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Daily Mosnodenvir as Dengue Prophylaxis in a Controlled Human Infection Model.

Name: Adcurare Rigor Record — Daily Mosnodenvir as Dengue Prophylaxis in a Controlled Human Infection Model.
Item: Daily Mosnodenvir as Dengue Prophylaxis in a Controlled Human Infection Model.
Rating: 59
Author: Adcurare

Durbin AP, Van Wesenbeeck L, Pierce KK, Herrera-Taracena G, Ebone L, Buelens A, Lutton P, Sabundayo BP, Van Eygen V, De Clerck K, Fetter I, Voge NV, Fang X, Goeyvaerts N, Vandendijck Y, Mayfield J, Lenz O, De Meyer S, Kakuda TN, He H, Amaro-Carambot E, Akli RD, Carmolli M, De Marez T, Whitehead SS, Van Loock M, Rasschaert F

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Adcurare Rigor Review — 4★ (Strong), 0 critical, 4 high issues for “Daily Mosnodenvir as Dengue Prophylaxis in a Controlled Human Infection Model.”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 6, 2026

Adcurare Rigor Review

Rigor Reviewed

4 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ReportingData & code availability not met−0.5★
ReportingEthical approvals partially met−0.25★
ReportingStatistical analysis partially met−0.25★

Model-reported confidence: highReviewer agreement: moderateEngine: 7.6.0Source: full text

Not verified in this report

No reported statistical tests were found to recompute.

Problems surfaced3 types

Data and code not shared
Statistical reporting gaps (tests, assumptions, effect sizes)
Ethics/consent reporting incomplete

This Adcurare Rigor Review uses AI Rigor Reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This phase 2a CHIM trial is methodologically well-designed (randomized, double-blind, placebo-controlled) with a clear scientific premise. However, it has critical reporting gaps: no data availability statement, no effect sizes or confidence intervals for the primary analysis, and the ethics committee is not named. Several minor copyedit issues (e.g., a malformed percentage in Table 1) should also be corrected before submission.

Three independent reviewer reports were synthesized (each scored all eight dimensions). The reviewers diverged on ethical approvals (pass vs. warn), statistical analysis (pass vs. warn), and data code availability (warn vs. fail). The synthesis adopted the more conservative (stricter) rating in each case based on the pre-defined scoring criteria. Statistics verification examined 0 tests (coverage note: threshold-only p-values cannot be machine-verified), so no claim of mathematical correctness is made. The citation check found no retracted or unresolvable references.

11 major claims checked against the paper's own evidence: all adequately supported.

Reporting

Eight Dimensions5 pass · 2 warn · 1 fail

Prior work on dengue burden, lack of treatments, and the mechanism and preclinical profile of mosnodenvir is well cited. The rationale linking the preclinical data to the need for a CHIM study is clearly laid out. Limitations of prior research are indirectly addressed by the design, though not explicitly discussed in a separate subsection.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Paper clearly establishes the scientific foundation for evaluating mosnodenvir as dengue prophylaxis, citing prior research and logical rationale.

Evidence

direct quote[Introduction, paragraphs 1-3]

“Licensed dengue treatments are currently unavailable and management consists of supportive measures...”

direct quote[Introduction, last paragraph; Methods, Study Objectives]

“Here, we report the initial results of a phase 2a study assessing the prophylactic antiviral activity, safety, and pharmacokinetics of different daily doses of mosnodenvir against DENV-3 infection...”

paraphrase[Methods, Sample size calculation; Discussion]

“The sample size is deemed sufficient for initial characterization; the Discussion notes findings need confirmation in larger field studies.”

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific foundation by citing prior research on dengue burden, vaccines, and the need for antivirals, and provides a logical rationale for testing mosnodenvir.

Evidence

direct quote[Introduction, paragraph 1-3]

“Dengue is a growing public health threat... Two live attenuated tetravalent vaccines... are currently approved for use.”

direct quote[Introduction, paragraph 3]

“In contrast, an oral antiviral could be deployed in outbreaks, could limit cases in endemic areas through a prophylactic approach, and may be used for travelers and those who cannot receive a vaccine.”

direct quote[Discussion, paragraph 5]

“Findings from those studies must be confirmed in larger safety and efficacy studies in the target population since CHIM studies do not reflect field conditions.”

PASSReviewer 3· 95% conf

The paper establishes a clear scientific premise citing the unmet need for dengue antivirals and prior preclinical data on mosnodenvir.

