Evaluation of immunogenicity and safety of Genevac B: A new recombinant hepatitis b vaccine in comparison with Engerix B and Shanvac B in healthy adults.

PURPOSE: Genevac B, a new indigenous recombinant hepatitis B vaccine was evaluated for its immunogenicity and safety in comparison with Engerix B (Smithkline Beecham Biologicals, Belgium) and Shanvac B (Shantha Biotechnics, India) in healthy adult volunteers. METHODS: While 240 study subjects were included in the Genevac B group, 80 each were the subjects for Engerix B and Shanvac B. A three dose regimen of 0,1,2 months was adopted with 20 gm dosage uniformly in all the three groups. Vaccinees were assessed during prevaccination, followup and post vaccination periods for clinical, haematological, biochemical and immunological parameters for safety and immunogenicity. RESULTS: Successful follow-up in all parameters for four months could be achieved in 92.5% (222/240) for Genevac B study subjects and the same was 85% (68/80) and 80% (64/80) for Engerix B and Shanvac B respectively. While 100% seroconversion was observed in all the three groups, the rate of seroprotectivity was 99.5% by Genevac B, 98.5% by Engerix B and 98.4% for Shanvac B. However the difference was not statistically significant (p>0.05). The GMT values of anti HBs after one month of completion of the vaccination were 735.50, 718.23 and 662.20 mIU/mL respectively. No systemic reaction was either seen or reported by the volunteers during the vaccination process of Genevac B and other two vaccines. Clinical, haematological and biochemical safety parameters remained within normal limits throughout the study period. CONCLUSION: The study confirms that Genevac B, the new recombinant Hepatitis B vaccine has the acceptable international standards of safety and immunogenicity.

A study on the comparison between clinical and microbiological diagnoses of sexually transmitted diseases.

The efficacy of microbiological diagnosis in sexually transmitted diseases (STDs) has been evaluated in comparison with the clinical diagnosis. Amongst the clinical diagnoses of single STDs, syphilis, genital warts, gonorrhoea and herpes genitalis were the predominant ones. Syphilis was the most predominant infection in both the single and mixed STD infections in Chennai. Clinical diagnoses of trichomoniasis, genital chlamydiasis and genital herpes were more accurate and correlated well with laboratory investigations. On the other hand, clinical diagnoses of gonorrhoea, candidiasis and syphilis were less accurate. More over many of these cases, clinically diagnosed as single, infection, were also positive for other STDs in the laboratory investigations. Double infections were clinically diagnosed only in 7 cases as against 11 cases in microbiological tests and one triple infection diagnosed in microbiological tests was diagnosed only as single disease clinically. Therefore, the laboratory/microbiological investigations have been emphasised to have better accuracy of diagnosis of STDs.

Mixed connective tissue disease--clinical and immunological profile.

AIM OF THE STUDY: To study the clinical and immunological profile of mixed connective tissue disease (MCTD) in rheumatic disease population. METHODS: We retrospectively analyzed 6400 cases of rheumatic disease population who took treatment in the Department of Rheumatology, Madras Medical College, Chennai during the period of 1996 to 1999, in which eight cases fulfilled the preliminary diagnostic criteria of mixed connective tissue disease devised by Kasukawa et al. All eight cases were studied in detail. RESULTS: All cases were females between 23 to 50 years of age. Polyarthritis, Raynaud's phenomenon and sclerodactyly were present in all eight patients. Oesophageal abnormalities, pulmonary changes and myositis were present in six patients. Facial erythema was observed in five patients. Alopecia and oral ulcers were seen in four patients. Two patients had pulmonary hypertension and migraine like headache. One patient had diffuse proliferative glomerulonephritis as an interesting feature by renal biopsy. Pleuritis, pericarditis and trigeminal neuropathy with lower cranial nerve palsies were present in one case each. Immunological tests showed presence of antinuclear antibodies and anti U1 ribonucleoprotein (anti U1RNP) antibodies in all eight patients. CONCLUSIONS: Mixed connective tissue disease should be considered as an important syndrome in any patient who presents with heterogeneous clinical presentation and who do not fit into any definite criteria of systemic connective tissue disorders.