The purpose of this study is to evaluate the safety, reactogenicity, and immune response of the SpFN COVID-19 vaccine with Army Liposomal Formulation QS21 (ALFQ) adjuvant in healthy adults ages 18-55.
This clinical protocol outlines a first-in-human study of the safety, tolerability, and immunogenicity of different doses of SpFN\_1B-06-PL + ALFQ prophylactic vaccine against COVID-19 in healthy adults. The experimental vaccine in this study contains 2 parts: the vaccine (called SpFN\_1B-06-PL) and an experimental adjuvant called ALFQ. An adjuvant is a substance added to vaccines that can help to make the vaccine more effective by improving the immune response or causing the immune response to last longer. The experimental vaccine in this study does not contain the virus and cannot cause you to become infected with the COVID-19 disease. A total of 72 healthy adult participants (age range 18-55) will be enrolled in this study. Participants will be enrolled into one of three study arms: Arm 1: 25 µg of SpFN\_1B-06-PL vaccine with 0.5 mL ALFQ adjuvant in a total 1.0 mL injection volume (20 participants) or Placebo (4 participants) on Study Days 1, 29, and 181. Arm 2: 50 µg of SpFN\_1B-06-PL vaccine with 0.5 mL ALFQ adjuvant in a total 1.0 mL injection volume (20 participants) or Placebo (4 participants) on Study Days 1, 29, and 181. Arm 3: 50 µg of SpFN\_1B-06-PL vaccine with 0.5 mL ALFQ adjuvant in a total 1.0 mL injection volume (20 participants) or Placebo (4 participants) on Study Days 1 and 181. Participants will: * Be randomly assigned to get either the experimental COVID-19 vaccine or a placebo * Receive 2 or 3 vaccine or placebo injections in the same arm muscle * Record any side effects that they may experience for 7 days after receiving the injections. * Have blood, nose swabs, and saliva samples collected at each visit. * Have urine samples collected for pregnancy testing (females only). * Undergo medical and physical examinations. * Answer questions about potential exposures to COVID-19 in their daily life. The duration of this study will be for about 18 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
29
SpFN\_1B-06-PL will be provided in a sterile, 2 mL single-use vial at 0.7 mL/vial, 90-110 ug/mL; ALFQ will be provided in a sterile 3 mL vial at 0.6 mL/vial
Normal saline will be provided in a sterile, single-use 10 mL vial
SpFN\_1B-06-PL will be provided in a sterile, 2 mL single-use vial at 0.7 mL/vial, 90-110 ug/mL; ALFQ will be provided in a sterile 3 mL vial at 0.6 mL/vial
WRAIR Clinical Trials Center
Silver Spring, Maryland, United States
Number of participants with local and systemic reactions
Post-vaccination reactions including erythema, induration, pain/tenderness, swelling, limitation of arm movement, fever, tiredness, chills, rash, myalgia, arthralgia, nausea, and headache.
Time frame: Day 0 to 7 post vaccination
Incidents of treatment-adverse events as assessed by FDA Toxicity grading scale.
Number of participants with treatment related adverse events on Day 0 through day 546.
Time frame: Day 0 to 546 post vaccination
Number of participants with humoral immune response at Study Day 43 (+/- 2).
Number of participants with quantitative humoral immune response at Day 43, two weeks after the second SpFN\_1B-06-PL + 0.5 mL ALFQ vaccine administration in Arms 1 \& 2 and six weeks after the first administration in Arm 3.
Time frame: Day 43 (+/- 2 days)
Number of participants with binding antibody response rate
The proportion of participants with detectable binding antibody responses, at baseline and at Study Days 8, 15, 29, 43, and 57.
Time frame: Days 8, 15, 29, 43, and 57.
Number of participants with neutralizing antibody response rate
The proportion of participants with neutralizing antibody titers (NAb) titers at ≥50% neutralization cutoff at the lowest level of dilution that optimizes interpretation at baseline and at Study Days 8, 15, 29, 43, and 57.
Time frame: Days 8, 15, 29, 43, and 57.
Number of participants with ACE-2 binding inhibition
The proportion of participants with ACE-2 binding inhibition following SpFN\_1B-06-PL + ALFQ vaccination.
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Time frame: Day 0 to 57 post vaccination