Safety and Immunogenicity of the Inactivated Rabies Vaccine RABIVAX-S Administered Intramuscularly and Intradermally

NCT05937113 | Completed Phase 4

• 1 other identifier: VX.2019.02
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, open-label, prospective, before-and-after comparison study in the same group. Subjects suitable for the study will be randomly assigned at a ratio of 1:1 (block 4) to use the study vaccine by one of two routes of administration: Intramuscular or Intramuscular. Previously-unvaccinated subjects receive three injections of vaccine on day 0, 7 and 21-28. The aim of the study is to evaluate the safety and immunogenicity of the inactivated rabies vaccine RABIVAX-S administered intramuscularly and intradermally according to a 3-dose regimen in healthy volunteers.

Conditions

Rabies

Keywords

Rabies; rabies vaccine; RABIVAX-S

Outcome Measures

Primary Outcomes (4)

• Rate of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE) after

  Solicited local and systemic AEs were assessed by study staff in 30 minutes after vaccination.

  Within 30 minutes of each vaccination

• Rate of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE)

  Solicited local AEs were assessed by study staff 30 minutes after vaccination then daily for 7 days

  within 7 days (day 1 to 7) of each vaccination and within 21 day after the first vaccination

• Rate of Subjects Experiencing Unsolicited Adverse Events (AE)

  Unsolicited AEs were observed by study staff while the subject is at a clinic for a study visit or reported by the subject at any time. Any sign or symptom that would normally be considered a "solicited AE" (for example, fever, nausea, injection site pain) starting after 7 days post-vaccination was to be recorded as an unsolicited AE

  during 21 days after the third vaccination

• Rate of Subjects Experiencing Unsolicited Serious Adverse Events (SAE)

  A serious adverse event (SAE) is defined as an AE that meets one of the following conditions: Deadly. Life-threatening. Requires inpatient hospital admission or extended stay in hospital. Causes birth defects. Causes permanent or permanent injury or disability. Critical medical events that may not be fatal, not life-threatening, or require inpatient treatment will be considered a SAE if it is judged by professional judgment that the incident would be potentially dangerous. subject's health and the need for medical or surgical intervention to prevent one of the aforementioned consequences

  Day 1 to Day 42

Secondary Outcomes (2)

• Rate of Subjects With Seroconversion of rabies virus neutralizing antibody (RVNA) for Vaccine Antigens for subgroup of subjects

  Day 0, day 7, day 21 and day 42

• Geometric Mean Titer (GMT) of rabies virus neutralizing antibody (RVNA) for Vaccine Antigens at Baseline and Day 22 or 49 after vaccination (depending on age group) for each antigenic component of the vaccine

  Day 0, day 7, day 21 and day 42

Study Arms (2)

Safety of a 3-dose regimen of RABIVAX-S in healthy participants aged 5 to 60 years

EXPERIMENTAL

RABIVAX-S is a pure, sterile inactivated rabies vaccine produced on vero cells. RABIVAX-S vaccine is lyophilized and is supplied with rehydration solution (1 vial containing 1 dose of lyophilized vaccine and 1 vial of rehydration solution).

Biological: RABIVAX-S

immunogenicityof a 3-dose regimen of RABIVAX-S in subgroup of participants

EXPERIMENTAL

RABIVAX-S is a pure, sterile inactivated rabies vaccine produced on vero cells. RABIVAX-S vaccine is lyophilized and is supplied with rehydration solution (1 vial containing 1 dose of lyophilized vaccine and 1 vial of rehydration solution).

Biological: RABIVAX-S

Interventions

RABIVAX-S BIOLOGICAL

1 ml dose vaccine containing ≥ 2.5 IU of purified rabies antigen (Pitman-Moore rabies virus strain 3218; acclimatized and cultured on vero cells, inactivated with β propiolactone). Pre-exposure prophylaxis regimens for two groups * Intramuscular 1ml on days D0, D7 and D21+7 * Intradermal injection 0.1 ml on days D0, D7 and D21+7 Blood samples were collected on days D0, D7 and D21 - 28

Safety of a 3-dose regimen of RABIVAX-S in healthy participants aged 5 to 60 years; immunogenicityof a 3-dose regimen of RABIVAX-S in subgroup of participants

Eligibility Criteria

• Age: 5 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy volunteers aged 5-60 years at the time of study screening.
• Consent to participate in the study by signing the consent to participate in the study after being provided with complete information about the study. The participation of research subjects under the age of 18 years will be signed by the legal guardian.
• Research subjects with normal health are determined according to personal medical history, clinical examination and laboratory tests within the clinically acceptable normal range.
• Able to follow the research process as assessed by the researcher.
• Women of reproductive age who have been using effective contraception for at least 4 weeks prior to screening and are willing to continue contraception until at least 4 weeks after the last dose of the study vaccine together. Men participating in the study agreed not to conceive until at least 4 weeks after the last dose of the study vaccine.

You may not qualify if:

• Subject is participating in any other clinical trial.
• Research facility staff working directly in this study and their families and relatives. Family, relatives are defined as spouses, parents, children or siblings, whether adopted or legally adopted.
• History of previous rabies vaccination (pre- or post-exposure regimen)
• Have received rabies immunoglobulin (human/equine) in the past.
• Fever (temperature ≥37°C) or moderate or severe acute illness, or infection on the day of vaccination.
• History of systemic hypersensitivity reaction to any vaccine component or history of life-threatening reaction to an experimental vaccine or a vaccine containing any vaccine-like substance study.
• Have received any immunoglobulin, blood, or blood-based product therapy in the past 3 months, which may interfere with the assessment of immune response.
• Known seropositive status for HIV antibody, HCV antibody or hepatitis B surface antigen (HBsAg) (retest not required).
• Receive any vaccine in the 4 weeks before the first trial vaccine
• Expect to receive any vaccine for 4 weeks after the trial vaccine is administered.
• Women who are pregnant or have a positive urine test or are not willing to use safe methods of contraception
• Women who are breastfeeding
• Participated in a clinical trial study within the past 3 months.
• Have a plan to donate blood while participating in the study
• History of or current drug or alcohol abuse within the past year.

Sponsors & Collaborators

• Vietnam Military Medical University: lead
• Vabiotech: collaborator

Study Sites (1)

CDC Thai Binh

Thái Bình, 410000, Vietnam

Location

Related Publications (1)

• Hung PN, Giang LTH, Anh NT, Anh BDT, Pho DC, Van Hung P. Safety and immunogenicity of an inactivated vero cell-based rabies vaccine (Rabivax-S) in pre-exposure prophylaxis schedule in Vietnam. Clin Exp Vaccine Res. 2025 Jan;14(1):51-58. doi: 10.7774/cevr.2025.14.e9. Epub 2025 Jan 22.

  PMID: 39927222 DERIVED

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Pham N Hung, As. Prof.

  Vietnam Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Epidemiology

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 10, 2023
• Study Start: June 13, 2020
• Primary Completion: July 2, 2020
• Study Completion: October 30, 2020
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)