The purpose of this study is to evaluate the safety and immune response to an HIV clade C vaccine and to an MF59- or alum-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.
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.
Occurrence of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2
Timeframe: Measured at Month 6.5
Level of Vaccine-induced Systemic IgG Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 2
Timeframe: Measured at Month 6.5
Occurrence of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3
Timeframe: Measured at Month 6.5
Level of Vaccine-induced Serum IgA Ab Binding to the 3 gp120 Env Proteins Contained in the Vaccine Regimen (ZM96, TV1.C, and 1086.C) in Group 1 and Group 3
Timeframe: Measured at Month 6.5
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Timeframe: Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Timeframe: Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Timeframe: Measured through Month Measured through 3 days after each vaccine dose at Months 0, 1, 3, 6, and 12
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Timeframe: Measured through 30 days after each vaccine dose at Months 0, 1, 3, 6, and 12
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Timeframe: Measured through 30 days after each vaccine dose at Months 0, 1, 3, 6, and 12
Number of Participants Reporting Serious Adverse Events (SAEs)
Timeframe: Measured through Month 18
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
Timeframe: Measured through Month 18
Number of Participants Reporting New Chronic Conditions (Requiring Medical Intervention for >= 30 Days)
Timeframe: Measured through Month 18
Chemistry and Hematology Laboratory Measures - ALT (SGPT), AST, Alkaline Phosphatase
Timeframe: Measured during screening, Days 7, 42, 98, 182, 378, and 455
Chemistry and Hematology Laboratory Measures - Creatinine
Timeframe: Measured during screening, Days 7, 42, 98, 182, 378, and 455
Chemistry and Hematology Laboratory Measures - Hemoglobin
Timeframe: Measured during screening, Days 7, 42, 98, 182, 378, and 455
Chemistry and Hematology Laboratory Measures - Lymphocytes, Neutrophils
Timeframe: Measured during screening, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455
Chemistry and Hematology Laboratory Measures - Platelets, WBC
Timeframe: Measured during screening, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Timeframe: Measured during screening, Days 0, 1, 3, 7, 42, 84, 85, 87, 91, 98, 182, 378, and 455
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
Timeframe: Measured through Month 18
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Timeframe: Measured through Month 18