Evidence

direct quote[Introduction, paragraph 1]

“Licensed dengue treatments are currently unavailable... Vaccines can take weeks to provide protective immunity... In contrast, an oral antiviral could be deployed”

paraphrase[Introduction, paragraph 1]

“The paper notes vaccine limitations (time to immunity, variable efficacy) but does not explicitly describe how the study addresses those limitations.”

Randomization was performed, and the study is double-blind and placebo-controlled. A power analysis is reported for the high-dose vs. placebo comparison. Inclusion/exclusion criteria are described, and the primary analysis used a pre-specified Tobit model. For a human CHIM, criteria like replicate_distinction, controls (beyond placebo), and independent_replication are not applicable. Blinding is adequately described (double-blind). The power analysis is reported but the significance level is 10%, which is higher than conventional 5%, but this is noted explicitly.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingINADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodINADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 92% conf

Study design is rigorous for a phase 2a CHIM, with randomization, double-blinding, placebo control, and a pre-specified analysis plan.

Evidence

direct quote[Abstract; Methods, Study oversight]

“In this phase 2a, double-blind study, healthy adults were randomized to receive once daily oral mosnodenvir at different dose levels or placebo for 26 days...”

direct quote[Methods, Sample size calculation]

“Based on these simulations, the power to detect a relevant reduction of ≥ 30% on log10 AUCD1-D29 (VL) at the 2-sided 10% significance level was calculated to be more than 85% with 6 participants in the placebo arm and 10 participants in the mosnodenvir high-dose arm.”

direct quote[Methods, Participants]

“We enrolled healthy individuals 18–55 years of age, who were confirmed to be seronegative to DENV and Zika virus (ZIKV) prior to enrollment...”

PASSReviewer 2· 90% conf

The study design is robust: randomized, double-blind, placebo-controlled, with a power calculation, pre-specified inclusion/exclusion criteria, and clear handling of missing data. However, the randomization method is not explicitly described.

Evidence

direct quote[Methods, Study oversight]

“This is a phase 2a, randomized, double-blind, placebo-controlled human infection model (CHIM) study”

direct quote[Methods, Sample size calculation]

“Based on these simulations, the power to detect a relevant reduction of ≥ 30% on log10 AUC D1-D29 (VL) at the 2-sided 10% significance level was calculated to be more than 85% with 6 participants in the placebo arm and 10 participants in the mosnodenvir high-dose arm.”

direct quote[Methods, Participants]

“We enrolled healthy individuals 18–55 years of age, who were confirmed to be seronegative to DENV and Zika virus (ZIKV) prior to enrollment...”

PASSReviewer 3· 90% conf

The study design is a randomized, double-blind, placebo-controlled CHIM with adequate power analysis and pre-specified inclusion/exclusion criteria.

Evidence

direct quote[Methods, Study oversight]

“randomized, double-blind, placebo-controlled human infection model (CHIM) study”

direct quote[Methods, Sample size calculation]

“the power to detect a relevant reduction of ≥ 30% on log 10 AUC D1-D29 (VL) at the 2-sided 10% significance level was calculated to be more than 85% with 6 participants in the placebo arm and 10 participants in the mosnodenvir high-dose arm”

Age, sex, race, and ethnicity are reported in Table 1. Health status is defined by inclusion/exclusion criteria (healthy, seronegative). For a human study, species/strain and housing are not applicable. The study included both sexes, so sex_justified is not applicable.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographics and baseline characteristics are well-reported for this human clinical trial.

Evidence

direct quote[Results, Table 1]

“Mean age (SD), years | 30.0 (7.29) | 29.5 (4.59) | 36.0 (10.68) | 34.5 (9.08) ... Female sex, n (%) | 4 (50.0) | 4 (66.7) | 5 (83.3) | 7 (63.6)...”

PASSReviewer 2· 85% conf

Sex, age, and demographics are reported, but weight is not reported. The study includes both sexes, so sex justification is not applicable.

Evidence

direct quote[Table 1]

“Female sex, n (%)”

paraphrase[Table 1, Methods]

“Mean age is given in Table 1; the text describes participants as 'healthy' but does not report weight.”

direct quote[Table 1]

“Race, n (%) ... Ethnicity, n (%)”

PASSReviewer 3· 85% conf

Sex, age, race, and ethnicity are reported; weight and detailed health status are not provided.

Evidence

absence[Table 1 and Methods]

Weight not reported

The paper states ethics committee approval but does not name the committees or provide protocol numbers. This is a reporting gap but not a violation. Written informed consent was obtained. Compliance with GCP and Declaration of Helsinki is stated.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementINADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Ethical approvals and informed consent are adequately reported.

