HIV InfectionsPhase 1HVTN316NCT06613789
Safety & Immunogenicity of 426c.Mod.Core-C4b Vaccine With 3M-052-AF+Alum in Infants Perinatally Exposed to HIV But Uninfected
A Phase 1 study testing 426c.Mod.Core-C4b, 3M-052-AF and Aluminum hydroxide suspension (Alum) in people with HIV Infections, run by HIV Vaccine Trials Network at 1 site in South Africa.
Trial summary
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 Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- 426c.Mod.Core-C4b, 3M-052-AF and Aluminum hydroxide suspension (Alum)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSouth Africa
- Study dates
- 30 Mar 2027to 3 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- 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)
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- Detectable hepatitis B surface antigen (HBsAg)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site
Soweto HVTN CRS
Soweto, Gauteng, 1862
Fatima Laher, 27-11-9899700, laherf@phru.co.za
Leonie Kruger, 27-11-9899700, krugerl@phru.co.za
About this study
Official title: A Partially Randomized Phase 1 Clinical Trial 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
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
Read the detailed description
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.
- Conditions
- HIV Infections
- Being tested
- 426c.Mod.Core-C4b, 3M-052-AF, Aluminum hydroxide suspension (Alum), Placebo and Diluent
- Keywords
- HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
426c.Mod.Core-C4bBiological
self-assembling nanoparticle expressing up to 7 molecules of the 426c.Mod.Core envelope immunogen.
3M-052-AFBiological
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
Aluminum hydroxide suspension (Alum) to be administered as 250 mcg (aluminum content) admixed with 426c.Mod.Core-C4b with 3M-052-AF.
Placebo and DiluentBiological
Tris-NaCl buffer.
| Study group | Role | What they receive |
|---|---|---|
| Part A, Group 1: 426c.Mod.Core-C4b (20 mcg) | Experimental | 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. Receives: Biological: 426c.Mod.Core-C4b |
| Part A, Group 2: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (0.3 mcg) + Alum (250 mcg) | Experimental | 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. Receives: Biological: 426c.Mod.Core-C4b; Biological: 3M-052-AF; Biological: Aluminum hydroxide suspension (Alum) |
| Part A, Group 3: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (0.75 mcg) + Alum (250 mcg) | Experimental | 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. Receives: Biological: 426c.Mod.Core-C4b; Biological: 3M-052-AF; Biological: Aluminum hydroxide suspension (Alum) |
| Part A, Group 4: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (1.5 mcg) + Alum (250 mcg) | Experimental | 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. Receives: Biological: 426c.Mod.Core-C4b; Biological: 3M-052-AF; Biological: Aluminum hydroxide suspension (Alum) |
| Part B, Group 5: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (TBD)* + Alum (250 mcg) | Active comparator | 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. Receives: Biological: 426c.Mod.Core-C4b; Biological: 3M-052-AF; Biological: Aluminum hydroxide suspension (Alum) |
| Part B, Group 6: Placebo | Placebo comparator | 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. Receives: Biological: Placebo and Diluent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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,
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: 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
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: Measured through out the study period
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]
Measured: 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
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: 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
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: Measured through 12 months post last vaccination at week 28
Number of participants reporting AEs leading to early participant withdrawal or permanent discontinuation
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: Measured through 12 months post last vaccination at week 28
Response rate of CD4bs-specific IgG binding antibodies
Measured by binding antibody multiplex assay (BAMA)
Measured: Measured 2 weeks after the 3rd vaccination at week 28
Magnitude of CD4bs-specific IgG binding antibodies
Measured by binding antibody multiplex assay (BAMA)
Measured: Measured 2 weeks after the 3rd vaccination at week 28
Response rate of CD4bs-specific memory B cells
Measured by flow cytometry
Measured: Measured 2 weeks after the 3rd vaccination at week 28
Magnitude of CD4bs-specific memory B cells
Measured by flow cytometry
Measured: Measured 2 weeks after the 3rd vaccination at week 28
Secondary outcomes (13)
Response rate of serum Ab neutralization of vaccine-matched viruses
Measured by TZM-bl pseudoneutralization assay
Measured: Measured 2 weeks after the 3rd vaccination at week 28
Magnitude of serum Ab neutralization of vaccine-matched viruses
Measured by TZM-bl pseudoneutralization assay
Measured: Measured 2 weeks after the 3rd vaccination at week 28
