Studies of immune response by antigen loaded biodegradable-polymer particles


 

Principal Investigator : Amulya K Panda

Research Associates
N Venkatesan
T Muthukumaran

Ph D Student
Yogesh K Katare

Collaborators
Om Singh
Rahul Pal
Lalit C Garg
Shantha Biotechnics Pvt Ltd, Hyderabad

The theme of the project is to evaluate the immunostimulatory activities associated with polymer entrapped antigens such as tetanus toxoid (TT), hepatitis B surface antigen (HBsAg) and plasmid DNA expressing antigens for development of single shot vaccines. The main objective is to study the immune response from biodegradable polymer particles entrapping antigens and plasmid DNA.

PLA particles entrapping immunoreactive TT were used along with alum to potentiate immune response in wistar rats. Both nano particles (< 1 mm) and microparticles (2-5 mm) were evaluated along with alum for immune responses. It was observed that the nanoparticles gives high early antibody responses whereas, in case of microparticles immune response peaked around 90 days of post immunization. Physical mixture of both nano and microparticles given along with alum generated a sustained immune response over the period of eight months. These results indicate that by judicious use of physical mixture of different size of particles, long lasting sustained immune response can be generated with single step immunization. Preliminary studies are being carried out to formulate particles having different in vitro antigen release characteristics so that a desired type of immune response can be generated.

Rats immunized with particles entrapping TT were boosted with 5lf of saline TT after a period of eight months to evaluate the secondary responses. It was observed that the secondary immune responses generated after boosting was higher in groups of animal immunized with particles in comparison to the alum adsorbed TT group. It was also observed that high secondary responses were generated from those particle groups where the primary immune response was very high. Animals immunized with particles when boosted after 8 months with low doses of TT in saline also gave high secondary immune responses.

The immunostimulatory potential of polymer particles base immunization was also investigated using a poor immunogen b-hCG without conjugation to an immunogenic carrier. With alum as adjuvant, no detectable anti-hCG antibody titers were detected by immunizating rats with b-hCG. PLA particles were formulated entrapping b-hCG and a single immunization schedule elicited antibody response. A combination of alum and microparticles immunization resulted in high antibody titers comparable to those achieved when CFA or IFA were employed. As observed for TT particles, the antibody titers from b-hCG particles gave a peak value on day 90, which was the characteristic of the polymer formulation. The anti-hCG antibody titers generated were bio-neutralizing as evident from a receptor binding inhibition assay. The affinity of the antibodies towards hCG was in the range of 1010 L/M and was of the same order as antibodies generated using CFA or IFA. With a single dose immunization of particles along with alum, significant anti-hCG antibody titers were measurable for six months of post immunization. These results showed that with the judicious use of particle and adjuvant, immunogenecity of a weak immunogen can be improved. These results also suggest that for antigens where alum does not provide adjuvant effect, combination of particles with alum may be a suitable alternative for generating a high antibody response.

Formulations of polymer particles entrapping HBsAg are being evaluated for in vitro release and in vivo responses. Recombinant HBsAg denaturation during polymer particles formulation and lyophilization are being studied in detail to prepare required size polymer particles entrapping immunoreactive HBsAg. Different formulation resulting in pulse release of HBsAg is also under investigation to mimic the HBsAg immunization schedule so that a single dose vaccine can be developed. Formulation and entrapment of HBsAg plasmid DNA in polymer matrix have been attempted to develop single dose DNA vaccine.

Publications

Original peer-reviewed articles

1.     Panda AK, Khan RH, Mishra S, Appa Rao KBC and Totey SM (2000) Influences of yeast extract on the specific cellular yield of ovine growth hormone in E.coli. Bioprocess Engineering 22:379-383.

2.     Patra AK, Gahlay GK, Reddy BVV, Gupta SK and Panda AK (2000) Refolding, structural transition and spermatozoa-binding of recombinant bonnet monkey (Macaca radiata) zona pellucida glycoprotein-C expressed in Escherichia coli. Eur J Biochem 267:7075-7081

Reviews/Proceedings

1.     Panda AK (2000) High cell density fermentation and improved refolding of inclusion body proteins from E.coli. In: Proceeding of AIBA Symposium, National Conferences on Emerging Trends in Biopharmaceutical Proteins and Role of Preparative Chromatography, New Delhi, 18-20 Dec 2000, 32-39.

2.     Panda AK (2001) Recombinant protein production from E.coli. In: Proceeding of Biohorizons - 2001, New Delhi, 23-24 Feb 2001, 3-4.