Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis

Rabies Clinical Trial

— RABVAX  

Official title:

Immunogenicity of a Two vs Three Dose, Intradermal (ID) vs Intramuscular (IM) Administration of a Licensed Rabies Vaccine for Pre-Exposure Vaccination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374814
• Other study ID #: 568085
• Status: Completed
• Phase: Phase 4
• Start date: March 24, 2015
• Est. completion date: September 22, 2016

Study information

• Verified date: June 2022
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effectiveness of a two dose versus a three dose schedule and intramuscular versus intradermal injection for pre-exposure prophylaxis.

Description:

This is an exploratory vaccine trial to evaluate immunogenicity of a non-licensed dosing schedule and route of administration for a currently FDA licensed rabies vaccine for pre-exposure prophylaxis against rabies infection. The goal of this study is to characterize the immune response and persistence of immunity to a shortened dose schedule and intradermal (ID) administration, relative to the current licensed dosing schedule of the rabies vaccine (3 dose (0, 7, 21 days) IM). Rabies virus is endemic throughout the world due to high rates of both wild and domestic animal rabies and the risk to deployed military in endemic areas is considerable. Currently the commonly supported pre-exposure prophylaxis regimen for rabies, in the United States is comprised of three, 1.0 ml intramuscular (IM) injections of the human diploid cell vaccine (HDCV) or purified chick embryo cell (PCEC) rabies vaccine on days 0, 7, and 21 or 28. Modified, two and three dose schedules of intradermal (ID) injections of 0.1 ml of HDCV and PCEC are utilized outside the US. These two and three dose intradermal schedules share a similar safety and immunogenicity profile to intramuscular vaccinations and are easily boosted at one year after vaccination. A death, from rabies, of a US Soldier returned from Afghanistan underscores the importance of rabies pre-exposure prophylaxis for soldiers and the need to evaluate the safest, most effective means of vaccinating large deploying forces. While the current three dose, 1 ml IM rabies series is effective, a shortened, equally effective vaccination series with significantly smaller dose per injection would greatly improve the logistics and cost associated with universal or even targeted coverage of deploying soldiers. Evaluation of a shorter, smaller-dose, pre-exposure vaccination series for rabies is the goal of this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 22, 2016
• Est. primary completion date: September 22, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

Male and non-pregnant females aged = 18 to = 60 years on the day of inclusion Able to comprehend and give informed consent Able to attend all scheduled visits and to comply with all trial procedures Subject in good health, based on medical history and physical examination

Exclusion Criteria:

1. Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post- menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination).

2. Participation 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. Previous history of receiving the rabies vaccine.

4. Previous history of receiving rabies immune globulin.

5. Any major psychiatric disorder, such as severe depression, severe anxiety disorder, psychosis, schizophrenia, other major psychiatric disorders, or seizures. History of mild depression or anxiety disorder that is well controlled is not an exclusion criteria.

6. Any history of cardiac arrhythmias, such as: Bradycardia, tachycardia, heart block, SVT, PAC, VF, VT, or any other conduction abnormalities.

7. Use of any immunosuppressive drug , including topical steroids of potency groups I, II or III within 30 days of the study period.

8. Any immunosuppressive disorder, such as HIV, common variable, active cancers or chemotherapy.

9. History of renal insufficiency or requiring dialysis.

10. Any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

11. Identified as an employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employee or the Investigator.

Related Conditions & MeSH terms

• Rabies

Intervention

Drug:
• Rabies vaccine
Compare dose schedule and route of administration
• Placebo
Placebo

Locations

Country	Name	City	State
United States	State University of New York, Upstate Medical University (SUNY-UMU)	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University	Walter Reed Army Institute of Research (WRAIR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Endy TP, Keiser PB, Wang D, Jarman RG, Cibula D, Fang H, Ware L, Abbott M, Thomas SJ, Polhemus ME. Serologic Response of 2 Versus 3 Doses and Intradermal Versus Intramuscular Administration of a Licensed Rabies Vaccine for Preexposure Prophylaxis. J Infec — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Protective Humoral Immune Response at 1 Month Post First Vaccination.	Percentage of subjects achieving the protective titer of = 0.5 IU/ml against rabies virus	1 month post first vaccination
Primary	Protective Humoral Immune Response 12 Months Post First Vaccination.	Percentage of subjects achieving the protective titer of = 0.5 IU/ml against rabies virus 12 months post vaccinations (prior to boost).	12 months post first vaccination
Secondary	Protective Humoral Immune Response 7 Days Post Booster at 12 Months Post First Vaccination.	Percentage of subjects achieving the protective titer of = 0.5 IU/ml against rabies virus at 7 days post boost.	up to 13 months post first vaccination