• Vaccine Name: V180 - unadjuvanted
• Target Pathogen: Dengue Virus
• Target Disease: Dengue Fever
• Type: investigational recombinant subunit vaccine
• Status: Clinical trial
• Host Species for Licensed Use: None
• Antigen: Truncated dengue envelope proteins (DEN-80E) for all 4 serotypes (Manoff et al., 2019)
• Immunization Route: Intramuscular injection (i.m.)
• Description: A recombinant subunit Dengue Virus vaccine that utilizes 80% of the Envelope protein of all 4 serotypes as the antigen (Manoff et al., 2019).

Human Response

• Vaccination Protocol: Among the 98 adults who were randomized into the trial, 57 (58%) were female, 92 (94%) were white, and the mean age was 27 years (range, 18 to 48 years). The gender, race/ethnicity, and age distributions were generally consistent across the treatment groups. The first, second, and third injections of trial product were received by 98 (100%), 94 (96%), and 90 (92%) of randomized participants, respectively. Overall, 83 (85%) participants completed the trial. (Manoff et al., 2019)
• Immune Response: Virus-Neutralizing Antibody:
  
  The unadjuvanted high-dose V180 formulation did not meet the pre-specified definition of a positive immune response, but showed limited evidence of immunogenicity for all 4 serotypes: SCRs ranged from 14.3 to 62.5%, while GMTs ranged from <10 to 20. There was no detectable immune response in the unadjuvanted medium-dose V180 group or the placebo group. For the unadjuvanted high-dose V180 formulation, GMTs for some serotypes increased by Month 3, and then returned to baseline by Month 8 (6 Months Postdose 3). Tetravalent or ≥trivalent responses were exhibited by lower proportions of recipients of high-dose unadjuvanted V180, and by no recipients of medium-dose unadjuvanted V180. In the majority of instances when participants had FRNT50 titers ≥10 for only 3 seotypes, DENV4 was the serotype with a titer <10.
  
  Memory B-Cell Responses:
  
  The mean change ranged from a 0.4-log decrease to 1-log increase among recipients of unadjuvanted high-dose V180, and generally increased <1 log among placebo recipients.
  
  (Manoff et al., 2019)
• Side Effects: For all 4 treatment types, pain/tenderness was the most frequent injection-site AE, followed by erythema and swelling. Fever (temperature ≥38.0°C [100.4°F]) was reported in 0 (0%) unadujuvanted recipients. (Manoff et al., 2019)