Vaccine News

A clinical-stage intranasal vaccine company developing parainfluenza virus 5 (PIV5)-vectored vaccines that harness the full breadth of the immune system to protect against serious infectious diseases today announced preliminary data from the first two cohorts of a Phase 1/2a clinical trial studying BLB201, a vaccine candidate against severe respiratory syncytial virus (RSV) disease.

On March 21, 2024, Blue Lake Biotechnology, Inc., stated the data show that BLB201 is immunogenic and well tolerated, with no significant safety events reported to date following a single intranasal dose in RSV seropositive children 18-59 months of age.

The ongoing trial is currently enrolling both RSV seropositive and RSV seronegative children as young as eight months of age.

No vaccine-related severe safety signals have been reported among the initial 10 participants ages 18-59 months who received the BLB201 study vaccine in this Phase 1/2a study (NCT05655182).

In the five participants who received the higher dose of 10⁷ PFU of BLB201, prominent increases in RSV neutralizing antibody (nAb) responses were observed at four weeks post-vaccination, with 80% having a 3.6- to 57-fold rise in nABs over baseline.

RSV-specific mucosal IgA antibody and cellular immune responses were also observed.

“Given the challenges of developing an RSV vaccine for children, it is highly encouraging that BLB201, our intranasal RSV vaccine candidate, has been well tolerated in this age group so far,” said Biao He, Ph.D., founder and CEO of Blue Lake Biotechnology, in a press release.

“It is also very exciting to see RSV-specific immune responses to our vaccine in children who have previously been exposed to RSV. We are eager to generate more data in younger children, including infants who have not had prior exposure to RSV, and to develop a highly effective and safe vaccine to protect this vulnerable population from RSV.” 

As of March 2024, approved antibody drugs and a maternal RSV vaccine can provide passive immunity against RSV in infants. However, no RSV vaccine has been approved for generating prophylactic immunity in infants and children.

Despite extensive efforts, the Federal Republic of Nigeria continues to confront an expanding Lassa fever outbreak in 2024, reporting new cases and deaths.

Throughout 2024, Nigeria's Centre for Disease Control and Prevention (NCDC) confirmed 682 cases and 128 deaths, which is a Lassa fever case fatality rate of 18.8%, far exceeding the rate recorded in 2023.

The report identified 62% of confirmed cases originating from Ondo, Edo, and Bauchi states.

The NCDC wrote in 2023 that annual outbreaks of Lassa fever also involved infection and death of healthcare workers. This loss of life is not just a statistic but a significant loss of a loved family member, a spouse, a parent, and often a seasoned healthcare worker and team member. This exacerbates the challenge of insufficient human resources for health in the country.'

As of March 2024, the U.S. Food and Drug Administration and the European Medicines Agency had not approved a Lassa fever virus vaccine candidate.

However, four vaccine candidates (INO-4500, MV-LASV, rVSV∆G-LASV-GPC, and EBS-LASV) have entered the clinical clinical stage.

Without an available vaccine, the U.S. CDC says the risk of Lassa virus infection is associated with peridomestic rodent exposure, where inappropriate food storage increases the risk.

The CDC says people should practice safe food precautions and avoid handling, cooking, or eating raw or undercooked meat or animal products.

A corporate venture firm focused on investing in companies developing innovative solutions and ideas today announced its participation in an extension of the Series C financing round for Nouscom, a clinical-stage immuno-oncology company.

Nouscom raised approximately $82 million in its oversubscribed Series C round, which was first announced in November 2023.

Angelini Ventures joins a syndicate of top-tier international healthcare investors by participating in Nouscom’s financing.

This new financing will enable Nouscom, based in Basel, Switzerland. to continue advancing and expanding its wholly-owned clinical pipeline to achieve multiple clinical value catalysts, including:

• Readout from its ongoing randomized Phase 2 clinical trial for NOUS-209, an off-the-shelf cancer vaccine for treating Mismatch Repair/Microsatellite Instable Metastatic Colorectal Cancer.
• Phase 1b study completion and progression of NOUS-209 monotherapy in Lynch Syndrome carriers investigating the potential to intercept, prevent, or delay cancer in high-risk individuals.
• Completion of the Phase 1b study for NOUS-PEV, a personalized cancer immunotherapy, in combination with a checkpoint inhibitor in patients with advanced melanoma and entry into randomized Phase 2 trials in indications with high unmet medical needs.

Dr. Marina Udier, Chief Executive Officer at Nouscom, commented in a press release on March 21, 2024: “We are delighted to have extended our successful Series C financing round and excited to have Angelini Ventures on board. Their support strengthens our commitment to innovation and accelerates our journey towards delivering next-generation treatments for cancer patients.”

