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Et opfølgningssamling af GBS-NN/NN2-vaccine hos raske gravide kvinder

1. september 2026 opdateret af: Minervax ApS

Et opfølgningsforsøg til vurdering

The main objective of the study is to evaluate the persistence of the immunoglobulin G (IgG) antibody responses, specific to Alpha-like protein CN (AlpCN), Ribosomal Protein N (RibN), Alpha-like protein 1N (Alp1N), and Alpha-like protein 2 and 3 (Alp2-3N), after a primary vaccination with GBS-NN/NN2 hos alle deltagere.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

137

Fase

  • Fase 2
  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Danmark
    • Capital Region
      • Copenhagen, Capital Region, Danmark, 2650
        • Hvidovre Hospital - Department Of Obstetrics And Gynaecology
    • Central Jutland
      • Aarhus N, Central Jutland, Danmark, 8200
        • Aarhus Universitetshospital
    • Region Syddanmark
      • Kolding, Region Syddanmark, Danmark, 6000
        • Sygehus Lillebælt - Kolding Sygehus
  • Sydafrika
    • Gauteng
      • Ga-Rankuwa, Gauteng, Sydafrika, 0204
        • Sefako Makgatho Health Sciences University, Medunsa Clinical Research Unit (MeCRU)
    • Guateng Province
      • Johannesburg, Guateng Province, Sydafrika, 2001
        • Wits Reproductive Health and HIV Institute (Wits RHI)
      • Pretoria, Guateng Province, Sydafrika, 0152
        • Setshaba Research Centre

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
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inkluderingskriterier:

  • Deltager, der bor i Danmark eller Sydafrika, der har deltaget enten i forsøg MVX0004 (NCT05154578) eller MVX0005 (NCT04596878) og har modtaget mindst 1 dosis af GBS-NN/NN2-vaccine.
  • Deltager, der er i stand til at læse og forstå og i stand til at give personlig underskrevet informeret samtykke.
  • Deltager, der er villig og i stand til at overholde planlagte besøg, undersøgelsesplanen og andre forsøgsprocedurer.
  • Deltager, der giver adgang til deres forsøgsrelaterede medicinske poster og til deres forsøgsmateriale fra forsøg MVX0004 eller MVX0005, uanset hvad der er relevant.
  • Deltager, der forventes at være tilgængelig i løbet af retssagen, og som kan kontaktes telefonisk under retssagedeltagelse.

Ekskluderingskriterier:

  • Ethvert personale, der er involveret i gennemførelsen af ​​retssagen (og deres familiemedlemmer), herunder, men ikke begrænset til, ansatte i webstedsmedarbejdere, Minervax -medarbejdere og enhver leverandør- eller kontraktforskningsorganisation (CRO) -ansatte.
  • Deltager med bekræftet gruppe B Streptococcus (GBS) -infektion siden deltagelse i forsøg MVX0004 eller MVX0005.
  • Deltager med enhver psykiatrisk tilstand, herunder nyere (inden for det forløbne år) aktive selvmordstanker/adfærd, der kan øge risikoen for prøvedeltagelse eller i efterforskerens dom, der gør deltageren uegnet til deltagelse i retssagen.
  • Deltager, der deltog i andre forsøg, der involverede undersøgelsesmedicin (er) eller enheder inden for 28 dage før retssagen, og/eller deltager i andre forsøg, der involverer undersøgelsesmedicin (er) eller enheder ved prøveindgangen, eller planlægger at (fortsætte med) at deltage i andre forsøg, der involverer undersøgelsesmedicin eller enheder i løbet af denne prøve.
  • Deltager med kendt eller mistænkt immundefekt eller kræft eller en familiehistorie med medfødt eller arvelig immundefekt.
  • Deltager, der modtager kronisk administration (defineret som mere end 14 kontinuerlige dage) af immunsuppressiva eller andre immunmodificerende lægemidler inden for 6 måneder før forsøgsindgangen. En immunsuppressiv dosis af glukokortikoid defineres som en systemisk dosis ≥10 mg prednison pr. Dag eller tilsvarende. Brugen af ​​aktuelle, inhalerede og nasale glukokortikoider vil være tilladt.
  • Deltager, der modtog blod, blodprodukter, plasmadivater eller ethvert immunoglobulinpræparater i de 12 uger før prøveindgangen eller planlægger at modtage sådanne produkter under denne prøve.
  • Deltager med nuværende eller historie om misbrug af stof eller alkohol, som bedømt af efterforskeren.
  • Deltager, der modtog ethvert markedsført eller undersøgelses- (bortset fra GBS-NN/NN2 i MVX0004- eller MVX0005-forsøget) GBS-vacciner, eller som planlægger at modtage ethvert markedsført eller efterforskning (bortset fra GBS NN/NN2) GBS-vacciner under dette forsøg.

