• Vaccine Name: V180 - Aluminum Hydroxide Alhydrogel™ Adjuvant
• Target Pathogen: Dengue Virus
• Target Disease: Dengue Fever
• Type: 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)
• E from Dengue virus 1 gene engineering:
  • Type: Recombinant protein preparation
  • Description: Truncated versions of E consisting of the N-terminal portion of E (DEN-80E) for all 4 serotypes. (Manoff et al., 2019)
  • Detailed Gene Information: Click Here.
• E protein from Dengue Virus 2 gene engineering:
  • Type: Recombinant protein preparation
  • Description: Truncated versions of E consisting of the N-terminal portion of E (DEN-80E) for all 4 serotypes. (Manoff et al., 2019)
  • Detailed Gene Information: Click Here.
• E from Dengue virus 3 gene engineering:
  • Type: Recombinant protein preparation
  • Description: Truncated versions of E consisting of the N-terminal portion of E (DEN-80E) for all 4 serotypes. (Manoff et al., 2019)
  • Detailed Gene Information: Click Here.
• E from Dengue virus 4 gene engineering:
  • Type: Recombinant protein preparation
  • Description: Truncated versions of E consisting of the N-terminal portion of E (DEN-80E) for all 4 serotypes. (Manoff et al., 2019)
  • Detailed Gene Information: Click Here.
• 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 with aluminum hydroxide adjuvant.

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: The medium-dose V180 formulation with Alhydrogel™ 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. For the medium-dose V180 formulation with Alhydrogel™, 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 medium-dose V180 with Alhydrogel. (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%) Alhydrogel™ recipients. (Manoff et al., 2019)