Evidence map›Paper›PMID 38761816›Full record

Trial reportThe Lancet. Microbe2024

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.

Brittany L Ober Shepherd, Paul T Scott, Jack N Hutter, Christine Lee, Melanie D McCauley, Ivelese Guzman, Christopher Bryant, Sarah McGuire, Jessie Kennedy, Wei-Hung Chen and 21 more

3 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Microbe, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04784767 phase1completednot on this map

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

TypeinterventionalSponsorU.S. Army Medical Research and Development CommandRan2021 to 2023Enrolled29ConditionsSARS-CoV-2 InfectionArms25 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)
NCT06863142 phase1recruitingnot on this mapstarted 2025, after this paper: background citation

VRC 328: A Phase I Open-Label Clinical Trial to Evaluate the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2025 to 2027Enrolled45ConditionsInfluenza Prevention, Seasonal InfluenzaArmsVRC-FLUMOS0116-00-VP, ALFQ
NCT07111078 phase1recruitingnot on this mapstarted 2025, after this paper: background citation

VRC 329: A Phase I Open-Label, Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Quadrivalent Influenza HA Stem Vaccine VRC-FLUMOS0122-00-VP (STEMos1) With and Without ALFQ Adjuvant in Healthy Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2025 to 2027Enrolled56ConditionsInfluenza Prevention, Pandemic Influenza PreventionArmsVRC-FLUMOS0122-00-VP, ALFQ
3 · Its place in the literature

Who cites it

37 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

31 authors.

Brittany L Ober ShepherdWalter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
Paul T ScottWalter Reed Army Institute of Research, Silver Spring, MD, USA; Global Clinical Development, Vaccines, Merck, Rahway, NJ, USA.
Jack N HutterWalter Reed Army Institute of Research, Silver Spring, MD, USA.
Christine LeeWalter Reed Army Institute of Research, Silver Spring, MD, USA.
Melanie D McCauleyWalter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
Ivelese GuzmanWalter Reed Army Institute of Research, Silver Spring, MD, USA.
Christopher BryantThe Emmes Company, Rockville, MD, USA.
Sarah McGuireThe Emmes Company, Rockville, MD, USA.
Jessie KennedyThe Emmes Company, Rockville, MD, USA.
Wei-Hung ChenWalter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
Agnes HajduczkiWalter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
Thembi MdluliWalter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
Anais Valencia-RuizWalter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
Mihret F AmareWalter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
Gary R MatyasWalter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
Mangala RaoWalter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
Morgane RollandWalter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
John R MascolaVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Stephen C De RosaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Departments of Lab Medicine and Pathology, University of Washington, Seattle, WA, USA.
M Juliana McElrathVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Departments of Lab Medicine and Pathology, University of Washington, Seattle, WA, USA.
David C MontefioriDuke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA; Department of Surgery, Duke University School of Medicine, Durham, NC, USA.
Leonid SerebryannyyVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Adrian B McDermottVaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA; Immunology, Sanofi Vaccines, Lyon, France.
Sheila A PeelWalter Reed Army Institute of Research, Silver Spring, MD, USA.
Natalie D CollinsWalter Reed Army Institute of Research, Silver Spring, MD, USA.
M Gordon JoyceWalter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
Merlin L RobbHenry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
Nelson L MichaelWalter Reed Army Institute of Research, Silver Spring, MD, USA. Electronic address: nelson.l.michael2.civ@health.mil.
Sandhya VasanWalter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
Kayvon ModjarradWalter Reed Army Institute of Research, Silver Spring, MD, USA; Vaccine Research and Development, Pfizer, Pearl River, NY, USA.
EID-030 Study Group

Funding

The Southwest National Primate Research Center Supplement- Infrastructure improvements of ABSL2 holding areasP51OD011133 · OD · TEXAS BIOMEDICAL RESEARCH INSTITUTE · PI Larry S. Schlesinger · 2012 to 2026
$129.7M
United States Military HIV Research Program (MHRP) Clinical Trials UnitUM1AI108568 · NIAID · WALTER REED ARMY INSTITUTE OF RESEARCH · PI Julie A. Ake, Merlin L Robb · 2014 to 2026
$24.3M
NIAID NIH HHS UM1 AI108568NIH HHS P51 OD011133
6 · The paper itself

Abstract

backgroundA self-assembling SARS-CoV-2 WA-1 recombinant spike ferritin nanoparticle (SpFN) vaccine co-formulated with Army Liposomal Formulation (ALFQ) adjuvant containing monophosphoryl lipid A and QS-21 (SpFN/ALFQ) has shown protective efficacy in animal challenge models. This trial aims to assess the safety and immunogenicity of SpFN/ALFQ in a first-in-human clinical trial.

methodsIn this phase 1, randomised, double-blind, placebo-controlled, first-in-human clinical trial, adults were randomly assigned (5:5:2) to receive 25 μg or 50 μg of SpFN/ALFQ or saline placebo intramuscularly at day 1 and day 29, with an optional open-label third vaccination at day 181. Enrolment and randomisation occurred sequentially by group; randomisation was done by an interactive web-based randomisation system and only designated unmasked study personnel had access to the randomisation code. Adults were required to be seronegative and unvaccinated for inclusion. Local and systemic reactogenicity, adverse events, binding and neutralising antibodies, and antigen-specific T-cell responses were quantified. For safety analyses, exact 95% Clopper-Pearson CIs for the probability of any incidence of an unsolicited adverse event was computed for each group. For immunogenicity results, CIs for binary variables were computed using the exact Clopper-Pearson methodology, while CIs for geometric mean titres were based on 10 000 empirical bootstrap samples. Post-hoc, paired one-sample t tests were used to assess the increase in mean log-10 neutralising antibody titres between day 29 and day 43 (after the second vaccination) for the primary SARS-CoV-2 targets of interest. This trial is registered at ClinicalTrials.gov, NCT04784767, and is closed to new participants.

findingsBetween April 7, and June 29, 2021, 29 participants were enrolled in the study. 20 individuals were assigned to receive 25 μg SpFN/ALFQ, four to 50 μg SpFN/ALFQ, and five to placebo. Neutralising antibody responses peaked at day 43, 2 weeks after the second dose. Neutralisation activity against multiple omicron subvariants decayed more slowly than against the D614G or beta variants until 5 months after second vaccination for both dose groups. CD4

interpretationSpFN/ALFQ was well tolerated and elicited robust and durable binding antibody and neutralising antibody titres against a broad panel of SARS-CoV-2 variants and other sarbecoviruses.

fundingUS Department of Defense, Defense Health Agency.

Indexed as

COVID-19COVID-19 VaccinesFerritinsLipid ALiposomesNanoparticlesSARS-CoV-2Spike Glycoprotein, CoronavirusAdjuvants, ImmunologicAdjuvants, VaccineAdultAntibodies, NeutralizingAntibodies, ViralDouble-Blind MethodFemaleHumansAdjuvants, ImmunologicAdjuvants, VaccineAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesFerritinsLipid ALiposomesmonophosphoryl lipid ANanovaccinessaponin QA-21V1SaponinsSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2

Identifiers

PMID38761816
PMCPMC11192176

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.