Et forsøg for at evaluere tolerabilitet og immunogenicitet af V540D hos raske voksne (V540D-004)
Et fase 1, randomiseret, dobbeltblindt, komparator-kontrolleret, dosis-eskaleringsforsøg til evaluering, tolerabilitet og immunogenicitet af V540D hos raske voksne.
Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause an infection. There are many different types of HPV. Most people's immune system can fight HPV infection and it goes away without treatment. For some people, HPV infections can last longer and may cause cancer years later.
A standard vaccine to prevent HPV-related cancers is GARDASIL®9 (G9). G9 protects against 9 types of HPV but it does not protect against other types of HPV. The study vaccine (called V540D) is designed to protect against the same HPV types that G9 protects against plus other HPV types. The main goal of this study is to learn about the safety of V540D in healthy adults and if people tolerate it.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
-
-
Florida
-
Hollywood, Florida, Forenede Stater, 33024
- Research Centers of America ( Hollywood ) ( Site 0001)
-
-
Georgia
-
Savannah, Georgia, Forenede Stater, 31406
- Velocity Clinical Research, Savannah ( Site 0005)
-
-
Missouri
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Kansas City, Missouri, Forenede Stater, 64114
- Alliance for Multispecialty Research, LLC ( Site 0003)
-
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Tennessee
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Knoxville, Tennessee, Forenede Stater, 37920
- Alliance for Multispecialty Research, LLC ( Site 0004)
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
The key inclusion criteria include but are not limited to the following:
- Is in good health based on medical history, physical examination, vital sign (VS) measurements and electrocardiograms (ECGs) performed before randomization
Exclusion Criteria:
The key exclusion criteria include but are not limited to the following:
- Has a history of abnormal Pap smears, HPV- related external genital lesions (eg, condyloma acuminate, vulval intraepithelial neoplasia (VIN), or prostatic intraepithelial neoplasia (PIN)) or external genital cancer (eg, penile cancer), HPV-related vaginal or anal lesions (eg, condyloma acuminata or vaginal intraepithelial neoplasia (VaIN)) or vaginal or anal cancer
- Has a history of cancer (malignancy)
- Has received any HPV vaccine or is expected to receive any HPV vaccine during the study, outside the protocol
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: V540D
Participants will receive vaccinations with V540D. |
Experimental vaccine and adjuvant administered via intramuscular (IM) injection |
|
Aktiv komparator: GARDASIL®9
Participants will receive vaccinations with GARDASIL®9. |
Suspension administered via IM injection
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Who Experience a Solicited Injection-Site Adverse Event (AE)
Tidsramme: Up to approximately 6 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to approximately 6 months
|
|
Number of Participants Who Experience a Solicited Systemic AE
Tidsramme: Up to approximately 6 months
|
Solicited systemic AEs include headache, fatigue, nausea, dizziness, muscle aches, joint pain. |
Up to approximately 6 months
|
|
Number of Participants Who Experience Immediate Reactions Occurring Within 30 Minutes After Any Vaccination
Tidsramme: Up to approximately 6 months
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Up to approximately 6 months
|
|
Number of Participants Who Experience Unsolicited AEs
Tidsramme: Up to approximately 7 months
|
An unsolicited AE is an event that is not predefined as a solicited AE or is predefined as a solicited AE but reported at any time outside the solicited time period. |
Up to approximately 7 months
|
|
Number of Participants Who Experience a Serious Adverse Event (SAE)
Tidsramme: Up to approximately 18 months
|
SAEs include AEs that result in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. |
Up to approximately 18 months
|
|
Number of Participants Who Experience a Medically-Attended AE (MAAE)
Tidsramme: Up to approximately 18 months
|
AEs in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Routine visits are not considered MAAEs. Examples of routine visits include physical examination, wellness visits, or vaccinations. |
Up to approximately 18 months
|
|
Number of Participants Who Experience an Event of Clinical Interest (ECI)
Tidsramme: Up to approximately 18 months
|
ECIs are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs). |
Up to approximately 18 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Immunoglobulin G (IgG) Geometric Mean Ratios (GMRs) for anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Tidsramme: Up to approximately 7 months
|
GMR of titers for participants vaccinated with V540D versus those who received GARDASIL®9 alone will be calculated. |
Up to approximately 7 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- V540D-004
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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