Ovarian activity and safety of a novel levonorgestrel/ethinyl estradiol continuous oral contraceptive regimen

Background

A continuous regimen of oral levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg was evaluated for inhibition of ovulation, time to return to ovulation after stopping treatment and safety.

Study Design

This open-label study was conducted in healthy women aged 18-35 years. Ovulation was documented before treatment, and then participants received oral tablets containing LNG 90 mcg/EE 20 mcg to be taken continuously for three 28-day intervals. Ovarian activity was assessed three times per week during the treatment period with transvaginal ultrasound scans and measurements of serum 17β-estradiol, progesterone, follicle-stimulating hormone and luteinizing hormone concentrations. Safety assessments included physical examinations, laboratory evaluations and adverse event records.

Results

Thirty-seven of the 58 subjects who received treatment met predefined criteria for efficacy analysis. No on-treatment ovulations occurred in the efficacy or intent-to-treat population. There was evidence of ovulation within 37 days of stopping treatment for 46 (98%) of 47 subjects evaluated posttreatment. The final subject with a history of polycystic ovarian syndrome ovulated by Day 66. The safety profile observed during this 84-day continuous regimen was similar to that seen with other low-dose oral contraceptives administered in a cyclic regimen.

Conclusions

The continuous LNG/EE regimen completely inhibited ovulation, with little evidence of follicular development and with rapid return of ovulatory capacity after stopping treatment.     

In vitro Actinomyces israelii biofilm development on IUD copper surfaces

Background

Female pelvic actinomycosis may involve fallopian tubes, ovaries, uterus and bladder. This condition is often associated with the use of intrauterine contraceptive devices (IUDs), vaginal pessaries and/or tampons. The predominant causative agent of human actinomycosis is Actinomyces israelii, which has been found on copper IUDs retrieved from patients.

Study Design

In this work, a biofilm of A. israelii was developed in vitro on copper surfaces immersed in a simulated uterine fluid under anaerobic conditions. The biofilm was characterized using scanning electron microscopy (SEM), energy dispersive X-ray and atomic force microscopy.

Results

The capacity of A. israelii to develop a biofilm over copper surfaces in synthetic media was demonstrated. SEM micrographies illustrate the exopolysaccharides production and bacterial distribution.

Conclusion

A. israelii was able to attach and grow in synthetic intrauterine media and to present on the copper surface is likely due to the production of biofilm.     

Can Lactobacillus acidophilus influence the adhesion capacity of Candida albicans on the combined contraceptive vaginal ring?

Background

This study was conducted to evaluate the influence of Lactobacillus acidophilus on the adhesion capacity of Candida albicans on the combined contraceptive vaginal ring (CCVR).

Study Design

Two vaginal isolates of C. albicans and an ATCC strain of lactobacilli were used. Isolated and associated yeasts and bacteria (co-aggregated) were employed on the CCVR adherence assays and scanning electron microscopy (SEM).

Results

Isolated yeasts and lactobacilli adhered strongly to the CCVR. After the co-aggregation, there were an increase in adhesion capacity of the yeasts (p<.001) and a diminished adhesion of the lactobacilli (p<.001). SEM showed the isolated and co-aggregated microorganisms intimately attached to the irregularities of the CCVR.

Conclusions

If these findings correlated with the conditions in vivo, the use of probiotics based on L. acidophilus or its presence in the vaginal microbiota would not protect against the adhesion of C. albicans to the ring.     

Antibiotic susceptibility of Salmonella enterica serovar Typhi isolated from blood cultures at the Ain M'lila hospital (Algeria), between 2005 and 2008

Introduction

Typhoid fever is a food- and water-borne disease, caused by Salmonella enterica serovar Typhi, responsible for high rates of morbidity and mortality in developing countries. Typhoid is also a public health problem in Algeria. Antimicrobial susceptibility surveillance must be applied to prevent the emergence of multidrug resistant strains.

Patients and methods

We studied the incidence of S. enterica serovar Typhi isolated from blood cultures in the Ain M’lila public hospital (Algeria), between 2005 and 2008. Blood cultures were performed in the febrile stage of infection and positive samples were identified by biochemical and antigenic tests. Susceptibility to ampicillin, cotrimoxazole, chloramphenicol and nalidixic acid was tested by antibiogram.

Results

One hundred and seventy-eight strains were isolated from blood cultures between 2005 and 2008. They were all susceptible to the antibiotics tested.

Discussion

Typhoid fever incidence has decreased in Algeria. In our region, it comes by outbreaks during the summer season, with no sporadic cases between the peaks. In our study, S. enterica serovar Typhi was still susceptible to antimicrobials despite the worldwide emergence of multidrug resistant strains.

Conclusion

A regular surveillance of Salmonella typhi antibiotic susceptibility is mandatory.     

Resemblance in Dietary Intakes between Urban Low-Income African-American Adolescents and Their Mothers: The Healthy Eating and Active Lifestyles from School to Home for Kids Study

Objectives

To examine the association and predictors of dietary intake resemblance between urban low-income African-American adolescents and their mothers.

