This is a phase 1, first-in-human, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and immunogenicity of VAX-A1 in healthy adults 18-40 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
80
0.5mL of placebo (normal saline) will be administered into the deltoid muscle
0.5mL of the low dose VAX-A1 will be administered into the deltoid muscle
0.5mL of the mid dose VAX-A1 will be administered into the deltoid muscle
Fusion Clinical Research
Adelaide, South Australia, Australia
RECRUITINGFrequency of solicited local reactions (redness, swelling, and pain at injection site)
Time frame: up to 7 days after each vaccination
Frequency of solicited systemic adverse events (AE) (fever, headache, fatigue, muscle pain, rash, joint pain, nausea/vomiting, diarrhea)
Time frame: up to 7 days after each vaccination
Frequency of laboratory abnormalities identified from protocol-scheduled safety laboratory assessments at 7 days after each vaccination and reported as AE
Time frame: 7 days after each vaccination
Frequency of unsolicited AE
Time frame: up to 30 days after each vaccination
Frequency of medically attended AE (MAAE)
Time frame: Up to 8 months after first vaccination
Frequency of new onset chronic illness (NOCI)
Time frame: up to 8 months after the first vaccination
Frequency of serious adverse events (SAE)
Time frame: from screening through up to 8 months after first vaccination
Occurrence of AE of special interest (AESI) (acute rheumatic fever [ARF], acute carditis [AC], and acute glomerulonephritis [AGN])
Time frame: up to 8 months after the first vaccination
Median value of each safety laboratory parameter assessed 7 days after each vaccination
Time frame: 7 days after each vaccination
Median change from baseline to 7 days after each vaccination for each safety laboratory parameter
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0.5mL of the high dose VAX-A1 will be administered into the deltoid muscle
Time frame: 7 days after each vaccination
Serum IgG geometric mean titer (GMT) at each scheduled immunogenicity sample collection visit for each vaccine antigen (SLO, C5a pep, SpyAD, GAC)
Time frame: Prior to each vaccination, 1 month after each vaccination and Month 8
Serum IgG geometric mean fold rise (GMFR) from baseline to each scheduled post-vaccination immunogenicity sample collection visit for each vaccine antigen (SLO, C5a pep, SpyAD, GAC)
Time frame: Prior to each vaccination, 1 month after each vaccination and Month 8
Percentage of participants achieving serum IgG ≥2-fold increase from baseline at each scheduled post-vaccination immunogenicity sample collection visit for each vaccine antigen (SLO, C5a pep, SpyAD, GAC)
Time frame: 1 month after each vaccination and Month 8
Percentage of participants with serum IgG ≥ LLOQ of the assay at each scheduled immunogenicity sample collection visit for each vaccine antigen (SLO, C5a pep, SpyAD, GAC)
Time frame: Prior to each vaccination, 1 month after each vaccination and Month 8