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

Primary Purpose

Rabies

Status
Completed
Phase
Phase 4
Locations
Vietnam
Study Type
Interventional
Intervention
RABIVAX-S
Sponsored by
Vietnam Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rabies focused on measuring Rabies, rabies vaccine, RABIVAX-S

Eligibility Criteria

5 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. Congenital or acquired immunodeficiency, immunosuppressive therapy such as antineoplastic chemotherapy or radiation within the previous 6 months, or long-term systemic corticosteroid therapy (Permission to use topical steroid/medication) Thrombocytopenia, bleeding disorders or anticoagulants in the 3 weeks prior to vaccination is contraindicated intramuscularly (IM) Subjects at high risk of exposure to rabies during the study period, for example veterinary surgeons (including students at veterinary colleges), technical staff working with doctors veterinarians, laboratory staff handling rabies-contaminated material, abattoir staff, zoo staff. Subject plans to have surgery in the next 3 months. Subjects using antimalarial drugs concurrently Clinically significant acute or chronic conditions such as pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, liver or renal disease, as determined by medical history and physical examination and in the opinion of the researcher may affect the objectives of the study. Any other condition that, in the opinion of the researcher as a member, would jeopardize the safety or rights of the subject or prevent the subject from completing the protocol procedures study.

Sites / Locations

  • CDC Thai Binh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

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

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.
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
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
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

Secondary Outcome Measures

Rate of Subjects With Seroconversion of rabies virus neutralizing antibody (RVNA) for Vaccine Antigens for subgroup of subjects
Serum specimens were tested for the presence and titer of rabies virus neutralizing antibody (RVNA) and the seroprotection rate was RVNA titer ≥0.5 IU/mL
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
Serum specimens during Phase 3 were tested for the presence and titer of RVNA

Full Information

First Posted
June 29, 2023
Last Updated
July 17, 2023
Sponsor
Vietnam Military Medical University
Collaborators
Vabiotech
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1. Study Identification

Unique Protocol Identification Number
NCT05937113
Brief Title
Safety and Immunogenicity of the Inactivated Rabies Vaccine RABIVAX-S Administered Intramuscularly and Intradermally
Official Title
A Cross-over, Open-label, Randomized Study Evaluating the Safety and Immunogenicity of the Inactivated Rabies Vaccine RABIVAX-S on Healthy Vietnamese Volunteers With 3 Doses of Pre-exposure Prophylaxis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 13, 2020 (Actual)
Primary Completion Date
July 2, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vietnam Military Medical University
Collaborators
Vabiotech

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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 D21-28 Intradermal injection 0.1 ml on days D0, D7 and D21-28 Randomization was performed according to two age stratifications: Stratification of research subjects from 5-15 years old Stratification of research subjects from 16-60 years old Population selected research subjects in the community in Dong Hung district, Thai Binh province

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies
Keywords
Rabies, rabies vaccine, RABIVAX-S

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safety of a 3-dose regimen of RABIVAX-S in healthy participants aged 5 to 60 years
Arm Type
Experimental
Arm Description
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).
Arm Title
immunogenicityof a 3-dose regimen of RABIVAX-S in subgroup of participants
Arm Type
Experimental
Arm Description
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).
Intervention Type
Biological
Intervention Name(s)
RABIVAX-S
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE) after
Description
Solicited local and systemic AEs were assessed by study staff in 30 minutes after vaccination.
Time Frame
Within 30 minutes of each vaccination
Title
Rate of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE)
Description
Solicited local AEs were assessed by study staff 30 minutes after vaccination then daily for 7 days
Time Frame
within 7 days (day 1 to 7) of each vaccination and within 21 day after the first vaccination
Title
Rate of Subjects Experiencing Unsolicited Adverse Events (AE)
Description
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
Time Frame
during 21 days after the third vaccination
Title
Rate of Subjects Experiencing Unsolicited Serious Adverse Events (SAE)
Description
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
Time Frame
Day 1 to Day 42
Secondary Outcome Measure Information:
Title
Rate of Subjects With Seroconversion of rabies virus neutralizing antibody (RVNA) for Vaccine Antigens for subgroup of subjects
Description
Serum specimens were tested for the presence and titer of rabies virus neutralizing antibody (RVNA) and the seroprotection rate was RVNA titer ≥0.5 IU/mL
Time Frame
Day 0, day 7, day 21 and day 42
Title
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
Description
Serum specimens during Phase 3 were tested for the presence and titer of RVNA
Time Frame
Day 0, day 7, day 21 and day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Congenital or acquired immunodeficiency, immunosuppressive therapy such as antineoplastic chemotherapy or radiation within the previous 6 months, or long-term systemic corticosteroid therapy (Permission to use topical steroid/medication) Thrombocytopenia, bleeding disorders or anticoagulants in the 3 weeks prior to vaccination is contraindicated intramuscularly (IM) Subjects at high risk of exposure to rabies during the study period, for example veterinary surgeons (including students at veterinary colleges), technical staff working with doctors veterinarians, laboratory staff handling rabies-contaminated material, abattoir staff, zoo staff. Subject plans to have surgery in the next 3 months. Subjects using antimalarial drugs concurrently Clinically significant acute or chronic conditions such as pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, liver or renal disease, as determined by medical history and physical examination and in the opinion of the researcher may affect the objectives of the study. Any other condition that, in the opinion of the researcher as a member, would jeopardize the safety or rights of the subject or prevent the subject from completing the protocol procedures study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pham N Hung, As. Prof.
Organizational Affiliation
Vietnam Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CDC Thai Binh
City
Thai Binh
ZIP/Postal Code
410000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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