Sikkerhed og effektivitet af GSK Neisseria Gonorrhoeae GMMA (NgG) undersøgelsesvaccine, når den administreres til raske voksne i alderen 18 til 50 år.
19. maj 2026 opdateret af: GlaxoSmithKline
En fase 1/2, observatørblind, randomiseret, placebo-kontrolleret multilande undersøgelse for at vurdere sikkerhed og effektivitet af GSK Neisseria Gonorrhoeae GMMA (NgG) undersøgelsesvaccine, når det administreres til raske voksne i alderen 18 til 50 år
Formålet med denne første gang i human proof of concept (FTiH-PoC) undersøgelse er at evaluere sikkerhed og reaktogenicitet, at demonstrere effektivitet og at udforske immunogeniciteten af GlaxoSmithKlines (GSK) Neisseria gonorrhoeae generaliserede moduler til membranantigener (GMMA) (NgG) undersøgelse. vaccine sammenlignet med placebo (saltvand).
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
The study included the following parts:
- Phase 1 - Dose-escalation safety lead-in in healthy participants.
- Phase 2 - Efficacy PoC in healthy participants considered at risk for gonorrhea.
The doses to be tested for efficacy would be selected based on the safety evaluation performed during the dose-escalation safety lead-in: in case more than one dose would show tolerability, the highest tolerated dose (HTD) and the dose below the highest tolerated (i.e., 2 doses) would be advanced in the efficacy PoC part of the study and compared versus placebo. In case only the lowest dose shows adequate tolerability, this would be the only dose tested in the PoC versus placebo.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1009
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Salvador, Brasilien, 41680-020
- GSK Investigational Site
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London, Det Forenede Kongerige, WC1E 6JB
- GSK Investigational Site
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London, Det Forenede Kongerige, SW10 9NH
- GSK Investigational Site
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Manila, Filippinerne, 1000
- GSK Investigational Site
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20009
- GSK Investigational Site
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Kansas
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Lenexa, Kansas, Forenede Stater, 66219
- GSK Investigational Site
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- GSK Investigational Site
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Missouri
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Springfield, Missouri, Forenede Stater, 65802
- GSK Investigational Site
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New York
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The Bronx, New York, Forenede Stater, 10467
- GSK Investigational Site
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 48202
- GSK Investigational Site
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Texas
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Austin, Texas, Forenede Stater, 78705
- GSK Investigational Site
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Lyon, Frankrig, 69004
- GSK Investigational Site
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Paris, Frankrig, 75475
- GSK Investigational Site
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Pierre-Bénite, Frankrig, 69495
- GSK Investigational Site
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Barcelona, Spanien, 08015
- GSK Investigational Site
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Madrid, Spanien, 28006
- GSK Investigational Site
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Madrid, Spanien, 28040
- GSK Investigational Site
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Valencia, Spanien, 46026
- GSK Investigational Site
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Johannesburg, Sydafrika, 2001
- GSK Investigational Site
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Soweto, Sydafrika, 2013
- GSK Investigational Site
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Bochum, Tyskland, 44787
- GSK Investigational Site
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Frankfurt, Tyskland, 60596
- GSK Investigational Site
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Hamburg, Tyskland, 20146
- GSK Investigational Site
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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
18 år til 50 år (Voksen)
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
Inklusionskriterier for sikkerhedsindledningsdelen til dosiseskalering
- Deltagere, som efter efterforskerens opfattelse kan og vil overholde protokollens krav.
- Skriftligt eller vidne/tommelprintet informeret samtykke opnået fra deltageren forud for udførelse af en undersøgelsesspecifik procedure.
- Raske deltagere som fastslået ved sygehistorie, klinisk undersøgelse og laboratorievurdering.
- En deltager mellem og med 18 og 50 år på tidspunktet for informeret samtykke.
- Kvindelige deltagere i ikke-fertil alder kan blive tilmeldt undersøgelsen. Ikke-fødepotentiale er defineret som præmenarche, nuværende bilateral tubal ligering eller okklusion, hysterektomi, bilateral ovariektomi eller postmenopause.
