A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult participants
Age range
18 Years – 40 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
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.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Vaccine Regimen
Timeframe: Measured through 7 days after participants' last vaccination at Month 0,1,3, and 6
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen
Timeframe: Measured through 7 days after each vaccination at Month 0, 1, 3, and 6
Frequency of Adverse Events by Relationship to the Study Product
Timeframe: Measured through 30 days after each vaccination at Month 0, 1, 3 and 6.
Frequency of SAEs, AESIs, and New Chronic Conditions
Timeframe: Measured through Month 18.
Alkaline Phosphatase, AST, ALT in U/L
Timeframe: Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182)
Hemoglobin, Creatinine in g/dL
Timeframe: Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182)
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Timeframe: Measured at Month 0 (Screening) ,0.5(Day 14), 1.5 (Day 42) , 3.5 (Day 98) and 6.5 (Day 182)
AEs or Reactro Leading to Early Participant Withdrawal or Early Discontinuation of Study Products Administration Throughout the Study.
Timeframe: Measured through month 12
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
Timeframe: Measured at Month 6.5
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine, After the Primary Vaccine Regimen. Measured by Flow Cytometry.
Timeframe: Measured at Month 6.5
Number of Participants With HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.]
Timeframe: Measured at Month 12
Level of the HIV-specific Total IgG Binding Antibody (Vaccine gp120 Panel) Response Magnitude as Assessed by Binding Antibody Multiplex Assay [Time Frame: Measured at Month 12.]
Timeframe: Measured at Month 12