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Biotechnology and Applied Biochemistry (2002) 36, (149–153) (Printed in Great Britain)

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Preformulation study of the vaccine candidate TAB9 against HIV-1

Néstor Expósito Raya*¹, Alina García Díaz*, Yamilka Carrazana López†, Diógenes Quintana Vazquez†, Dagmara Pichardo Díaz‡, Nieves Martínez de la Puente§ and Carlos Duarte Cano†

Key words: adjuvant, adsorption, Alhydrogel, formulation, immunogenicity.

¹To whom correspondence should be addressed(e-mail nestor@cigb.edu.cu).

A preformulation study was performed for the evaluation of a vaccine candidate against HIV-1. Aluminium hydroxide was used in the preformulation. However, this adjuvant is not a good adsorbent for basic proteins since it is positively charged at a physiological pH. In the present study, we determined the adsorption of TAB9 (basic protein, pI: 11.3) by treating Alhydrogel with different ions. The immunogenicity of the vaccine candidate against HIV was also evaluated using three batches, 9801-A, 9802-A and 9803-A, and a placebo P-001. The evaluation was performed twice (0 and 9 months). Each batch was tested using groups of 10 mice that had a single inoculation. The results showed that the protein was totally adsorbed to the aluminium gel. Seroconvertion was attained in all analysed batches, indicating the potentiality of TAB9 as a vaccine candidate.

Received 31 May 2002; accepted 24 July 2002

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