The purpose of this study is to assess the safety of 3 doses of 2 new Strep A vaccine formulations, one with an Alum adjuvant, and the other with AS37 adjuvant. The Strep A vaccine will be tested for the first time in humans, in healthy young adults 18 to 25 years of age. The study will also assess if the vaccines have any immediate reactions and if they induce an immune response. A low, medium, and high dose of each formulation of the vaccine will be assessed in sequence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
108
Low dose Strep A Alum vaccine will be administered intramuscularly (IM)
Medium dose Strep A Alum vaccine will be administered IM
High dose Strep A Alum vaccine will be administered IM
Low dose Strep A AS37 vaccine will be administered IM
Medium dose Strep A AS37 vaccine will be administered IM
High dose Strep A AS37 vaccine will be administered IM
Strep A Alum Placebo will be administered IM
GSK Investigational Site
Botany, New South Wales, Australia
RECRUITINGGSK Investigational Site
Camberwell, Victoria, Australia
RECRUITINGNumber of participants with solicited administration site events
Solicited administration-site events include pain, redness, and swelling at the administration site.
Time frame: Up to 7 days after each study intervention administration occurring at Day 1, Day 31, and Day 121
Number of participants with solicited systemic events
Solicited systemic events include fever, headache, myalgia (muscle pain), arthralgia (joint pain), and fatigue (tiredness). Fever is defined as body temperature equal to or above 38.0°C. The preferred location for measuring temperature is the axilla.
Time frame: Up to 7 days after each study intervention administration occurring at Day 1, Day 31, and Day 121
Number of participants with unsolicited adverse events (AEs)
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs include both serious and nonserious AEs.
Time frame: Up to 30 days after each study intervention administration occurring at Day 1, Day 31, and Day 121
Number of participants with laboratory abnormalities
Time frame: 7 days after each study intervention administration at Day 8, Day 38, and Day 128
Number of participants with adverse events of special interest (AESIs)
AESIs include potential immune-mediated disorders (pIMDs) and rheumatic carditis.
Time frame: From Day 1 to Day 301
Number of participants with serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity, abnormal pregnancy outcomes, or other medically significant events.
Time frame: From Day 1 to Day 301
Number of participants with AEs leading to withdrawal from the study or to discontinuation of study vaccine
Time frame: From Day 1 to Day 301
Geometric mean concentrations of immunoglobulin G (IgG) against Streptolysin O (SLO), S. pyogenes Cell Envelope Protease (SpyCEP), S. pyogenes Adhesion and Division protein (SpyAD), and Group A Carbohydrate (GAC), as measured by multiplex immunoassay
Time frame: Before each study intervention (Day 1, Day 31, and Day 121), 30 days after each study intervention (Day 31, Day 61, and Day 151), and 7 days and 6 months after the third study intervention administration (Days 128 and 301, respectively)
Geometric mean fold increase of IgG against SLO, SpyCEP, SpyAD, and GAC, as measured by multiplex immunoassay
Time frame: 30 days after each study intervention administration compared to before each study intervention administration (Day 31 versus Day 1, Day 61 versus Day 31, and Day 151 versus Day 121) and to before study intervention administration (Day 1)
Number of participants with greater than or equal to (>=) 2-fold and >=4 fold increase in IgG antibody concentration against SLO, SpyCEP, SpyAD, and GAC, as measured by multiplex immunoassay
Time frame: 30 days after each study intervention administration (Day 31, Day 61, and Day 151) compared to before study intervention administration (Day 1)
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