Improved Tdap Vaccine Adjuvanted with CpG 1018 Launches Phase 1 Clinical Trial

Serum Institute of India (SIIPL), the largest vaccine manufacturer in the world by doses, and California-based Dynavax Technologies Corporation jointly announced that the first participant had been dosed in a Phase 1 clinical trial evaluating a tetanus, diphtheria, and acellular pertussis (Tdap) booster vaccine candidate adjuvanted with CpG 1018.

Dynavax anticipates the Phase 1 study results to be available in the fourth quarter of 2021.

Dynavax and SIIPL are collaborating to develop an adjuvanted Tdap vaccine (Tdap-1018) to address the shortcomings of the currently marketed acellular pertussis vaccines. The incidence of pertussis infection in the USA and other industrialized countries has been rising since the switch from whole-cell pertussis to acellular pertussis vaccines in the 1990s.

Although currently marketed acellular pertussis vaccines effectively provide initial protection from disease, rates of pertussis continue to rise due to waning immunity over time. These vaccines may not prevent the pertussis bacteria from colonizing in the patient, potentially allowing previously vaccinated, asymptomatic individuals, to spread the disease.

This vaccine candidate has the potential to provide an alternative to the current booster dose given at 10 years of age and older to increase the durability of the immune response and reduce transmission from vaccinated individuals who may still spread the disease even if they are asymptomatic.

Sharing his thoughts, Mr. Adar Poonawalla, CEO, Serum Institute of India, said in a press statement issued on February 4, 2021, "The addition of CpG 1018 adjuvant to our Tdap vaccine will ensure the development of this much needed improved Acellular pertussis-based combination vaccine to protect the children, adolescents and adults in the developed world. Even though there is a lot to be done before the vaccine is fully developed, this marks a key step towards a promising and healthy future."

The U.S. Centers for Disease Control recommends the Tdap vaccine for all children 7 years and older, adolescents from 11-12 years of age, pregnant women (during the 3rd trimester), and adults who have never been received Tdap, also adults should receive a booster dose every 10 years because they are often the source of infection for infants.