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Confronto della sicurezza e dell'immunogenicità del vaccino 426c.Mod.Core-C4b adiuvato con 3M-052-AF + allume nei neonati con esposizione perinatale all'HIV che non presentano HIV alla nascita (HVTN316)

16 settembre 2026 aggiornato da: HIV Vaccine Trials Network

Uno studio clinico di fase 1 per valutare la sicurezza e l'immunogenicità del vaccino 426c.Mod.Core-C4b adiuvato con 3M-052-AF + allume in neonati con esposizione perinatale all'HIV che non presentano HIV alla nascita

The purpose of this study is to evaluate the safety and immunogenicity of 426c.Mod.Core-C4b vaccine adjuvanted with 3M-052-AF + Alum in infants with perinatal HIV exposure who are without HIV at birth

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study will compare the safety and immunogenicity of an experimental HIV vaccine in infants with perinatal HIV exposure who are without HIV at birth. The study vaccine is called 426c.Mod.Core-C4b. The vaccine is mixed with an adjuvant called 3M-052-AF + Alum.

This study is divided into 2 parts: Part A and B. Part A has 4 groups, while Part B has 2 groups. Part A of the study is testing the vaccine alone or in combination with different doses of adjuvant. Part B is testing study vaccine and the safest dose of adjuvants from Part A versus placebo. Depending on their group, participants will receive 426c.Mod.Core-C4b, 426c.Mod.Core-C4b vaccine adjuvanted with 3M-052-AF + Alum, or a placebo by injection at Months 0, 3, and 7.

Additional study visits will occur at Day 1, Week 2, Month 3 1/2, Month 7 1/2, Month 10, Year 1, Year 1 1/2, and Year 1 3/4. Study visits may include physical exams, blood and saliva collection for the infants and questionnaires, counselling, blood, and optional breastmilk collection for the mothers of infants.

Tipo di studio

Interventistico

Iscrizione (Stimato)

22

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Sud Africa
    • Gauteng
      • Soweto, Gauteng, Sud Africa, 1862
        • Soweto HVTN CRS
        • Contatto:
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Non più vecchio di 1 settimana (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria: Mother

  • Mother's age is at least 18 years and is willing and able to provide written informed consent for their and their infant's participation in this study
  • Mother is in the second or third trimester of singleton pregnancy, as determined by a clinical exam or sonography and reported menstrual history
  • Mother agrees to donate umbilical cord blood
  • Mother has a planned Caesarian delivery at Chris Hani Baragwanath Academic Hospital (Soweto) and plans to remain in the area after delivery and through study duration
  • Mother is determined by the site investigator to be in good overall health at the time of delivery based on medical history and physical exam
  • Mother has a documented CD4 count of more than 350 cells/mcL at screening
  • Mother has been on cART for at least 16 weeks prior to delivery and intends to continue with cART for the duration of breastfeeding
  • Mother has a viral load of less than 400 copies/mL between 2 weeks before and 7 days after delivery
  • Mother has access to the participating HVTN CRS and is willing to be followed for the planned duration of the study
  • Mother demonstrates understanding of this study and is able and willing to complete the informed consent process and delivery with verbal demonstration of understanding of all questionnaire items answered incorrectly
  • Mother agrees not to enroll either self or infant in another research study for the duration of the trial without prior approval of the HVTN 316 PSRT.
  • Mother has confirmed positive HIV-1 status documented by medical records at any time during or prior to screening, and confirmed by the HVTN CRS by serology

Exclusion Criteria: Mother

  • Any World Health Organization (WHO) grade IV illness within 1 year prior to study enrollment, as determined by the history and physical examination and review of the medical record (if available). These include HIV wasting syndrome; PJP pneumonia; cerebral toxoplasmosis; extrapulmonary cryptococcosis; progressive multifocal leukoencephalopathy; any disseminated endemic mycosis (histoplasmosis); candidiasis of the esophagus, trachea, bronchi, or lung; disseminated atypical mycobacteria; non-typhoid salmonella septicemia; extrapulmonary tuberculosis; lymphoma; and Kaposi's sarcoma.
  • Prior participation in any HIV-1 vaccine or anti-HIV antibody-mediated prevention trial
  • Receipt of any investigational agent during this pregnancy
  • Receipt of blood products, immunoglobulin (Ig), or immunomodulating therapy within 45 days prior to, and the day of delivery
  • Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence, assessment of infant safety or reactogenicity, or a volunteer's ability to give informed consent
  • Any condition that places the newborn at higher risk of early-onset sepsis, such as concern for active maternal infection at delivery, as determined by local site investigators (eg, fever)
  • Detectable hepatitis B surface antigen (HBsAg)

Inclusion Criteria: Infant

  • Born via Caesarean delivery to a pregnant woman living with HIV-1 who meets all maternal inclusion/exclusion criteria listed above
  • Estimated gestational age at birth is at least 37 weeks

Note: If gestational age at birth is not documented in the infant's available birth records, study staff may assess gestational age at the earliest possible opportunity during the screening period and use this assessment for purposes of eligibility determination.

