Health TrialsbyHealthPanel

Safety & Immunogenicity of 426c.Mod.Core-C4b Vaccine With 3M-052-AF+Alum in Infants Perinatally Exposed to HIV But Uninfected

ConditionHIV Infections
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 7
SponsorHIV Vaccine Trials Network

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 426c.Mod.Core-C4b

    Biological/Vaccine

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

  • 3M-052-AF

    Biological/Vaccine

    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

  • Aluminum hydroxide suspension (Alum)

    Biological/Vaccine

    Aluminum hydroxide suspension (Alum) to be administered as 250 mcg (aluminum content) admixed with 426c.Mod.Core-C4b with 3M-052-AF.

  • Placebo and Diluent

    Biological/Vaccine

    Tris-NaCl buffer.

Treatment groups

22 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Part A, Group 1: 426c.Mod.Core-C4b (20 mcg)Experimental treatment 1 intervention
Group B: Part A, Group 2: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (0.3 mcg) + Alum (250 mcg)Experimental treatment 3 interventions
Group C: Part A, Group 3: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (0.75 mcg) + Alum (250 mcg)Experimental treatment 3 interventions
Group D: Part A, Group 4: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (1.5 mcg) + Alum (250 mcg)Experimental treatment 3 interventions
Group E: Part B, Group 5: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (TBD)* + Alum (250 mcg)Active comparator 3 interventions
Group F: Part B, Group 6: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants reporting local reactogenicity signs and symptoms and number of local reactogenicity signs and symptoms experienced by each participant

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]

Time frame
Measured through 14 days following receipt of study product at day 5, week 12, and week 28
2

Number of participants reporting systemic reactogenicity signs and symptoms symptoms and number of systemic reactogenicity signs and symptoms experienced by each participant,

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]

Time frame
Measured through 14 days following receipt of study product at day 5, week 12, and week 28
3

Number of participants reporting adverse events and overall number of adverse events

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]

Time frame
Measured through out the study period
4

Number of participants reporting serious adverse events and overall number of serious adverse events

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]

Time frame
Measured through 12 months post last vaccination at week 28

Secondary outcomes

1

Response rate of serum Ab neutralization of vaccine-matched viruses

Measured by TZM-bl pseudoneutralization assay

Time frame
Measured 2 weeks after the 3rd vaccination at week 28
2

Magnitude of serum Ab neutralization of vaccine-matched viruses

Measured by TZM-bl pseudoneutralization assay

Time frame
Measured 2 weeks after the 3rd vaccination at week 28
3

Differential neutralization of HIV-1 strains that are diagnostic for CD4bs bNAb precursors

Measured by TZM-bl assay

Time frame
Measured 2 weeks after the 3rd vaccination at week 28
4

Response rate of serum Ab neutralization of heterologous HIV-1 strains

Measured by TZM-bl assay

Time frame
Measured 2 weeks after the 3rd vaccination at week 28

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HIV Vaccine Trials Network

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Fred Hutchinson Cancer Center

Collaborator

Access to Advanced Health Institute (AAHI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: