Smallpox vaccine study yields favorable results

February 7, 2018, US Army Medical Research Institute of Infectious Diseases

Officials from Bavarian Nordic yesterday announced the results of a successful Phase 3 clinical trial led by USAMRIID that demonstrated the safety and efficacy of the company's investigational, non-replicating smallpox vaccine, IMVAMUNE.

The product is being developed as an alternative to the current U.S. licensed replicating smallpox vaccine, ACAM2000, which cannot be used by certain populations, including people with atopic dermatitis and HIV. It is already approved in Canada and the European Union.

USAMRIID study director Phillip R. Pittman, M.D., collaborated with the U.S. Defense Health Agency to enroll 440 subjects at a U.S. military post in South Korea. The randomized, open-label study had two co-primary endpoints. The first was to show that IMVAMUNE induced a non-inferior antibody response when compared with ACAM2000. In this study, the peak neutralizing antibodies induced by IMVAMUNE were shown to be twofold higher than those stimulated by ACAM2000, demonstrating a statistically superior immune response.

The second co-primary endpoint was to demonstrate an attenuation or prevention of a "take" in volunteers previously vaccinated with IMVAMUNE. Historically, a take is a measure of efficacy against smallpox in people vaccinated for the first time. It consisted of a pustule, scab and scar that developed on the skin following initial vaccination with replicating smallpox vaccines like ACAM2000. Following the second vaccination, those who had developed a protective showed either a reduced take or none at all. This also was achieved in the USAMRIID-Bavarian Nordic study.

"If approved, this will have a direct impact on improving force health protection for U.S. Soldiers and other service members who are required to be immunized against ," said COL Gary Wheeler, commander of USAMRIID.

According to Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, IMVAMUNE has been given to more than 7,800 subjects in 21 clinical studies, including this trial and one other Phase 3 study. He said the company plans to file a Biological License Application with the U.S. Food and Drug Administration later this year.

"This program has only been possible through the consistent and strong support of numerous U.S. Government agencies and demonstrates what can be achieved through a successful public-private partnership to protect the public from the deliberate release of the ," Chaplin added.

Explore further: Creation of synthetic horsepox virus could lead to more effective smallpox vaccine

More information: Study details are available at clinicaltrials.gov/ct2/show/NCT01913353

Related Stories

Creation of synthetic horsepox virus could lead to more effective smallpox vaccine

January 19, 2018
UAlberta researchers created a new synthetic virus that could lead to the development of a more effective vaccine against smallpox. The discovery demonstrates how techniques based on the use of synthetic DNA can be used to ...

Man who got smallpox vaccine passes milder infection to sex partner

February 28, 2013
(HealthDay)—A man recently vaccinated for smallpox under a U.S. Defense Department program passed a milder, related form of the disease on to a man he had sex with, and that man then passed it on to yet another man, federal ...

Recommended for you

Researchers publish study on new therapy to treat opioid use disorder

May 22, 2018
Better delivery of medications to treat opioid use disorder (OUD) is key to addressing the opioid crisis and helping the 2.6 million Americans affected by the disease.

Could nonprofit drug companies cut sky-high prices?

May 17, 2018
(HealthDay)—Generic prescription drugs should be cheap, but prices for some have soared in the United States in recent years. Now a group of U.S. hospitals thinks it has a solution: a nonprofit drug maker.

Fewer antibiotics for kids, but more ADHD drugs

May 15, 2018
(HealthDay)—American kids are taking fewer prescription medications these days—but certain drugs are being prescribed more than ever, a new government study finds.

Opioid makers' perks to docs tied to more prescriptions

May 14, 2018
Doctors who accept perks from companies that make opioid painkillers are more likely to prescribe the drugs for their patients, new research suggests.

Less is more when it comes to prescription opioids for hospital patients, study finds

May 14, 2018
In a pilot study published in JAMA Internal Medicine, Yale researchers significantly reduced doses of opioid painkillers given to hospital patients. By delivering the opioids with a shot under the skin or with a pill instead ...

Generic options provide limited savings for expensive drugs

May 7, 2018
Generic drug options did not reduce prices paid for the cancer therapy imatinib (Gleevec), according to a Health Affairs study released today in its May issue.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.