the body," he said.

"It can reactivate at any time, often without warning," he warned. "This dormancy also allows the virus to evade the immune system, which prevents the body from eliminating the infection."

"It can reactivate at any time, often without warning."

"While there are no cures yet, progress in vaccine development and antiviral therapies is promising," he said.

"Public health measures to reduce transmission and improve treatment are critical in managing the global burden of HSV."

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Anna Wald, M.D., professor of medicine, laboratory medicine and epidemiology at the University of Washington, noted that the nature of the herpes virus, much like chickenpox and shingles, makes the development of a cure difficult – although early, preclinical trials are underway. 

According to Wald, there have also been some attempts to develop a preventative HSV vaccine that have failed. (iStock)

"[A] cure is likely to require gene therapy, which is a potentially risky approach for a non-lethal disease," Wald, who was not involved in the research, told Fox News Digital. "So progress is slow as a result."

There have also been some attempts to develop a prophylactic vaccine that have failed, according to the doctor.

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"Testing vaccines for prevention is very expensive, but there are some new candidate vaccines that will hopefully be in trials in the next few years," she shared.

"In my opinion, a preventative vaccine would be an optimal approach, but we don't yet know how to make one that will work – and testing them is a lengthy and costly process."

Angelica Stabile is a lifestyle reporter for Fox News Digital.

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