Kvindelige deltagere i den fødedygtige alder kan blive tilmeldt undersøgelsen, hvis deltageren:
- har praktiseret tilstrækkelig prævention i 1 måned forud for administration af studieintervention, og
- har negativ graviditetstest på dagen for undersøgelsens interventionsadministration, og
- har indvilliget i at fortsætte med tilstrækkelig prævention i hele behandlingsperioden og i 1 måned efter afslutningen af undersøgelsens interventionsadministrationsserie.
Inklusionskriterier for effektivitet PoC-delen
- Deltagere, som efter efterforskerens opfattelse kan og vil overholde protokollens krav.
- Skriftligt eller vidne/tommelprintet informeret samtykke opnået fra deltageren forud for udførelse af en undersøgelsesspecifik procedure.
Sunde deltagere som etableret af:
- For de 2 undergrupper af intensiv sikkerhedsmonitorering (dvs. de første 30 hiv-negative forsøgspersoner pr. gruppe efterfulgt af de første 8 hiv-positive forsøgspersoner pr. gruppe): sygehistorie, klinisk undersøgelse og laboratorievurdering.
- For alle de resterende deltagere: sygehistorie, klinisk undersøgelse.
- I risiko for gonokokkinfektioner baseret på seksuelle adfærdskarakteristika: dette kan omfatte mænd, der har sex med mænd, præ-eksponeringsprofylakse for hiv-brugere, personer, der engagerer sig i transaktionelle kønsdeltagere med nuværende eller tidligere STI-diagnose, deltagere på tidspunktet for STI-screening eller søgning andre STI-tjenester.
- En deltager mellem og med 18 og 50 år på tidspunktet for informeret samtykke. Transkønnede mænd og kvinder og andre kønsukonforme personer, der identificerer sig selv som hverken mænd eller kvinder, kan blive tilmeldt undersøgelsen, baseret på deres risikofaktorer. Til formålet med denne undersøgelse vil de blive fulgt op i henhold til deres biologiske køn (sex ved fødslen), seksuel orientering og genital/seksuel anatomi
- Deltagere af ikke-fertil alder kan tilmeldes undersøgelsen. Dette omfatter transmænd, der ikke har gennemgået kønsbekræftende operationer af deres kønsorganer.
Deltagere i den fødedygtige alder kan tilmeldes undersøgelsen, hvis deltageren:
- har praktiseret tilstrækkelig prævention i 1 måned forud for administration af studieintervention, og
- har negativ graviditetstest på dagen for undersøgelsens interventionsadministration, og
- har indvilliget i at fortsætte med tilstrækkelig prævention i hele behandlingsperioden og i 1 måned efter afslutningen af undersøgelsens interventionsadministrationsserie.
Ekskluderingskriterier:
Medicinske forhold Dosis-eskaleringssikkerhed indledningsdel
- Enhver klinisk signifikant hæmatologisk/biokemisk laboratorieabnormitet.
- Enhver anden klinisk tilstand, som efter investigators mening kan udgøre en yderligere risiko for deltageren på grund af deltagelse i undersøgelsen.
- Anamnese med enhver reaktion/overfølsomhed, der sandsynligvis vil blive forværret af en komponent af undersøgelsens intervention(er).
- Enhver bekræftet formodet immunsuppressiv/immundefekt tilstand baseret på sygehistorie og fysisk undersøgelse.
- Overfølsomhed over for latex.
- Akut/kronisk klinisk signifikant pulmonal, kardiovaskulær, lever/nyrefunktionsabnormitet, som bestemt ved fysisk undersøgelse/laboratorietest.
- Tilbagevendende historie/ukontrollerede neurologiske lidelser eller anfald.
- Historie om invasiv meningokoksygdom. Effekt PoC-del: HIV-negativ intensiv sikkerhedsovervågning, HIV-negativ fuld tilmelding og for alle resterende deltagere
- Gonokokinfektion identificeret inden for 14 dage før randomisering.
- Enhver anden klinisk tilstand, som efter investigators mening kan udgøre en yderligere risiko for deltageren på grund af deltagelse i undersøgelsen.
