Immunogenicity and Safety of Freeze-Dried Human Rabies Vaccine (Vero Cell) in Patients Infected With Human Immunodeficiency Virus (HIV)

Trial details

Who runs it

Liaoning Chengda Biotechnology CO., LTD

Trial code

NCT07932132

Record updated

12 November 2026

Original description

This is a prospective, open-label, randomized controlled clinical trial designed to evaluate rabies virus neutralizing antibody responses to rabies vaccination among patients infected with human immunodeficiency virus (HIV). Eligible participants will be divided into two groups according to baseline CD4+ T cell count before randomization. Within each group, participants will be randomly assigned to one of two different rabies vaccination regimens for simulated post-exposure prophylaxis. Blood samples will be collected before vaccination and at scheduled time points after vaccination. Rabies virus neutralizing antibody titers will be tested to assess the seroconversion rate and geometric mean concentration (GMC). Adverse events after vaccination will also be recorded.Read full original descriptionShow less

This is a prospective, open-label, randomized controlled clinical trial designed to evaluate rabies virus neutralizing antibody responses to rabies vaccination among patients infected with human immunodeficiency virus (HIV). Eligible participants will be divided into two groups according to baseline CD4+ T cell count before randomization. Within each group, participants will be randomly assigned to one of two different rabies vaccination regimens for simulated post-exposure prophylaxis. Blood samples will be collected before vaccination and at scheduled time points after vaccination. Rabies virus neutralizing antibody titers will be tested to assess the seroconversion rate and geometric mean concentration (GMC). Adverse events after vaccination will also be recorded.

Inclusion: HIV-infected participants aged 18 to 60 years, able to provide valid identification; Normal liver and renal function confirmed by laboratory testing within 7 days prior to screening or on the day of screening; Receiving antiretroviral therapy (ART) for at least 6 months with a stable CD4+ T cell count ≥350 cells/mm³; or receiving ART for at least 6 months with a CD4+ T cell count <350 cells/mm³ and previously treated, well-controlled opportunistic infections (no clinical signs of active opportunistic infection, normal routine blood tests, and normal liver and renal test results); No active opportunistic infection or tumor, no history of drug allergy, and no other severe acute or chronic illnesses; Willing to participate in the study voluntarily and provide written informed consent; Participants are able to attend all scheduled visits as required by the protocol, with no plans for long term absence or relocation away from the study site; Axillary temperature ≤37.2℃ at screening.

Exclusion: History of receiving any blood, blood products or immunoglobulin within 3 months prior to the first vaccine dose, or plans to use these products within 1 month after the last vaccine dose; Receipt of immunosuppressive therapy within 3 months prior to enrollment, including continuous administration of systemic glucocorticoids (for 14 days or longer at a dose of ≥20 mg per day); Participating in another clinical trial (vaccine or drug) or planning to participate in another clinical trial during the course of this trial; History of rabies vaccination; History of allergy to any component of the study vaccine, including excipients and antibiotics; Presence of any acute disease, or chronic disease in active phase; History of serious adverse events following administration of other vaccines; Any condition that may interfere with study outcomes or study procedures, as assessed by the investigator; Confirmed pregnancy (positive urine pregnancy test at enrollment), or women of childbearing potential planning to become pregnant within 2 months.

ClinicalTrials.gov NCT07932132