Phase 1
N=51
Evaluating the Safety and Immunogenicity of Stabilized CH505 TF chTrimer in Healthy, HIV-uninfected Adult Participants.
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT04915768 ↗Enrolled (actual)
51
Serious AEs
2.0%
Results posted
Feb 2026
Primary outcome: Primary: Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration — 11; 10; 12; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- CH505 TF chTrimer (Biological); 3M-05-AF (Biological); Aluminum hydroxide suspension (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jul 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration |
11; 10; 12; 9; 2; 1 | — |
| PRIMARY Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Pain and/or Tenderness |
0; 0; 0; 0; 7; 8 | — |
| PRIMARY Number of Participants Showing Systemic Vaccination Reactogenicity Signs and Symptoms |
1; 2; 1; 1; 3; 1 | — |
| PRIMARY Number of Participants Reporting Unsolicited Adverse Events (AEs) Tabulated by Maximum Severity Grade |
0; 1; 3; 5; 8; 4 | — |
| PRIMARY Number of Participants Reporting Serious Adverse Events (SAEs) |
1; 0; 0; 0 | — |
| PRIMARY Number of Participants Reporting One or More Medically Attended Adverse Events (MAAEs) |
9; 1; 6; 6 | — |
| PRIMARY Number of Participants Reporting Adverse Events of Special Interest (AESIs) |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Study Product Discontinuation Associated With an Unsolicited AE or Reactogenicity |
6; 1; 1; 1 | — |
| PRIMARY 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 |
— | — |
| PRIMARY Response Rate of Serum Antibody Neutralization of Vaccine-matched Tier 2 HIV-1 Strains |
— | — |
| PRIMARY Magnitude of Serum Antibody Neutralization of Vaccine-matched Tier 2 HIV-1 Strains |
— | — |
| SECONDARY Response Rate of Serum IgG Binding Antibodies |
— | — |
| SECONDARY Magnitude of Serum IgG Binding Antibodies |
— | — |
| SECONDARY Response Rate of Serum Antibody Neutralization of Heterologous HIV-1 Strains |
— | — |
| SECONDARY Magnitude of Serum Antibody Neutralization of Heterologous HIV-1 Strains |
— | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Able and willing to complete the informed consent process, including an Assessment of Understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly.
- 18-55 years old, inclusive, on day of enrollment.
- Available for clinic follow-up through the last clinic visit, willing to undergo lymph node fine needle aspiration and leukapheresis, and willing to be contacted 12 months after the last vaccine administration.
- Agrees not to enroll in another study of an investigational agent during participation in the trial.
- In good general health according to the clinical judgement of the site investigator.
- Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgement of the site investigator.
- Assessed as low risk for HIV acquisition per low risk guidelines (see protocol for more information), agrees to discuss HIV infection risks, agrees to risk reduction counseling, and agrees to avoid behavior associated with high risk of HIV exposure through the final study visit. Low risk may include persons stably taking PrEP (pre- exposure prophylaxis) as prescribed for 6 months or longer.
- Hemoglobin >12.5 mg/dL to 18 mg/dL
- White blood cell (WBC) count > 3,500/mm³
- Platelets ≥125,000 /mm³
- Alanine aminotransferase (ALT) 2 years ago) not associated with other neurologic symptoms,
- mild psoriasis that does not require ongoing systemic treatment
- History of allergy to local anesthetic (Novocaine, Lidocaine).
- Investigator concern for difficulty with venous access based upon clinical history and physical examination. For example, history of IV drug abuse or substantial difficulty with previous blood draws.
Data sourced from ClinicalTrials.gov (NCT04915768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.