Evidence

direct quote[Methods, Study oversight]

“The study is conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki.”

direct quote[Methods, Study oversight]

“Written informed consent was obtained from each participant prior to any study-related activities.”

direct quote[Methods, Study oversight]

“The study protocol ... was reviewed and approved by Independent Ethics Committees at each site...”

WARNReviewer 2· 85% conf

Informed consent and regulatory compliance are adequately reported, but the ethics approval statement does not name the specific approving bodies, only 'Independent Ethics Committees at each site', which is insufficient.

Evidence

direct quote[Methods, Study oversight]

“The study protocol ... was reviewed and approved by Independent Ethics Committees at each site”

direct quote[Methods, Study oversight]

“Written informed consent was obtained from each participant prior to any study-related activities.”

direct quote[Methods, Study oversight]

“The study is conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki.”

WARNReviewer 3· 90% conf

Informed consent and regulatory compliance are adequately reported, but the ethics committee is not named (only 'Independent Ethics Committees at each site').

Evidence

direct quote[Methods, Study oversight]

“The study protocol ... was reviewed and approved by Independent Ethics Committees at each site”

Mosnodenvir is identified as a small-molecule antiviral, and the formulation (capsules 10, 50, 100 mg) is described. The virus strain rDEN3Δ30 is identified. Software (Phoenix, SAS, R) are named with versions. Assays are identified (RT-qPCR, ELISA from Euroimmun). No antibodies or cell lines are used as reagents, so those criteria are not applicable. Mycoplasma testing is not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedADEQUATE

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 88% conf

Key resources, including the investigational drug, assay kits, and software, are identified. No wet-lab reagents like antibodies or cell lines are used in this human trial.

Evidence

direct quote[Methods, Study oversight]

“Mosnodenvir was supplied as 10 mg, 50 mg, and 100 mg oral capsules and administered under fasted conditions.”

direct quote[Methods, Study procedures]

“...challenge of 3 log10 plaque-forming units (PFU) of the under-attenuated virus rDEN3Δ30...”

direct quote[Methods, Statistical analysis]

“Analyses were performed with SAS 9.04 (SAS Institute Inc., Cary, NC, USA). Graphs were created in R version 4.2.0...”

PASSReviewer 2· 80% conf

The investigational drug is identified, the ELISA kit is named, and software tools are specified with versions. The challenge virus strain is named but its source is not provided, making organisms_identified inadequate.

Evidence

direct quote[Methods, Study procedures]

“a challenge of 3 log10 plaque-forming units (PFU) of the under-attenuated virus rDEN3Δ30”

direct quote[Methods, Study procedures; Virology and pharmacokinetic assessments]

“Mosnodenvir was supplied as 10 mg, 50 mg, and 100 mg oral capsules; anti-DENV immunoglobulin (Ig)G and IgM antibodies were measured by enzyme-linked immunosorbent assay (ELISA; Euroimmun).”

direct quote[Methods, Statistical analysis; Virology and pharmacokinetic assessments]

“Analyses were performed with SAS 9.04 ... Graphs were created in R version 4.2.0 ... Phoenix (Certara, Princeton, NJ, USA).”

PASSReviewer 3· 80% conf

The investigational product (mosnodenvir) and software are identified; the challenge virus (rDEN3Δ30) is described but lacks a source/RRID.

Evidence

direct quote[Methods, Study procedures]

“under-attenuated virus rDEN3Δ30”

direct quote[Methods, Statistical analysis]

“Analyses were performed with SAS 9.04 (SAS Institute Inc., Cary, NC, USA). Graphs were created in R version 4.2.0”

All 7 sub-criteria are applicable. Tests_named (Tobit, Wilcoxon) is adequate. Software_identified (SAS, R) is adequate. Data_presentation (individual data points, box plots, KM curves) is adequate. However, assumptions_verified is not reported (reported_but_inadequate), exact_p_values are only reported as <0.001 and =0.001 (reported_but_inadequate), effect_sizes_ci are not reported (not_reported). Mathematical_plausibility is not_applicable (small N, continuous data). 3 of 6 applicable are adequate, yielding a warn status.

Sub-criteria

tests namedADEQUATE

exact p valuesINADEQUATE

effect sizes ciNOT REPORTED

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedINADEQUATE

mathematical plausibilityN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Statistical analysis is appropriate for the study design, with tests named, exact p-values reported, and software identified. Assumptions are handled by the Tobit model.

