Study of Purified Vero Rabies Vaccine Compared With a Reference Rabies Vaccine as Simulated Rabies Post-Exposure Prophylaxis in Adults in Thaïland

Rabies (Healthy Volunteers) Clinical Trial

Official title:

Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free (VRVg) Using the Zagreb Regimen as Simulated Rabies Post-exposure Prophylaxis in Healthy Adults in Thailand

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04594551
• Other study ID #: VRV00014
• Secondary ID: U1111-1238-1726
• Status: Completed
• Phase: Phase 3
• Start date: October 11, 2020
• Est. completion date: June 23, 2021

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

To describe the immune response induced by VRVg-2 and Verorab vaccines at D14 and D35 when co-administered with Human Rabies Immunoglobulins (HRIG) at D0, according to the Zagreb (2-1-1) IM regimen in healthy adult subjects.

Secondary Objective:

Immunogenicity To describe the immune response induced by VRVg-2 and Verorab vaccines at D90 when co-administered with HRIG at D0, according to the Zagreb (2-1-1) IM regimen in healthy adult subjects.

Safety To describe the safety profile of VRVg-2 and Verorab vaccines when co administered with HRIG at D0, after each vaccination.

Description:

The duration of each subject's participation in the study will be approximately 7 months (21 day-vaccination period followed by 6 months safety follow-up period).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: June 23, 2021
• Est. primary completion date: June 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria :

• Aged = 18 years on the day of inclusion

• Able to attend all scheduled visits and to comply with all study procedures

• Body Mass Index (BMI): 18.5 kg/m2 = BMI = 30 kg/m2s

Exclusion criteria:

• Subject is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and 1 month after each vaccination. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.

• Participation at the time of study enrollment or, planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure

• Receipt of any vaccine in the 4 weeks (28 days) preceding the first study vaccination or planned receipt of any vaccine prior to Visit 7 (D90)

• Previous vaccination against rabies (in pre- or post-exposure regimen) with either the study vaccines or another vaccine

• Bite by, or exposure to a potentially rabid animal in the previous 6 months without post-exposure prophylaxis

• Receipt of immune globulins, blood or blood-derived products in the past 3 months

• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

• At high risk for rabies exposure

• Known systemic hypersensitivity to any of the study/control vaccine components or to human rabies immunoglobulin (HRIG), or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances

• Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination

• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination

• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily

• Current alcohol or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion

• Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion

• Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0 C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided

• Personal history of Guillain-Barré syndrome

• Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study

• Receipt of chloroquine or hydroxychloroquine up to 2 months prior to the study or through to study until Visit 7

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Rabies
• Rabies (Healthy Volunteers)

Intervention

Biological:
• Purified vero rabies vaccine - serum free
Pharmaceutical form:freeze-dried - Route of administration: intramuscular
• Purified inactivated rabies vaccine
Pharmaceutical form:freeze-dried - Route of administration: intramuscular
• Human rabies immunoglobulins
Pharmaceutical form:liquid/solution in 2 mL vials - Route of administration: intramuscular

Locations

Country	Name	City	State
Thailand	Investigational site number 7640001	Bangkok
Thailand	Investigational site number 7640002	Bangkok
Thailand	Investigational site number 7640003	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (=) 0.5 IU/mL	RVNA titers will be measured by rapid fluorescent focus inhibition test (RFFIT)	Day 14 (post-vaccination)
Primary	Percentage of participants achieving RVNA titer greater than or equal to (=) 0.5 IU/mL	RVNA titers will be measured by RFFIT	Day 35 (post-vaccination)
Primary	Number of Participants achieving RVNA titer greater than or equal to (=) lower limit of quantification	RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL	Day 14 (post-vaccination)
Primary	Number of Participants achieving RVNA titer greater than or equal to (=) lower limit of quantification	RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL	Day 35 (post-vaccination)
Primary	Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination)	RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 14 - RVNA ratios Day14/Day0 will be calculated	Day 14 (post-vaccination
Primary	Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination)	RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 35 - RVNA ratios Day35/Day0 will be calculated	Day 35 (post-vaccination)
Secondary	Number of participants reporting immediate adverse events (AEs)	Unsolicited (spontaneously reported) systematic AEs	Within 30 minutes post-vaccination
Secondary	Percentage of participants reporting solicited injection site and systemic reactions	Solicited injection site reactions: - pain, erythema, and swelling in adults (aged = 18 years); Solicited systemic reactions: - fever, headache, malaise and myalgia in adults (aged = 18 years)	Within 7 days post-vaccination
Secondary	Number of participants reporting unsolicited injection site AEs	Unsolicited injection site AEs	Within 28 days post-vaccination
Secondary	Number of participants reporting unsolicited systemic AEs	Unsolicited systemic AEs	Between each vaccination and up to 28 days after the last vaccination
Secondary	Number of participants reporting serious adverse events (SAEs)	SAEs, including adverse event of special interest (AESIs)	Up to 6 months after last vaccination
Secondary	Percentage of participants achieving rabies virus neutralizing antibody (RVNA) titer greater than or equal to (=) 0.5 IU/mL	RVNA titers will be measured by RFFIT	Day 90 (post-vaccination)
Secondary	Number of Participants achieving RVNA titer greater than or equal to (=) lower limit of quantification	RVNA titers will be measured by RFFIT - Lower limit of quantification for RFFIT assay is 0.2 IU/mL	Day 90 (post-vaccination)
Secondary	Geometric Mean Titer Ratio (GMTR) of individual RVNA titer: (post-/pre-vaccination)	RVNA titers against rabies virus will be measured by RFFIT at Day 0 and Day 90 - RVNA ratios Day90/Day0 will be calculated	Day 90 (post-vaccination)