Safety & Immunogenicity of 426c.Mod.Core-C4b Vaccine With 3M-052-AF+Alum in Infants Perinatally E… (NCT06613789) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety & Immunogenicity of 426c.Mod.Core-C4b Vaccine With 3M-052-AF+Alum in Infants Perinatally Exposed to HIV But Uninfected
South Africa22 participantsStarted 2026-07-13
Plain-language 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
Who can participate
Age range
7 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 h…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants reporting local reactogenicity signs and symptoms and number of local reactogenicity signs and symptoms experienced by each participant
Timeframe: 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,
Timeframe: 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
Timeframe: Measured through out the study period
4
Number of participants reporting serious adverse events and overall number of serious adverse events
Timeframe: Measured through 12 months post last vaccination at week 28
5
Number of participants reporting medically attended adverse events and overall number of medically attended adverse events
Timeframe: Measured through 12 months post last vaccination at week 28
6
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