Immunogenicity and Safety of Freeze-Dried Human Rabies Vaccine (Vero Cell) in Patients Infected With Human Immunodeficiency Virus (HIV)
NCT07932132, Phase 4, Recruiting, Liaoning Chengda Biotechnology CO., LTD
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Immunogenicity and Safety of Freeze-Dried Human Rabies Vaccine (Vero Cell) in Patients Infected With Human Immunodeficiency Virus (HIV) | ClinicalTrials.gov |
| NCT number | NCT07932132 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 160 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Liaoning Chengda Biotechnology CO., LTD | ClinicalTrials.gov |
| Conditions | Rabies, HIV Infections | ClinicalTrials.gov |
| Interventions | Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Seroconversion rate and geometric mean concentration (GMC) of rabies virus neutralizing antibodies at 14 days after completion of the full vaccination course | 14 days after completion of the full vaccination course | Seroconversion rate and GMC of rabies virus neutralizing antibodies among HIV-infected participants who are seronegative at baseline (Day 0). Seroconversion is defined as a rabies virus neutralizing antibody titer ≥0.5 IU/mL. Rabies virus neutralizing antibodies will be assessed by the rapid fluorescent focus inhibition test (RFFIT). | ClinicalTrials.gov |
| Primary | Incidence of adverse events after vaccination | 30 minutes, 0-7 days, and 8-14 days after each vaccine dose | Incidence of immediate local and systemic adverse events recorded within 30 minutes after each vaccination; incidence of solicited local and systemic adverse events collected 0-7 days after each dose; incidence of unsolicited adverse events collected 8-14 days after each dose. Adverse events are defined as any untoward medical occurrence in a participant administered vaccine, not necessarily having a causal relationship with vaccination. | ClinicalTrials.gov |
| Secondary | Seroconversion rate and GMC of rabies virus neutralizing antibodies at 14 days after the first dose of vaccination | 14 days after the first dose of vaccination | Seroconversion rate and GMC of rabies virus neutralizing antibodies at 14 days after the first dose vaccination among HIV-infected participants who are seronegative at baseline (Day 0). Seroconversion is defined as a rabies virus neutralizing antibody titer ≥0.5 IU/mL. Rabies virus neutralizing antibodies will be assessed by RFFIT. | ClinicalTrials.gov |
| Secondary | Seroconversion rate and GMC of rabies virus neutralizing antibodies at 90 days after completion of the full vaccination course | 90 days after completion of the full vaccination course | Seroconversion rate and GMC of rabies virus neutralizing antibodies at 90 days after completion of the full vaccination course among HIV-infected participants who are seronegative at baseline (Day 0). Seroconversion is defined as a rabies virus neutralizing antibody titer ≥0.5 IU/mL. Rabies virus neutralizing antibodies will be assessed by RFFIT. | ClinicalTrials.gov |
| Secondary | Seroconversion rate and GMC of rabies virus neutralizing antibodies after booster vaccination | 14 days after booster vaccination | Seroconversion rate and GMC of rabies virus neutralizing antibodies 14 days after booster vaccination, in participants who remain seronegative (titer \<0.5 IU/mL) at 14 days after completion of the full vaccination course. Booster vaccination consists of 2 doses administered on day 0 and day 3 of the booster phase. Seroconversion is defined as a rabies virus neutralizing antibody titer ≥0.5 IU/mL. Rabies virus neutralizing antibodies will be assessed by RFFIT. | ClinicalTrials.gov |
| Secondary | Seroconversion rate and GMC of rabies virus neutralizing antibodies at Day 28 within the Essen regimen group | Day 28 within the Essen vaccination regimen | Seroconversion rate and GMC of rabies virus neutralizing antibodies at Day 28 among HIV-infected participants who are seronegative at baseline (Day 0) and assigned to the Essen five dose regimen. Seroconversion is defined as a rabies virus neutralizing antibody titer ≥0.5 IU/mL. Rabies virus neutralising antibodies will be assessed by RFFIT. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)