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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. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.[

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

112

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20037
    • Kansas
      • Lenexa, Kansas, Forenede Stater, 66219
        • Johnson County Clin-Trials
        • Kontakt:
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: rVSVΔG-SUDV-GP
Biologisk: rVSVΔG-SUDV-GP
rVSVΔG-SUDV-GP
Placebo komparator: Placebo
Placebo/Diluent
Andet: Placebo
Placebo

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Safety and tolerability of rVSVΔG-SUDV-GP vaccination: solicited reactogenicity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 7 Months
Occurrence, onset, duration, severity, and relationship to IP of SAEs and AESIs throughout the study period
7 Months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
SUDV-GP-specific serum antibody responses
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

International AIDS Vaccine Initiative

Samarbejdspartnere

Biomedical Advanced Research and Development Authority

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. april 2027

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IAVI C109

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

IPD sharing plans are currently under internal discussion.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Sudan Virus Disease

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Betingelser

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