Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants With… (NCT06694753) | Clinical Trial Compass
RecruitingPhase 1
Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall Good Health in South Africa.
South Africa96 participantsStarted 2025-12-15
Plain-language summary
The purpose of this study is to evaluate the safety and immunogenicity of mRNAs encoding HIV immunogens (eOD-GT8 60mer, core-g28v2 60mer, N332-GT5 gp151) in adult participants without HIV and in overall good health in South Africa.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Demonstrates an understanding of the study and is able and willing to complete the informed consent process.
✓. 18 to ≤ 55 years old, on day of enrollment.
✓. Available for clinic follow-up through the last clinic visit.
✓. Willingness to undergo FNA and leukapheresis.
✓. 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 IAVI Medical Monitor are required prior to enrollment into DESIIGN001/IAVI G004.
✓. In good general health according to the clinical judgment of the Investigator.
✓. Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgment of the Investigator.
✓. Assessed by clinical staff as having a low likelihood of acquiring HIV per guidelines (see Appendix 4), agrees to discuss their potential for HIV acquisition, agrees to prevention counseling, and agrees to avoid behaviors associated with a higher likelihood of acquiring HIV through the final study visit. "Low likelihood" may include persons stably taking pre-exposure prophylaxis (PrEP) as prescribed in Appendix 4.
Exclusion criteria
✕5. Negative HIV test results by one of the following options:
✕6. Negative for anti-Hepatitis C virus (HCV) Abs (anti-HCV) or negative HCV nucleic acid test (NAT) if anti-HCV Abs are detected.
What they're measuring
1
To assess the incidence of local and systemic reactogenecity and treatment-emergent adverse events [Safety and Tolerability].
Timeframe: Measured a minimum of 7 days following receipt of any study vaccination
2
To evaluate the induction of VRC01- or BG18-class IgG B cell responses by the vaccine regimens.
Timeframe: V01 [W0, baseline] V04 [W7.5, 7.5 wks. post 1st vacc.] V06 [W10, 2 wks. post 2nd vacc.] V07 [W15.5, 7.5 wks. post 2nd vacc.]
✕7. Negative for Hepatitis B surface antigen (HBsAg).
✕8. For volunteers AFAB or assigned intersex at birth who are capable of becoming pregnant (hereafter referred to as "persons of pregnancy potential"):
✕9. Volunteers AFAB or assigned intersex at birth must agree to not seek pregnancy through alternative methods, such as oocyte retrieval, artificial insemination, or in vitro fertilization from at least 21 days prior to enrollment through 8 weeks after their last scheduled vaccination time point.
✕. Volunteer is nursing or pregnant.
✕. Body mass index (BMI) ≥40 kg/m2. Enrollment of individuals with BMI ≥40 kg/m2, whom the site investigator assesses are in good health, may be considered by the IAVI Medical Monitor.
✕. Diabetes mellitus (DM). Type 2 DM controlled with diet alone (and confirmed by HgbA1c ≤7% within the last 6 months) or a history of isolated gestational diabetes are not exclusionary. Enrollment of individuals with Type 2 DM that is well controlled on hypoglycemic agent(s) may be considered by the IAVI Medical Monitor on a case-by-case basis, provided that the HgbA1c is ≤8% within the last 6 months (CRC staff may draw these at screening).