- Anamnese med enhver reaktion eller overfølsomhed, der sandsynligvis vil blive forværret af en komponent i undersøgelsens intervention(er).
- Enhver bekræftet eller mistænkt immunsuppressiv/immundefekt tilstand baseret på sygehistorie og fysisk undersøgelse.
- Kendt seropositivitet for HIV-infektion, uanset viræmi og CD4-celletal
- Overfølsomhed over for latex.
- Akut/kronisk klinisk signifikant pulmonal, kardiovaskulær, lever/nyrefunktionsabnormitet, som bestemt ved fysisk undersøgelse/laboratorietest.
- Tilbagevendende historie/ukontrollerede neurologiske lidelser eller anfald.
- Historie om invasiv meningokoksygdom.
Udelukkelseskriterierne afbildet ovenfor og følgende ekskluderingskriterier gælder kun for de hiv-positive deltagere (undergruppe af intensiv sikkerhedsovervågning og fuld tilmelding af hiv-positive deltagere):
Seropositivitet for HIV-infektion, hvis:
- CD4-celletal < 350 celler/mm3 i de sidste 6 måneder
- viral load > 50 cp/ml i de sidste 6 måneder
- deltageren ikke er i antiretroviral behandling (ART) i > 3 måneder eller har skiftet fra en anden ART inden for de sidste 3 måneder.
For både undergruppe af intensiv sikkerhedsmonitorering (første 30 hiv-negative forsøgspersoner pr. gruppe og de første 8 hiv-positive forsøgspersoner pr. gruppe) gælder disse eksklusionskriterier:
Enhver klinisk signifikant hæmatologisk/biokemisk laboratorieabnormitet.
Forudgående/Samtidig behandling Gælder for både dosis-eskaleringssikkerhedsindføringsdelen og PoC-delen
- Brug af ethvert forsøgs-/ikke-registreret produkt ud over undersøgelsens intervention(er) i perioden, der begynder 30 dage før den første dosis/deres planlagte brug i undersøgelsesperioden.
- Tidligere og planlagt vaccination med en OMV-baseret Neisseria meningitidis gruppe B-vaccine (f.eks. Bexsero, MeNZB-vaccine eller MenBvac på et hvilket som helst tidspunkt før første dosis og i hele undersøgelsesperioden.
- Planlagt administration/administration af en vaccine, der ikke er forudset af undersøgelsesprotokollen i perioden, der starter 15 dage før den første dosis og slutter 15 dage efter den sidste dosis af vaccineadministrationen*.
- Administration af langtidsvirkende immunmodificerende lægemidler i perioden, der starter 6 måneder før den første dosis af undersøgelsesintervention/planlagt administration på et hvilket som helst tidspunkt i undersøgelsesperioden.
- Administration af immunglobuliner/evt. blodprodukter/plasmaderivater i perioden, der starter 3 måneder før administration af den første dosis af undersøgelsesintervention/planlagt administration i undersøgelsesperioden.
- Kronisk administration (defineret som mere end 14 dage i alt) af immunsuppressiva/andre immunmodificerende lægemidler i perioden, der starter 3 måneder før den/de første undersøgelsesinterventionsdosis(er). For langtidsvirkende immunmodificerende lægemidler, se ovenfor. For kortikosteroider vil dette betyde prednisonækvivalent ≥20 mg/dag for voksne deltagere/≥0,5 mg/kg/dag. Inhalerede og topiske steroider er tilladt.
Følgende udelukkelseskriterium gælder kun for PoC-delen:
•Kronisk/langvarig brug af systemiske antibiotika med aktivitet mod Neisseria gonorrhoeae.
- Tidligere/samtidig klinisk undersøgelseserfaring, der gælder for både dosis-eskaleringssikkerheds-indledningsdelen og PoC-delen. Samtidig deltagelse i et andet klinisk studie, på et hvilket som helst tidspunkt i undersøgelsesperioden, hvor deltageren har været/vil blive udsat for en undersøgelse/ et ikke-efterforskningsmæssigt indgreb.
Andre undtagelser, der gælder for både dosis-eskaleringssikkerhedsledende del og PoC-delen
- Drægtig/ammende hun.
