A study among adults, children and infants in Kenya to determine if a new type of glycoconjugate vaccine incorporating a synthetic carbohydrate component is safe and induces immunity against Shigella.
The purpose of this study is to examine the safety and immunogenicity of two doses of the parenteral synthetic carbohydrate-based conjugate vaccine against Shigella flexneri 2a (Shigella flexneri 2a-Tetanus Toxoid15 (SF2a-TT15)) adjuvanted or not with Alhydrogel in infants in an endemic country (Kenya), the target population for the vaccine, using an age-descending approach. In total, 232 participants will be enrolled in the study: 16 adults (18-50 years-old), 16 children (2-5 years-old) and 200 infants (9 months-old +/ 1 mo). The vaccine will be tested in adults first, then in children and eventually in infants in Kenya (where Shigella infection is present), based on the safety/tolerability in each group before to moving to the other. Participants will be randomly assigned to receive the study vaccine or a placebo control (same solution but without the vaccine component). The participants will have to go through all the trial procedures including the 14 visits (3 injections and 11 follow-up) during a 16 months period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
248
Intramuscular injection of experimental vaccine (adjuvanted 10 µg)
Intramuscular injection of experimental vaccine (not adjuvanted 10 µg)
Intramuscular injection of Placebo with alhydrogel
KEMRI / Henry M. Jackson Foundation Medical Research International
Kericho, Kenya
Number, proportion,severity and relatedness of adverse events (AEs) to measure the safety and tolerability of SF2a-TT15 vaccine (2 μg OS and 10 μg OS) in each cohort.
Solicited reactions, AEs, SAEs assessed post-vaccination using targeted physical examinations, vital signs, and clinical laboratory tests
Time frame: 15 months
Analyses of the serum anti-S. flexneri 2a lipopolysaccharide (LPS) IgG antibody response in the infant target population to assess the immunogenicity of the vaccine.
Proportion of responders (4-fold increases over baseline) in serum anti-S. flexneri 2a LPS IgG antibody response
Time frame: 15 months
The number and proportion of responders, the geometric mean titer (GMT), mean fold-rises (compared to baseline), and peak-post-vaccination of the serum bactericidal activity (SBA) antibody (functionality of SF2a-specific IgGs antibodies in infants).
Proportion of responders (4-fold increases over baseline) in serum bactericidal activity (SBA) antibody
Time frame: 15 months
Analyses of the serum anti-S. flexneri 2a LPS Immunoglobulins G (IgG) antibody response in the adult and children cohorts.
Proportion of responders (4-fold increases over baseline) in serum anti-S. flexneri 2a LPS IgG antibody response
Time frame: 15 months
Comparison of the Measle-Rubella (MR) vaccine immune response in SF2a-TT15 vaccinees and placebo groups for the infant cohort.
The antibody titer to the MR vaccine will be compared between SF2a-TT15 vaccinees and placebo groups to assess whether the SF2a-TT15 Shigella vaccine candidate impacts on the immunogenicity of the MR vaccine.
Time frame: 15 months
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Intramuscular injection of the not adjuvanted Placebo
Intramuscular injection of experimental vaccine (adjuvanted 2 µg)
Intramuscular injection of experimental vaccine (not adjuvanted 2 µg)