Clinical Trial: RNActive® Rabies Vaccine (CV7201) in Healthy Adults

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase I Safety and Immunogenicity Trial of an Investigational RNActive® Rabies Vaccine (CV7201) in Healthy Adults

Brief Summary: The purpose of this trial is to assess the safety and immunogenicity of an investigational RNActive® rabies vaccine (CV7201) in healthy adults.

Detailed Summary:
Sponsor: CureVac AG

Current Primary Outcome: Number of drug related adverse events/serious adverse events (AEs/SAEs) [ Time Frame: up to 210 days ]

Intraindividually SAEs are collected and reported from ICF signature (pre-screening visit) to the end-of-study visit V9 (= day 91 in cohorts 1 - 4, day 120 in cohorts 5 - 13) . The time from pre-screening to V1 (day 0, 1st vaccination) may vary from 15 to 90 days, hence the duration of SAE monitoring may vary depending on the cohort number and the individual interval between pre-screening visit (Vps) and first vaccination (V1) between 106 and 210 days.

IMP-related AEs/SAEs are recorded from the first vaccination (visit V1 = day0) to visit V9, day 91/120).



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The lowest CV7201 dose to elicit rabies VNTs ≥ 0.5 IE/ml [ Time Frame: Rabies VNTs measured 14 days after the 3rd vaccination (Visit 8) ]
    Rabies virus neutralizing titers (VNTs) measured in serum blood samples taken 14 days after the the last vaccination (Visit 8). V8 in cohorts 1 to 4 =day 42 after the first vaccination; V8 in cohorts 5 - 13 = day 70 after the first vaccination.
  • Number of treatment discontinuation due to IMP-related AEs/SAEs [ Time Frame: 28 days (for cohorts 1 - 4) or 56 days (for cohorts 5 - 13), i.e. from visits V1 to V5 ]

    Number of subjects discontinued from treatment after the first or second vaccination due to vaccination-related reactions or AEs/SAEs.

    Period for observation in order to decide on withdrawal of subjects from next vaccination starts with Visit 1 (day 0, first vaccination) and lasts until the day of the third scheduled vaccination (pre-vaccination examination).



Original Secondary Outcome: Same as current

Information By: CureVac AG

Dates:
Date Received: August 22, 2014
Date Started: October 2013
Date Completion: March 2019
Last Updated: August 12, 2016
Last Verified: August 2016