Healthy volunteers (prevention of invasive nontyphoidal Salmonella disease and typhoid fever)
Conditions
Interventions
Product Name: iNTS-TCV vaccine
Product Code: GSK4077164A
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Not Applicable
Current Sponsor code: 2363-GMMA
Other descriptive name: Salmo
Sponsors
GlaxoSmithKline Biologicals SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participants, who, in the opinion of the Investigator, can and will comply with the requirements of the protocol. - Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study-specific procedure. - Healthy participants as established by medical history, clinical examination, and laboratory assessment. - Participant satisfying screening requirements. - A male or female between and including 18 and 50 years of age at the time of the first study intervention administration. - Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, or post-menopause. - Female participants of childbearing potential may be enrolled in the trial if the participant: o Has practiced adequate contraception for 1 month prior to study intervention administration, and o Has a negative pregnancy test on the day of study intervention administration, and o Has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series. - Blood sample for simultaneous follicle-stimulating hormone (FSH) and estradiol levels may be collected at the discretion of the Investigator to confirm non-reproductive potential according to local laboratory reference range. - Genetic testing for HLA-B27 will be performed at Screening and only participants with a negative result will be allowed to participate in the study*. *Only for Stage 1. - For Malawi (Stage 2), the participant lives in Blantyre and has agreed to remain in Blantyre for the study duration. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 155 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Medical Conditions - Known exposure to S. Typhi and nontyphoidal Salmonella confirmed by blood culture during the period starting 3 years prior to first study intervention administration confirmed using past medical history. - History of any reaction or hypersensitivity associated with any component of the study interventions. - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. - Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests. - Recurrent history or uncontrolled neurological disorders or seizures. - Any clinically significant* hematological and/or biochemical laboratory abnormality. * The Investigator should use his/her clinical judgment to decide which abnormalities are clinically significant from the panel of tests in the list of safety assays. - Clinical conditions representing a contraindication to IM injections and/or blood draws. - Any behavioral or cognitive impairment or psychiatric disease that in the opinion of the Investigator, may interfere with the participant’s ability to participate in the study. - Confirmed positive COVID-19 polymerase chain reaction or lateral flow test during the period starting 28 days before the first administration of study vaccines (Day -28 to Day 1). - Acute or chronic illness which may be severe enough to preclude participation. - Any other clinical condition that, in the opinion of the Investigator, might pose additional risk to the participant due to participation in the study. - All medical conditions will be assessed by the Investigator who may use his/her discretion to decide if the participant meets the exclusion criteria. Prior/Concomitant Therapy - History of receiving any typhoid vaccine (Ty21a, Vi capsular polysaccharide, or TCV) in the participant’s life. - History of receiving any investigational iNTS or GMMA vaccines in the participant’s life. - Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days (Days -30 to 1) before the first dose of study interventions, or their planned use during the study period. - A vaccine not foreseen by the study protocol administered during the period starting at 14 days before the first dose and ending 28 days after the last dose of study interventions administration*, with the exception of flu vaccines or COVID-19 vaccine. *In case emergency mass vaccination for an unforeseen public health threat (eg, a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly. When regulations allow, the recommended time intervals for administration of these vaccines are at least 7 days before or 7 days after (at least 14 days before or 14 days after in case of live vaccines) each dose of study intervention administration. - Administration of long-acting immune-modifying drugs at any time during the study period (eg, infliximab). - Administration of Ig and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study interventions or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the safety and reactogenicity profile of GSK Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid conjugate vaccine (iNTS-TCV) vaccine in healthy European/African adults;Secondary Objective: • To evaluate the long term safety profile of GVGH iNTS-TCV vaccine in healthy European/African adults • To evaluate the immunogenicity profile of GVGH iNTS-TCV vaccine in healthy European adults • To evaluate seroresponse with the GVGH iNTS-TCV vaccine after each study intervention administration in healthy European adults • To evaluate the immunogenicity profile of GVGH iNTS-TCV vaccine in healthy African adults • To evaluate seroresponse with the GVGH iNTS-TCV vaccine after each study intervention administration in healthy African adults ;Primary end point(s): 1. Number of participants in Europe/Stage 1 with solicited administration site events after the first study intervention administration 2. Number of participants in Europe/Stage 1 with solicited administration site events after the second study intervention administration 3. Number of participants in Europe/Stage 1 with solicited administration site events after the third study intervention administration 4. Number of participants in Europe/Stage 1 with solicited systemic events after the first study intervention administration 5. Number of participants in Europe/Stage 1 with solicited systemic events after the second study intervention administration 6. Number of participants in Europe/Stage 1 with solicited systemic events after the third study intervention administration 7. Number of participants in Europe/Stage 1 with unsolicited adverse events (AEs) after the first study intervention administration 8. Number of participants in Europe/Stage 1 with unsolicited AEs after the second study intervention administration 9. Number of participants in Europe/Stage 1 with unsolicited AEs after the third study intervention administration 10. Number of participants in | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of participants with SAEs 2. Number of participants with AEs/SAEs leading to withdrawal from the study 3. Anti-serotype specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) in participants in Europe/Stage 1, and between group ratios 4. Anti-serotype specific IgG within-participant geometric mean ratios (GMRs) in participants in Europe/Stage 1 5. Number of participants in Europe/Stage 1 achieving, for each antigen (Ag), at least a 4-fold rise in anti-serotype specific IgG antibody concentration 6. Number of participants in Europe/Stage 1 with Anti-S. typhi Vi Ag IgG antibody concentrations equivalent to = 4.3 micrograms per milliliter (µg/mL) 7. Anti-serotype specific IgG GMCs in participants in Africa/Stage 2, and between-group ratios 8. Anti-serotype specific IgG within-participant GMRs in participants in Africa/Stage 2 9. Number of participants in Africa/Stage 2 achieving, for each Ag, at least a 4 fold rise in anti serotype specific IgG antibody concentration 10. Number of participants in Africa/Stage 2 with Anti-S. Typhi Vi Ag IgG antibody concentrations equivalent to = 4.3 µg/mL;Timepoint(s) of evaluation of this end point: 1,2. From 28 days after the third study intervention administration (Day 197) up to study end (Day 337) 3, 6, 7, 10. At Days 1, 57 and 169 (before each study intervention administration) and at Days 29, 85 and 197 (28 days after each study intervention administration) 4, 8. At 28 days after each study intervention administration compared to each study intervention administration baseline (Day 29 versus Day 1, Day 85 versus Day 57 and Day 197 versus Day 169) 5, 9. At Days 29, 85 and 197 (28 days after each study intervention administration) compared to Day 1 (first study intervention administration baseline) | — |
Countries
Belgium, Malawi
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals SA
Outcome results
None listed