Study of the Safety and Immunogenicity of an Adenovirus-based Tuberculosis Vaccine

NCT00800670 | Terminated Phase 1

• 1 other identifier: REB 09-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this Phase 1 study is to evaluate the safety and immune responses of a new tuberculosis vaccine, Ad5Ag85A, administered to healthy volunteers. 48 subjects will be recruited, 24 who have previously been vaccinated with BCG and 24 who have not received BCG vaccine. Two doses of the vaccine will be compared.

Conditions

Tuberculosis

Keywords

tuberculosis; vaccine; adenovirus

Outcome Measures

Primary Outcomes (1)

• Local and systemic signs and symptoms and laboratory toxicity

  24 weeks

Secondary Outcomes (1)

• Immunogenicity will be compared among the groups by determining the level and quantity of antigen-specific T cells by human interferon ELISA and Elispot assay

  24 weeks

Study Arms (2)

Lower dose

EXPERIMENTAL

Lower dose of Ad5Ag85A: 10\^8pfu

Biological: Ad5Ag85A

Higher dose

EXPERIMENTAL

Higher dose of vaccine Ad5Ag85A: 10\^9pfu

Biological: Ad5Ag85A

Interventions

Ad5Ag85A BIOLOGICAL

Single intra-muscular administration of 10\^8 pfu of recombinant-deficient human adenoviral TB vaccine (Ad5Ag85A)

Lower dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy human subjects who are between 18 and 55 years of age with or without a history of BCG vaccination.
• HIV antibody negative
• For women, negative pregnancy test and practising two acceptable forms of contraception for the duration of the study (barrier contraceptive, birth control pill, surgically sterile, post-menopausal 2yrs, abstinence)
• For men, using barrier contraception for the duration of the study

You may not qualify if:

• Pregnant or lactating women
• Subjects who have any acute or chronic illnesses including active tuberculosis or receiving any drug treatment in the opinion of the investigator likely to affect the immune system.
• Subjects with symptoms suggestive of an upper respiratory tract infection (including cough, runny nose, or sore throat)
• Subjects who have a history of active or latent TB infection or whose PBMCs are strongly responsive to ESAT6/CFP10 stimulation using a commercial interferon gamma release assay for TB \[consistent with latent TB infection\].
• Subjects who have laboratory values outside the normal range.
• Not available for scheduled follow-up visits. Subjects enrolled in the trial must be followed at 7 days, and then at 2, 4, 8, 16 and 24 weeks post-vaccination.
• Failure to provide written consent.
• Known allergy to vaccine components
• Known exposure to active TB within past 6 months or subjects whose occupation puts them at increased risk of TB exposure (based on Hamilton Health Science/St Joseph Healthcare list of high risk personnel)
• Any abnormality on chest x-ray suggestive of active or remote tuberculosis infection.
• PPD skin test within last 12 months
• BCG status unknown

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (2)

• Smaill F, Jeyanathan M, Smieja M, Medina MF, Thanthrige-Don N, Zganiacz A, Yin C, Heriazon A, Damjanovic D, Puri L, Hamid J, Xie F, Foley R, Bramson J, Gauldie J, Xing Z. A human type 5 adenovirus-based tuberculosis vaccine induces robust T cell responses in humans despite preexisting anti-adenovirus immunity. Sci Transl Med. 2013 Oct 2;5(205):205ra134. doi: 10.1126/scitranslmed.3006843.

  PMID: 24089406 RESULT

• Jeyanathan M, Damjanovic D, Yao Y, Bramson J, Smaill F, Xing Z. Induction of an Immune-Protective T-Cell Repertoire With Diverse Genetic Coverage by a Novel Viral-Vectored Tuberculosis Vaccine in Humans. J Infect Dis. 2016 Dec 15;214(12):1996-2005. doi: 10.1093/infdis/jiw467. Epub 2016 Oct 4.

  PMID: 27703038 RESULT

MeSH Terms

Conditions

Tuberculosis; Adenoviridae Infections

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; DNA Virus Infections; Virus Diseases

Study Officials

• Zhou Xing, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Fiona M Smaill, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: December 1, 2008
• First Posted: December 2, 2008
• Study Start: June 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: July 1, 2013
• Last Updated: September 8, 2017

Record last verified: 2017-09

Locations

CA (1)