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En undersøgelse for at lære om vaccinen RSVpreF hos gravide deltagere med hiv og deres spædbørn (MORISOT)

30. juni 2026 opdateret af: Pfizer

Et fase 3, randomiseret, dobbeltblindet, placebokontrolleret forsøg til evaluering af sikkerhed, tolerabilitet og immunogenicitet af respiratorisk syncytialvirus (RSV) præfusion F-underenhedsvaccine hos gravide deltagere, der lever med hiv og deres spædbørn

Formålet med undersøgelsen er at lære om RSVpreF-vaccinens sikkerhed og immunaktivitet. Det vil blive undersøgt hos spædbørn født af mødre, der lever med hiv. Disse spædbørn kan have større chancer for at blive syge eller dø på grund af RSV-infektion. Respiratory Syncytial Virus (RSV) er en almindelig type virus (kim), der kan forårsage alvorlig sygdom (luftvejssygdomme), hvor der er behov for lægehjælp. Vacciner hjælper din krop med at danne antistoffer, som hjælper med at bekæmpe sygdomme. Antistofferne er stoffer, din krop bruger til at bekæmpe en infektion. Antistofferne kan overføres til spædbarnet gennem moderens moderkage.

Undersøgelsen vil se på sikkerheden, tolerabiliteten og immunaktiviteten hos mødre og deres spædbørn.

Denne undersøgelse søger gravide kvinder, der er:

  • Mindre end eller lig med 49 år og har HIV (human immundefekt virus -
  • Modtagelse af standard medicinsk behandling under graviditeten
  • Har ikke syfilis (bakteriel seksuelt overført sygdom), hepatitis B-virus ((HBV) leverinfektion), tuberkulose ((TB) bakteriel lungeinfektion).
  • Har været i stabil (antiretroviral) HIV-behandling i mere end eller lig med 90 dage.
  • accepterer at være til stede ved alle studiebesøg, procedurer og blodudtagninger.

Deltagerne vil enten modtage:

  • RSVpreF-vaccine
  • En placebo. En placebo har ingen medicin, men den ligner bare undersøgelsesvaccinen.

Gravide deltagere vil blive involveret i undersøgelsen fra:

  • samtykke under deres nuværende graviditet, og
  • i 6 måneder efter fødslen af ​​deres baby (omkring 10 måneder i alt). Gravide deltagere vil have mindst 5 planlagte besøg i denne undersøgelse. Spædbørnsdeltagere: Alle berettigede babyer født af tilmeldte mødre vil blive fulgt op fra fødslen i op til 6 måneder. Spædbørns deltagere vil have mindst 3 studiebesøg, hvor nogle besøg på stedet kan ske via hjemmebesøg eller over telefon.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

681

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Sydafrika
    • Eastern Cape
      • East London, Eastern Cape, Sydafrika, 5241
        • Synergy Biomed Research Institute
    • Free State
      • Bloemfontein, Free State, Sydafrika, 9301
        • Josha Research
    • Gauteng
      • Benoni, Gauteng, Sydafrika, 1500
        • Worthwhile Clinical Trials
      • Boksburg, Gauteng, Sydafrika, 1459
        • REIMED Reiger Park
      • Johannesburg, Gauteng, Sydafrika, 2001
        • Wits RHI
      • Johannesburg, Gauteng, Sydafrika, 2013
        • University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)
      • Johannesburg, Gauteng, Sydafrika, 2093
        • Wits VIDA Nkanyezi Research Unit
      • Pretoria, Gauteng, Sydafrika, 0184
        • Botho ke Bontle Health Services
      • Pretoria, Gauteng, Sydafrika, 0152
        • Setshaba Research Centre
    • KwaZulu-Natal
      • Ladysmith, KwaZulu-Natal, Sydafrika, 3370
        • Qhakaza Mbokodo Research Clinic
    • Limpopo
      • Polokwane, Limpopo, Sydafrika, 0699
        • Gole Biomed Research Centre
    • Western Cape
      • Cape Town, Western Cape, Sydafrika, 7700
        • MRC Unit on Child And Adolescent Health
      • Cape Town, Western Cape, Sydafrika, 7750
        • Gugulethu Green Clinic
      • Worcester, Western Cape, Sydafrika, 6850
        • FAMCRU - Worcester

