Back to results

Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis (RABVAX)

Primary Purpose

Rabies

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Rabies vaccine

Placebo

About this trial

This is an interventional basic science trial for Rabies

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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:

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).
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.
Previous history of receiving the rabies vaccine.
Previous history of receiving rabies immune globulin.
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.
Any history of cardiac arrhythmias, such as: Bradycardia, tachycardia, heart block, SVT, PAC, VF, VT, or any other conduction abnormalities.
Use of any immunosuppressive drug , including topical steroids of potency groups I, II or III within 30 days of the study period.
Any immunosuppressive disorder, such as HIV, common variable, active cancers or chemotherapy.
History of renal insufficiency or requiring dialysis.
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.
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.

Sites / Locations

State University of New York, Upstate Medical University (SUNY-UMU)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Rabies vaccine IM 3 dose

Rabies vaccine ID 3 dose

Rabies vaccine IM 2 dose

Rabies vaccine ID 2 dose

Placebo IM 1 dose

Placebo ID 1 dose

Arm Description

Intramuscular injection: 1mL at 0, 7 and 21 days. An additional 1 mL intramuscular dose at day 365

Intradermal injection: 0.1mL at 0, 7 and 21 days. A single intramuscular 1 mL dose at day 365

Intramuscular injection: 1mL at 0, 7 days. An additional 1 mL intramuscular dose at day 365

Intradermal injection: 0.1mL at 0, 7 days. A single intramuscular 1 mL dose at day 365

Albumin and saline comparator, Intramuscular injection: 1mL

Albumin and saline comparator, Intradermal injection: 0.1mL

Outcomes

Primary Outcome Measures

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

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).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02374814

First Posted

February 23, 2015

Last Updated

June 10, 2022

Sponsor

State University of New York - Upstate Medical University

Collaborators

Walter Reed Army Institute of Research (WRAIR)

1. Study Identification

Unique Protocol Identification Number

NCT02374814

Brief Title

Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

March 24, 2015 (Actual)

Primary Completion Date

September 22, 2016 (Actual)

Study Completion Date

September 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

State University of New York - Upstate Medical University

Collaborators

Walter Reed Army Institute of Research (WRAIR)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rabies

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rabies vaccine IM 3 dose

Arm Type

Active Comparator

Arm Description

Intramuscular injection: 1mL at 0, 7 and 21 days. An additional 1 mL intramuscular dose at day 365

Arm Title

Rabies vaccine ID 3 dose

Arm Type

Experimental

Arm Description

Intradermal injection: 0.1mL at 0, 7 and 21 days. A single intramuscular 1 mL dose at day 365

Arm Title

Rabies vaccine IM 2 dose

Arm Type

Experimental

Arm Description

Intramuscular injection: 1mL at 0, 7 days. An additional 1 mL intramuscular dose at day 365

Arm Title

Rabies vaccine ID 2 dose

Arm Type

Experimental

Arm Description

Intradermal injection: 0.1mL at 0, 7 days. A single intramuscular 1 mL dose at day 365

Arm Title

Placebo IM 1 dose

Arm Type

Placebo Comparator

Arm Description

Albumin and saline comparator, Intramuscular injection: 1mL

Arm Title

Placebo ID 1 dose

Arm Type

Placebo Comparator

Arm Description

Albumin and saline comparator, Intradermal injection: 0.1mL

Intervention Type

Drug

Intervention Name(s)

Rabies vaccine

Other Intervention Name(s)

Rabavert

Intervention Description

Compare dose schedule and route of administration

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Albumin

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Protective Humoral Immune Response at 1 Month Post First Vaccination.

Description

Percentage of subjects achieving the protective titer of ≥ 0.5 IU/ml against rabies virus

Time Frame

1 month post first vaccination

Title

Protective Humoral Immune Response 12 Months Post First Vaccination.

Description

Percentage of subjects achieving the protective titer of ≥ 0.5 IU/ml against rabies virus 12 months post vaccinations (prior to boost).

Time Frame

12 months post first vaccination

Secondary Outcome Measure Information:

Title

Protective Humoral Immune Response 7 Days Post Booster at 12 Months Post First Vaccination.

Description

Percentage of subjects achieving the protective titer of ≥ 0.5 IU/ml against rabies virus at 7 days post boost.

Time Frame

up to 13 months post first vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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). 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. Previous history of receiving the rabies vaccine. Previous history of receiving rabies immune globulin. 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. Any history of cardiac arrhythmias, such as: Bradycardia, tachycardia, heart block, SVT, PAC, VF, VT, or any other conduction abnormalities. Use of any immunosuppressive drug , including topical steroids of potency groups I, II or III within 30 days of the study period. Any immunosuppressive disorder, such as HIV, common variable, active cancers or chemotherapy. History of renal insufficiency or requiring dialysis. 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Polhemus, MD

Organizational Affiliation

State University of New York - Upstate Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

State University of New York, Upstate Medical University (SUNY-UMU)

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31802120

Citation

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 Infect Dis. 2020 Apr 7;221(9):1494-1498. doi: 10.1093/infdis/jiz645.

Results Reference

result

Learn more about this trial

Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis

We'll reach out to this number within 24 hrs