Een proef om de verdraagbaarheid en immunogeniciteit van V540D bij gezonde volwassenen te evalueren (V540D-004)
Een fase 1, gerandomiseerde, dubbelblinde, comparator-gecontroleerde dosis-escalatiestudie om de verdraagbaarheid en immunogeniciteit van V540D bij gezonde volwassenen te evalueren.
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
-
-
Florida
-
Hollywood, Florida, Verenigde Staten, 33024
- Research Centers of America ( Hollywood ) ( Site 0001)
-
-
Georgia
-
Savannah, Georgia, Verenigde Staten, 31406
- Velocity Clinical Research, Savannah ( Site 0005)
-
-
Missouri
-
Kansas City, Missouri, Verenigde Staten, 64114
- Alliance for Multispecialty Research, LLC ( Site 0003)
-
-
Tennessee
-
Knoxville, Tennessee, Verenigde Staten, 37920
- Alliance for Multispecialty Research, LLC ( Site 0004)
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: V540D
Participants will receive vaccinations with V540D. |
Experimental vaccine and adjuvant administered via intramuscular (IM) injection |
|
Actieve vergelijker: GARDASIL®9
Participants will receive vaccinations with GARDASIL®9. |
Suspension administered via IM injection
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Participants Who Experience a Solicited Injection-Site Adverse Event (AE)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Total Immunoglobulin G (IgG) Geometric Mean Ratios (GMRs) for anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Medical Director, Merck Sharp & Dohme LLC
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- V540D-004
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .