The current clinical study will evaluate the GVGH Quadrivalent Pan-Salmonella vaccine for the first time in healthy adults in Africa. The purpose of the current Phase 1 study is to evaluate the safety, reactogenicity, and the immune response induced by the Pan-Salmonella vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
196
Participants receive low dose of the Pan-Salmonella-with-Alum.
Participants receive full dose of the Pan-Salmonella-with-Alum.
Participants receive low dose of the Pan-Salmonella-without-Alum.
Participants receive full dose of the Pan-Salmonella-without-Alum.
Participants receive Typhoid Vi conjugate vaccine as control
Participants receive Placebo (saline solution) as control.
GSK Investigational Site
Bloemfontein, South Africa
RECRUITINGNumber of participants with solicited administration site events
Assessed solicited administration site events will be pain, redness and swelling.
Time frame: From Day 1 to Day 7
Number of participants with solicited administration site events
Time frame: From Day 61 to Day 67
Number of participants with solicited administration site events
Time frame: From Day 181 to Day 187
Number of participants with solicited systemic events
Assessed solicited systemic events will be fever, headache, myalgia, arthralgia and fatigue.
Time frame: From Day 1 to Day 7
Number of participants with solicited systemic events
Time frame: From Day 61 to Day 67
Number of participants with solicited systemic events
Time frame: From Day 181 to Day 187
Number of participants with unsolicited events
An unsolicited adverse event (AE) is an AE that was either not included in the list of solicited AEs, or could. be included in the list of solicited AEs but with an onset outside the specified period of. follow-up for solicited AEs. Unsolicited AEs must have been communicated by participants who have signed informed consent. Unsolicited AEs include serious and non-serious AEs.
Time frame: From Day 1 to Day 30
Number of participants with unsolicited events
Time frame: From Day 61 to Day 91
Number of participants with unsolicited events
Time frame: From Day 181 to Day 211
Number of participants with serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that, at any dose, results in persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening, or results in death.
Time frame: From Day 1 to Day 211
Number of participants with adverse events (AEs) or SAEs leading to withdrawal from the study or discontinuation of study intervention
Time frame: From Day 1 to Day 211
Number of participants with changes from baseline or changes from normal values for hematological, renal, and hepatic panels test results
Time frame: At Day 8
Number of participants with changes from baseline or changes from normal values for hematological, renal, and hepatic panels test results
Time frame: At Day 68
Number of participants with changes from baseline or changes from normal values for hematological, renal, and hepatic panels test results
Time frame: At Day 188
Number of participants with serious adverse events (SAEs)
Time frame: From Day 211 to Day 361
Number of participants with AEs/SAEs leading to withdrawal from the study or discontinuation of study intervention
Time frame: From Day 211 to Day 361
Geometric mean concentration (GMC) of anti-serotype specific immunoglobulin G (IgG) antibody
The GMC will be determined using Enzyme-linked immunosorbent assay (ELISA).
Time frame: Pre-intervention at Day 1, Day 61 and Day 181
Adjusted GMC of anti-serotype specific IgG antibody
Time frame: Pre-intervention at Day 1, Day 61 and Day 181
GMC of anti-serotype specific IgG antibody
Time frame: At Day 31, Day 91 and Day 211
Adjusted GMC of anti-serotype specific IgG
Time frame: At Day 31, Day 91 and Day 211
Number of participants with anti-serotype specific IgG antibody concentration fold increase
At least a 4-fold rise will be evaluated.
Time frame: At Day 31, Day 91 and Day 211 compared with baseline (Day 1)
Number of participants with Anti-Vi Ag IgG antibody concentrations
The concentration considered will be equivalent to ≥4.3 microgram per milliliter (μg/mL).
Time frame: Pre-dose at Day 1, Day 61 and Day 181
Number of participants with Anti-Vi Ag IgG antibody concentrations
The concentration considered will be equivalent to ≥4.3 μg/mL
Time frame: At Day 31, Day 91 and Day 211
Number of participants with Anti-Vi Ag IgG antibody concentrations
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The concentration considered will be ≥2.0 μg/mL
Time frame: Pre-dose at Day 1, Day 61 and Day 181
Number of participants with Anti-Vi Ag IgG antibody concentrations
The concentration considered will be ≥2.0 μg/mL.
Time frame: At Day 31, Day 91 and Day 211