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

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Nøgleinklusionskriterier - Moderlige deltagere

  • Kvinder ≤49 år, som er mellem 24 0/7 og 36 0/7 uger af graviditeten på dagen for planlagt vaccination, med en ukompliceret singleton-graviditet, som ikke har nogen kendt øget risiko for komplikationer.
  • Bekræftet stabil HIV-sygdom.
  • Aktuel og stabil brug af antiretroviral terapi (ART) i mindst 90 dage før tilmelding.
  • Føtalt anomali-ultralydsundersøgelse blev udført ved ≥18 uger af graviditeten, uden at der blev observeret signifikante føtale abnormiteter.
  • Intention om at føde på et hospital eller fødested, hvor undersøgelsesprocedurer kan opnås.
  • Deltageren er villig til at give informeret samtykke til, at deltagerens spædbarn kan deltage i undersøgelsen.
  • I stand til at give underskrevet informeret samtykke, hvilket omfatter overholdelse af kravene og begrænsninger, der er anført i det informerede samtykkedokument (ICD) og i denne protokol.

Nøgleinklusionskriterier - spædbørnsdeltagere

  • Bevis for en underskrevet og dateret ICD, underskrevet af forældrene/værgene.
  • Forældre/værge, der er villige og i stand til at overholde planlagte besøg, undersøgelsesplaner, laboratorietests og andre undersøgelsesprocedurer

Nøgleudelukkelseskriterier - Moderlige deltagere

  • Pregnancy body mass index (BMI) på >40 kg/m2. Hvis BMI før graviditet ikke er tilgængelig, kan BMI på tidspunktet for det første obstetriske besøg under den aktuelle graviditet anvendes.
  • Deltager med opportunistiske infektioner eller malignitet.
  • Anamnese med aktiv kronisk viral hepatitis med biokemiske tegn på aspartataminotransferase (AST) eller alaninaminotransferase (ALT) værdier >5 gange den øvre normalgrænse inden for 6 måneder før indskrivning.
  • Anamnese med alvorlig bivirkning forbundet med en vaccine og/eller alvorlig allergisk reaktion (f.eks. anafylaksi) over for en hvilken som helst komponent i undersøgelsesinterventionen eller enhver relateret vaccine.
  • Nuværende graviditet som følge af in vitro-befrugtning. Deltagere, der vides at have brugt clomiphenecitrat og/eller letrozol med eller uden intrauterin insemination (IUI), er tilladt.
  • Aktuelle graviditetskomplikationer eller abnormiteter på tidspunktet for samtykke, der vil øge risikoen forbundet med deltagelse i og afslutning af undersøgelsen, herunder men ikke begrænset til følgende:
  • Præeklampsi, eclampsia eller ukontrolleret svangerskabsforhøjelse.
  • Placenta abnormitet.
  • Polyhydramnios eller oligohydramnios.
  • Betydelig blødning eller blodkoagulationsforstyrrelse.
  • Endokrine lidelser, herunder ubehandlet hyperthyroidisme eller ubehandlet hypothyroidisme. Dette omfatter også forstyrrelser af glukoseintolerance (f.eks. diabetes mellitus type 1 eller 2), før graviditet eller opstår under graviditet, hvis de er ukontrollerede på tidspunktet for samtykket.
  • Eventuelle tegn på for tidlig fødsel med den aktuelle graviditet eller under igangværende indgreb (medicinsk/kirurgisk) i den aktuelle graviditet for at forhindre for tidlig fødsel.
  • Tidligere graviditetskomplikationer eller abnormiteter på tidspunktet for samtykke, baseret på investigatorens vurdering, som vil øge risikoen forbundet med deltagelse i og afslutning af undersøgelsen, herunder men ikke begrænset til følgende:
  • Forudgående præmatur fødsel ved ≤34 ugers graviditet
  • Forudgående dødfødsel eller neonatal død
  • Tidligere spædbarn med en kendt genetisk lidelse eller betydelig medfødt anomali
  • Ikke-hiv-associeret medfødt eller erhvervet immundefekt lidelse, eller reumatologisk lidelse eller anden sygdom, der kræver kronisk behandling med kendt immunsuppressiv medicin.
  • Brug af antituberkulosebehandling i øjeblikket eller på et hvilket som helst tidspunkt under denne nuværende graviditet.