  • Weight at birth is at least 2.5 kg
  • Has initiated ARV prophylaxis consistent with current site-specific standard of care
  • Hemoglobin (HgB) more than 14.0 g/dL
  • White blood cell (WBC) count ≥ 7,000 cells/mm3
  • Platelets more than 100,000 cells/mm3
  • Alanine aminotransferase (ALT) less than 1.25 times upper limit of age-adjusted normal
  • Creatinine less than 1.1 times upper limit of age adjusted normal
  • Negative HIV-1 nucleic acid test (NAT) on specimen drawn within 72 hours of birth
  • Written informed consent provided by mother
  • Age is equal to or less than 7 days

Exclusion Criteria: Infant

  • Any clinically significant congenital anomaly/birth defect
  • Documented or suspected serious medical illness, infection, clinically significant finding from physical examination, or immediate life-threatening condition, including requirement for ongoing supplemental oxygen, as judged by the examining clinician
  • Receipt of or anticipated need for blood products, immunoglobulin, or immunosuppressive therapy. This includes infants who require hepatitis B immunoglobulin (HBIG), but it does not require exclusion of infants who receive hepatitis B vaccine in the newborn period.
  • Receipt of any other investigational product

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Part A, Group 1: 426c.Mod.Core-C4b (20 mcg)

Participants will receive 426c.Mod.Core-C4b (20 mcg) alone to be administered as two 0.25-mL intramuscular (IM) doses, one into each thigh at weeks 0, 12, and 28.
Biologico: 426c.Mod.Core-C4b

self-assembling nanoparticle expressing up to 7 molecules of the 426c.Mod.Core envelope immunogen.
Sperimentale: Part A, Group 2: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (0.3 mcg) + Alum (250 mcg)

Participants will receive 426c.Mod.Core-C4b (20 mcg) admixed with 3M-052-AF (0.3 mcg) and aluminum hydroxide suspension (Alum) (250 mcg) to be administered as two 0.25-mL IM doses, one into each thigh at weeks 0, 12, and 28.
Biologico: 426c.Mod.Core-C4b

self-assembling nanoparticle expressing up to 7 molecules of the 426c.Mod.Core envelope immunogen.

Biologico: 3M-052-AF

3M-052-AF is an aqueous formulation (AF) of a lipidated small molecule imidazoquinoline that is a Toll-like receptor (TLR)7/8 and inflammasome agonist. To be administered as 0.3 mcg, 0.75 mcg, or 1.5 mcg admixed with 426c.Mod.Core-C4b, with Alum

Biologico: Aluminum hydroxide suspension (Alum)

Aluminum hydroxide suspension (Alum) to be administered as 250 mcg (aluminum content) admixed with 426c.Mod.Core-C4b with 3M-052-AF.
Sperimentale: Part A, Group 3: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (0.75 mcg) + Alum (250 mcg)

Participants will receive 426c.Mod.Core-C4b (20 mcg) admixed with 3M-052-AF (0.75 mcg) and aluminum hydroxide suspension (Alum) (250 mcg) to be administered as two 0.25-mL IM doses, one into each thigh at weeks 0, 12, and 28.
Biologico: 426c.Mod.Core-C4b

self-assembling nanoparticle expressing up to 7 molecules of the 426c.Mod.Core envelope immunogen.

Biologico: 3M-052-AF

3M-052-AF is an aqueous formulation (AF) of a lipidated small molecule imidazoquinoline that is a Toll-like receptor (TLR)7/8 and inflammasome agonist. To be administered as 0.3 mcg, 0.75 mcg, or 1.5 mcg admixed with 426c.Mod.Core-C4b, with Alum

Biologico: Aluminum hydroxide suspension (Alum)

Aluminum hydroxide suspension (Alum) to be administered as 250 mcg (aluminum content) admixed with 426c.Mod.Core-C4b with 3M-052-AF.
Sperimentale: Part A, Group 4: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (1.5 mcg) + Alum (250 mcg)

Participants will receive 426c.Mod.Core-C4b (20 mcg) admixed with 3M-052-AF (1.5 mcg) and aluminum hydroxide suspension (Alum) (250 mcg) to be administered as two 0.25-mL IM doses, one into each thigh at weeks 0, 12, and 28.
Biologico: 426c.Mod.Core-C4b

self-assembling nanoparticle expressing up to 7 molecules of the 426c.Mod.Core envelope immunogen.

