AzTrials
AzTrials

SARS-CoV-2 InfectionPhase 1NCT04784767

PHASE 1 SARS-COV-2-Spike-Ferritin-Nanoparticle (SpFN) Vaccine With ALFQ Adjuvant for Prevention of COVID-19

A Phase 1 study testing 25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant), Sodium chloride, USP, for injection (0.9% NaCl) and 50 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant) in people with SARS-CoV-2 Infection, run by U.S. Army Medical Research and Development Command at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2 Infection
What is being tested?
25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant), Sodium chloride, USP, for injection (0.9% NaCl) and 50 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
29 participants
Where
1 siteUnited States
Study dates
5 Apr 2021to 30 Oct 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.
Show all 25Show fewer
  • 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.
  • Received an experimental COVID-19 vaccine outside of this study or a COVID-19 vaccine that has been given Emergency Use Authorization from the FDA
  • Received live attenuated vaccine from 30 days before Study Day 1 until 30 days after the last study injection.
  • Received killed or inactivated vaccine from 14 days before Study Day 1 and until 30 days after the last study injection.
  • Received experimental therapeutic agents within three months before the first study injection or has plans to receive any experimental therapeutic agents during the entire course of the study.
  • Concurrent participation in another study requiring blood draws or exposure to investigational or non-investigational vaccine/product (pharmaceutical or device) throughout the study period.
  • Has an acute illness or temperature ≥38.0 degrees Celsius (C)/100.4 degrees Fahrenheit (F) on any study injection day or within 48 hours of planned study injection.
  • In the physician investigator's opinion, is unable to communicate reliably, is unlikely to adhere to study requirements, or has a condition that would limit completion of the study.
  • Is unwilling to have their samples collected and stored for future research.
  • Emergency medical services personnel and healthcare provider with patient contact in potentially high risk/high exposure settings as per screening physician's assessment.
  • Current smoker or inhales vaporized nicotine "Vaping" daily. Current smoker is defined as an adult who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • WRAIR Clinical Trials Center

    Silver Spring, Maryland, 20910

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant), Sodium chloride, USP, for injection (0.9% NaCl), 50 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant)
Keywords
COVID-19, SARS-Cov-2, SARS, Coronavirus
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant)Biological

    Also called 25 µg SpFN + ALFQ

    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

  • Sodium chloride, USP, for injection (0.9% NaCl)Drug

    Also called Placebo

    Normal saline will be provided in a sterile, single-use 10 mL vial

  • 50 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant)Biological

    Also called 50 µg SpFN + ALFQ

    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

Study groups in NCT04784767
Study groupRoleWhat they receive
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.
Receives: Biological: 25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant)
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.
Receives: Drug: Sodium chloride, USP, for injection (0.9% NaCl)
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.
Receives: Biological: 50 µg SpFN_1B-06-PL + ALFQ (QS21 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.
Receives: Drug: Sodium chloride, USP, for injection (0.9% NaCl)
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.
Receives: Biological: 50 µg SpFN_1B-06-PL + ALFQ (QS21 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.
Receives: Drug: Sodium chloride, USP, for injection (0.9% NaCl)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 0 to 7 post vaccination

  2. 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.

    Measured: Day 0 to 546 post vaccination

  3. 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.

    Measured: Day 43 (+/- 2 days)

Secondary outcomes (3)

  1. 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.

    Measured: Days 8, 15, 29, 43, and 57.

  2. 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.

    Measured: Days 8, 15, 29, 43, and 57.

  3. Number of participants with ACE-2 binding inhibition

    The proportion of participants with ACE-2 binding inhibition following SpFN_1B-06-PL + ALFQ vaccination.

    Measured: Day 0 to 57 post vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2021
  2. Study start5 Apr 2021
  3. Primary completion31 Mar 2023
  4. Study completion30 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04784767
Sponsor's protocol ID
S-20-03
Other IDs
WRAIR # 2847, EID030, IND 27301
Status last verified
Jun 2025
First submitted
3 Mar 2021
Last updated
17 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38761816

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant), Sodium chloride, USP, for injection (0.9% NaCl) and 50 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant) in people with SARS-CoV-2 Infection, run by U.S. Army Medical Research and Development Command at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with local and systemic reactions (time frame: Day 0 to 7 post vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04784767, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in