Methods

Detailed dietary data collected from 121 child-parent pairs in Chicago during fall 2003 were used. The association was assessed using correlation coefficients, kappa, and percentage of agreement, as well as logistic regression models.

Results

Overall, the association was weak as indicated by correlations and other measures. None of the mother-son correlations for nutrients and food groups were greater than 0.20. Mother-daughter pairs had stronger correlations (0.26 for energy and 0.30 for fat). The association was stronger in normal-weight mothers than in mothers with overweight or obesity. Logistic models showed that mother being a current smoker, giving child more pocket money, and allowing child to eat or purchase snacks without parental permission or presence predicted a higher probability of resemblance in undesirable eating patterns, such as high-energy, high-fat, and high-snack intakes (P<0.05).

Conclusions

Mother-child diet association was generally weak, and varied considerably across groups and intake variables in this homogenous population. Some maternal characteristics seem to affect the association.     

Eleusine indica L. possesses antioxidant activity and precludes carbon tetrachloride (CCl4)-mediated oxidative hepatic damage in rats

Objectives

The purpose of this study was to evaluate the ability of aqueous extract of Eleusineindica to protect against carbon tetrachloride (CCl₄)-induced hepatic injury in rats.

Methods

The antioxidant activity of E. indica was evaluated using the 1,1-diphenyl-2-picrylhydrazyl (DPPH) free radical scavenging assay. The total phenolic content of E. indica was also determined. Biochemical parameters [e.g. alanine aminotransferase (ALT), aspartate aminotransferase (AST), malondialdehyde (MDA), glutathione (GSH), catalase, glutathione peroxidase, glutathione reductase, glutathione S-transferase and quinone reductase] were used to evaluate hepatic damage in animals pretreated with E. indica and intoxicated with CCl₄. CCl₄-mediated hepatic damage was also evaluated by histopathologically.

Results

E. indica extract was able to reduce the stable DPPH level in a dose-dependent manner. The half maximal inhibitory concentration (IC₅₀) value was 2350 μg/ml. Total phenolic content was found to be 14.9 ± 0.002 mg/g total phenolic expressed as gallic acid equivalent per gram of extract. Groups pretreated with E. indica showed significantly increased activity of antioxidant enzymes compared to the CCl₄-intoxicated group (p < 0.05). The increased levels of serum ALT and AST were significantly prevented by E. indica pretreatment (p < 0.05). The extent of MDA formation due to lipid peroxidation was significantly reduced (p < 0.05), and reduced GSH was significantly increased in a dose-dependently manner (p < 0.05) in the E. indica-pretreated groups as compared to the CCl₄-intoxicated group. The protective effect of E. indica was further evident through decreased histopathological alterations in the liver.

Conclusion

The results of our study indicate that the hepatoprotective effects of E. indica might be ascribable to its antioxidant and free radical scavenging property.     

Investigation and management of an imipenem-resistant oxa-23 Acinetobacter baumannii outbreak in an intensive care unit

Objectives

The study objectives were to describe the investigation and management of an imipenem-resistant Acinetobacter baumannii outbreak that occurred in the 15-bed ICU of a tertiary care teaching hospital (Brest, France), during the summer 2008.

Patients and methods

Patients harboring an imipenem-resistant A. baumannii strain were defined as case patients. We described case occurrence and steps taken to control the outbreak: contact isolation, reinforcement of hygiene procedures, unit shutdown decision, unit disinfection, and reopening. We also made a case control study and a cost analysis of the outbreak management.

Results

During a 10-day period, five patients were positive for a single clone of imipenem-resistant oxa-23 A. baumannii. Four patients presented with ventilation-acquired pneumonia and one was asymptomatic. The first two patients died one day after the first swab which led to the identification of A. baumannii. No additional case was noted in the ICU or in other hospital units after deciding to close the ICU. The cost of outbreak management was estimated at 264,553 euros. The case control study identified several factors associated with infection or colonization: length of stay in the ICU, chronic respiratory disease, number of previous antibiotic classes used, duration of ventilation, prone position, echocardiography, and presence of a nasogastric tube.

Conclusion

This outbreak occurred during the summer period requiring the shutdown of the ICU and inducing a considerable cost. Rapid reactions of the ICU staff during the outbreak enabled to limit the epidemic.     

In vitro activity of new antimicrobial agents against glycopeptide-resistant Enterococcus faecium clinical isolates from France between 2006 and 2008

Objective

The aim of this study was to determine the in vitro activity of six new antimicrobial agents against glycopeptide-resistant enterococci (GRE) strains from France.

Methods

Sixty epidemiologically unrelated clinical isolates of Enterococcus faecium (vanA or vanB), received at the National Reference Centre for Enterococci (CNR-Enc) between 2006 and 2008, were studied. The MICs of the following antibiotics were determined by broth microdilution according to Antibiogram Committee of the French Society for Microbiology (CA-SFM) guidelines: quinupristin-dalfopristin (Q-D), linezolid (LZD), daptomycin (DPT), tigecycline (TGC), ceftobiprole (CFT), and telavancin (TLV). Strains were classified using clinical breakpoints recommended by the CA-SFM (Q-D, LZD, TGC), or the Clinical and Laboratory Standards Institute (DPT).