Biologico: 3M-052-AF

3M-052-AF is an aqueous formulation (AF) of a lipidated small molecule imidazoquinoline that is a Toll-like receptor (TLR)7/8 and inflammasome agonist. To be administered as 0.3 mcg, 0.75 mcg, or 1.5 mcg admixed with 426c.Mod.Core-C4b, with Alum

Biologico: Aluminum hydroxide suspension (Alum)

Aluminum hydroxide suspension (Alum) to be administered as 250 mcg (aluminum content) admixed with 426c.Mod.Core-C4b with 3M-052-AF.
Comparatore attivo: Part B, Group 5: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (TBD)* + Alum (250 mcg)

Participants will receive 426c.Mod.Core-C4b (20 mcg) admixed with 3M-052-AF (TBD) and Alum (250 mcg) to be administered as two 0.25-mL IM doses, one into each thigh at weeks 0, 12, and 28.
Biologico: 426c.Mod.Core-C4b

self-assembling nanoparticle expressing up to 7 molecules of the 426c.Mod.Core envelope immunogen.

Biologico: 3M-052-AF

3M-052-AF is an aqueous formulation (AF) of a lipidated small molecule imidazoquinoline that is a Toll-like receptor (TLR)7/8 and inflammasome agonist. To be administered as 0.3 mcg, 0.75 mcg, or 1.5 mcg admixed with 426c.Mod.Core-C4b, with Alum

Biologico: Aluminum hydroxide suspension (Alum)

Aluminum hydroxide suspension (Alum) to be administered as 250 mcg (aluminum content) admixed with 426c.Mod.Core-C4b with 3M-052-AF.
Comparatore placebo: Part B, Group 6: Placebo

Participants will receive Placebo (Tris Sodium Chloride (NaCl) buffer ) to be administered as two 0.25-mL IM doses, one into each thigh at weeks 0, 12, and 28.
Biologico: Placebo and Diluent

Tris-NaCl buffer.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of participants reporting local reactogenicity signs and symptoms and number of local reactogenicity signs and symptoms experienced by each participant
Lasso di tempo: Measured through 14 days following receipt of study product at day 5, week 12, and week 28

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]
Measured through 14 days following receipt of study product at day 5, week 12, and week 28
Number of participants reporting systemic reactogenicity signs and symptoms symptoms and number of systemic reactogenicity signs and symptoms experienced by each participant,
Lasso di tempo: Measured through 14 days following receipt of study product at day 5, week 12, and week 28

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]
Measured through 14 days following receipt of study product at day 5, week 12, and week 28
Number of participants reporting adverse events and overall number of adverse events
Lasso di tempo: Measured through out the study period

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]
Measured through out the study period
Number of participants reporting serious adverse events and overall number of serious adverse events
Lasso di tempo: Measured through 12 months post last vaccination at week 28

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]
Measured through 12 months post last vaccination at week 28
Number of participants reporting medically attended adverse events and overall number of medically attended adverse events
Lasso di tempo: Measured through 12 months post last vaccination at week 28

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]
Measured through 12 months post last vaccination at week 28
Number of participants reporting adverse events of special interest (AESIs) that are Potential Immune Mediated Medical Conditions (PIMMCs) and overall number of AESIs that are PIMMCs
Lasso di tempo: Measured through 12 months post last vaccination at week 28

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]
Measured through 12 months post last vaccination at week 28
Number of participants reporting AEs leading to early participant withdrawal or permanent discontinuation
Lasso di tempo: Measured through 12 months post last vaccination at week 28

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]
Measured through 12 months post last vaccination at week 28
Response rate of CD4bs-specific IgG binding antibodies
Lasso di tempo: Measured 2 weeks after the 3rd vaccination at week 28

Measured by binding antibody multiplex assay (BAMA)
Measured 2 weeks after the 3rd vaccination at week 28
Magnitude of CD4bs-specific IgG binding antibodies
Lasso di tempo: Measured 2 weeks after the 3rd vaccination at week 28

Measured by binding antibody multiplex assay (BAMA)
Measured 2 weeks after the 3rd vaccination at week 28
Response rate of CD4bs-specific memory B cells
Lasso di tempo: Measured 2 weeks after the 3rd vaccination at week 28

Measured by flow cytometry
Measured 2 weeks after the 3rd vaccination at week 28
Magnitude of CD4bs-specific memory B cells
Lasso di tempo: Measured 2 weeks after the 3rd vaccination at week 28

Measured by flow cytometry
Measured 2 weeks after the 3rd vaccination at week 28

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Response rate of serum Ab neutralization of vaccine-matched viruses
Lasso di tempo: Measured 2 weeks after the 3rd vaccination at week 28

Measured by TZM-bl pseudoneutralization assay
Measured 2 weeks after the 3rd vaccination at week 28
Magnitude of serum Ab neutralization of vaccine-matched viruses
Lasso di tempo: Measured 2 weeks after the 3rd vaccination at week 28

Measured by TZM-bl pseudoneutralization assay
Measured 2 weeks after the 3rd vaccination at week 28
Differential neutralization of HIV-1 strains that are diagnostic for CD4bs bNAb precursors
Lasso di tempo: Measured 2 weeks after the 3rd vaccination at week 28

Measured by TZM-bl assay
Measured 2 weeks after the 3rd vaccination at week 28
Response rate of serum Ab neutralization of heterologous HIV-1 strains
Lasso di tempo: Measured 2 weeks after the 3rd vaccination at week 28

Measured by TZM-bl assay
Measured 2 weeks after the 3rd vaccination at week 28
Magnitude of serum Ab neutralization of heterologous HIV-1 strains
Lasso di tempo: Measured 2 weeks after the 3rd vaccination at week 28

Measured by TZM-bl assay
Measured 2 weeks after the 3rd vaccination at week 28
Response rate (i.e., percentage) of CD4bs-specific, including VRC01-class, B cells
Lasso di tempo: Measured 2 weeks after the 3rd vaccination at week 28

Measured by BCR sequencing of sorted B cells
Measured 2 weeks after the 3rd vaccination at week 28
Magnitude of CD4bs-specific, including VRC01-class, B cells
Lasso di tempo: Measured 2 weeks after the 3rd vaccination at week 28

Measured by BCR sequencing of sorted B cells
Measured 2 weeks after the 3rd vaccination at week 28
Response rate of vaccine-specific and CD4bs-specific binding antibodies
Lasso di tempo: Measured 6 months and 12 months after the 3rd vaccination at week 28

Measured by BAMA
Measured 6 months and 12 months after the 3rd vaccination at week 28
Magnitude of vaccine-specific and CD4bs-specific binding antibodies
Lasso di tempo: Measured 6 months and 12 months after the 3rd vaccination at week 28

Measured by BAMA
Measured 6 months and 12 months after the 3rd vaccination at week 28
Response rate of CD4bs-specific memory B cells
Lasso di tempo: Measured 6 months and 12 months after the 3rd vaccination at week 28

Measured by flow cytometry
Measured 6 months and 12 months after the 3rd vaccination at week 28
Response rate of serum neutralization
Lasso di tempo: Measured 6 months and 12 months after the 3rd vaccination at week 28

Measured by TZM-bl assay
Measured 6 months and 12 months after the 3rd vaccination at week 28
Magnitude of serum neutralization
Lasso di tempo: Measured 6 months and 12 months after the 3rd vaccination at week 28

Measured by TZM-bl assay
Measured 6 months and 12 months after the 3rd vaccination at week 28
EPI vaccine-specific binding antibody responses
Lasso di tempo: Measured 2 weeks, 6 months, and 12 months after the 3rd vaccination at week 28

Assessed by Pediatric Vaccine Multiplex Assay (PVMA)
Measured 2 weeks, 6 months, and 12 months after the 3rd vaccination at week 28

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

HIV Vaccine Trials Network

Collaboratori

National Institute of Allergy and Infectious Diseases (NIAID)
Fred Hutchinson Cancer Center
Access to Advanced Health Institute (AAHI)

Investigatori

  • Cattedra di studio: Amy Violari, Perinatal HIV Research Unit

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 marzo 2027

Completamento primario (Stimato)

3 giugno 2027

Completamento dello studio (Stimato)

3 giugno 2027

Date di iscrizione allo studio

Primo inviato

23 settembre 2024

Primo inviato che soddisfa i criteri di controllo qualità

23 settembre 2024

Primo Inserito (Effettivo)

26 settembre 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HVTN 316
  • UM1AI068614 (Sovvenzione/contratto NIH degli Stati Uniti)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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