Anthrax Vaccine Clinical Trial to Assess Dose Reduction and Route Change

(AVRP Trial)

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen by Jennifer Wright, DVM

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Centers for Disease Control and Prevention

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Anthrax Clinical Trial Objectives: To assess whether: * Anthrax vaccine (AVA or BioThrax, BioPort Corp. Lansing MI) administered by the intramuscular (IM) route elicits antibody responses that are not inferior (i.e., "non-inferior") to that achieved by the currently licensed schedule. * BioThrax administered by the IM route and containing fewer numbers of doses elicits antibody responses that are not inferior (i.e., "non-inferior") to that achieved by the currently licensed schedule. * Differences in reactogenicity exist between the IM and subcutaneous (SQ) administration of BioThrax. Additionally for the final report we will assess whether: * Occurrence of adverse events following AVA administration is influenced by selected risk factors.

Research Team

Jennifer Wright, DVM

Principal Investigator

Centers for Disease Control and Prevention

Eligibility Criteria

Inclusion Criteria

Read and signed the Informed Consent Document

Female or male, 18 to 61 years old (up to 62nd birthday)

Females must agree to exercise adequate birth control from the time of the screening procedures to one month after the last vaccination

Treatment Details

Interventions

• Anthrax Vaccine Adsorbed (Vaccine)

Participant Groups

Group I: Anthrax Vaccine Adsorbed 8-IM Experimental Treatment 1 Intervention

receive 8 injections of AVA IM administered at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.

Group II: Anthrax Vaccine Adsorbed 7-IM Experimental Treatment 1 Intervention

receive 7 injections of AVA IM administered at 0m, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.

Group III: Anthrax Vaccine Adsorbed 5-IM Experimental Treatment 1 Intervention

receive 5 injections of AVA IM administered at 0m, 1m, 6m, and 2 boosters - 30m and 42m.

Group IV: Anthrax Vaccine Adsorbed 4-IM Experimental Treatment 1 Intervention

receive 4 injections of AVA IM; months 0, 2, 6 and a booster at month 42

Group V: Anthrax Vaccine Adsorbed 8-SQ Active Control 1 Intervention

receive 8 injections of AVA injected SQ at the same points as the original licensure: 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.

Group VI: Saline placebo IM or SQ Placebo Group 1 Intervention

Saline injections to be administered either IM or SQ at 0m, 2weeks, 1m, 6m, 12m, 18m, and 2 boosters - 30m and 42m.

Who Is Running the Clinical Trial?

Centers for Disease Control and Prevention

Lead Sponsor

Trials

902

Recruited

25,020,000+

Dr. Debra Houry

Centers for Disease Control and Prevention

Chief Medical Officer

MD, MPH

Dr. Susan Monarez

Centers for Disease Control and Prevention

Chief Executive Officer

PhD

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Paul Klotman

Baylor College of Medicine

Chief Executive Officer since 2010

MD, PhD

James Versalovic

Baylor College of Medicine

Chief Medical Officer since 2020

MD from Baylor College of Medicine

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University

Walter Reed Army Institute of Research (WRAIR)

Collaborator

Trials

111

Recruited

108,000+

Colonel Eli Lozano

Walter Reed Army Institute of Research (WRAIR)

Chief Executive Officer since 2023

BSc from United States Military Academy at West Point, Master's in Health Care Administration from Baylor University, Master's in Strategic Studies from U.S. Air War College

Dr. Deborah Shear

Walter Reed Army Institute of Research (WRAIR)

Chief Medical Officer since 2023

MD from Uniformed Services University of the Health Sciences

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine