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Objective This study was designed with objective to study pain response of infants to change in sequence of administration of Hepatitis B and DTwP vaccines. Methods This was a randomized parallel control trial. The study was carried out in the immunization clinic of the Department of Pediatrics, LLRM Medical College, Meerut. One hundred and thirty healthy term infants up to 4 months of age were injected either DTwP vaccine first or Hepatitis B vaccine first, followed one minute later by the other vaccine. Result Baseline characteristics did not differ between the groups. The mean (SD) of AUC of MFCS and NIPS was significantly more in DF group as compared to HF group (for MFCS 25.5 ± 5.4 versus 22.5 ± 5.5, p < 0.01; for NIPS 31.77 ± 5.5 versus 27.64 ± 6.9, p < 0.01). Similarly mean (SD) of AUC of Heart rate and saturation of oxygen showed significant variation in DF group as compared to HF group (for heart rate 591.6 ± 55 versus 559.6 ± 49, p < 0.01; for SpO 2 326.4 ± 12 versus 335 ± 8, p < 0.01). Conclusion These results showed that infant experienced lesser pain when Hepatitis B was administered first than when DTwP vaccine was given first. [ABSTRACT FROM AUTHOR]

Some of the adverse side-effects such as leukocytosis, hyperinsulinemia, hypoglycemia and sensitization to histamine, caused by diphtheria, tetanus and whole cell pertussis (DTwP) vaccines are related to the presence of non-inactivated pertussis toxin (PTx) residues (NiPTxR). The CHO cell clustering assay is an in vitro assay to measure NiPTxR in DTwP vaccines based on the ability of active PTx to cause cellular clustering. To study the biochemical mechanism involved in the clustering effect in CHO cells induced by PTx and by two DTwP vaccines, the levels of total cyclic cAMP were measured and compared to those obtained after treatment with cholera toxin (CTx) able to induce CHO cells elongation instead of cell clustering. Our results showed an increment of cAMP levels by CTx and total cell elongation in CHO cells. However, changes in cAMP levels were not associated with the total clustering induced by PTx or by DTwP vaccines. The high correlation seen between the levels of NiPTxR in the DTwP vaccines determined by the in vivo lethal histamine sensitization (HIST) assay and the in vitro CHO cell clustering assay indicated that the latter could be a suitable alternative test to HIST assay for the toxicological approval and release of batches of DTwP vaccines in their final formulation for human use in accordance with the application of the 3R's principle. • The clustering activity of A-protomer, B-oligomer from pertussis toxin (PTx), PTx and filamentous hemagglutinin were compared using CHO cells. • The clustering effects of PTx and DTwP vaccines were not associated with changes of the cAMP levels in CHO cells. • The clustering induced by PTx does not decrease CHO cell survival or cell cycle. • The effect of aluminum hydroxide, thimerosal and LPS present in DTwP vaccine was evaluated on CHO cell morphology. • Levels of the active PTx in DTwP vaccines in the CHO assay correlates with the in vivo histamine sensitization assay. [ABSTRACT FROM AUTHOR]