Clinical Trial to Evaluate the Safety and Immunogenicity of Ferritin Nanoparticles Expressing Nat… (NCT05903339) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Clinical Trial to Evaluate the Safety and Immunogenicity of Ferritin Nanoparticles Expressing Native-like HIV-1 Envelope Trimers Followed by Boost With mRNA Lipid Nanoparticles Encoding a Native-like HIV-1 Envelope Trimer in Adults Without HIV
United States36 participantsStarted 2023-08-29
Plain-language summary
This first-in-human (FIH) phase 1 clinical trial will evaluate a prime-boost regimen of immunogens designed to induce HIV-1 Env V3-glycan-specific broadly neutralizing antibodies (V3G bNAbs). The priming immunogen (V3G CH848 Pr-NP1) consists of ferritin NPs expressing 8 copies of an Env trimer. This immunogen will be boosted with an mRNA LNP (V3G CH848 mRNA-Tr2), encoding a soluble Env trimer which does not utilize the ferritin NP design.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Able and willing to complete the informed consent process, including an Assessment of Understanding (AoU): Volunteer demonstrates an understanding of this study and completes a questionnaire prior to first vaccination with verbal demonstration of understanding of questionnaire items that were answered incorrectly.
* 18 to 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 study-product administration.
* Agrees not to enroll in another study of an investigational agent during participation in the trial. If a potential participant is already enrolled in another clinical trial, approvals from the other trial sponsor and the HVTN 307 PSRT are required prior to enrollment into HVTN 307.
* In good general health according to the clinical judgment 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 by clinical staff as having a low likelihood of acquiring HIV per guidelines, agrees to discuss their potential for HIV acquisition, agrees to risk-reduction counseling, and agrees to avoid behaviors associated with a higher likelihood of acquiring HIV through the final study visit. Low likelihood ma…
What they're measuring
1
Local reactogenicity signs and symptoms for a minimum of 14 days following receipt of any study vaccine
Timeframe: 2 weeks following any injection
2
Systemic reactogenicity signs and symptoms for a minimum of 14 days following receipt of any study vaccine.
Timeframe: 2 weeks following any injection
3
Number of SAEs (Serious Adverse Events) leading to early participant withdrawal or permanent discontinuation
Timeframe: 12 months following receipt of any study product
4
Number of MAAEs (medically attended adverse event) leading to early participant withdrawal or permanent discontinuation
Timeframe: 12 months following receipt of any study product
5
Number of AESIs (Adverse events of special interest) leading to early participant withdrawal or permanent discontinuation
Timeframe: 12 months following receipt of any study product
6
Number of AEs (adverse events) leading to early participant withdrawal or permanent discontinuation
Timeframe: 12 months following receipt of any study product
7
Frequency of the V3G-specific precursor IgM+ and IgG+ B cells.
Trial details
NCT IDNCT05903339
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)