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.
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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