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NCT07207408ClinicalTrials.gov

Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age

Phase 2, Randomized, Multicenter Trial of the Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

This study will evaluate the immunogenicity, safety, and tolerability of rF1V-1018 vaccine

Phase 2148 participants recherchés4 sites1 pays

Catégories

Maladies infectieuses100%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered after enrolment began (about 25 days after the recorded start)First posted 2025-10-06; recorded start 2025-09-11
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 1 other study in this databaseCounted from the lead sponsor named in the record (Dynavax Technologies Corporation)
  • No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre5/8

    Multi-centre: 4 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration3/5

    Registered within 30 days of the study start

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleSMALL

A small study: 148 participants (target), run at 4 sites.

How this score is built
  • Enrolment20/40

    148 participants (target)

  • Site count7/25

    4 sites

  • Country count0/15

    Single country

  • Planned duration7/10

    Planned over about 24 months

  • Sponsor scale1/10

    Dynavax Technologies Corporation has led 2 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Résumé

This study will evaluate the immunogenicity, safety, and tolerability of rF1V-1018 vaccine

This dose-finding study will evaluate the immunogenicity, safety, and tolerability of multiple doses and regimens of rF1V-1018 vaccine in healthy adults. Immunogenicity blood samples will be drawn at several timepoints during the study. Participants will return to the clinic for periodic visits for study specific evaluations including evaluation of immunogenicity and safety. Safety assessments will be done at regular intervals through the end of the trial. Six dose regimens will be tested in Part 1 of the study. Up to two dose regimens from Part 1 will be chosen for Part 2 of the study.

Affections

  • Prevention of Pneumonic Plague Resulting From Aerosol Exposure to Yersinia Pestis

Éligibilité

SexeTous
Âges18 Years – 55 Years
Volontaires sainsOui

Éligibilité telle qu'elle figure dans le registre

Inclusion Criteria: 1. Adults 18 to 55 years of age 2. Healthy participants or participants with stable pre-existing medical conditions Pre-existing stable medical condition means a participant who: has full capacity of daily activity and no major medication modification within 3 months prior to Day 1; has not undergone surgical or minimally-invasive intervention or had any hospitalization/emergency room visit for the specific medical condition. 3. Able to comply with the protocol schedule and procedures 4. Able and willing to provide written informed consent 5. If female of child-bearing potential and heterosexually active, has practiced adequate contraception for at least 28 days prior to vaccination, has negative pregnancy tests just prior to vaccination, and has agreed to continue adequate contraception through three months following the final trial injection A premenopausal woman who has at least one of the following is considered not of childbearing potential: 1. Documented hysterectomy 2. Documented bilateral salpingectomy 3. Documented bilateral oophorectomy 4. Documented and current bilateral tubal ligation or occlusion Exclusion Criteria: 1. A history of plague disease or have previously received any plague vaccine 2. Active tuberculosis or other systemic infectious process 3. History of human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) infection, or positive test for antibody to HIV, HBV, or HCV 4. History of autoimmune disorder 5. History of sensitivity to any component of trial vaccines 6. Body mass index ≥ 30 kg/m2 7. Has received the following prior to any trial injection: a) ≤ 14 days: i) Any licensed or authorized inactivated vaccines (including vaccines containing mRNA or CpG) b) ≤ 28 days: i) Any live vaccine ii) Any investigational medicinal agent c) ≤ 90 days: i) Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first trial vaccine administration or planned administration during the trial period. (For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent). Inhaled, topical, and intraarticular steroids are allowed. ii) Granulocyte or granulocyte-macrophage colony stimulating factor iii) Immunoglobulins or any blood products (receipt of certain monoclonal antibodies may on a case-by-case basis be non-exclusionary if approved via consultation with Sponsor Medical Monitor) iv) Antisense oligonucleotides v) Drugs/investigational agents with very long half-lives (defined as ≥ 60 days) (eg, radioactive iodine, amiodarone, liraglutide, nirsevimab, teplizumab, evinacumab, and obinutuzumab) vi) Infusion of blood products d) At any time: DNA plasmids or other genetic therapy intended to integrate permanently into host cells 8. If female is pregnant (known before or established at the time of screening), breastfeeding, or planning breastfeeding or a pregnancy 9. Is undergoing chemotherapy or expected to receive chemotherapy during the trial period; has a diagnosis of cancer within the last 5 years other than squamous cell or basal cell carcinoma of the skin 10. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator 11. Oral temperature ≥ 38°C (≥ 100.4°F) at the time of vaccine administration 12. History of acute myocardial infarction (AMI) or documented coronary artery disease (CAD) \-

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 2
RépartitionRandomisée
Modèle d'interventionSEQUENTIAL
Objectif principalPREVENTION
InsuQUADRUPLE (4)
Recrutement148 participants recherchés

Promoteur et collaborateurs

  • Dynavax Technologies Corporation Promoteur
  • United States Department of Defense Collaborateurs

Groupes et interventions

  • Part 1 Arm 1EXPERIMENTAL
  • Part 1 Arm 2EXPERIMENTAL
  • Part 1 and Part 2: Arm 3EXPERIMENTAL

    This Part 1 arm was selected for Part 2.

  • Part 1 and Part 2: Arm 4EXPERIMENTAL

    This Part 1 arm was selected for Part 2.

  • Part 1 Arm 5EXPERIMENTAL
  • Part 1 Arm 6EXPERIMENTAL

Interventions

  • Produit biologique rF1V-1018

    Regimen 1

  • Produit biologique rF1V-1018

    Regimen 2

  • Produit biologique rF1V-1018

    Regimen 3

  • Produit biologique rF1V-1018

    Regimen 4

  • Produit biologique rF1V-1018

    Regimen 5

  • Produit biologique rF1V-1018

    Regimen 6

Critères de jugement

  1. Critère de jugement principal

    Anti-rF1V antibody level

    Délai 4 weeks after final study vaccine

  2. Critère de jugement principal

    Evaluate safety of rF1V-1018

    Evaluate adverse events

    Délai injection reactions through 7 days after each study vaccine, adverse events for 28 days after each study vaccine; SAEs, MAEs, imAESIs through 6 months after the final study vaccine

Dates

Date de début11 septembre 2025 (réelle)
Achèvement principal29 janvier 2027 (estimée)
Achèvement31 août 2027 (estimée)
Première publication6 octobre 2025 (réelle)
Dernière mise à jour18 juin 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisjuin 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

1 site est en recrutement

United States

ÉtablissementVilleÉtat ou régionStatut
CTI Clinical Research CenterCincinnatiOhioEn recrutement
AMR- El DoradoEl DoradoKansasActif, sans recrutement
AMR- Las VegasLas VegasNevadaActif, sans recrutement
103MiamiFloridaActif, sans recrutement

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.

Registre: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07207408