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A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUDV) Vaccine for the Prevention of SUDV Disease in Adults in Good General Health

13 maggio 2026 aggiornato da: International AIDS Vaccine Initiative

A Phase 1, Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-SUDV-GP Vaccine in Adults in Good General Health

A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUDV) Vaccine for the Prevention of SUDV Disease in Adults in Good General Health.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a Phase 1, Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSVΔG-SUDV-GP Vaccine in Adults in Good General Health. Participants will be screened up to 28 days before Investigational Product (IP) administration and will be followed for 6 months after IP administration. The study will evaluate 4 different dose levels (2 X106 1X107, 2 X 107, 5 X 107) in 4 different participant groups for which enrollment will initiate sequentially. Starting with the lowest dose group, four sentinel participants will be enrolled in a sequential manner with no more than one participant enrolled across all sites per day. A safety review will be performed by the Sponsor after enrollment of the fourth sentinel participant, after which point the remainder of participants will be enrolled in group 1. In addition, a safety assessment will be performed by the Sponsor before opening enrollment in group 2. This assessment will be performed after enrollment of the 9th participant in group 1. The same sentinel dosing followed by safety reviews approach will be repeated for each group at each dose level.[

Tipo di studio

Interventistico

Iscrizione (Stimato)

112

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • District of Columbia
      • Washington D.C., District of Columbia, Stati Uniti, 20037
    • Kansas
      • Lenexa, Kansas, Stati Uniti, 66219
        • Johnson County Clin-Trials
        • Contatto:
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02115
        • Brigham and Women's Hospital
        • Investigatore principale:
          • Lindsey Baden, MD
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria

  1. Adults in good general health
  2. Participants who are 18 to 50 years of age
  3. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
  4. In the opinion of the PI, participant understands risks and written informed consent will be obtained before any study-related procedures are performed
  5. Willing to undergo HIV testing, risk reduction counseling, and receive HIV test results
  6. All sexually active participants must consistently use male or female condoms with all sexual partners for 3 months following IP administration
  7. All individuals of childbearing potential engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception from at least 2 weeks before and continue until 3 months following receipt of vaccine/placebo
  8. All individuals of childbearing potential must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Activities (SOA)
  9. All participants must be willing to forgo donation of blood or any other tissues from screening onward throughout the course of the study

Exclusion Criteria

  1. Any clinically relevant abnormality on history or examination including:

    history of immunodeficiency or autoimmune disease history of splenectomy history of malignancy in the past 5 years use of corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the Investigator within the previous 6 months body mass index (BMI) ≥ 35.0 kg/m2

  2. Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the Investigator makes the participant unsuitable for participation in the study
  3. Individuals who are pregnant or breastfeeding
  4. Bleeding disorder that was diagnosed by a physician
  5. Infectious disease: Confirmed HIV-1 or HIV-2 infection, chronic active hepatitis B infection, current hepatitis C infection, active syphilis, or medically diagnosed long COVID 19 Syndrome. Also excluded are participants with active, serious infections requiring parenteral antibiotic, antiviral, or antifungal therapy within 30 days prior to enrollment.
  6. Any abnormal laboratory parameters at screening per protocol.
  7. Receipt of live attenuated influenza vaccine within the previous 14 days, any other live attenuated vaccine within the previous 30 days or planned receipt within 30 days after vaccination with IP; or receipt of non-live attenuated vaccine within the previous 14 days or planned receipt within 14 days after vaccination with IP, including COVID-19 vaccines
  8. Receipt of blood transfusion or blood-derived products within the previous 3 months
  9. Prior potential exposure to Marburg Virus, or a medical history of hemorrhagic fever
  10. Prior receipt of any VSV-vectored vaccine, any Marburg vaccine, or any vaccine containing a filovirus component. Prior receipt of monoclonal or polyclonal antibodies directed against Marburg or other filovirus in the past 12 months
  11. Current participation in another clinical trial, within 3 months prior to enrollment.
  12. History of severe local or systemic reactogenicity to vaccines, or severe allergy to food or medications, and/or allergy to any component of this vaccine.
  13. Neuropsychiatric condition or substance abuse that compromises safety of the participant and precludes compliance with the protocol

  14. Current or planned occupational (medical care, childcare) or household contact (residing in the same household) from screening through 3 months after IP administration with any individual at increased risk from exposure to a live viral vaccine including infants ≤ 1 year of age, adults

    ≥75 years of age, or immunocompromised individuals.

  15. In the opinion of the PI, it is not in the best interest of the participant to participate in the trial
  16. A history of long-term treatment (≥ 4 weeks) for arthritis
  17. Participants currently experiencing a rash or who have a history of severe, chronic, or frequent rash will be excluded.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: rVSVΔG-SUDV-GP
Biologico: rVSVΔG-SUDV-GP
rVSVΔG-SUDV-GP
Comparatore placebo: Placebo
Placebo/Diluent
Altro: Placebo
Placebo

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety and tolerability of rVSVΔG-SUDV-GP vaccination: solicited reactogenicity
Lasso di tempo: 14 Days
Occurrence, onset, duration, and severity of local and systemic solicited adverse events within 14 days following vaccination
14 Days
Safety and tolerability of rVSVΔG-SUDV-GP vaccination: unsolicited reactogenicity
Lasso di tempo: 28 Days
Occurrence, onset, duration, severity, and relationship to IP of unsolicited adverse events, including safety laboratory parameters, within 28 days following vaccination
28 Days
Safety and tolerability of rVSVΔG-SUDV-GP vaccination: SAEs and AESIs
Lasso di tempo: 7 Months
Occurrence, onset, duration, severity, and relationship to IP of SAEs and AESIs throughout the study period
7 Months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
SUDV-GP-specific serum antibody responses
Lasso di tempo: Throughout the study, up to 6 months after immunization
Proportion of participants with binding antibody responses to SUDV-GP
Throughout the study, up to 6 months after immunization
SUDV-GP-specific serum antibody responses magnitude and duration
Lasso di tempo: Throughout the study, up to 6 months after immunization
Magnitude and duration of binding antibody to SUDV-GP throughout the full study period (1 week, 2 weeks, 4 weeks, 2 months, 3 months, 6 months after immunization)
Throughout the study, up to 6 months after immunization
SUDV-GP-specific serum antibody neutralization
Lasso di tempo: Throughout the study, up to 6 months after immunization
Proportion of participants with neutralizing antibody against Sudan virus as measured by PRNT assay
Throughout the study, up to 6 months after immunization
SUDV-GP-specific serum antibody magnitude and duration of neutralization
Lasso di tempo: Throughout the study, up to 6 months after immunization
Magnitude and duration of neutralizing antibody against Marburg virus as measured by PRNT assay throughout the full study period (1 week, 2 weeks, 4 weeks, 2 months, 3 months, 6 months after immunization)
Throughout the study, up to 6 months after immunization

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

International AIDS Vaccine Initiative

Collaboratori

Biomedical Advanced Research and Development Authority

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 aprile 2027

Completamento dello studio (Stimato)

1 aprile 2027

Date di iscrizione allo studio

Primo inviato

27 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

27 aprile 2026

Primo Inserito (Effettivo)

4 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

13 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IAVI C109

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

IPD sharing plans are currently under internal discussion.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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