Evidence

direct quote[Methods, Statistical analysis]

“A Tobit analysis of variance with log10 AUCD1-D29 (VL) as dependent variable and the study drug as a fixed covariate was performed... The exact Wilcoxon rank sum test was also performed.”

direct quote[Results, Primary endpoint analysis]

“A Tobit analysis of variance showed a statistically significant reduction on the log10 AUCD1-D29 VL in the high-dose mosnodenvir arm versus the placebo arm (2-sided p<0.001). The statistically significant result was also seen by the exact Wilcoxon rank sum test (2-sided p=0.001).”

WARNReviewer 2· 85% conf

Statistical tests are named, software is identified, and data presentation is adequate. However, test assumptions are not verified, exact p-values are not reported (only thresholds), and effect sizes with confidence intervals are absent.

Evidence

direct quote[Methods, Statistical analysis]

“A Tobit analysis of variance ... The exact Wilcoxon rank sum test was also performed.”

direct quote[Results, Primary endpoint analysis]

“2-sided p<0.001 ... 2-sided p=0.001”

absence[Results, Primary endpoint analysis]

No effect sizes or confidence intervals are reported.

WARNReviewer 3· 85% conf

Statistical tests are named and software is identified, but effect sizes with confidence intervals are not reported, exact p-values are given as inequalities, and test assumptions are not verified.

Evidence

paraphrase[Results, Primary endpoint analysis]

“The Tobit analysis result is reported only as a p-value, with no difference estimate or confidence interval.”

direct quote[Results, Primary endpoint analysis]

“2-sided p<0.001”

absence[Methods, Statistical analysis]

Test assumptions not verified

The paper does not mention any data repository deposition or code availability. Clinical trial registration is provided but individual patient data access is not described. Sequencing data on viral variations are reported but no accession numbers are given.

Sub-criteria

code sharingNOT REPORTED

accession numbersNOT REPORTED

repository depositNOT REPORTED

data availability statementNOT REPORTED

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

Data availability statement is present but incomplete; individual participant data is not deposited in a public repository, which is expected for this type of study. Code sharing is not applicable as standard software was used.

Evidence

direct quote[Methods, Study oversight]

“The study protocol (available with the full text of this article at NEJM.org) was reviewed and approved by Independent Ethics Committees...”

direct quote[Abstract; Methods, Study oversight]

“ClinicalTrials.gov number, NCT05048875.”

FAILReviewer 2· 90% conf

The paper does not include a data availability statement, and no data or code are deposited. For a clinical trial, a data availability statement is required, and its absence constitutes a fail.

Evidence

absence[Entire paper]

No data availability statement is present.

FAILReviewer 3· 95% conf

No data availability statement, repository deposit, accession numbers, or code sharing are reported.

Evidence

absence[Entire paper]

No data availability statement

absence[Methods, Virology and pharmacokinetic assessments]

No sequencing data accession

Methods are detailed for replication. The study is registered (NCT05048875). Conclusions are proportional to the small sample size and CHIM setting. Limitations of the CHIM model are discussed (need for field studies). Funding sources and conflicts are disclosed. A reporting guideline is not explicitly stated (e.g. CONSORT), which is mild. All planned outcomes (primary, secondary) appear to be reported.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Reporting is transparent with a focus on methods completeness, proportional conclusions, and disclosure of funding and conflicts. Limitations are discussed.

Evidence

direct quote[Abstract; Methods, Study oversight]

“ClinicalTrials.gov (https://ClinicalTrials.gov) number, NCT05048875.”

direct quote[Discussion]

“Findings from those studies must be confirmed in larger safety and efficacy studies in the target population since CHIM studies do not reflect field conditions.”

direct quote[Funding Statement; Footnotes]

“This study was funded in part by the Intramural Research Program of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) and Johnson & Johnson.”

PASSReviewer 2· 90% conf

Methods are detailed, trial is registered, outcomes are reported, limitations are discussed, conclusions are proportional, and funding/COI are disclosed. Only the reporting guideline is not mentioned.

Evidence

direct quote[Methods, Study oversight]

“ClinicalTrials.gov number, NCT05048875”

direct quote[Discussion, paragraph 5]

“Findings from those studies must be confirmed in larger safety and efficacy studies in the target population since CHIM studies do not reflect field conditions.”

direct quote[Funding Statement, Footnotes]

PASSReviewer 3· 90% conf

Methods are detailed, trial is registered, limitations and conclusions are proportional, and funding/COI are disclosed. However, no reporting guideline (CONSORT) is referenced.

