Sapienza University of Rome

TB vaccine ‘could help prevent MS’

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MRI brain scan showing multiple sclerosis lesions


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An anti-tuberculosis vaccine could prevent multiple sclerosis, early research suggests.

A small-scale study by researchers at the Sapienza University of Rome has raised hopes that the disease can be warded off when early symptoms appear.

More research is needed before the BCG vaccine can be trialled on MS patients.

The MS Society said the chance to take a safe and effective preventative treatment after a first MS-like attack would be a huge step forward.

MS is a disease affecting nerves in the brain and spinal cord, causing problems with muscle movement, balance and vision.

Early signs include numbness, vision difficulties or problems with balance.

BCG vaccine

  • Bacillus Calmette-Guerin (BCG) is a live vaccine made up of a weakened strain of Mycobacterium bovis, a bacterium that causes tuberculosis (TB) in cattle
  • The bacteria are altered so that they do not cause a TB infection, but stimulate the body’s immune system to make it resistant to the disease
  • The vaccine has existed for 80 years and is one of the most widely used of all current vaccines, reaching more than 80% of newborns and infants in countries where it is part of the national childhood immunisation programme

About half of people with a first episode of symptoms go on to develop MS within two years, while 10% have no more problems.

In the study, published in the journalNeurology, Italian researchers gave 33 people who had early signs of MS an injection of BCG vaccine.

The other 40 individuals in the study were given a placebo.

After five years, 30% of those who received the placebo had not developed MS, compared with 58% of those vaccinated.

“These results are promising, but much more research needs to be done to learn more about the safety and long-term effects of this live vaccine,” said study leader Dr Giovanni Ristori.

“Doctors should not start using this vaccine to treat MS or clinically isolated syndrome.”

Dr Susan Kohlhaas, head of biomedical research at the MS Society, said it was a small but interesting study.

“It’s really encouraging to see positive results from this small trial, but they’ll need validating in larger and longer-term studies before we know if the BCG vaccination can reduce the risk of someone developing MS.

“Ultimately, the chance to take a safe and effective preventative treatment after a first MS-like attack would be a huge step forward.”

The findings add weight to a theory that exposure to infections early in life might reduce the risk of diseases such as MS by stimulating the body’s immune system.

Dr Dennis Bourdette, of Oregon Health and Science University in Portland, US, said the research suggested “BCG could prove to be a ‘safe, inexpensive, and handy’ treatment for MS”.

He wrote in an accompanying editorial in Neurology: “The theory is that exposure to certain infections early in life might reduce the risk of these diseases by inducing the body to develop a protective immunity.”

Esmolol May Stabilize Heart Rate in Septic Shock Patients.

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For patients in septic shock who have an excessively high heartbeat, use of the beta blocker esmolol helped to lower and maintain heartbeat rates without adverse effects.

Andrea Morelli, MD, from the Department of Anesthesiology and Intensive Care, University of Rome, “La Sapienza,” Italy, and colleagues conducted a randomized phase 2 trial at the University of Rome hospital intensive care unit between November 2010 and July 2012. The researchers randomly assigned 154 patients whose heartbeats exceeded 95 beats per minute (BPM) and who required high doses of norepinephrine to receive either continuous infusion of esmolol to maintain heart rate between 80 and 94 BPM (n = 77) or to receive standard treatment (n = 77) of norepinephrine during intensive care unit stays.

The target heartbeat rate was achieved in all patients in the esmolol group and was significantly lower than for patients in the control group. The median heart rate reduction came to −28 BPM for the esmolol group compared with −6 BPM for the control group (P < .001). The median continuously infused dose for esmolol was 100 mg/h (interquartile range [IQR], 50 – 300 mg/h).

The mortality rate for the esmolol group came to 49.4% for the esmolol group compared with 80.5% for the control group (P < .001). Stroke volume index was significantly higher in the esmolol group (P = .02), as was the left ventricular stroke work index (P = .03). Fluid requirements were reduced in the esmolol group compared with controls (P < .001), although no clinically relevant differences existed between groups for some other cardiopulmonary variables.

