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Oral delivery of BCG Moreau Rio de Janeiro gives equivalent protection against tuberculosis but with reduced pathology compared to parenteral BCG Danish vaccination.
Vaccine 2010; 28(43):7109-16V

Abstract

There is a need for an improved vaccine to better control human tuberculosis (TB), as the only currently available TB vaccine, bacillus Calmette-Guerin (BCG) delivered parenterally, offers variable levels of efficacy. Therefore, recombinant strains expressing additional antigens are being developed alongside alternative routes to parenteral delivery. There is strong evidence that BCG Moreau (RdJ) is a safe and effective vaccine in humans when given by the oral route. This study compared the efficacy of a single oral dose of wild type BCG Moreau Rio de Janeiro (RdJ), or a recombinant RdJ strain expressing Ag85B-ESAT6 fusion protein, formulated with and without lipid to enhance oral delivery, with subcutaneous BCG Danish 1331 and saline control groups in a guinea pig aerosol infection model of pulmonary tuberculosis. Protection was measured as survival at 30 weeks post-challenge and reduced bacterial load and histopathology in lungs and spleen. Results showed that a single oral dose of BCG Moreau (RdJ) or recombinant BCG Moreau (RdJ)-Ag85B-ESAT6, formulated with or without lipid, gave protection equivalent to subcutaneously delivered BCG Danish in the 30 weeks post-challenge survival study. The orally delivered vaccines gave reduced pathology scores in the lungs (three of the four formulations) and spleens (all four formulations) compared to subcutaneously delivered BCG Danish. The oral wild type BCG Moreau (RdJ) in lipid and the unformulated oral wild type BCG Moreau (RdJ) vaccine also gave statistically lower bacterial loads in the lungs and spleens, respectively, compared to subcutaneously delivered BCG Danish. This study provides further evidence to show that lipid formulation does not impair vaccine efficacy and may enhance the delivery and stability of oral vaccines intended for use in countries with poor health infrastructure. Oral delivery also avoids needles (and associated cross-infection risks) and immunisation without the need for specially trained medical professional staff.

Authors+Show Affiliations

Centre for Emergency Preparedness and Response, Health Protection Agency, Porton Down, Salisbury, Wiltshire SP4 0JG, UK. simon.clark@hpa.org.ukNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20708695

Citation

Clark, Simon O., et al. "Oral Delivery of BCG Moreau Rio De Janeiro Gives Equivalent Protection Against Tuberculosis but With Reduced Pathology Compared to Parenteral BCG Danish Vaccination." Vaccine, vol. 28, no. 43, 2010, pp. 7109-16.
Clark SO, Kelly DL, Badell E, et al. Oral delivery of BCG Moreau Rio de Janeiro gives equivalent protection against tuberculosis but with reduced pathology compared to parenteral BCG Danish vaccination. Vaccine. 2010;28(43):7109-16.
Clark, S. O., Kelly, D. L., Badell, E., Castello-Branco, L. R., Aldwell, F., Winter, N., ... Marsh, P. D. (2010). Oral delivery of BCG Moreau Rio de Janeiro gives equivalent protection against tuberculosis but with reduced pathology compared to parenteral BCG Danish vaccination. Vaccine, 28(43), pp. 7109-16. doi:10.1016/j.vaccine.2010.07.087.
Clark SO, et al. Oral Delivery of BCG Moreau Rio De Janeiro Gives Equivalent Protection Against Tuberculosis but With Reduced Pathology Compared to Parenteral BCG Danish Vaccination. Vaccine. 2010 Oct 8;28(43):7109-16. PubMed PMID: 20708695.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral delivery of BCG Moreau Rio de Janeiro gives equivalent protection against tuberculosis but with reduced pathology compared to parenteral BCG Danish vaccination. AU - Clark,Simon O, AU - Kelly,Dominic L F, AU - Badell,Edgar, AU - Castello-Branco,Luiz Roberto, AU - Aldwell,Frank, AU - Winter,Nathalie, AU - Lewis,David J M, AU - Marsh,Philip D, Y1 - 2010/08/12/ PY - 2010/05/27/received PY - 2010/07/29/revised PY - 2010/07/30/accepted PY - 2010/8/17/entrez PY - 2010/8/17/pubmed PY - 2010/12/31/medline SP - 7109 EP - 16 JF - Vaccine JO - Vaccine VL - 28 IS - 43 N2 - There is a need for an improved vaccine to better control human tuberculosis (TB), as the only currently available TB vaccine, bacillus Calmette-Guerin (BCG) delivered parenterally, offers variable levels of efficacy. Therefore, recombinant strains expressing additional antigens are being developed alongside alternative routes to parenteral delivery. There is strong evidence that BCG Moreau (RdJ) is a safe and effective vaccine in humans when given by the oral route. This study compared the efficacy of a single oral dose of wild type BCG Moreau Rio de Janeiro (RdJ), or a recombinant RdJ strain expressing Ag85B-ESAT6 fusion protein, formulated with and without lipid to enhance oral delivery, with subcutaneous BCG Danish 1331 and saline control groups in a guinea pig aerosol infection model of pulmonary tuberculosis. Protection was measured as survival at 30 weeks post-challenge and reduced bacterial load and histopathology in lungs and spleen. Results showed that a single oral dose of BCG Moreau (RdJ) or recombinant BCG Moreau (RdJ)-Ag85B-ESAT6, formulated with or without lipid, gave protection equivalent to subcutaneously delivered BCG Danish in the 30 weeks post-challenge survival study. The orally delivered vaccines gave reduced pathology scores in the lungs (three of the four formulations) and spleens (all four formulations) compared to subcutaneously delivered BCG Danish. The oral wild type BCG Moreau (RdJ) in lipid and the unformulated oral wild type BCG Moreau (RdJ) vaccine also gave statistically lower bacterial loads in the lungs and spleens, respectively, compared to subcutaneously delivered BCG Danish. This study provides further evidence to show that lipid formulation does not impair vaccine efficacy and may enhance the delivery and stability of oral vaccines intended for use in countries with poor health infrastructure. Oral delivery also avoids needles (and associated cross-infection risks) and immunisation without the need for specially trained medical professional staff. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/20708695/Oral_delivery_of_BCG_Moreau_Rio_de_Janeiro_gives_equivalent_protection_against_tuberculosis_but_with_reduced_pathology_compared_to_parenteral_BCG_Danish_vaccination_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(10)01110-2 DB - PRIME DP - Unbound Medicine ER -