Differential neutralization of HIV-1 strains that are diagnostic for CD4bs bNAb precursors
Measured by TZM-bl assay
Measured: Measured 2 weeks after the 3rd vaccination at week 28
Response rate of serum Ab neutralization of heterologous HIV-1 strains
Measured by TZM-bl assay
Measured: Measured 2 weeks after the 3rd vaccination at week 28
Magnitude of serum Ab neutralization of heterologous HIV-1 strains
Measured by TZM-bl assay
Measured: Measured 2 weeks after the 3rd vaccination at week 28
Response rate (i.e., percentage) of CD4bs-specific, including VRC01-class, B cells
Measured by BCR sequencing of sorted B cells
Measured: Measured 2 weeks after the 3rd vaccination at week 28
Magnitude of CD4bs-specific, including VRC01-class, B cells
Measured by BCR sequencing of sorted B cells
Measured: Measured 2 weeks after the 3rd vaccination at week 28
Response rate of vaccine-specific and CD4bs-specific binding antibodies
Measured by BAMA
Measured: Measured 6 months and 12 months after the 3rd vaccination at week 28
Magnitude of vaccine-specific and CD4bs-specific binding antibodies
Measured by BAMA
Measured: Measured 6 months and 12 months after the 3rd vaccination at week 28
Response rate of CD4bs-specific memory B cells
Measured by flow cytometry
Measured: Measured 6 months and 12 months after the 3rd vaccination at week 28
Response rate of serum neutralization
Measured by TZM-bl assay
Measured: Measured 6 months and 12 months after the 3rd vaccination at week 28
Magnitude of serum neutralization
Measured by TZM-bl assay
Measured: Measured 6 months and 12 months after the 3rd vaccination at week 28
EPI vaccine-specific binding antibody responses
Assessed by Pediatric Vaccine Multiplex Assay (PVMA)
Measured: Measured 2 weeks, 6 months, and 12 months after the 3rd vaccination at week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start30 Mar 2027 (estimated)
- Primary completion3 Jun 2027 (estimated)
- Study completion3 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part A is dose escalating. Part B is parallel.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HIV Vaccine Trials Network
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Fred Hutchinson Cancer Center, Access to Advanced Health Institute (AAHI)
- Responsible party
- Sponsor
- Investigators
- Amy Violari, Study chair, Perinatal HIV Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613789
- Sponsor's protocol ID
- HVTN 316
- Other IDs
- UM1AI068614
- Acronym
- HVTN316
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Partially Randomized Phase 1 Clinical Trial 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
- ClinicalTrials.gov ID
- NCT06613789
- Acronym / sponsor ID
- HVTN316 / HVTN 316
- Conditions
- HIV Infections
- Keywords
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- HIV Vaccine Trials NetworkResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Fred Hutchinson Cancer Center, Access to Advanced Health Institute (AAHI)
- Study start
- 30 Mar 2027 (estimated)
- Primary completion
- 3 Jun 2027 (estimated)
- Study completion
- 3 Jun 2027 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Part A is dose escalating. Part B is parallel.
| Arm | Type | Receives |
|---|---|---|
| Part A, Group 1: 426c.Mod.Core-C4b (20 mcg) | Experimental | Biological: 426c.Mod.Core-C4bParticipants 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. |
| Part A, Group 2: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (0.3 mcg) + Alum (250 mcg) | Experimental | Biological: 426c.Mod.Core-C4b, Biological: 3M-052-AF, Biological: Aluminum hydroxide suspension (Alum)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. |
| Part A, Group 3: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (0.75 mcg) + Alum (250 mcg) | Experimental | Biological: 426c.Mod.Core-C4b, Biological: 3M-052-AF, Biological: Aluminum hydroxide suspension (Alum)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. |
| Part A, Group 4: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (1.5 mcg) + Alum (250 mcg) | Experimental | Biological: 426c.Mod.Core-C4b, Biological: 3M-052-AF, Biological: Aluminum hydroxide suspension (Alum)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. |
| Part B, Group 5: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (TBD)* + Alum (250 mcg) | Active comparator | Biological: 426c.Mod.Core-C4b, Biological: 3M-052-AF, Biological: Aluminum hydroxide suspension (Alum)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. |
| Part B, Group 6: Placebo | Placebo comparator | Biological: Placebo and DiluentParticipants 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. |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 426c.Mod.Core-C4bself-assembling nanoparticle expressing up to 7 molecules of the 426c.Mod.Core envelope immunogen. | Biological | Part A, Group 1: 426c.Mod.Core-C4b (20 mcg), Part A, Group 2: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (0.3 mcg) + Alum (250 mcg), Part A, Group 3: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (0.75 mcg) + Alum (250 mcg), Part A, Group 4: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (1.5 mcg) + Alum (250 mcg), Part B, Group 5: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (TBD)* + Alum (250 mcg) |
