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Vergleich der Sicherheit und Immunogenität des mit 3M-052-AF + Alaun adjuvantierten 426c.Mod.Core-C4b-Impfstoffs bei Säuglingen mit perinataler HIV-Exposition, die bei der Geburt kein HIV haben (HVTN316)

16. September 2026 aktualisiert von: HIV Vaccine Trials Network

Eine klinische Phase-1-Studie zur Bewertung der Sicherheit und Immunogenität des mit 3M-052-AF + Alaun adjuvantierten 426c.Mod.Core-C4b-Impfstoffs bei Säuglingen mit perinataler HIV-Exposition, die bei der Geburt kein HIV haben

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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

22

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Südafrika
    • Gauteng
      • Soweto, Gauteng, Südafrika, 1862

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

Nicht älter als 1 Woche (Kind)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Biologisch: 426c.Mod.Core-C4b

self-assembling nanoparticle expressing up to 7 molecules of the 426c.Mod.Core envelope immunogen.
Experimental: 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.
Biologisch: 426c.Mod.Core-C4b

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

Biologisch: 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

Biologisch: 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.
Experimental: 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.
Biologisch: 426c.Mod.Core-C4b

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

Biologisch: 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

Biologisch: 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.
Experimental: 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.
Biologisch: 426c.Mod.Core-C4b

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

Biologisch: 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

Biologisch: 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.
Aktiver Komparator: 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.
Biologisch: 426c.Mod.Core-C4b

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

Biologisch: 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

Biologisch: 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.
Placebo-Komparator: 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.
Biologisch: Placebo and Diluent

Tris-NaCl buffer.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of participants reporting local reactogenicity signs and symptoms and number of local reactogenicity signs and symptoms experienced by each participant
Zeitfenster: 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,
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Measured 2 weeks after the 3rd vaccination at week 28

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Response rate of serum Ab neutralization of vaccine-matched viruses
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

HIV Vaccine Trials Network

Mitarbeiter

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

Ermittler

  • Studienstuhl: Amy Violari, Perinatal HIV Research Unit

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. März 2027

Primärer Abschluss (Geschätzt)

3. Juni 2027

Studienabschluss (Geschätzt)

3. Juni 2027

Studienanmeldedaten

Zuerst eingereicht

23. September 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. September 2024

Zuerst gepostet (Tatsächlich)

26. September 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HVTN 316
  • UM1AI068614 (US NIH Stipendium/Vertrag)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

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