- Kvinde, der planlægger at blive gravid/planlægger at seponere præventionsforanstaltninger inden 1 måned efter afslutningen af undersøgelsens interventionsadministrationsserie.
- Eventuelt studiepersonale/deres umiddelbare pårørende, familie/husstandsmedlemmer.
- Livsstilshensyn, der kan forstyrre gennemførelsen af undersøgelsen/ udgøre yderligere risici for deltagernes rettigheder og velvære.
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: Sekventiel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Phase 1: Neisseria gonorrhoeae GMMA (NgG) 12.5 micrograms (µg) Group
Participants received 2 doses of NgG 12.5 µg investigational vaccine on Day 1 and Day 61.
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2 doses of NgG 12.5 µg investigational vaccine administered intramuscularly.
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Eksperimentel: Phase 1: NgG 25 µg Group
Participants received 2 doses of NgG 25 µg investigational vaccine on Day 1 and Day 61.
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2 doses of NgG 25 µg investigational vaccine administered intramuscularly.
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Eksperimentel: Phase 1: NgG 50 µg Group
Participants received 2 doses of NgG 50 µg investigational vaccine on Day 1 and Day 61.
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2 doses of NgG 50 µg investigational vaccine administered intramuscularly.
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Placebo komparator: Phase 1: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
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2 doses of placebo administered intramuscularly.
Andre navne:
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Eksperimentel: Phase 2: NgG Highest tolerated dose (HTD; 50 µg) Group
Participants received 2 doses of NgG HTD (50 µg) investigational vaccine on Day 1 and Day 61.
The HTD was selected based on the safety evaluation performed in Phase 1.
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2 doses of NgG 50 µg investigational vaccine administered intramuscularly.
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Eksperimentel: Phase 2: NgG dose below HTD (bHTD; 25 µg) Group
Participants received 2 doses of NgG bHTD (25 µg) investigational vaccine on Day 1 and Day 61.
The bHTD is selected based on the safety evaluation performed in Phase 1.
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2 doses of NgG 25 µg investigational vaccine administered intramuscularly.
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Placebo komparator: Phase 2: Placebo Group
Participants received 2 doses of placebo on Day 1 and Day 61.
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2 doses of placebo administered intramuscularly.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Phase 1: Number of Participants Reporting Any Solicited Administration Site Events
Tidsramme: From Day 1 to Day 7
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Assessed solicited administration site events included injection site pain, erythema (redness), and swelling.
Any = occurrence of the event regardless of intensity grade.
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From Day 1 to Day 7
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Phase 1: Number of Participants Reporting Any Solicited Administration Site Events
Tidsramme: From Day 61 to Day 67
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Assessed solicited administration site events included injection site pain, erythema (redness), and swelling.
Any = occurrence of the event regardless of intensity grade.
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From Day 61 to Day 67
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Phase 1: Number of Participants Reporting Any Solicited Systemic Events
Tidsramme: From Day 1 to Day 7
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Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia).
Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral cavity.
Any = occurrence of the event regardless of intensity grade.
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From Day 1 to Day 7
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Phase 1: Number of Participants Reporting Any Solicited Systemic Events
Tidsramme: From Day 61 to Day 67
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Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia).
Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral cavity.
Any = occurrence of the event regardless of intensity grade.
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From Day 61 to Day 67
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Phase 1: Number of Participants Reporting Any Unsolicited Adverse Events (AEs)
Tidsramme: From Day 1 to Day 30
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An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Unsolicited AEs include both serious and non-serious AEs.
Any = occurrence of the event regardless of intensity grade.
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From Day 1 to Day 30
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Phase 1: Number of Participants Reporting Any Unsolicited AEs
Tidsramme: From Day 61 to Day 90
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An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Unsolicited AEs include both serious and non-serious AEs.
Any = occurrence of the event regardless of intensity grade.
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From Day 61 to Day 90
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Phase 1: Number of Participants Reporting Any Serious Adverse Events (SAEs) and AEs Leading to Withdrawal
Tidsramme: From Day 1 after the first dose to Day 241
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An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator.
An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention.
The AE may or may not be considered related to the study intervention.
