Vaccine News

Theratechnologies Inc. recently presented data from a study in which the use of Trogarzo® (ibalizumab), a monoclonal antibody antiretroviral therapy (ART), was associated with favorable virologic outcomes compared to non-ibalizumab regimens used in routine care in heavily treatment-experienced people with HIV.

In the new study, using ibalizumab resulted in a statistically significant doubling of the likelihood of viral undetectability and a much longer duration of undetectability and viral suppression compared to a real-world, non-ibalizumab control group from the Observational Pharmaco-Epidemiology Research & Analysis (OPERA®) database.

The ibalizumab study is thought to be the first matching-adjusted indirect treatment comparison study in HIV, an approach designed to facilitate a closely matched comparison from a synthesized, real-world population when randomization to a control arm would be impractical or unethical.

Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies, stated in a press release on May 4, 2023, “This is the largest dataset and longest follow-up for Trogarzo® since our Phase 3 study, and reinforces its importance in a patient population that historically has had limited novel treatment options.”

The study evaluated data from 76 participants in two clinical trials (Phase 2b and Phase 3) who received 800 mg of ibalizumab every two weeks (treatment arm) and compared those data to outcomes from 65 individuals treated with non-ibalizumab-containing regimens as routine care in the OPERA® cohort (control arm).

Standardized mortality rate weighting ensured a balance between the treatment and control groups regarding baseline age, CD4 cell count, viral load, and susceptibility to specific ART agents.

At 24 weeks, investigators observed a statistically significant doubling of the likelihood of viral undetectability (defined as VL <50 c/mL) in the treatment arm versus the control arm (SMR-weighted hazard ratio [HR]: 1.98; 95% confidence interval [CI]: 1.02, 3.69).

Achievement of viral suppression (defined as VL <200 c/mL) was also more likely with ibalizumab, though this finding did not reach statistical significance (SMR-weighted HR: 1.28; 95% CI: 0.82, 2.06).

Among those who achieved undetectability on ibalizumab, 95% maintained undetectability through the end of follow-up.

Additionally, the exact significance emerged for maintaining viral suppression, which was 18 times lower for real-world non-ibalizumab regimens.

For both durability analyses, confidence intervals were wide but statistically significant (SMR-weighted HR: 18.36; 95% CI: 2.48, 135.68).

Note: Monoclonal antibody antiretroviral therapy is not an HIV vaccine candidate.

The U.S. Centers for Disease Control and Prevention (CDC) reissued its Alert - Level 2, Practice Enhanced Precautions notice regarding the ongoing Marburg virus disease (MVD) outbreak in the Republic of Equatorial Guinea.

As of May 12, 2023, the CDC says, 'Reconsider non-essential travel to mainland Equatorial Guinea.'

If you travel to Equatorial Guinea, you should:

• Avoid contact with sick people with fever, muscle pain, and rash symptoms.
• Avoid contact with blood and other body fluids.
• Avoid contact with dead bodies or items that have been in contact with dead bodies, participate in funeral or burial rituals, or attend a funeral or burial.
• Avoid visiting healthcare facilities in the outbreak area for nonurgent medical care or non-medical reasons.
• Avoid visiting traditional healers.
• Avoid contact with fruit bats and the caves and mines where they live.
• Avoid nonhuman primates (e.g., chimpanzees, gorillas).

Furthermore, visitors should watch their health for symptoms of Marburg, a viral hemorrhagic fever, while in the outbreak area and 21 days after leaving the outbreak area.

As of May 14, 2023, other Marburg outbreak alerts have been issued this year for Africa. 

Unfortunately, there are no Marburg vaccines available.

Local media recently reported a case of Ebola virus disease in The Democratic Republic of Congo (DRC) on May 8, 2023. The last Ebola outbreak in the DRC occurred in 2022.

“Regarding Ebola virus disease surveillance, we received a sample that turned out to be positive from the Kyondo health zone and in the Butembo site. We have received four samples, and among the four, one is positive,” commented Damulo Luhavo, the communicator of the provincial health division of Butembo.

Luhavo called on the local population to continue to be vaccinated. 

As of May 13, 2023, various Ebola vaccines and Monoclonal Antibody therapies are available.

This news article did not disclose which type of Ebola, Sudan or Zaire, was detected.

CNA reported yesterday another young woman living in Taiwan was diagnosed with the A H1N2 variant (H1N2v) of the novel swine influenza virus.

As of May 11, 2023, this is only the third swine flu case ever seen in Taiwan, according to the Centers for Disease Control.

This zoonotic influenza case came into contact with swine from working at a pig farm. But the virus was not detected in any of the pigs on the farm where the girl worked.

Close contacts were identified, but none tested positive for the H1N2v virus.