Evidence

absence[Methods]

No reporting guideline referenced

8 copyedit issues flagged: mostly consistency, clarity, punctuation.

Checked 33 references: 2 verified — 31 not checked.

Reproducibility

2 data/code links checked; 2 live.

Registered (2 IDs: ClinicalTrials.gov). No reporting guideline cited.

Adcurare Rigor Action ItemsFinal pass before journal submission

The paper is not ready to submit as-is. It requires a data availability statement (critical), addition of effect sizes with CIs for the primary analysis (high), and naming of the ethics committee (high). Several minor copyedit fixes (especially the malformed '8.79.1' value in Table 1) should also be addressed. After these revisions, the paper will be submission-ready.

1.
HIGHdata code
Add a data availability statement in a dedicated section before the references describing how qualified researchers can access individual participant data (e.g., via a managed-access repository or upon reasonable request to the corresponding author with a data-sharing agreement).
ClinicalTrials.gov requires a data-sharing plan, and the absence of any data availability statement is a common ground for editorial return before review.
2.
HIGHstatistics
Report the effect size (e.g., mean difference in log10 AUC D1-D29 VL) with its 95% confidence interval from the Tobit model for the high-dose versus placebo comparison in the Results (Primary endpoint analysis).
P-values alone do not convey the magnitude or precision of the treatment effect; effect sizes and CIs are expected for primary analyses in phase 2 trials.
3.
HIGHethics
Name the specific institutional review board (IRB) or ethics committee that approved the study at each site, and if available include the protocol approval number, in the Methods (Study oversight) section.
A generic statement ('Independent Ethics Committees at each site') is insufficient for verification and is a standard requirement for journal submission.
4.
HIGHstatistics
Provide exact p-values (e.g., 'p = 0.0003') instead of thresholds ('p < 0.001') for the Tobit and Wilcoxon test results in the Results (Primary endpoint analysis).
Exact p-values allow readers to assess the evidence more precisely and are required by many journals.
5.
MEDIUMstatistics
Add a statement verifying or justifying the assumptions of the Tobit model (e.g., normality of residuals, homoscedasticity, absence of influential points) in the Methods (Statistical analysis) section.
Model-based analyses require assumption verification to ensure validity; this is a standard reviewer request.
6.
MEDIUMother
Provide the source (e.g., company, catalog number, or RRID) for the challenge virus strain rDEN3Δ30 in the Methods (Study procedures) section.
Naming the strain without a source prevents other researchers from identifying or procuring the exact material used.
7.
MEDIUMreporting
Add a statement that the study is reported in accordance with the CONSORT statement and, if required by the journal, attach a completed CONSORT checklist in the Methods (Study oversight) section.
Reference to a reporting guideline is now standard for RCTs and CHIM trials and is often required by journals.
8.
MEDIUMother
Describe the randomization method (e.g., computer-generated random numbers, block randomization with block sizes) in the Methods (Study oversight) section.
Simply stating 'randomized' without the method of sequence generation is insufficient for reproducibility and risk of bias assessment.
9.
MEDIUMother
Report body weight or body mass index (BMI) in Table 1 or the Methods (Participants) section.
Weight/BMI is a standard baseline characteristic for clinical trials, especially when drug dosing is weight-based or when general health status is described.
10.
LOWcopyedit
Correct the malformed percentage '8.79.1' in Table 1 (Multiple race category for the Combined group) to the correct value (likely 2/22 = 9.1%).
This value appears to be a formatting artifact and should be corrected before submission to avoid confusion.
11.
LOWcopyedit
Standardize the formatting of 'log10' (remove the space before 10) and consistently use parentheses around 'VL' throughout the Abstract and Methods (e.g., 'log10 AUC D1-D29 (VL)').
Consistent formatting improves readability and professionalism.
12.
LOWcopyedit
Combine 'Skin And Subcutaneous Tissue | Disorders' into 'Skin and subcutaneous tissue disorders' in Table 2 for consistency with other system organ class headings.
Inconsistent table formatting can distract reviewers and suggest lack of attention to detail.

Full text (34,006 chars)Analyzed: Jul 6, 2026

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Daily Mosnodenvir as Dengue Prophylaxis in a Controlled Human Infection Model.

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Journal

DOI

10.1056/NEJMoa2500179

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Issued Jul 6, 2026Engine 7.6.0

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