Clinical Trial: Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Multivalent Recombinant OspA Vaccine Candidate Against Lyme Borreliosis, In Healthy Adults Aged Below 40 Years

Brief Summary:

Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy adults below 40 years of age.

180 subjects will be enrolled in 6 treatment groups (different doses; different formulation: with/without adjuvant); vaccinations will be given I.M.(intramuscular) into the deltoid region on Days 0, 28 and 56. Study participants will be followed up until one year after first vaccination.


Detailed Summary:

This is an observer-blind, partially randomized, multi-center dose escalation Phase I study which aims to assess the safety, immunogenicity and dose response of VLA15 in healthy adults aged below 40 years.

Overall 180 subjects will be enrolled in 6 treatment groups: VLA15 12µg with and w/o (without) Alum, VLA15 48µg with and w/o Alum, VLA15 90µg with and w/o Alum.

For the first 24 subjects, the study will be open-label and subjects will not be randomized but included into a staggered dose escalation scheme for safety precaution. Thereafter, the study will be conducted observer-blind in respect to the investigators and site staff involved in clinical evaluation of subjects, subjects will be blinded as well. Remaining 156 subjects will be randomized into the 6 treatment groups. I.M. vaccinations are administered on Days 0, 28 and 56 into deltoid region of the non-dominant arm.

The study will investigate the safety and tolerability as well as immunogenicity of VLA15. The primary objective addresses safety and tolerability of the vaccine up to three months after enrollment, i.e. 84 days after first vaccination. The study includes 1 screening visit and 8 outpatient visits from day 0 through day 365. In addition, safety phone calls will be performed.


Sponsor: Valneva Austria GmbH

Current Primary Outcome:

  • Rate of SAEs to Day 84 [ Time Frame: up to Day 84 (Month 3) after first vaccination ]
  • Rate of related SAEs to Day 84 [ Time Frame: up to Day 84 (Month 3) after first vaccination ]
  • Rate of any solicited or unsolicited Grade 3 or Grade 4 events up to Day 84 [ Time Frame: up to Day 84 (Month 3) after first vaccination ]
  • Rate of any solicited or related unsolicited Grade 3 or Grade 4 events up to Day 84 [ Time Frame: up to Day 84 (Month 3) after first vaccination ]
  • Rate of solicited local AEs within 7 days after each and after any vaccination up to Day 84 [ Time Frame: up to Day 84 (Month 3) after first vaccination ]
  • Rate of solicited systemic AEs within 7 days after each and after any vaccination up to Day 84 [ Time Frame: up to Day 84 (Month 3) after first vaccination ]
  • Rate of unsolicited AEs to Day 84, including clinically significant laboratory parameter changes [ Time Frame: up to Day 84 (Month 3) after first vaccination ]
  • Rate of related unsolicited AEs to Day 84, including clinically significant laboratory parameter changes [ Time Frame: up to Day 84 (Month 3) after first vaccination ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • ^Rate of SAEs during the entire study period [ Time Frame: up to Day 365 (Month 12) ]
  • Rate of related SAEs during the entire study period [ Time Frame: up to Day 365 (Month 12) ]
  • Rate of any solicited or unsolicited Grade 3 or Grade 4 AEs during the entire study period [ Time Frame: up to Day 365 (Month 12) ]
  • Rate of any solicited or related unsolicited Grade 3 or Grade 4 AEs during the entire study period [ Time Frame: up to Day 365 (Month 12) ]
  • Rate of unsolicited AEs during the entire study period [ Time Frame: up to Day 365 (Month 12) ]
  • Rate of related unsolicited AEs during the entire study period [ Time Frame: up to Day 365 (Month 12) ]
  • Changes in laboratory parameters and rate of subjects with abnormal laboratory parameter [ Time Frame: up to Day 365 (Month 12) ]
  • GMTs (Geometric Mean Titre) for IgG against each OspA serotype ST1 to ST6, determined by ELISA [ Time Frame: Day 0, 28, 56, 84, 180, 236 and 365 ]
  • SCRs (Seroconversion Rate, defined based on fold increase of each OspA serotype specific IgG (ST1 to ST6) as compared to baseline) [ Time Frame: Day 28, 56, 84, 180, 236 and 365 ]
  • GMFR (Geometric Mean of the fold rise as compared to baseline) for IgG against each OspA serotype ST1 to ST6, determined by ELISA [ Time Frame: Day 28, 56, 84, 180, 236 and 365 ]


Original Secondary Outcome: Same as current

Information By: Valneva Austria GmbH

Dates:
Date Received: December 21, 2016
Date Started: January 2017
Date Completion: September 2018
Last Updated: March 21, 2017
Last Verified: March 2017