Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis

NCT02374814 | Completed Phase 4 Results

• 1 other identifier: 568085
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Rabies

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

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

  up to 13 months post first vaccination

Study Arms (6)

Rabies vaccine IM 3 dose

ACTIVE COMPARATOR

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

Drug: Rabies vaccine

Rabies vaccine ID 3 dose

EXPERIMENTAL

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

Drug: Rabies vaccine

Rabies vaccine IM 2 dose

EXPERIMENTAL

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

Drug: Rabies vaccine

Rabies vaccine ID 2 dose

EXPERIMENTAL

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

Drug: Rabies vaccine

Placebo IM 1 dose

PLACEBO COMPARATOR

Albumin and saline comparator, Intramuscular injection: 1mL

Drug: Placebo

Placebo ID 1 dose

PLACEBO COMPARATOR

Albumin and saline comparator, Intradermal injection: 0.1mL

Drug: Placebo

Interventions

Rabies vaccine DRUG

Compare dose schedule and route of administration

Also known as: Rabavert

Rabies vaccine ID 2 dose; Rabies vaccine ID 3 dose; Rabies vaccine IM 2 dose; Rabies vaccine IM 3 dose

Placebo DRUG

Placebo

Also known as: Albumin

Placebo ID 1 dose; Placebo IM 1 dose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead
• Walter Reed Army Institute of Research (WRAIR): collaborator

Study Sites (1)

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

Syracuse, New York, 13210, United States

Location

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

  PMID: 31802120 RESULT

MeSH Terms

Conditions

Rabies

Interventions

Rabies Vaccines; Albumins

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Timothy Endy
• Organization: SUNY Upstate Medical University

endyt@upstate.edu

315-464-7692

Study Officials

• Mark Polhemus, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Microbiology and Immunology

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: March 2, 2015
• Study Start: March 24, 2015
• Primary Completion: September 22, 2016
• Study Completion: September 22, 2016
• Last Updated: June 13, 2022
• Results First Posted: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)