Taiwan's first human H1N2v infection was reported in April 2021.

Unlike swine flu, avian influenza Highly Pathogenic Avian Influenza (HAPI) viruses have been detected in birds, mammals (cats, bears, dogs), and humans during 2022-2023.

The U.S. Centers for Disease Control and Prevention (CDC) Technical Report issued on March 17, 2023, confirmed the current risk to the public from HPAI A(H5N1) viruses remains low.

However, continued sporadic human infections are anticipated because of the potential for influenza viruses to evolve.

As of April 6, 2023, about 240 cases of human infection with avian influenza A(H5N1) virus have been reported from four countries within the Western Pacific Region since January 2003.

Of these bird flu cases, 135 were fatal, resulting in a case fatality rate of 56%.

Should a human pandemic occur in 2023, the U.S. government has already stockpiled U.S. FDA-approved bird flu vaccines, and other development efforts have been funded as of May 12, 2023.

Furthermore, the CDC says annual flu shots are not designed to protect people against either bird or swine flu infections.

The World Health Organization (WHO) External Situation Report #2 confirmed yesterday that the Kingdom of Eswatini reported its first cholera case in April 2023, related to cross-border transmission from Mozambique and a second case without travel history. 

In total, 24 countries have reported cholera cases since the beginning of 2023.

The overall capacity to respond to multiple and simultaneous outbreaks continues to be strained due to the global lack of resources, including shortages of the oral cholera vaccine.

Based on the current situation, the WHO assessed on May 11, 2023, the risk at the global level is very high.

Cholera outbreak news is posted by Vax-Before-Travel.

Before visiting Eswatini in southeast Africa, the U.S. CDC suggests various travel vaccinations, including yellow fever.

Data published by Sanofi today from the HARMONIE Phase 3b clinical trial show an 83.21% (95% CI 67.77 to 92.04; P<0.001) reduction in hospitalizations due to RSV-related lower respiratory tract disease (LRTD) in younger infants who received a single dose of Beyfortus® (Nirsevimab).

While the U.S. Food and Drug Administration approved a multi-dose, injectable monoclonal antibody (mAbs) therapy in 1998, this new therapy has been authorized in Canada, Europe, and the U.K. as of May 12, 2023.

The Hospitalized RSV Monoclonal Antibody Prevention (HARMONIE) study is a large (8,000), multi-country interventional clinical trial aiming to determine the efficacy and safety of a single intramuscular dose of nirsevimab, with data collected in a real-world setting during the 2022-2023 RSV season. 

The data from HARMONIE also show that nirsevimab reduced the incidence of hospitalizations due to severe RSV-related LRTD (patients whose oxygen level is under 90% and require oxygen supplementation) by 75.71% (95% CI 32.75 to 92.91; P<0.001).

Additionally, nirsevimab demonstrated a reduction of 58.04% (95% CI 39.69 to 71.19; P<0.001) in the incidence of all-cause LRTD hospitalization compared to infants who received no RSV intervention.  

Throughout HARMONIE, nirsevimab maintained a favorable safety profile, consistent with the pivotal trial results.

In a press release, Dr. Simon Drysdale, Consultant Pediatrician in Infectious Diseases at St. George’s University Hospital NHS Foundation Trust and Co-Chief Investigator of HARMONIE, stated, “RSV-related chest infections lead to high numbers of infants under 12 months old being hospitalized every year."

"These data reinforce the potential public health benefit of nirsevimab in helping reduce the strain on hospitals caused each year by RSV.”

Additional RSV vaccine and monoclonal antibody news are posted by Precision Vaccinations. 

The recent Aboviral Diseases Report of the Puerto Rico Department of Health indicates the Zika virus has returned in 2023.

As of May 5, 2023, Report #17 data indicates 21 probable Zika cases were confirmed in 2023.

Since its first detection in March 2014, the Pan American Health Organization (PAHO) has confirmed local transmission of Zika in all countries and territories in the Region of the Americas, except for continental Chile, Uruguay, and Canada.

In 2022, Barbados had the highest Zika incidence and case fatality rate. Other Zika outbreak countries were Guatemala, El Salvador, and Costa Rica.

Zika is a viral disease transmitted by mosquitoes, says the PAHO. About 25% of infected people may develop symptoms. The illness is usually mild, lasting between two and seven days.

However, the Puerto Rico Department of Health and the U.S. CDC surveyed women who gave birth to infants from August to December 2016.

This survey determined there are no known ways to prevent the adverse effects of Zika infection during pregnancy.

One is Microcephaly, a condition where a baby's head is much smaller than expected. 

As of May 11, 2023, there are no approved vaccines to prevent Zika infections.