Nøgleudelukkelseskriterier - spædbørnsdeltagere

• Spædbarn, der er en direkte efterkommer (f.eks. barn eller barnebarn) af personalet på investigatorstedet eller sponsor- og sponsordelegerede medarbejdere, der er direkte involveret i udførelsen af ​​undersøgelsen.

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: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Biologisk: Placebp
Placebo
Eksperimentel: RSVpreF-vaccine
RSV-vaccine (RSVpreF)
Biologisk: RSVpreF-vaccine
RSVpreF-vaccine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Maternal Participants With Prespecified Local Reactions Within 7 Days After Vaccination
Tidsramme: From Day 1 to Day 7 after vaccination
Local reactions included redness, swelling, and pain at injection site and were recorded in electronic diary (e-diary). Redness and swelling were measured by the maternal participant and recorded in measuring device units (mdu) in the e-diary (range: 1 to 21). 1 mdu = 0.5 centimetre (cm). Redness and swelling were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization for severe pain at the injection site). Grade 4 reactions were classified by the investigator or medically qualified designee.
From Day 1 to Day 7 after vaccination
Percentage of Maternal Participants With Prespecified Systemic Events Within 7 Days After Vaccination
Tidsramme: From Day 1 to Day 7 after vaccination
Systemic events included fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting and diarrhea and were recorded by participants in the e-diary. Fever was defined as an oral temperature greater than or equal to (>=) 38.0 degree Celsius (C) and classified as mild (38.0 to 38.4 degree C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C) and grade 4 (>40.0 degree C). Headache, nausea, fatigue, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily activity). Vomiting: mild (1-2 times in 24 hours [H]), moderate (>2 times in 24 H), severe (required intravenous [IV] hydration). Diarrhea: mild (2-3 loose stools in 24 H), moderate (4-5 loose stools in 24 H), severe (>=6 loose stools in 24 H). For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by investigator or medically qualified designee.
From Day 1 to Day 7 after vaccination
Percentage of Maternal Participants With Adverse Events (AEs) From the Time of Vaccination Through 1 Month After Vaccination
Tidsramme: From vaccination on Day 1 up to 1 month after vaccination
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included in this outcome measure.
From vaccination on Day 1 up to 1 month after vaccination
Percentage of Maternal Participants With Adverse Event of Special Interest (AESIs)
Tidsramme: From vaccination on Day 1 up to 6 months after delivery (up to maximum of 10 months)
AESIs are a subset of targeted medical events based on review of known pharmacology, toxicology findings, possible class effects, published literature, and signals arising from safety data assessments, and on population under study. AESIs were based on targeted medical events associated with pregnant maternal participants prior to/during delivery and post delivery. For maternal participants, the following were considered as protocol defined AESIs: diagnosis of Guillain-Barré syndrome; diagnosis of acute polyneuropathy without an underlying etiology; hypertensive disorders of pregnancy; preterm delivery (delivery at <37 0/7 weeks' gestation) and atrial fibrillation. AESIs was to be recorded as an AE or serious adverse event (SAE) on the case report form (CRF).
From vaccination on Day 1 up to 6 months after delivery (up to maximum of 10 months)
Percentage of Maternal Participants With SAEs From Vaccination Throughout the Study
Tidsramme: From vaccination on Day 1 up to 6 months after delivery (up to maximum of 10 months)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event.
From vaccination on Day 1 up to 6 months after delivery (up to maximum of 10 months)
Percentage of Infant Participants With AESIs From Birth Through 6 Months of Age
Tidsramme: From birth up to 6 months of age
AESIs are a subset of targeted medical events based on review of known pharmacology, toxicology findings, possible class effects, published literature, and signals arising from safety data assessments, and on population under study. AESIs were based on targeted medical events associated with infants at birth. For infant participants the following were considered as protocol defined AESIs: preterm birth (born at <37 0/7 week's gestation); birth weight 1001-2500 grams (g); developmental delay. Extremely preterm birth (born at <28 0/7 week's gestation) and extremely low birth weight (less than or equal to [<=] 1000 g) were reported as serious AESIs.
From birth up to 6 months of age
Number of Infant Participants With Reported Neonatal Deaths From Birth Through 1 Months of Age
Tidsramme: Within 1 Month after birth
Neonatal death was defined as the death of a live-born infant that occurred within a month after birth.
Within 1 Month after birth
Number of Infant Participants With Congenital Malformations/Anomalies at Birth
Tidsramme: At birth
Congenital malformations/anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life.
At birth
Number of Infant Participants With Other Neonatal Problems at Birth
Tidsramme: At birth
Other neonatal problem included dysmaturity, neonatal illness, hospitalization, and drug therapies.
At birth
Number of Infant Participants According to Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute After Birth
Tidsramme: 1 minute after birth
APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor.
1 minute after birth
Number of Infant Participants According to APGAR Score at 5 Minutes After Birth
Tidsramme: 5 minutes after birth
APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor.
5 minutes after birth
Number of Infant Participants According to APGAR Score at 10 Minutes After Birth
Tidsramme: 10 minutes after birth
APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor.
10 minutes after birth
Number of Infant Participants According to Gestational Age (GA) at Birth
Tidsramme: At birth
GA at birth was collected as:>=24 to <28 weeks, >=28 to <34 weeks, >=34 to <37 weeks, >=37 to <42 weeks, and >=42 weeks.
At birth
Number of Infant Participants Requiring Hospitalization at Birth
Tidsramme: From birth until discharge from hospitalization (up to a maximum of 72 hours)
Length of hospitalization at birth refers to the amount of time the infant remains admitted to the healthcare facility immediately following delivery and if that length of time is greater than or less than 72 hours. Postnatal standard of care procedures in South Africa were as follows: healthy newborns and their mothers were typically discharged within 24 hours after an uncomplicated vaginal delivery, or within 72 hours following an uncomplicated Caesarean section. These practices were supported by the Guidelines for Maternity Care in South Africa.
From birth until discharge from hospitalization (up to a maximum of 72 hours)
Percentage of Infant Participants With AEs From Birth to 1 Month of Age
Tidsramme: From birth to 1 month of age
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
From birth to 1 month of age
Percentage of Infant Participants With SAEs From Birth Through 6 Months of Age
Tidsramme: From birth to 6 months of age
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event.
From birth to 6 months of age
Percentage of Infant Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Birth Through 6 Months of Age
Tidsramme: From birth to 6 months of age
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. NDCMCs were reported as both AEs and SAEs.
From birth to 6 months of age

