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Virus Vaccine

25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant) for COVID-19

Phase 1
Waitlist Available
Led By Paul Scott, M.D., MPH
Research Sponsored by U.S. Army Medical Research and Development Command
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 8, 15, 29, 43, and 57.
Awards & highlights

Study Summary

This trial will test if a new COVID-19 vaccine is safe for adults, if it causes any side effects, and if it causes an immune response.

Eligible Conditions
  • COVID-19

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 8, 15, 29, 43, and 57.
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 8, 15, 29, 43, and 57. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidents of treatment-adverse events as assessed by FDA Toxicity grading scale.
Number of participants with humoral immune response at Study Day 43 (+/- 2).
Number of participants with local and systemic reactions
Secondary outcome measures
Number of participants with ACE-2 binding inhibition
Number of participants with binding antibody response rate
Number of participants with neutralizing antibody response rate

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: 3A: 50 µg of SpFN + ALFQ on Days 1 and 181.Experimental Treatment1 Intervention
Up to 20 participants will receive 2 intramuscular injections of: 50 ug of SpFN_1B-06-PL with 0.5 mL ALFQ adjuvant.
Group II: 2A: 50 µg of SpFN + ALFQ on Days 1, 29, and 181.Experimental Treatment1 Intervention
Up to 20 participants will receive 3 intramuscular injections of: 50 ug of SpFN_1B-06-PL with 0.5 mL ALFQ adjuvant.
Group III: 1A: 25 µg of SpFN + ALFQ on Days 1, 29 and 181.Experimental Treatment1 Intervention
Up 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.
Group IV: 1B: Placebo (Sodium chloride, USP, for injection (0.9% NaCl) on Days 1, 29 and 181.Placebo Group1 Intervention
4 participants will receive 1.0mL of normal saline as Placebo on Study Days 1, 29, and 181.
Group V: 2B: Placebo (Sodium chloride, USP, for injection (0.9% NaCl) on Days 1, 29, and 181.Placebo Group1 Intervention
4 participants will receive 1.0mL of normal saline as Placebo on Study Days 1, 29, and 181.
Group VI: 3B: Placebo (Sodium chloride, USP, for injection (0.9% NaCl) on Days 1 and 181.Placebo Group1 Intervention
4 participants will receive 1.0mL of normal saline as Placebo on Study Days 1 and 181.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

U.S. Army Medical Research and Development CommandLead Sponsor
285 Previous Clinical Trials
245,130 Total Patients Enrolled
2 Trials studying COVID-19
Walter Reed Army Institute of Research (WRAIR)FED
107 Previous Clinical Trials
36,735 Total Patients Enrolled
1 Trials studying COVID-19
200 Patients Enrolled for COVID-19
Henry M. Jackson Foundation for the Advancement of Military MedicineOTHER
92 Previous Clinical Trials
92,580 Total Patients Enrolled
4 Trials studying COVID-19
1,000 Patients Enrolled for COVID-19

Media Library

SpFN Vaccine (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04784767 — Phase 1
COVID-19 Research Study Groups: 1A: 25 µg of SpFN + ALFQ on Days 1, 29 and 181., 1B: Placebo (Sodium chloride, USP, for injection (0.9% NaCl) on Days 1, 29 and 181., 2A: 50 µg of SpFN + ALFQ on Days 1, 29, and 181., 2B: Placebo (Sodium chloride, USP, for injection (0.9% NaCl) on Days 1, 29, and 181., 3A: 50 µg of SpFN + ALFQ on Days 1 and 181., 3B: Placebo (Sodium chloride, USP, for injection (0.9% NaCl) on Days 1 and 181.
COVID-19 Clinical Trial 2023: SpFN Vaccine Highlights & Side Effects. Trial Name: NCT04784767 — Phase 1
SpFN Vaccine (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04784767 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have researchers conducted any past experiments with 25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant)?

"Presently, 100 medical studies are exploring the effects of 25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant), with a quarter of these trials in Phase 3. The hub for this research is Philadelphia, Pennsylvania but 385 other locations have been conducting their own experiments."

Answered by AI

Has the combination of 25 µg SpFN_1B-06-PL and ALFQ (with QS21 Adjuvant) been sanctioned by the FDA?

"Given the limited data regarding efficacy and safety, our assessment concluded that 25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant) has a score of 1 on Power's scale from 1 to 3."

Answered by AI

What is the current enrollment rate for this experiment?

"At the present moment, this particular research is not taking on any new participants. It was first posted to clinicaltrials.gov on April 5th 2021 and underwent its latest edit on September 13th 2021. If you're still interested in finding a suitable trial, 1045 studies related to Covid-19 are currently recruiting, as well as 100 trials for 25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant)."

Answered by AI

Are there currently any available slots for participants in this clinical trial?

"Unfortunately, no new participants are being enrolled in this trial. It was first posted April 5th 2021 and last updated September 13th 2021. Other studies may be of interest; There are 1045 trials actively recruiting patients with Covid-19 and 100 trials enlisting volunteers for 25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant)."

Answered by AI

Does this research endeavor permit the enrollment of individuals aged 55 or older?

"Based on the requirements of this trial, potential enrollees must be between 18 and 55 years old."

Answered by AI

What primary indications are associated with 25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant)?

"25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant) can be employed to alleviate the symptoms of diarrhea. It is also useful for combating inflammation in the nasal mucosa, general surgical procedures, and corneal edema."

Answered by AI

How can I become a participant in this investigative research?

"To qualify for this clinical trial, potential participants must have a covid-19 diagnosis and be between 18 to 55 years old. At present, the study is looking to enroll 29 patients in total."

Answered by AI
~7 spots leftby Mar 2025