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

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.

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Kurz gefasst

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

Phase 2148 Teilnehmende gesucht4 Studienzentren1 Land

Kategorien

Infektionskrankheiten100%

In 1 Register registriert

ClinicalTrials.govNCT07207408Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten

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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.

Not stated: Registered after enrolment began (about 25 days after the recorded start)First posted 2025-10-06; recorded start 2025-09-11
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: 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.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1 other study in this databaseCounted from the lead sponsor named in the record (Dynavax Technologies Corporation)
Not stated: 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.

Zusammenfassung

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.

Erkrankungen

Prevention of Pneumonic Plague Resulting From Aerosol Exposure to Yersinia Pestis

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – 55 Years
Gesunde Freiwillige	Ja

Eignung im Wortlaut des Registers

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) \-

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 2
Zuteilung	Randomisiert
Interventionsmodell	SEQUENTIAL
Primäres Ziel	PREVENTION
Verblindung	QUADRUPLE (4)
Teilnahme	148 Teilnehmende gesucht

Sponsor und Mitwirkende

Dynavax Technologies Corporation Sponsor
United States Department of Defense Mitwirkende

Studienarme und Interventionen

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

Interventionen

Biologikum rF1V-1018
Regimen 1
Biologikum rF1V-1018
Regimen 2
Biologikum rF1V-1018
Regimen 3
Biologikum rF1V-1018
Regimen 4
Biologikum rF1V-1018
Regimen 5
Biologikum rF1V-1018
Regimen 6

Endpunkte

Primärer Endpunkt
Anti-rF1V antibody level
Zeitrahmen 4 weeks after final study vaccine
Primärer Endpunkt
Evaluate safety of rF1V-1018
Evaluate adverse events
Zeitrahmen 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

Daten

Daten
Startdatum	11. September 2025 (tatsächlich)
Primärer Abschluss	29. Januar 2027 (geschätzt)
Abschluss	31. August 2027 (geschätzt)
Erstveröffentlichung	6. Oktober 2025 (tatsächlich)
Zuletzt aktualisiert	18. Juni 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	Juni 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

1 Studienzentrum rekrutiert

United States

United States
Einrichtung	Stadt	Bundesland oder Region	Status
CTI Clinical Research Center	Cincinnati	Ohio	Rekrutiert
AMR- El Dorado	El Dorado	Kansas	Aktiv, rekrutiert nicht
AMR- Las Vegas	Las Vegas	Nevada	Aktiv, rekrutiert nicht
103	Miami	Florida	Aktiv, rekrutiert nicht

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.

Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.

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