PHASE 1 SARS-COV-2-Spike-Ferritin-Nanoparticle (SpFN) Vaccine With ALFQ Adjuvant for Prevention of COVID-19
Randomized Double-blind Placebo-Controlled Study in Healthy Adults to Evaluate Safety/Tolerability/Immunogenicity of Ranging Doses SARS-COV-2SPFN_1B-06-PL With Army Liposomal Formulation QS21 (ALFQ) for Prevention of COVID-19
4 other identifiers
interventional
29
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2021
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2021
CompletedFirst Posted
Study publicly available on registry
March 5, 2021
CompletedStudy Start
First participant enrolled
April 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2023
CompletedJune 17, 2025
June 1, 2025
2 years
March 3, 2021
June 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Day 43 (+/- 2 days)
Secondary Outcomes (3)
Number of participants with binding antibody response rate
Days 8, 15, 29, 43, and 57.
Number of participants with neutralizing antibody response rate
Days 8, 15, 29, 43, and 57.
Number of participants with ACE-2 binding inhibition
Day 0 to 57 post vaccination
Study Arms (6)
1A: 25 µg of SpFN + ALFQ on Days 1, 29 and 181.
EXPERIMENTALUp to 20 participants will receive 25 µg of SpFN\_1B-06-PL vaccine with 0.5 mL ALFQ adjuvant in a total 1.0 mL injection volume.
1B: Placebo (Sodium chloride, USP, for injection (0.9% NaCl) on Days 1, 29 and 181.
PLACEBO COMPARATOR4 participants will receive 1.0mL of normal saline as Placebo on Study Days 1, 29, and 181.
2A: 50 µg of SpFN + ALFQ on Days 1, 29, and 181.
EXPERIMENTALUp to 20 participants will receive 3 intramuscular injections of: 50 ug of SpFN\_1B-06-PL with 0.5 mL ALFQ adjuvant.
2B: Placebo (Sodium chloride, USP, for injection (0.9% NaCl) on Days 1, 29, and 181.
PLACEBO COMPARATOR4 participants will receive 1.0mL of normal saline as Placebo on Study Days 1, 29, and 181.
3A: 50 µg of SpFN + ALFQ on Days 1 and 181.
EXPERIMENTALUp to 20 participants will receive 2 intramuscular injections of: 50 ug of SpFN\_1B-06-PL with 0.5 mL ALFQ adjuvant.
3B: Placebo (Sodium chloride, USP, for injection (0.9% NaCl) on Days 1 and 181.
PLACEBO COMPARATOR4 participants will receive 1.0mL of normal saline as Placebo on Study Days 1 and 181.
Interventions
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
Eligibility Criteria
You may qualify if:
- Must be a male or non-pregnant, non-breastfeeding female between the ages of 18 and 55 years, inclusive, at the time of enrollment.
- Must be willing and able to read, sign, and date the informed consent document.
- Must demonstrate an understanding of the study with a passing score (90% or greater) on the Test of Understanding (TOU) by the third attempt, before study-related procedures are performed.
- Must be willing and able to comply with study requirements and be available for follow-up visits for the entire study.
- Must have the means to be contacted by telephone and/or video for remote follow-up visits as needed.
- Must have a body mass index (BMI) ≥18.1 kg/m2 and \<35.0 kg/m2.
- Have no previously documented COVID-19/SARS-CoV-2 infection
- Must agree to refrain from donating blood or plasma outside of this study for the duration of participation in this study.
- Must have acceptable screening laboratory findings: white blood cell (WBC), hemoglobin, platelet count, prothrombin (PT), prothrombin time (PTT), aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), creatinine, and total bilirubin) within 14 days before Study Day 1.
- Must be healthy based on the physician investigator's clinical judgment after review of past medical history, medication use, vital signs, and an abbreviated physical examination.
- Biological females must have a negative urine pregnancy test at screening and a negative urine pregnancy test immediately before each study injection.
- Biological females of reproductive capacity must use an acceptable method of contraception, beginning 30 days before enrollment, and until at least 60 days after the last study injection.
You may not qualify if:
- Has plans to become pregnant or is currently pregnant or breastfeeding.
- Seropositive to COVID-19 by binding antibody titer assay.
- Confirmed positive for active infection of human immunodeficiency virus (HIV), hepatitis C virus (HCV), or presence of Hepatitis B surface antigen (HbsAg).
- Has known or suspected congenital or acquired immunodeficiency, or recent history or current use of immunosuppressive therapy.
- History of organ and or stem cell transplantation.
- Has a history of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved a cure.
- Has diabetes mellitus type 1 or type 2 (including cases controlled with diet alone) and/or thyroid disease.
- Has major psychiatric illness during the last 12 months that, in the physician investigator's opinion, would preclude participation.
- Has a history of other chronic diseases or conditions
- Has a current or history of substance abuse that, in the physician investigator's opinion, would preclude participation.
- Has tattoos, scars, or other marks that would, in the opinion of the physician investigator, interfere with the assessment of the injection site.
- Has a known allergy or history of anaphylaxis or other serious reaction to a vaccine, vaccine component, or latex.
- Had major surgery (per the physician investigator's judgment) in the month before screening or has plans to have major surgery during the study.
- Received blood products or immunoglobulin in the three months before screening or has plans to use during the study.
- Donated a unit of blood within eight weeks before Study Day 1 or has plans to donate blood during the study.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
WRAIR Clinical Trials Center
Silver Spring, Maryland, 20910, United States
Related Publications (1)
Ober Shepherd BL, Scott PT, Hutter JN, Lee C, McCauley MD, Guzman I, Bryant C, McGuire S, Kennedy J, Chen WH, Hajduczki A, Mdluli T, Valencia-Ruiz A, Amare MF, Matyas GR, Rao M, Rolland M, Mascola JR, De Rosa SC, McElrath MJ, Montefiori DC, Serebryannyy L, McDermott AB, Peel SA, Collins ND, Joyce MG, Robb ML, Michael NL, Vasan S, Modjarrad K; EID-030 Study Group. SARS-CoV-2 recombinant spike ferritin nanoparticle vaccine adjuvanted with Army Liposome Formulation containing monophosphoryl lipid A and QS-21: a phase 1, randomised, double-blind, placebo-controlled, first-in-human clinical trial. Lancet Microbe. 2024 Jun;5(6):e581-e593. doi: 10.1016/S2666-5247(23)00410-X. Epub 2024 May 15.
PMID: 38761816DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Scott, M.D., MPH
Walter Reed Army Institute of Research (WRAIR)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2021
First Posted
March 5, 2021
Study Start
April 5, 2021
Primary Completion
March 31, 2023
Study Completion
October 30, 2023
Last Updated
June 17, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share