Millions of people's health is at risk by the mosquito-transmitted, vaccine-preventable chikungunya virus (CHIKV), but most Americans are unaware of its global impact.

In-person information about a newly approved chikungunya virus (CHIKV) vaccine will be shared at the Walter E. Washington Convention Center in Washington, D.C., from April 1-4, 2024.

Valneva SE, a France-based specialty vaccine company, today announced it will present its single-shot chikungunya vaccine for adults, IXCHIQ®, and participate in a panel discussion on efforts to eradicate chikungunya outbreaks at the 24th World Vaccine Congress.

XCHIQ®, the world's first and only chikungunya vaccine approved in the U.S., was recently recommended by the CDC's Advisory Committee on Immunization Practices for international travelers to at-risk areas.

As of March 21, 2024, CHIKV was identified in nearly 115 countries, primarily in the Region of the Americas. As of December 2023, approximately 460,000 CHIKV cases and 360 related deaths have been reported worldwide.

On the evening of April 2, Valneva will attend the Vaccine Industry Excellence Awards ceremony, where the vaccine is a finalist for the Best Prophylactic Vaccine award for IXCHIQ®.

And on April 3, Valneva's Chief Medical Officer, Dr. Juan Carlos Jaramillo, will participate in the "Vaccine Development and Efforts towards Eradicating Chikungunya" panel discussion.

For further details, contact Laetitia Bachelot-Fontaine, VP, Global Communications and European Investor Relations, at [email protected]

The U.S. CDC published today the Emerging Infectious Diseases, Early Release, Volume 30, Number 4—April 2024, that concluded where feasible, vaccination against hepatitis A, meningococcal disease (IMD), and mpox should be encouraged among at-risk groups and offered along with program services that target those groups.

On March 18, 2024, these CDC researchers wrote, 'We provide a descriptive, cross-sectional analysis of the concurrent outbreaks of hepatitis A and IMD in Florida in the context of an ongoing global mpox epidemic that also is disproportionally affecting MSM.'

'Through this analysis, we attempted to identify common and distinct features of each outbreak and synergistic factors that might have affected disease progression and control.'

'We observed a high percentage of concurrent HIV infection among hepatitis A, IMD, and most notably, mpox case-patients.'

The U.S. Food and Drug Administration has approved vaccines that can prevent certain sexually transmitted diseases (STDs) caused by infections from bacteria, viruses, or parasites. Various STD vaccines are available at health clinics and pharmacies in the U.S.

Merck today announced positive data from multiple Phase 3 studies evaluating V116, the company’s investigational, adult-specific 21-valent pneumococcal conjugate vaccine.

Across the clinical studies presented at the 13th Meeting of the International Society of Pneumonia and Pneumococcal Diseases in Cape Town, South Africa, on March 19, 2024, V116 was shown to be immunogenic for all 21 serotypes covered by the vaccine in a variety of adult populations, including those who had not previously received a pneumococcal vaccine (pneumococcal vaccine-naïve), those who had previously received a pneumococcal vaccine (pneumococcal vaccine-experienced) and those with an increased risk of pneumococcal disease, including people living with human immunodeficiency virus.

In all STRIDE studies presented at the meeting, V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116.

Several studies presented today were included in the filing submission to the U.S. Food and Drug Administration (FDA). The FDA granted V116 priority review with a Prescription Drug User Fee Act of June 17, 2024.

If approved by the FDA, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults. 

The U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization say the increased number of measles outbreaks is a global threat in 2024.

As of March 14, 2024, a total of 58 measles cases were reported by 17 U.S. jurisdictions: Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York City, Ohio, Pennsylvania, Virginia, and Washington.

In 2023, a total of 58 measles cases were reported by 20 U.S. jurisdictions.

In 2024, the Chicago Department of Public Health (CDPH) confirmed twelve measles cases, including an active outbreak at a local shelter in Pilsen. CDPH is coordinating a comprehensive, city-wide response to the first measles cases in Chicago in five years.

CDPH is encouraging all new arrivals to Chicago and every Chicagoan to get the measles-mumps-rubella (MMR) vaccine if they haven't already done so.

The vast majority of Chicagoans are vaccinated against measles and therefore not at high risk," said CDPH Commissioner Olusimbo 'Simbo' Ige, MD, MPH, in a press release on March 12, 2024.

"But those who are unvaccinated need to take precautions. If they're exposed, quarantine immediately and connect with their healthcare provider. Above all else, get vaccinated so you, too, can be protected from this virus."

In the U.S., MMR vaccines are available at most community pharmacies as of March 18, 2024.