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While this respiratory disease is generally related to camel interactions in the Kingdom of Saudi Arabia, clinical efforts to produce a Middle East Respiratory Syndrome (MERS) vaccine have been elusive.
Since April 2012 and as of mid-March 2025, six World Health Organization regions have reported 2,618 cases of MERS, including 945 deaths, a significant case-fatality rate.
To address this need, CEPI announced, on March 25, 2025, a $2.6 million investment in moving a promising vaccine candidate into preclinical trials.
This new investment, developed by Newark, DE-based Uvax Bio, an early-stage vaccine technology company spun out of The Scripps Research Institute, is based on proprietary protein nanoparticle technology, 1c-SApNP®, licensed from Scripps Research.
The technology is already being tested against other infectious diseases, including HIV, where an in-human trial is ongoing.
Dr. Kent Kester, Executive Director of Vaccine R&D, CEPI, commented in a press release, “Uvax Bio’s unique vaccine could help strengthen our response to future MERS outbreaks while informing us of the vaccines being developed against other coronaviruses.”
Uvax’s novel vaccine design uses tiny protein “nanoparticles” to closely resemble or mimic the size and shape of the MERS coronavirus.
Uvax Bio has analyzed viral structures and designed the technology to present enhanced antigens —parts of the virus that trigger an immune response—in a multilayered scaffold layout. This design offers stability and allows for as many as twenty antigens to be presented at once, which could help provide strong protection by generating both antibody and T-cell immunity.
The 1c-SApNP® technology is also unique as it has been combined with a process called ‘glycan trimming.’
Here, sugar molecules—called glycans—that would generally cover the MERS virus are shortened in the nanoparticle virus-mimicking vaccine design. This could expose additional sites on the antigen surface, enhancing the immune response.
In addition to the vaccine candidate, several MERS vaccines are in clinical development addressing this zoonotic disease with an unknown source in 2025.
Since the Mpox virus swept around the world in May 2022, Germany's Standing Commission on Vaccination has recommended that people at an elevated risk of infection receive a preventive vaccination.
After millions of JYNNEOS® (MVA-BN®, IMVAMUNE®) doses were administered, an observational study published positive effectiveness data today.
The Lancet Infectious Diseases published results from a study conducted at Charité – Universitätsmedizin Berlin on March 18, 2025, that found one dose of the JYNNEOS was 84% in people without HIV and 58% effective against mpox infection overall.
However, due to the significant drop in Mpox infections in the second half of 2022, the study could not determine the additional effect of a second vaccine dose.
Furthermore, Breakthrough infections were associated with reduced symptoms, compared with infections in unvaccinated individuals.
In a related press release, Prof. Leif Erik Sander, Director of the Department of Infectious Diseases and Critical Care Medicine at Charité and a research group leader at the Berlin Institute of Health at Charité, stated, "Our results confirm that a single dose of the vaccine provides good protection against Mpox, at least for a short time."
"That is a very good figure, which is likely increased further by the second vaccine dose."
"The reason is that developing immune protection after vaccination presumably requires specific immune cells called T cells. These T cells often appear at lower levels in people with HIV and are not fully functional, which translates to a weaker immune response. This also corresponds to our observation that these participants experienced fewer local and systemic side effects after receiving the vaccine."
"We assume that people living with HIV develop protection against Mpox after the second vaccine dose, and urgently advise these people to receive the two vaccine doses."
"The immune system typically develops longer-lasting immune protection when exposed to the vaccine on more than one occasion."
Further studies will be required to determine the precise extent of the protective effect in different groups following two vaccine doses.
As of March 29, 2025, the JYNNEOS vaccine is commercially available at many clinics and pharmacies in the United States.
Uvax Bio, LLC today announced the interim analysis results from its first Phase 1 clinical trial evaluating the Company’s HIV-1 vaccine candidates, UVAX-1107 and UVAX-1197.
In the first stage of this trial, the subjects received either UVAX-1107 adjuvanted with CpG 1018® and aluminum hydroxide or placebo.
