RabiesPhase 4NCT05937113
Safety and Immunogenicity of the Inactivated Rabies Vaccine RABIVAX-S Administered Intramuscularly and Intradermally
A Phase 4 study testing RABIVAX-S in people with Rabies, run by Vietnam Military Medical University at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- RABIVAX-S
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteVietnam
- Study dates
- 13 Jun 2020to 30 Oct 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Rabies
- Being tested
- RABIVAX-S
- Keywords
- Rabies, rabies vaccine, RABIVAX-S
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RABIVAX-SBiological
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Biological: RABIVAX-S |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
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
Measured: 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
Serum specimens during Phase 3 were tested for the presence and titer of RVNA
Measured: Day 0, day 7, day 21 and day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start13 Jun 2020
- Primary completion2 Jul 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vietnam Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Vabiotech
- Responsible party
- Principal investigator, Pham Ngoc Hung, Vietnam Military Medical University
- Investigators
- Pham N Hung, As. Prof., Principal investigator, Vietnam Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937113
- Sponsor's protocol ID
- VX.2019.02
- Status last verified
- Jul 2023
- First submitted
- 29 Jun 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39927222
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05937113
- Acronym / sponsor ID
- VX.2019.02
- Conditions
- Rabies
- Keywords
- Rabies, rabies vaccine, RABIVAX-S
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Vietnam Military Medical UniversityUniversity, hospital or other
- Collaborators
- Vabiotech
- Study start
- 13 Jun 2020 (actual)
- Primary completion
- 2 Jul 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safety of a 3-dose regimen of RABIVAX-S in healthy participants aged 5 to 60 years | Experimental | Biological: RABIVAX-SRABIVAX-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). |
| immunogenicityof a 3-dose regimen of RABIVAX-S in subgroup of participants | Experimental | Biological: RABIVAX-SRABIVAX-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). |
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RABIVAX-S1 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 | Biological | 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 |
Primary outcome
Rate of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE) after
Time frame: Within 30 minutes of each vaccination
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)
Time frame: within 7 days (day 1 to 7) of each vaccination and within 21 day after the first vaccination
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)
Time frame: during 21 days after the third vaccination
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)
Time frame: Day 1 to Day 42
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
2 secondary outcomes
Rate of Subjects With Seroconversion of rabies virus neutralizing antibody (RVNA) for Vaccine Antigens for subgroup of subjects
Time frame: 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
Time frame: Day 0, day 7, day 21 and day 42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Derived from this study: PubMed 39927222Hung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pham N Hung, As. Prof. principal investigator
Vietnam Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RABIVAX-S in people with Rabies, run by Vietnam Military Medical University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE) after (time frame: Within 30 minutes of each vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05937113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.