Dengusiil Dengue Vaccine
Serum Institute of India (SII) Pvt. Ltd. Dengusiil tetravalent dengue vaccine live attenuated is conducting clinical research in 2024. TOI reported Dengusiil was formulated to contain DENV 1, DENV 3, and DENV 4 serotypes at not less than 2.5 log10 PFUs and DENV 2 at not less than 3 log10 PFUs per single dose of 0.5 mL. Results from a study published in August 2023 reported that the vaccine was highly immunogenic. More than 69% of participants had tetravalent seroconversion, and more than 15 had trivalent seroconversion. These researchers concluded a single dose of dengue vaccine was safe and well tolerated in adults. The vaccine was highly immunogenic, with trivalent or tetravalent seroconversion and seropositivity in most of the participants.
On June 6, 2024, PTI reported an expert committee in India recommended continuing the phase 2 clinical study.
Serum Institute of India is the world's largest vaccine manufacturer by number of doses produced and sold globally.
Dengusill Vaccine Availability
SII says Dengusiil will be commercialized in India, Pakistan, Bangladesh, Nepal, Bhutan, Maldives, and Sri Lanka.
Dengusill Vaccine Indication
Dengue fever virus is transmitted to humans by infected mosquitoes. In 2024, outbreaks were reported in over 100 countries. Dengue is endemic in India, with an overall seroprevalence of 48·7 % (95 % CI 43·5–54·0).
Dengusill Vaccine Side Effects
The phase 1 clinical trial concluded Dengusill was safe and well tolerated with no causally related serious adverse event reported in the study.
Dengusiil Dengue Vaccine Clinical Trials
The Phase I, double-blind, randomized, placebo-controlled trial on 60 healthy individuals aged 18 to 45 years in Australia to assess the safety and immunogenicity of the Dengusiil tetravalent live attenuated dengue vaccine. The study was conducted from December 2019 - June 2021. Results: 60 participants were randomized to receive dengue vaccine (n = 40) or placebo (n = 20). 23 participants (59 %) showed DENV vaccine viremia post-vaccination for any of the four serotypes, with the majority on day 9 and day 11. At baseline, all participants were naïve by dengue PRNT50 for all four serotypes in both the study groups except for four in the dengue vaccine group and two in the placebo group. On day 57, the GMTs of neutralizing antibodies ranged from 66.76 (95 % CI 36.63, 121.69) to 293.84 (95 % CI 192.25, 449.11) for all four serotypes in the dengue vaccine group. On day 181 though the titers declined, they still remained much higher than the baseline. The titers in the placebo group did not change after vaccination. Seroconversion through day 85 ranged from 79.5 % for DENV 1 to 100 % for DENV2 while in the placebo group, no participant showed seroconversion through day 85. Similar trends were noted when PRNT was done using wild DENV serotypes in both vaccine and placebo groups.
