PA83-FhCMB Plant-Derived Recombinant Protective Antigen (rPA) Anthrax Vaccine

NCT02239172 | Completed Phase 1

• 1 other identifier: FhCMB rPA83-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study is to evaluate and compare the safety, reactogenicity, and tolerability of the PA83-FhCMB vaccine candidate delivered at 4 dose levels with Alhydrogel

Conditions

Anthrax

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events

  Up to 3 months

Secondary Outcomes (1)

• Change from Baseline in antibody titer after three immunizations

  Up to 6 months

Study Arms (4)

12.5 µg + Alhydrogel

EXPERIMENTAL

vaccine

Biological: PA83-FhCMB

25 µg + Alhydrogel

EXPERIMENTAL

vaccine

Biological: PA83-FhCMB

50 µg + Alhydrogel

EXPERIMENTAL

vaccine

Biological: PA83-FhCMB

100 µg + Alhydrogel

EXPERIMENTAL

vaccine

Biological: PA83-FhCMB

Interventions

PA83-FhCMB BIOLOGICAL

100 µg + Alhydrogel; 12.5 µg + Alhydrogel; 25 µg + Alhydrogel; 50 µg + Alhydrogel

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Citizen or permanent resident of the US
• Male or female aged 18 to 49 years inclusive
• Able to give written informed consent
• Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations at baseline
• Females should fulfill one of the following criteria:
• At least one year post-menopausal
• Surgically sterile
• Willing to use a medically approved form of contraception (eg, oral, implantable, transdermal, or injectable hormonal contraceptive; intrauterine device; barrier protection to include female condom, diaphragm, cervical cap, or male condoms in conjunction with spermicide) for 30 days prior to first vaccination and through the end of the study
• Willing to abstain from sexual intercourse for 30 days prior to first vaccination and through the end of the study
• Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of each dose
• Comprehension of the study requirements
• Expressed availability for the required study period
• Ability to attend scheduled visits and to be contacted by telephone throughout the follow-up period

You may not qualify if:

• History of anthrax disease or receipt of anthrax vaccine
• Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical or surgical treatment or a significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening
• Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies
• Pregnancy or lactation
• Cancer or treatment for cancer, within the previous 3 years, excluding basal cell carcinoma
• Presence of any medical condition that may be associated with impaired immune responsiveness, including diabetes mellitus, per the investigator's discretion
• Presently receiving or history of receiving, during the preceding 3-month period, any medications or other treatments that may adversely affect the immune system
• This includes allergy injections, immune globulin, interferon, immunomodulators, cytotoxic drugs, or systemic corticosteroids (oral or injectable; 20 mg/day x 14 days or longer)
• Radiation therapy
• Intranasal and topical corticosteroids will be allowed
• Receipt or planned administration of a non study vaccine within 14 days prior to vaccination and throughout the study period (30 days for live vaccines) Immunization on an emergency basis with Tetanus Toxoids Adsorbed for adult use (Td or Tdap) or influenza vaccine up to 14 days before or at least 14 days after a dose of study vaccine will be allowed
• History of anaphylactic type reaction to injected vaccines
• History of drug or chemical abuse in the year before the study
• Receipt of any investigational product or nonregistered drug within 30 days prior to vaccination or currently enrolled in any investigational drug study or intends to enroll in such a study within the ensuing study period
• Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the study period

Sponsors & Collaborators

• Fraunhofer, Center for Molecular Biotechnology: lead

Study Sites (1)

Walter Reed Army Institute of Research, Clinical Trials Center

Silver Spring, Maryland, 20910, United States

Location

Related Publications (1)

• Paolino KM, Regules JA, Moon JE, Ruck RC, Bennett JW, Remich SA, Mills KT, Lin L, Washington CN, Fornillos GA, Lindsey CY, O'Brien KA, Shi M, Mark Jones R, Green BJ, Tottey S, Chichester JA, Streatfield SJ, Yusibov V. Safety and immunogenicity of a plant-derived recombinant protective antigen (rPA)-based vaccine against Bacillus anthracis: A Phase 1 dose-escalation study in healthy adults. Vaccine. 2022 Mar 15;40(12):1864-1871. doi: 10.1016/j.vaccine.2022.01.047. Epub 2022 Feb 10.

  PMID: 35153091 DERIVED

MeSH Terms

Conditions

Anthrax

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: September 12, 2014
• Study Start: August 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

US (1)