Tuberculosis Clinical Trial
Official title:
A Randomized, Double-blind, Dose-escalation Clinical Trial of the Safety, Reactogenicity and Immunogenicity of MTBVAC Compared to BCG Vaccine SSI, in Newborns Living in a Tuberculosis Endemic Region With a Safety Arm in Adults
Randomized, controlled, double blind clinical trial in 2 stages (adult stage, infant stage). The first stage includes 18 HIV uninfected, QFT negative, BCG vaccinated, adult participants, randomized 1:1 to receive BCG Vaccine SSI or MTBVAC at equivalent dose (5x10E05 CFU/0.1mL) (n=9 in each group). Upon favourable safety review by the DSMB for all 18 adults up to day 28 after study vaccination, the second stage will commence in thirty-six (36) HIV unexposed, BCG naïve, newborn infants, randomized 1:3 to receive BCG Vaccine SSI or MTBVAC at one of three different dose levels ( (n=9 in each group).
Adult Stage:
Eighteen (18) adult participants will be recruited and randomized equally into 1 of 2 study
groups (n=9 per group): MTBVAC highest dose group (approx. 5x10E05 CFU/0.1mL) or BCG SSI
standard human dose (approx. 5x10E05 CFU/0.1mL).
Safety assessments will be conducted at D0, D7, D14, D28, D56, D90, and D180 post study
vaccination. A diary card will be used to collect solicited local, regional, and systemic
adverse event data from D0 through D14. Reactogenicity data will be collected at each study
visit. Non-serious adverse events will be collected through D28. Serious adverse events will
be collected during the entire study period.
Infant Stage:
Thirty-six (36) infant participants will be recruited, randomized and allocated into 4 groups
of 9 participants: BCG (single dose level 2.5 x 10E05 CFU/0.05 mL); or MTBVAC at three
different dose levels (lowest 2.5x10E03 CFU/0.05mL, middle 2.5x10E04 CFU/0.05mL, highest
2.5x10E05 CFU/0.05mL).
Vaccination of neonates will be staggered by cohorts on a 3 verum : 1 control basis to allow
gradual evaluation of safety and reactogenicity, as follows:
Cohort 1: 9 who receive the lowest MTBVAC dose level and 3 BCG control; Cohort 2: 9 who
receive the highest MTBVAC dose level and 3 BCG control; Cohort 3: 9 who receive the highest
MTBVAC dose level and 3 BCG control.
All AEs and biochemical and haematological parameters (safety data) collected up until Day 28
after vaccination of the last subject of each cohort will be reviewed by DSMB to authorize
progression to the next group. Safety assessments will be conducted at D0, D7, D14, D28, D70,
D90, D180 and D360 post study vaccination. A diary card will be used to collect solicited
local, regional, and systemic adverse event data from D0 through D14. Reactogenicity data
will be collected at each study visit. Non-serious adverse events will be collected through
D28. Serious adverse events will be collected during the entire study period. Unscheduled
follow-up face-to-face visits will be performed as needed for safety and adverse event
management.
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