First-in-Human, Randomised, Dose-Finding Single Center Study to evaluate three dose levels of a novel malaria vaccine, MSP3-CRM-Vac4All/ Alhydrogel® : 3 µg, 10 µg and 30 µg
A total of 42 healthy male and female participants aged 18 to 55 years will be enrolled and randomized into one of three cohorts. Three dose levels of a novel malaria vaccine, MSP3-CRM-Vac4All/ Alhydrogel®, will be evaluated: 3 µg, 10 µg and 30 µg total MSP3-CRM197 conjugate protein (corresponding to 1, 3, 10 µg MSP3 protein) administered as a primary series of three intramuscular (IM) injections, given on day 1, day 28, and day 56.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
42
The Investigational Medicinal Product (IMP) or in short Investigational Product (IP) is the MSP3-CRM-Vac4All/ Alhydrogel® vaccine
Malaria Research and Training Center (MRTC), University of Sciences Techniques and Technologies of Bamako, Mali
Bamako, Mali
To measure the frequency and grade of each solicited local and systemic reactions during the 7 days following each vaccination of MSP3-CRM-Vac4All/ Alhydrogel® for each dose levels (3 µg, 10 µg and 30 µg), administered on Day 1, 28 and 56
Frequency and grade of each solicited local and systemic reactions during the 7 days following each vaccination, for each treatment group.
Time frame: Over 7 days following vaccination
To measure the frequency and grade of any unsolicited AEs during the 28 days following each vaccination of MSP3-CRM-Vac4All/ Alhydrogel® for each dose levels (3 µg, 10 µg and 30 µg), administered on Day 1, 28 and 56
Frequency and grade of any unsolicited AEs during the 28 days following each vaccination, for each treatment group.
Time frame: Over 28 days following vaccination
To measure the frequency of Serious Adverse Events (AEs) following the first dose of the vaccine until the last follow-up visit.
Frequency of Serious Adverse Events (AEs) observed from the first dose of the vaccine until the last follow-up visit.
Time frame: Over 12 month following first vaccination
To measure the number of subjects with Adverse Events (AEs) during the 28 days following each vaccination, for each dose levels (3 µg, 10 µg and 30 µg), administered on Day 1, 28 and 56
Number of subjects with Adverse Events (AEs) during the 28 days following each vaccination, for each treatment group.
Time frame: Over 28 days following vaccination
To measure the frequency and grade of each solicited systemic and local reaction during the 7 days following each vaccination, for the combined active vaccination group
Frequency and grade of solicited systemic and local reaction during the 7 days following each vaccination, for the combined active vaccination group.
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Time frame: 7 days following vaccination
To measure the frequency and grade of each unsolicited systemic and local reaction during the 28 days for the combined active vaccination group of each dose levels (3 µg, 10 µg and 30 µg), administered on Day 1, 28 and 56
Frequency and grade of unsolicited systemic and local reaction during the 28 days following each vaccination, for the combined active vaccination group.
Time frame: 28 days following vaccination
To measure the number of subjects with Adverse Events during the 28 days each vaccination, for the combined active vaccination group.
the number of subjects with Adverse Events during the 28 days each vaccination, for the combined active vaccination group.
Time frame: 28 days after vaccination
To measure the seroresponse rates (defined as the proportion with 2, 3, and 4-fold rise in titre of anti-MSP3 antibodies) determined 28 days after each vaccination as compared to baseline (Day 1), by treatment group.
Seroresponse rates (defined as the proportion with 2, 3, and 4-fold rise in titre of anti-MSP3 antibodies) determined 28 days after each vaccination as compared to baseline (Day 1), by treatment group.
Time frame: 28 days after vaccination
To measure the Geometric mean titres (GMT) of anti-MSP3 antibodies 28 days after each vaccination, by treatment group (total IgG and IgG sub classes).observed during the 28 days following each vaccination, for the combined active vaccination group.
Geometric mean titres (GMT) of anti-MSP3 antibodies 28 days after each vaccination, by treatment group (total IgG and IgG sub classes).
Time frame: 28 days after each vaccination
To measure Geometric mean fold increase (GMFI) of anti-MSP3 antibodies determined 28 days after each vaccination as compared to baseline (total IgG and IgG sub classes).
Geometric mean fold increase (GMFI) of anti-MSP3 antibodies determined 28 days after each vaccination as compared to baseline (total IgG and IgG sub classes).
Time frame: 28 days after each vaccination
To measure the Proportion of participants with seroresponse across all time points
Proportion of participants with seroresponse across all time points
Time frame: one month, 3 months, 6 months and 12 months after first vaccination
To measure the Seroresponse rates, GMTs and GMFI of anti-MSP3 antibodies 3, 6 and 12 months after first vaccination (total IgG and IgG sub classes).
Seroresponse rates, GMTs and GMFI of anti-MSP3 antibodies 3, 6 and 12 months after first vaccination (total IgG and IgG sub classes).
Time frame: 3, 6 and 12 month after first vaccination
To measureIgG ability to recognize the native protein on merozoite by using Western Blot (WB) and IFAT methods
IgG ability to recognize the native protein on merozoite by using Western Blot (WB) and IFAT methods
Time frame: one month after each vaccination and 3 months, 6 months and 12 months after first vaccination