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Non-Pregnant Participants: No GBS-NN/NN2 Booster Dose
Participants who received at least one dose of GBS-NN/NN2 during the parent trial (MVX0004) who do not become pregnant during this trial will not receive a GBS-NN/NN2 booster dose.
Eksperimentel: Pregnant Participants: GBS-NN/NN2 Booster Dose
Participants who received at least one dose of GBS-NN/NN2 during the parent trial (MVX0004) and, become pregnant during this trial, and qualify, will receive a GBS-NN/NN2 booster dose.
Biologisk: GBS-NN/NN2-vaccine
0,5 ml (50 μg GBS-NN +50 μg GBS-NN2 adsorberet til 0,5 mg aluminium som Alhydrogel®)
Ingen indgriben: Pregnant Participants: No GBS-NN/NN2 Booster Dose
Participants who received at least one dose of GBS-NN/NN2 during the parent trial (MVX0004) and, become pregnant during this trial but do not qualify for receiving a GBS-NN/NN2 booster dose.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
All Participants: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum
Tidsramme: Up to approximately 4 years
Up to approximately 4 years

Sekundære resultatmål

Resultatmål
Tidsramme
Antal deltagere, der oplever SAES blandt gravide deltagere, der modtog GBS-NN/NN2 Booster-dosis
Tidsramme: Op til cirka 6 måneder efter levering
Op til cirka 6 måneder efter levering
Concentration of IgG Antibodies to AlpN Proteins in Blood Serum in Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Tidsramme: Pre-dose, 1 month post-dose, at delivery, and 6 months post-delivery
Pre-dose, 1 month post-dose, at delivery, and 6 months post-delivery
Concentration Ratio of IgG Antibodies Between Maternal and Cord Blood at Delivery in Pregnant Participants who Received the GBS-NN/NN2 Booster Dose and their Infant
Tidsramme: At Delivery, at any time during the trial (Up to approximately 4 years)
At Delivery, at any time during the trial (Up to approximately 4 years)
Concentration of IgG Antibodies to AlpN Proteins in Blood Serum at Delivery in Pregnant Participants who did not Receive the GBS-NN/NN2 Booster Dose
Tidsramme: At Delivery, at any time during the trial (Up to approximately 4 years)
At Delivery, at any time during the trial (Up to approximately 4 years)
Concentration Ratio of IgG Antibodies Between Maternal and Cord Blood at Delivery in Participants who did not Receive the of GBS-NN/NN2 Booster Dose
Tidsramme: At Delivery, at any time during the trial (Up to approximately 4 years)
At Delivery, at any time during the trial (Up to approximately 4 years)
Concentration of IgG Antibody to AlpN Proteins in Blood Serum in Infants Born to Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Tidsramme: At birth and at 1 and 3 months post-birth
At birth and at 1 and 3 months post-birth
Concentration of IgG Antibody to AlpN Proteins in Cord Blood in Infants Born to Pregnant Participants who did not Receive the GBS-NN/NN2 Booster Dose
Tidsramme: At Delivery, at any time during the trial (Up to approximately 4 years)
At Delivery, at any time during the trial (Up to approximately 4 years)
All Participants: Number of Participants Experiencing Procedure-related Serious Adverse Events (SAEs)
Tidsramme: Up to approximately 4 years
Up to approximately 4 years
Number of Participants Experiencing Solicited Local and Systemic Adverse Events (AEs) Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Tidsramme: Up to approximately Day 7 post-dose
Up to approximately Day 7 post-dose
Number of Participants Experiencing Unsolicited AEs Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Tidsramme: Up to approximately Day 28 post-dose
Up to approximately Day 28 post-dose
Number of Participants Experiencing AEs of Special Interest (AESI) Among Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Tidsramme: Up until delivery, at any time during the trial (Up to approximately 4 years)
Up until delivery, at any time during the trial (Up to approximately 4 years)
Gestational Age (GA) of Infants Born to Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Tidsramme: At Delivery, at any time during the trial (Up to approximately 4 years)
At Delivery, at any time during the trial (Up to approximately 4 years)
Weight of Infants Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Tidsramme: At Delivery, at any time during the trial (Up to approximately 4 years)
At Delivery, at any time during the trial (Up to approximately 4 years)
Length of Infants Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Tidsramme: At Delivery, at any time during the trial (Up to approximately 4 years)
At Delivery, at any time during the trial (Up to approximately 4 years)
Head Circumference of Infants Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Tidsramme: At Delivery, at any time during the trial (Up to approximately 4 years)
At Delivery, at any time during the trial (Up to approximately 4 years)
Apgar Score of Infants Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Tidsramme: At Delivery, at any time during the trial (Up to approximately 4 years)
At Delivery, at any time during the trial (Up to approximately 4 years)
Number of Infants Experiencing Unsolicited AEs Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Tidsramme: Up to 1 month post-birth
Up to 1 month post-birth
Number of Infants Experiencing Medically-attended AEs (MAAEs) Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Tidsramme: Up to 6 months post-birth
Up to 6 months post-birth
Number of Infants Experiencing SAEs Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Tidsramme: Up to 6 months post-birth
Up to 6 months post-birth
Number of Infants Experiencing AESIs Born from Pregnant Participants who Received the GBS-NN/NN2 Booster Dose
Tidsramme: Up to 6 months post-birth
Up to 6 months post-birth

Samarbejdspartnere og efterforskere

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

Sponsor

Minervax ApS

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)

7. marts 2025

Primær færdiggørelse (Anslået)

30. juni 2029

Studieafslutning (Anslået)

30. juni 2029

Datoer for studieregistrering

Først indsendt

9. september 2024

Først indsendt, der opfyldte QC-kriterier

9. september 2024

Først opslået (Faktiske)

19. september 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. september 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MVX008
  • 2024-516364-28 (EudraCT nummer)

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 .

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