Imovax® Rabies and VERORAB® Immunogenicity and Safety after One Week 2-sites Intradermal or 1-site Intramuscular Pre-Exposure Prophylaxis Regimens, Followed by a Simulated Intradermal or Intramuscular Post-Exposure Prophylaxis Regimen at One Year

Registry ID

PHRR181120-001988

Secondary Identification Number

VAJ00001

FDA Clinical Trial Reference (CTR) Number

2017-CT0432

Scientific Title

Phase III, open-label, randomized, controlled trial conducted in healthy subjects aged 2 years and older in the Philippines

Project Description

This is a Phase III, open-label, randomized, controlled trial conducted in the Philippines. A total of 570 healthy subjects aged ≥ 2 years will be randomized into 5 groups for pre-exposure prophylaxis (PrEP):

Project Duration

Start Date	Duration in Months	Target Completion Date	Actual Completion Date
2018-09-26	14	2019-11-26	0000-00-00

Project Status

Ongoing

Implementing Agency (Primary Sponsor)

Institution	Classification	Region	LTO #
Sanofi Pasteur	Private Business	NCR	CDRR-NCR-S-8

Funding Agency (Sources of Monetary or Material Support)

Institution	Region
Sanofi Pasteur	NCR

Contact for Public Queries

Name	E-Mail	Institution and Institution Address
Erah Jean Baria	erahjean.baria@sanofi.com	21st flr, One World Place, 32nd st. BGC Taguig City

Contact for Scientific Queries

Name	E-Mail	Institution and Institution Address
Thelma Laot	thelma.laot@sanofi.com	21st flr, One World Place, 32nd st. BGC Taguig City

Investigating Team

Name	Expertise	Affiliation
Beatriz P. Quiambao, MD	Pedia Infectious	Research Institute for Tropical Medicine
Jonathan Lim, MD	Pedia Infectious	Chong Hua Hospital

Project Location and Institutional Ethics Review Board

Project Location	Institutional Ethics Review Board
Research Institute for Tropical Medicine	Research Institute for Tropical Medicine Institutional Review Board
Chong Hua Hospital	Chong Hua Hospital Institutional Review Board

Health Condition(s) or Problem(s) Studied

Rabies

Primary Outcomes

To demonstrate that a short IM PrEP regimen is non-inferior to the reference IM PrEP regimen in terms of seroconversion rate 14 days after the last PrEP vaccination with HDCV (Group 1 versus Group 2).

Key Secondary Outcomes

Unspecified

Recruitment Status

Completed

Countries of Recruitment

Philippines

Research Classification

Clinical Trial

FDA Document Tracking Number

2017-CTO432

FDA Approval Date

2018-01-19

ERC Approval Date

0000-00-00

Target Sample Size (Philippines)

570

Actual Sample Size (Philippines)

Unspecified

Reason for the difference between Target & Actual Sample Sizes

Unspecified

Date of First Enrollment

26 Sep 2018

Key Inclusion and Exlusion Criteria (CT)

Inclusion:

1) Aged ≥ 2 years* on the day of inclusion

2) Subject aged < 18 years: Assent form has been signed and dated by

the subject (as appropriate, according to country-specific institution

requirements), and informed consent form (ICF) signed and dated by

the parent or another legally acceptable representative

Subject aged ≥ 18 years: ICF signed and dated by the subject

3) The subject (and parent/legally acceptable representative, if applicable)

is able to attend all scheduled visits and to comply with all trial

Exclusion:

1) 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 until at least 4 weeks after the last

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.

2) Participation at the time of study enrollment (or in the 4 weeks

preceding the first trial vaccination) or planned participation during the

present trial period in another clinical trial investigating a vaccine, drug,

medical device, or medical procedure.

3) Receipt of any vaccine in the 4 weeks preceding the first trial

vaccination or planned receipt of any vaccine in the 4 weeks following

any trial vaccination except for influenza vaccination, which may be

received at least 2 weeks before study vaccines. This exception includes

monovalent pandemic influenza vaccines and multivalent influenza

vaccines.

4) Previous vaccination at any time against rabies with either the trial

vaccine or another vaccine

5) Receipt of immune globulins, blood, or blood-derived products in the

past 3 months

6) 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)

7) Known systemic hypersensitivity to any of the vaccine components, or

history of a life-threatening reaction to the vaccines used in the trial or

to a vaccine containing any of the same substances

8) Self-reported thrombocytopenia, contraindicating IM vaccination

9) Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding

inclusion, contraindicating intramuscular vaccination

10) Deprived of freedom by an administrative or court order, or in an

emergency setting, or hospitalized involuntarily

11) Current alcohol abuse or drug addiction

12) Chronic illness that, in the opinion of the investigator, is at a stage

where it might interfere with trial conduct or completion

13) 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

14) 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 (i.e., parent, spouse, natural or adopted child)

of the Investigator or employee with direct involvement in the proposed

study

15) History of Guillain-Barré syndrome

16) Receipt of chloroquine or other medications used for malaria

chemoprophylaxis, with or without other anti-malarial treatment, for

more than 4 weeks (duration of anti-malarial course) and part of the

treatment received within the 2 weeks before vaccination,

contraindicating intradermal vaccination

Study Type

Interventional

Intervention Name

Imovax® Rabies, Human Diploid Cell Vaccine (HDCV) and Verorab®, Purified Vero cell Rabies Vaccine (PVRV)

Intervention Description

Imovax Rabies - Freeze-dried suspension of inactivated rabies virus reconstituted with 1 mL

diluent.
Verorab - Freeze-dried inactivated rabies virus rehydrated with diluent

Amendment Approval Date/Reasons

None

Method of Allocation

Randomized

Masking / Blinding

Open Label

Masking Details

Unspecified

Assignment

Parallel

Purpose

To demonstrate that a short IM PrEP regimen is non-inferior to the reference

IM PrEP regimen in terms of seroconversion rate 14 days after the last PrEP

vaccination with HDCV (Group 1 versus Group 2).

Phase

Phase III

Research Utilization

Utilization	Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others