UVAX-1107 was immunogenic and generated robust IgG responses to the vaccine antigen derived from an HIV-1 strain known as BG505. 100% of subjects in the vaccine group demonstrated antibody responses after two priming vaccinations with UVAX-1107.
Antibody response titers increased >200-fold 14 days after the 2nd dose compared to the same period following the first dose.
“We are pleased that our first Phase 1 trial is progressing smoothly, and we have preliminary confirmation that UVAX-1107 was well tolerated at all doses by the study participants, and no vaccine-related serious adverse events were reported,” said Pedro Garbes, M.D., Vice President and Global Clinical Lead of Uvax Bio, in a press release on November 19, 2024.
“As per the time of this 1st interim analysis, no participant was withdrawn from the study due to local/systemic reactogenicity; local and systemic adverse events were mild to moderate, transient, and resolved on average within two days. These preliminary safety results are aligned with expectations for an adjuvanted protein-based vaccine.”
UVAX-1107 utilizes Uvax Bio’s 1c-SApNP® vaccine development platform to generate virus-like particles that closely resemble the target virus in size, shape, and multivalent antigen display; in this case, 20 copies of the native-like, prefusion-stabilized trimeric HIV-1 antigen.
As part of the Immunisation Agenda 2030, a World Health Organization (WHO) study published today in eBioMedicine named 17 pathogens that regularly cause diseases in communities as top priorities for new vaccine development.
In five out of six WHO regions, annual child deaths and contribution to antimicrobial resistance were the most heavily weighted criteria.
“Too often global decisions on new vaccines have been solely driven by return on investment, rather than by the number of lives that could be saved in the most vulnerable communities,” said Dr Kate O’Brien, Director of the Immunization, Vaccines and Biologicals Department at WHO, in a press release on November 5, 2024.
Pathogens where vaccines are approaching regulatory approval, policy recommendation, or introduction
- Dengue virus
- Group B Streptococcus
- Extra-intestinal pathogenic E. coli
- Mycobacterium tuberculosis (TB)
- RSV
Pathogens where vaccine research is needed
- Group A streptococcus
- Hepatitis C virus
- HIV-1
- Klebsiella pneumoniae
Pathogens where vaccines need to be further developed
- Cytomegalovirus
- Influenza virus (broadly protective vaccine)
- Leishmania species
- Non-typhoidal Salmonella
- Norovirus
- Plasmodium falciparum (malaria)
- Shigella species
- Staphylococcus aureus
This global prioritization exercise for endemic pathogens complements the WHO R&D blueprint for epidemics, identifying priority pathogens that could cause future epidemics or pandemics.
The International AIDS Vaccine Initiative (IAVI) recently announced that clinical trial sites in the Lassa fever-endemic countries of Ghana, Liberia, and Nigeria were vaccinating volunteers in IAVI's C105 study of a Lassa fever vaccine candidate.
This study is designed to evaluate the vaccine candidate’s safety, tolerability, and immunogenicity at two different dosage levels in adults, including people living with HIV, as well as in adolescents and children two years of age and older.
The IAVI C105 study results are expected in 2025. Should the vaccine candidate be found safe and efficacious, IAVI is committed to making its Lassa vaccine affordable and accessible to all needy populations.
As of August 28, 2024, no Lassa fever vaccine currently exists. However, several vaccine candidates are conducting research.
Lassa virus (LASV) is a zoonotic disease that causes the acute viral hemorrhagic illness called Lassa fever, for which treatment is limited.
People can get Lassa fever by contacting infected rats or their saliva, urine, or droppings. The U.S. CDC says that LASV can spread among people.
About 300,000 people fall ill across West Africa annually, though the actual disease burden is thought to be much higher. For these reasons, Lassa fever is featured in the World Health Organization’s R&D Blueprint and requires urgent action due to its potential to cause an outbreak of international concern.
