This is an open-label Phase 1 study to examine the safety and immunogenicity of the CH505 TF chTrimer vaccine with 3M-052-AF +/- Alum adjuvant in healthy adults. The primary hypothesis is that the CH505 TF chTrimer will expand CH103-like B-cell precursors. HVTN 300 Part A examined the safety and immunogenicity of the CH505TF chTrimer with 5 mcg 3M-052-AF + 500 mcg Alum. HVTN 300 Part B was added to this protocol with a goal of assessing the optimal dosing and combination of 3M-052-AF and Alum adjuvant, that can potentially lead to improved neutralizing antibody activity and decreased reactogenicity, compared to Part A. Three groups were added to Part B (Group 2: 3 mcg 3M-052-AF without Alum, Group 3: 3 mcg 3M-052 with Alum, and Group 4: 5 mcg 3M-052-AF without Alum). HVTN 300 Part B is being added to this protocol with a goal of assessing the optimal dosing and combination of 3M-052-AF and Alum adjuvant, that can potentially lead to improved neutralizing antibody activity and decreased reactogenicity, compared to Part A. Three groups have been added to Part B (Group 2: 3 mcg 3M-052-AF without Alum, Group 3: 3 mcg 3M-052 with Alum, and Group 4: 5 mcg 3M-052-AF without Alum).
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Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration
Timeframe: Measured through 7 days after each study product administration at Study Day 0 (Month 0), Day 56 (Month 2), Day 112 (Month 4), Day 224 (Month 8), and Day 364 (Month 12)
Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness
Timeframe: Measured through 7 days after each study product administration at Study Day 0 (Month 0), Day 56 (Month 2), Day 112 (Month 4), Day 224 (Month 8), and Day 364 (Month 12)
Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms
Timeframe: Measured through 7 days after each study product administration at Study Day 0 (Month 0), Day 56 (Month 2), Day 112 (Month 4), Day 224 (Month 8), and Day 364 (Month 12)
Number of Participants Reporting Unsolicited Adverse Events (AEs) Tabulated by Maximum Severity Grade
Timeframe: All unsolicited adverse events were collected for 30 days after any receipt of study vaccination. Some adverse events (noted in description) were collected for 12 months following any receipt of study product (up to 104 weeks)
Number of Participants Reporting Serious Adverse Events (SAEs)
Timeframe: Serious adverse events (SAEs) were collected throughout the study and for 12 months following any receipt of study product (up to 104 weeks)
Number of Participants Reporting One or More Medically Attended Adverse Events (MAAEs)
Timeframe: Medically attended adverse events (MAAEs) were collected throughout the study and for 12 months following any receipt of study product (up to 104 weeks)
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
Timeframe: Adverse events of special interest (AESIs)were collected throughout the study and for 12 months following any receipt of study product (up to 104 weeks)
Number of Participants With Study Product Discontinuation Associated With an Unsolicited AE or Reactogenicity
Timeframe: Measured through 12 months following any receipt of study product (up to 104 weeks
Frequency of the CD4 Binding-site, V2 Apex and V3 Glycan (bnAb Region at the Base of the V3 Loop), and/or CH505TF-specific IgG+ B Cells
Timeframe: Measured at baseline, 2 weeks post 3rd vaccination, 2 weeks post 4th vaccination and 2 weeks post 5th vaccination
Response Rate of Serum Antibody Neutralization of Vaccine-matched Tier 2 HIV-1 Strains
Timeframe: Measured at baseline, 2 weeks post 3rd vaccination, 2 weeks post 4th vaccination and 2 weeks post 5th vaccination
Magnitude of Serum Antibody Neutralization of Vaccine-matched Tier 2 HIV-1 Strains
Timeframe: Measured at baseline, 2 weeks post 3rd vaccination, 2 weeks post 4th vaccination and 2 weeks post 5th vaccination