“Compared with standard treatment, esmolol also increased stroke volume, maintained [mean arterial pressure], and reduced norepinephrine requirements without increasing the need of inotropic support or causing adverse effects on organ function,” the researchers write.

Because esmolol is short-acting and has a half-life of about 2 minutes, it enables rapid resolution of any potential adverse effects. These new findings, the researchers write, suggest esmolol “allows better ventricular filling during diastole, hence, improving stroke volume and thereby improving the efficiency of myocardial work and oxygen consumption.”

Limitations of the study include selection of a predefined arbitrary heart rate threshold and the requirement that the study be nonblinded and not placebo-controlled. In addition, results might not be similar in a less at-risk population.

Paves the Way

“This is the unblindable trial. There’s no way to blind this trial. That will always be a limitation of whatever comes down the road,” R. Phillip Dellinger, MD, professor and head of critical care medicine at Cooper University Hospital in Camden, New Jersey, told Medscape Medical News. Dr. Dellinger is first author of a recent articleon treatment guidelines for sepsis.

The new study, Dr. Dellinger said, “clears the way for a larger phase 3 trial, and it offers support for moving the physiology in the direction that would, on the surface, look beneficial. It shows that it’s safe. The secondary outcomes all moved in a positive direction or didn’t move at all. So there are no signals here of potential problems with doing this; instead there is evidence that it helps cardiac function.”

Some aspects of this phase 2 trial differ from many phase 2 trials, he added. “This trial picked a population that would be predicted to more likely benefit from beta blockage, which is requiring very high doses of norepinephrine and being tachycardic.” Limiting the trial population may be better than including a large population in a study and dividing them up in subgroup analyses, he said, but the results might not be generalizable to a larger population.

In summary, Dr. Dellinger said, “Even though the trial was small, I think it was encouraging.”

This research was funded by the Department of Anesthesiology and Intensive Care of the University of Rome, “La Sapienza.” Dr. Morelli reports receiving honoraria for speaking at Baxter symposia. One coauthor reports serving as a consultant for and receiving honoraria from speaking at Baxter. The other authors and Dr. Dellinger have disclosed no relevant financial relationships.

Human Papilloma Virus Vaccine and Primary Ovarian Failure: Another Facet of the Autoimmune/Inflammatory Syndrome Induced by Adjuvants..

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Zabludowicz Center for Autoimmune Diseases Sheba Medical Center, Tel-Hashomer, Israel; Rheumatology Unit, Department of Internal Medicine and Medical Specialities, Sapienza University of Rome, Rome, Italy.

Abstract

PROBLEM:

Post-vaccination autoimmune phenomena are a major facet of the autoimmune/inflammatory syndrome induced by adjuvants (ASIA) and different vaccines, including HPV, have been identified as possible causes.

METHOD OF STUDY:

The medical history of three young women who presented with secondary amenorrhea following HPV vaccination was collected. Data regarding type of vaccine, number of vaccination, personal, clinical and serological features, as well as response to treatments were analyzed.

RESULTS:

All three patients developed secondary amenorrhea following HPV vaccinations, which did not resolve upon treatment with hormone replacement therapies. In all three cases sexual development was normal and genetic screen revealed no pertinent abnormalities (i.e., Turner’s syndrome, Fragile X test were all negative). Serological evaluations showed low levels of estradiol and increased FSH and LH and in two cases, specific auto-antibodies were detected (antiovarian and anti thyroid), suggesting that the HPV vaccine triggered an autoimmune response. Pelvic ultrasound did not reveal any abnormalities in any of the three cases. All three patients experienced a range of common non-specific post-vaccine symptoms including nausea, headache, sleep disturbances, arthralgia and a range of cognitive and psychiatric disturbances. According to these clinical features, a diagnosis of primary ovarian failure (POF) was determined which also fulfilled the required criteria for the ASIA syndrome.

CONCLUSION:

We documented here the evidence of the potential of the HPV vaccine to trigger a life-disabling autoimmune condition. The increasing number of similar reports of post HPV vaccine-linked autoimmunity and the uncertainty of long-term clinical benefits of HPV vaccination are a matter of public health that warrants further rigorous inquiry.

Source: Pubmed