The results of the PrEPVacc HIV vaccine trial conducted in Africa between 2020 and 2024 show conclusively that neither of the two experimental vaccine regimens tested reduced HIV infections among the study population.
The PrEPVacc vaccine trial results, announced at AIDS 2024 in Germany in July 2024, report more infections in the two vaccine arms than in the placebo arms. Still, the researchers say they cannot draw a definitive conclusion about this because the statistical ‘confidence intervals’ for the comparison are so wide, indicating high uncertainty.
PrEPVacc tested two different combinations of HIV vaccines.
One regimen combined a DNA vaccine (DNA-HIV-PT123) with a protein vaccine (AIDSVAX B/E), and the other combined the same DNA vaccine, a modified non-dividing virus vector (MVA-CMDR), and a protein-based vaccine (CN54gp140).
The vaccination schedule included four vaccine injection visits: three over approximately six months and a fourth a year after enrolment.
The PrEPVacc trial was stopped in November 2023 when it became clear to independent experts monitoring the study data that there was little or no chance of the vaccines demonstrating efficacy in preventing HIV acquisition.
Dr Peter Gilbert, Principal Investigator, who is independent of the PrEPVacc study and has no ties with it, commented in a press release on July 23, 2024, “Given the PrEPVacc results that the estimated rates of HIV-1 acquisition were higher in the vaccine arms than the placebo arm, it is important to thoroughly quantify and communicate the precision available for drawing inferences about whether the vaccines truly elevated risk or, alternatively, a statistical fluke occurred and the vaccines were indeed safe."
"P-values are incomplete tools for this task because they cannot be interpreted in terms of the question, ‘What is the chance the vaccine elevated the acquisition rate?’
“To fill this gap, I conducted a Bayesian analysis that provides answers to this desired interpretation, using the same method that I previously applied to other HIV vaccine efficacy trials."
"The result was that, for each vaccine, there is close to a 50-50 chance that the vaccine elevated acquisition risk vs. the vaccine was safe, as a synthesis of results over multiple ways to do the analysis, most importantly considering different prior distributions for vaccine efficacy," added Dr. Gilbert.
As of August 2, 2024, the U.S. FDA has approved an HIV vaccine.
Gilead Sciences, Inc. today announced full efficacy and safety results from its pivotal HIV-1 Phase 3 clinical trial.
Detailed data from the trial’s interim analysis announced in June 2024 showed that lenacapavir, the company’s twice-yearly injectable HIV-1 capsid inhibitor, demonstrated zero infections, 100% efficacy, and superiority to background HIV incidence for the investigational use of HIV prevention in cisgender women.
Lenacapavir also demonstrated superior prevention of HIV infections when compared with once-daily oral Truvada.
The new data provide details on the efficacy, safety, and tolerability of twice-yearly lenacapavir injections; drug adherence among trial participants, including poor levels of adherence to daily oral pre-exposure prophylaxis (PrEP) and high levels of adherence to lenacapavir; and demographic and behavioral characteristics of trial participants, including pregnant women and adolescents.
The data were published today in The New England Journal of Medicine.
“These stellar results show that twice-yearly lenacapavir for PrEP, if approved, could offer a highly effective, tolerable and discreet choice that could potentially improve PrEP uptake and persistence, helping us to reduce HIV in cisgender women globally,” said Linda-Gail Bekker, MBChB, DTM&H, DCH, FCP(SA), PhD, Director of the Desmond Tutu HIV Center at the University of Cape Town, South Africa, and former President of the International AIDS Society, in a press release on July 24, 2024.
“PURPOSE 1 also sets a new standard for person-centered HIV prevention trials, demonstrating what can happen when a thoughtful scientific and community-focused trial design, a promising drug candidate, and an inclusive trial implementation plan come together.”
Gilead expects results in late 2024/early 2025 from the program’s other pivotal trial, PURPOSE 2, which is assessing twice-yearly lenacapavir for PrEP among men.
Currently, there are no cures for HIV or AIDS or preventive vaccines available.
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