Pertussis, or more commonly referred to as whopping cough, annually strikes an estimated 16 million children across the globe. Nearly 200,000 people die from the disease each year, largely in under-developed countries. The disease takes a toll on everyone, but can be most deadly in infants.
Research indicates that the recent re-emergence of pertussis in the US and around the world is potentially associated with the lack of mucosal immunity elicited by existing pertussis vaccines. BlueWillow’s proprietary vaccine adjuvant technology may therefore play a key role in future pertussis vaccines. When administered intranasally, NE vaccines elicit both systemic and mucosal immune responses, which could enhance protection against respiratory diseases like pertussis.
Pertussis is a highly contagious respiratory illness caused by the bacteria Bordetella pertussis. Prevention by vaccination is of primary importance given the seriousness of the disease in infants and young children.
Since whole-cell pertussis vaccines were replaced with acellular vaccines in the 1990s, pertussis has reemerged at a startling rate in the U.S. despite nationwide vaccine coverage in excess of 95%. With a 50-year high of nearly 50,000 reported U.S. cases in 2012, pertussis is the most common of the vaccine-preventable diseases. This resurgence is mirrored throughout the industrial world despite similar high rates of vaccination.
Recent research conducted in baboons at the CBER Division of Bacterial, Parasitic and Allergenic Products at the Food and Drug Administration (FDA) suggests that current acellular pertussis vaccines protect against pertussis, but fail to prevent infection colonization and transmission, which could be contributing to the worldwide pertussis resurgence. The researchers observed that previously infected baboons, and those animals vaccinated with the whole-cell vaccine, possessed strong Th17 and Th1 memory, whereas baboons vaccinated with the acelluar vaccine induced a Th1/Th2 response instead1.
BlueWillow’s nanoemulsion (NE) adjuvant is uniquely suited to enable vaccines for both respiratory and sexually transmitted infections, which involve pathogens that enter the body across mucosal surfaces. When used with intranasal vaccination, the NE adjuvant elicits Th17 for mucosal protection as well as Th1 systemic immunity. The mucosal immunity elicited by NE vaccines provides critical protection against these infections at their port of entry into the body.
Recent studies in rats have demonstrated that intranasal NE-aP vaccination elicits serum bactericidal activity comparable to intramuscular aP vaccination:
In addition, rats vaccinated with the intranasal NE vaccine had markedly higher Th17 responses, as shown below:
Based on the above findings, BlueWillow, NIH, FDA and a leading global vaccine company are collaborating to test an intranasal NE-aP in the baboon challenge model, to examine disease protection and prevention of carriage.
1 Jason M. Warfel, Lindsey I. Zimmerman, and Tod J. Merkel. “Acellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model”. PNAS 2014 111 (2) 787-792; published ahead of print November 25, 2013, doi:10.1073/pnas.1314688110
In July 2013, BlueWillow Biologics entered into an agreement with the Division of Microbiology and Infectious Diseases (DMID), a division of NIAID. Under the agreement, DMID has agreed to fund certain activities and studies in support of developing an intranasal NE vaccine for pertussis. Such activities and studies are currently underway.