A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for them since the date of withdrawal/last contact.
Any = occurrence of the event regardless of intensity grade.
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From Day 1 after the first dose to Day 241
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Phase 1: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values
Tidsramme: At Day 8 compared to baseline (Day 1)
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The safety laboratory data included haematological parameters [hemoglobin, lymphocytes, platelets, neutrophils, and white blood cells (WBC)] and biochemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Blood Urea Nitrogen and Creatinine).
Categories reported when comparing Day 1 (baseline) and Day 8 haematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g.
ALT, Within, Within).
Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
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At Day 8 compared to baseline (Day 1)
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Phase 1: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values
Tidsramme: At Day 68 compared to baseline (Day 61)
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The safety laboratory data included haematological parameters (hemoglobin, lymphocytes, platelets, neutrophils, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine).
Categories reported when comparing Day 61 (baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g.
ALT, Within, Within).
Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
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At Day 68 compared to baseline (Day 61)
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Phase 2: Incidence Rate of Confirmed Gonorrhea Cases
Tidsramme: From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
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Incidence of first confirmed gonorrhea cases by positive Nucleic Acid Amplification Test (NAAT) at the anorectal and/or urogenital location were evaluated.
The incidence rate (y/PT) of confirmed gonorrhea cases, expressed in terms of 100 person-years, was calculated as the number of confirmed gonorrhea cases (y) in a group, over the sum of individual person-times at risk (PT) in the same group, and multiplied by 100.
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From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
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Phase 2: Number of Participants Reporting Any Solicited Administration Site Events
Tidsramme: From Day 1 to Day 7
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Assessed solicited administration site events included injection site pain, erythema (redness), and swelling.
Any = occurrence of the event regardless of intensity grade.
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From Day 1 to Day 7
|
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Phase 2: Number of Participants Reporting Any Solicited Administration Site Events
Tidsramme: From Day 61 to Day 67
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Assessed solicited administration site events included injection site pain, erythema (redness), and swelling.
Any = occurrence of the event regardless of intensity grade.
|
From Day 61 to Day 67
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Phase 2: Number of Participants Reporting Any Solicited Systemic Events
Tidsramme: From Day 1 to Day 7
|
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia).
Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral cavity.
Any = occurrence of the event regardless of intensity grade.
|
From Day 1 to Day 7
|
|
Phase 2: Number of Participants Reporting Any Solicited Systemic Events
Tidsramme: From Day 61 to Day 67
|
Assessed solicited systemic events included headache, fatigue (tiredness), myalgia (muscle pain), arthralgia (joint pain), and fever (pyrexia).
Fever is defined as body temperature >=38ºC; preferred location for measuring the temperature is oral.
Any = occurrence of the event regardless of intensity grade.
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From Day 61 to Day 67
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Phase 2: Number of Participants Reporting Any Unsolicited AEs
Tidsramme: From Day 1 to Day 30
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An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Unsolicited AEs include both serious and non-serious AEs.
Any = occurrence of the event regardless of intensity grade.
|
From Day 1 to Day 30
|
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Phase 2: Number of Participants Reporting Any Unsolicited AEs
Tidsramme: From Day 61 to Day 90
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An unsolicited AE is an AE that is either not included in the list of solicited events or can be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Unsolicited AEs include both serious and non-serious AEs.
Any = occurrence of the event regardless of intensity grade.
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From Day 61 to Day 90
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Phase 2: Number of Participants Reporting Any SAEs and AEs Leading to Withdrawal
Tidsramme: From Day 1 after the first dose to Day 451
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An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcome or any other situation as determined by the investigator.
An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention.
The AE may or may not be considered related to the study intervention.
A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for them since the date of withdrawal/last contact.
Any = occurrence of the event regardless of intensity grade.
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From Day 1 after the first dose to Day 451
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Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values in HIV Negative (HIV-) Subset
Tidsramme: At Day 8 compared to baseline (Day 1)
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The safety laboratory data included haematological parameters (hemoglobin, lymphocytes, platelets, neutrophils, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine).
Categories reported when comparing Day 1 (baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g.
ALT, Within, Within).
Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
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At Day 8 compared to baseline (Day 1)
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Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values for HIV Positive (HIV+) Subset
Tidsramme: At Day 8 compared to baseline (Day 1)
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The safety laboratory data included haematological parameters (hemoglobin, absolute lymphocyte count, platelets, absolute neutrophil count, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine).
Categories reported when comparing Day 1 (baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g.
ALT, Within, Within).
Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
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At Day 8 compared to baseline (Day 1)
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Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values for HIV- Subset
Tidsramme: At Day 68 compared to baseline (Day 61)
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The safety laboratory data included haematological parameters (hemoglobin, lymphocytes, platelets, neutrophils, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine).
Categories reported when comparing Day 61 (baseline) and Day 68 haematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g.
ALT, Within, Within).
Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
|
At Day 68 compared to baseline (Day 61)
|
|
Phase 2: Number of Participants With Change From Baseline in Haematological and Biochemical Laboratory Values HIV+ Subset
Tidsramme: At Day 68 compared to baseline (Day 61)
|
The safety laboratory data included haematological parameters (hemoglobin, absolute lymphocyte count, platelets, absolute neutrophil count, and WBC) and biochemical parameters (ALT, AST, Blood Urea Nitrogen and Creatinine).
Categories reported when comparing Day 61 (baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>, <range at baseline>, <range at timing> (e.g.
ALT, Within, Within).
Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Unknown = No results are available for the corresponding laboratory parameter at the specific timepoint.
|
At Day 68 compared to baseline (Day 61)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Phase 2: Incidence Rates of Confirmed Gonorrhea Cases With and Without Chlamydia Trachomatis Co-infection
Tidsramme: From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
|
Confirmed gonorrhea cases by positive NAAT with and without chlamydia trachomatis co-infection at the pharyngeal and/or anorectal and/or urogenital location are reported.
The incidence rate (y/PT) of confirmed gonorrhea cases with and without Chlamydia Trachomatis co-infection, expressed in terms of 100 person-years, was calculated as the number of confirmed gonorrhea cases with and without Chlamydia Trachomatis co-infection (y) in a group, over the sum of individual person-times at risk (PT) in the same group, and multiplied by 100.
|
From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
|
|
Phase 2: Incidence Rates of Symptomatic and Confirmed Gonorrhea Cases
Tidsramme: From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
|
Symptomatic gonorrhea cases which were later confirmed gonorrhea cases are reported.
Symptomatic gonorrhea cases are defined as participants with symptoms suggestive of gonorrhea at the infected anatomical site which were later confirmed by a positive NAAT at the anorectal and/or urogenital location.
The incidence rate (y/PT) of confirmed gonorrhea cases, expressed in terms of 100 person-years, was calculated as the number of confirmed gonorrhea cases (y) in a group, over the sum of individual person-times at risk (PT) in the same group, and multiplied by 100.
|
From 1 month post-Dose 2 (Day 91) to 13 months post-Dose 2 (Day 451)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 (Faktiske)
28. november 2022
Primær færdiggørelse (Faktiske)
22. maj 2025
Studieafslutning (Faktiske)
22. maj 2025
Datoer for studieregistrering
Først indsendt
25. november 2022
Først indsendt, der opfyldte QC-kriterier
25. november 2022
Først opslået (Faktiske)
30. november 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 216156
- 2022-500883-37-00 (Anden identifikator: EU CT number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
IPD for denne undersøgelse vil blive gjort tilgængelig via webstedet for anmodning om kliniske undersøgelsesdata.
IPD-delingstidsramme
IPD vil blive gjort tilgængelig inden for 6 måneder efter offentliggørelsen af resultaterne af de primære endepunkter, et nøgle sekundært endepunkt og sikkerhedsdata for undersøgelsen.
IPD-delingsadgangskriterier
Adgang gives, efter at et forskningsforslag er indsendt og har modtaget godkendelse fra det uafhængige evalueringspanel, og efter en datadelingsaftale er på plads.
Adgangen gives i en indledende periode på 12 måneder, men en forlængelse kan gives, når det er berettiget, i op til yderligere 12 måneder.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .