Safety and Immunogenicity of MVA85A, in Healthy Volunteers in Cape Town

NCT00460590 | Completed Phase 1 DMC

• 1 other identifier: TB008
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the safety of MVA85A in healthy volunteers in Cape Town. We have shown that MVA85A is safe and immunogenic in both a mycobacterially naïve population in the UK and in a more mycobacterially exposed population in The Gambia. The studies described here will be to assess the safety of MVA85A in 2 groups of adults, those with and without prior BCG vaccination. Once safety data has been obtained in these 2 groups, we will assess the safety of MVA85A in adolescents who have been previously vaccinated with BCG.

Conditions

Tuberculosis

Keywords

Tuberculosis; TB; MVA 85A

Outcome Measures

Primary Outcomes (1)

• To assess the safety of a single intradermal injection of 5 x 107pfu MVA85A, when administered to healthy subjects. The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events (AEs).

  year

Secondary Outcomes (1)

• To assess the immunogenicity of a single vaccination with MVA85A in healthy subjects. The specific endpoints for immunogenicity will be markers of cell-mediated immunity as outlined above

  year

Study Arms (3)

1

EXPERIMENTAL

12 adults with prior BCG

Biological: MVA 85A

2

EXPERIMENTAL

12 adults without prior BCG

Biological: MVA 85A

3

EXPERIMENTAL

12 Adolescents

Biological: MVA 85A

Interventions

MVA 85A BIOLOGICAL

ID vaccine

1; 2; 3

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy adults aged 18 to 50 years (for the first 2 arms)
• Healthy adolescents (aged 12-14) for the third arm of the study
• Screening Elispot negative (less than 17 spots/million PBMC) in all 3 ESAT6 pools and all 3 CFP10 pools
• Mantoux test \<15mm (\<10mm if BCG naïve)
• CXR normal with no evidence of active or past TB
• For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day of vaccination
• Agreement to refrain from blood donation during the course of the study
• Written informed consent
• Willingness to undergo an HIV test

You may not qualify if:

• Any deviation from the normal range in biochemistry or haematology blood tests or in urine analysis as defined in Appendix I
• Mantoux \>15mm
• Prior receipt of a recombinant MVA or Fowlpox vaccine
• Use of any investigational or non-registered drug, live vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period
• Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisolone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection and asplenia
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
• Evidence of cardiovascular disease
• History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
• History of diabetes mellitus
• Chronic or active neurological disease requiring ongoing specialist or medical supervision
• Chronic gastrointestinal disease requiring ongoing specialist or medical supervision
• History of \> 2 hospitalisations for invasive bacterial infections (pneumonia, meningitis)
• Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
• Seropositive for hepatitis B surface antigen (HBsAg)

Sponsors & Collaborators

• University of Oxford: lead
• University of Cape Town: collaborator

Study Sites (1)

University Cape Town

Cape Town, 7925, South Africa

Location

Related Publications (2)

• Tanner R, Kakalacheva K, Miller E, Pathan AA, Chalk R, Sander CR, Scriba T, Tameris M, Hawkridge T, Mahomed H, Hussey G, Hanekom W, Checkley A, McShane H, Fletcher HA. Serum indoleamine 2,3-dioxygenase activity is associated with reduced immunogenicity following vaccination with MVA85A. BMC Infect Dis. 2014 Dec 3;14:660. doi: 10.1186/s12879-014-0660-7.

  PMID: 25466778 DERIVED

• Hawkridge T, Scriba TJ, Gelderbloem S, Smit E, Tameris M, Moyo S, Lang T, Veldsman A, Hatherill M, Merwe Lv, Fletcher HA, Mahomed H, Hill AV, Hanekom WA, Hussey GD, McShane H. Safety and immunogenicity of a new tuberculosis vaccine, MVA85A, in healthy adults in South Africa. J Infect Dis. 2008 Aug 15;198(4):544-52. doi: 10.1086/590185.

  PMID: 18582195 DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

MVA 85A

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Greg Hussey, Professor

  University Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 13, 2007
• First Posted: April 16, 2007
• Study Start: October 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: August 7, 2008

Record last verified: 2008-06

Locations

ZA (1)