| 3M-052-AF3M-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 | Biological | Part A, Group 2: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (0.3 mcg) + Alum (250 mcg), Part A, Group 3: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (0.75 mcg) + Alum (250 mcg), Part A, Group 4: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (1.5 mcg) + Alum (250 mcg), Part B, Group 5: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (TBD)* + Alum (250 mcg) |
| 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. | Biological | Part A, Group 2: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (0.3 mcg) + Alum (250 mcg), Part A, Group 3: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (0.75 mcg) + Alum (250 mcg), Part A, Group 4: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (1.5 mcg) + Alum (250 mcg), Part B, Group 5: 426c.Mod.Core-C4b (20 mcg) + 3M-052-AF (TBD)* + Alum (250 mcg) |
| Placebo and DiluentTris-NaCl buffer. | Biological | Part B, Group 6: Placebo |
Primary outcome
Number of participants reporting local reactogenicity signs and symptoms and number of local reactogenicity signs and symptoms experienced by each participant
Time frame: 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]
Number of participants reporting systemic reactogenicity signs and symptoms symptoms and number of systemic reactogenicity signs and symptoms experienced by each participant,
Time frame: 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]
Number of participants reporting adverse events and overall number of adverse events
Time frame: 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]
Number of participants reporting serious adverse events and overall number of serious adverse events
Time frame: 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]
Number of participants reporting medically attended adverse events and overall number of medically attended adverse events
Time frame: 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]
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
Time frame: 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]
Number of participants reporting AEs leading to early participant withdrawal or permanent discontinuation
Time frame: 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]
Response rate of CD4bs-specific IgG binding antibodies
Time frame: Measured 2 weeks after the 3rd vaccination at week 28
Measured by binding antibody multiplex assay (BAMA)
Magnitude of CD4bs-specific IgG binding antibodies
Time frame: Measured 2 weeks after the 3rd vaccination at week 28
Measured by binding antibody multiplex assay (BAMA)
Response rate of CD4bs-specific memory B cells
Time frame: Measured 2 weeks after the 3rd vaccination at week 28
Measured by flow cytometry
Magnitude of CD4bs-specific memory B cells
Time frame: Measured 2 weeks after the 3rd vaccination at week 28
Measured by flow cytometry
13 secondary outcomes
Response rate of serum Ab neutralization of vaccine-matched viruses
Time frame: Measured 2 weeks after the 3rd vaccination at week 28
Magnitude of serum Ab neutralization of vaccine-matched viruses
Time frame: Measured 2 weeks after the 3rd vaccination at week 28
Differential neutralization of HIV-1 strains that are diagnostic for CD4bs bNAb precursors
Time frame: Measured 2 weeks after the 3rd vaccination at week 28
Response rate of serum Ab neutralization of heterologous HIV-1 strains
Time frame: Measured 2 weeks after the 3rd vaccination at week 28
Magnitude of serum Ab neutralization of heterologous HIV-1 strains
Time frame: Measured 2 weeks after the 3rd vaccination at week 28
Response rate (i.e., percentage) of CD4bs-specific, including VRC01-class, B cells
Time frame: Measured 2 weeks after the 3rd vaccination at week 28
Magnitude of CD4bs-specific, including VRC01-class, B cells
Time frame: Measured 2 weeks after the 3rd vaccination at week 28
Response rate of vaccine-specific and CD4bs-specific binding antibodies
Time frame: Measured 6 months and 12 months after the 3rd vaccination at week 28
Magnitude of vaccine-specific and CD4bs-specific binding antibodies
Time frame: Measured 6 months and 12 months after the 3rd vaccination at week 28
Response rate of CD4bs-specific memory B cells
Time frame: Measured 6 months and 12 months after the 3rd vaccination at week 28
Response rate of serum neutralization
Time frame: Measured 6 months and 12 months after the 3rd vaccination at week 28
Magnitude of serum neutralization
Time frame: Measured 6 months and 12 months after the 3rd vaccination at week 28
EPI vaccine-specific binding antibody responses
Time frame: Measured 2 weeks, 6 months, and 12 months after the 3rd vaccination at week 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Violari study chair
Perinatal HIV Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 426c.Mod.Core-C4b, 3M-052-AF and Aluminum hydroxide suspension (Alum) in people with HIV Infections, run by HIV Vaccine Trials Network at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Manager ((206) 667-4212, itindale@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants reporting local reactogenicity signs and symptoms and number of local reactogenicity signs and symptoms experienced by each participant (time frame: Measured through 14 days following receipt of study product at day 5, week 12, and week 28). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.