The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as a prime-boost regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected adults.
Age range
18 Years – 50 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
Timeframe: Measured through 3 days after participants' each vaccination at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Timeframe: Measured through 3 days after participants' each vaccination at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Timeframe: Measured through 30 days after each vaccine dose at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Timeframe: Measured through 30 days after each vaccine dose at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B
Number of Participants Reporting Serious Adverse Events (SAEs)
Timeframe: Measured through Month 8 for part A and Month 14 for part B
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
Timeframe: Measured through Month 8 for part A and Month 14 for part B
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Timeframe: Measured during Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B
Alk Phos, AST, ALT in UL
Timeframe: Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B
Hemoglobin, Creatinine in g/dL
Timeframe: Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Timeframe: Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part B
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Timeframe: Measured through study completion, up to 31 months