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Geometric Mean Titer (GMT) of Neutralizing Titer (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Before Vaccination and at Delivery: Maternal Participants
Tidsramme: Before vaccination on Day 1 and at delivery
GMTs and the corresponding 2-sided 95% confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the neutralizing titers and the corresponding CIs based on the Student t distribution.
Before vaccination on Day 1 and at delivery
Geometric Mean Fold Rise (GMFR) of NTs for RSV A and RSV B From Before Vaccination to Delivery: Maternal Participants
Tidsramme: Before vaccination on Day 1 to delivery
GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs based on the Student t distribution. The GMFR for each vaccine group was defined as the geometric mean of the fold rises in the assay results from the specified time points.
Before vaccination on Day 1 to delivery

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer

Efterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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)

12. marts 2024

Primær færdiggørelse (Faktiske)

11. juni 2025

Studieafslutning (Faktiske)

11. juni 2025

Datoer for studieregistrering

Først indsendt

8. marts 2024

Først indsendt, der opfyldte QC-kriterier

19. marts 2024

Først opslået (Faktiske)

22. marts 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C3671032

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Pfizer vil give adgang til individuelle afidentificerede deltagerdata og relaterede undersøgelsesdokumenter (f.eks. protokol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) efter anmodning fra kvalificerede forskere og underlagt visse kriterier, betingelser og undtagelser. Yderligere detaljer om Pfizers datadelingskriterier og proces for at anmode om adgang kan findes på: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

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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