Results

All strains were susceptible to LZD and DPT (MIC₉₀, 4 and 2 μg/ml, respectively) and only a single strain presented intermediate susceptibility to tigecycline (MIC₉₀, 0.25 μg/ml). Thirty percent of strains were resistant to Q-D (MIC₉₀, 4 μg/ml), and CFT was constantly inactive (MIC₉₀, 64 μg/ml). Finally, TLV showed low-level MICs (MIC₉₀, 0.5 μg/ml) against vanB-positive isolates but not against vanA-positive isolates (MIC₉₀, 8 μg/ml).

Conclusion

Although several antibiotics are still active against GRE, it is essential to maintain an active antimicrobial resistance surveillance for these microorganisms considered as a model of multidrug resistance with a potential to transfer resistance to other bacterial species (e.g. Staphylococcus aureus).     

Estudios de contactos para infecciones de transmisión sexual. ¿Una actividad descuidada?

Objectives

To undertake a critical literature review of published evidence on the effectiveness of contact tracing in sexually transmitted infections, mechanisms of referral, and the criteria for initiating this activity. To describe how these factors vary by causative agent and to characterize the current state of contact tracing in sexually transmitted infections in developed countries.

Methods

A systematic literature review was undertaken using online databases and scientific publications, as well as guidelines and documents pertaining to the legal framework within which contact tracing takes place.

Results

Contact tracing is specifically recommended for infections caused by Neisseria gonorrhoeae, Chlamydia trachomatis, syphilis and HIV. The principal approaches to contact tracing reported were patient referral, provider referral or conditional patient referral. In addition, patient-dispensed partner treatment and the use of new technologies were reported. Numerous studies have evaluated the efficacy, effectiveness and social and legal context of contact tracing in different countries and populations. This situation contrasts with that in Spain, where there is a notable absence of guidelines, legal framework and formal studies dealing with contact tracing in sexually transmitted infections.

Conclusions

Contact tracing is an increasingly important tool in the public health management of sexually transmitted infections and should be valued as such. This activity should be an integral and effective component of the control and prevention of sexually transmitted infection programmes in all autonomous regions in Spain. Research in this field is required to develop the legal framework and practice guidelines appropriate to the local context.     

The re-emergence of pertussis in Tunisia

Objective

The authors had for aim to analyze pertussis epidemiology in Tunisia by studying nasopharyngeal specimens of infants hospitalized in Tunis.

Methods

Between march 2007 and march 2008, clinical nasopharyngeal samples were collected from infants with a suspected diagnosis of whooping cough, pertussoid cough, or pertussis-like syndrome, admitted at the Tunis children's hospital. The laboratory diagnostic criteria were culture isolation of Bordetella species on Bordet-Gengou medium and real-time PCR.

Results

Fifty-nine percent of the 74 investigated children with suspected pertussis were less than two months of age. The diagnosis of pertussis was proved positive by real-time PCR for 41%. Culture was negative in all cases.

Conclusions

Whooping cough is still prevalent in Tunisia despite an important vaccination coverage. Real-time PCR is an invaluable tool for the rapid diagnosis of pertussis, however culture must also be associated.     

Genetic background of lead and mercury metabolism in a group of medical students in Austria

Background

Information on the impact of genetic predisposition on metal toxicokinetics in the human body is limited. There is increasing evidence that certain genetic polymorphisms modify lead and mercury toxicokinetics. This called for analysis of further candidate genes.

Objectives

Medical students (N=324) were examined in order to detect potential associations between lead exposure and polymorphisms in HFE, VDR, ALAD, and MT genes, as well as between mercury exposure and GSTT1, GSTM1, GSTA1, GSTP1, GCLC, and MT polymorphisms.

Methods

The levels of lead and mercury exposure of students were determined by blood, urine, and hair analyses (ICP-MS, CV-AAS). Genotyping of common polymorphisms was examined by MALDI-TOF MS and the TaqMan methodology. Associations between lead and mercury exposures and genetic background were examined by bivariate analysis, and by categorical regression analysis (CATREG) controlled by metal- and matrix-specific variables.

Results

Lead and mercury levels in urine, blood, and hair indicated low exposures. VDR polymorphism and joint presence of VDR/ALAD polymorphisms were significantly and independently associated with urine lead concentrations (CATREG P<0.05). Polymorphisms in GSTP1-114 and MT4 genes as well as dual gene combinations including GSTP1, GCLC, GSTT1, and GSTM1 polymorphisms were independent variables related to mercury body burdens (CATREG P<0.05). GSTP1-114/GSTT1 and GSTP1-105/GCLC combinations showed synergistic effects on hair mercury levels compared to single-gene variants.

Conclusions

We found evidence that certain genetic backgrounds were associated with lead and mercury metabolism, suggesting gene-environment and gene-gene-environment interactions. The modes of interaction remain to be evaluated.     

Malaria severity criteria and prognostic factors among children in Dakar

Introduction

Severity factors associated with malaria as well as prognostic factors for death were assessed at the Dakar Centre Hospitalier National d’Enfants Albert Royer de Fann (CHNEAR).

Patients and methods

A prospective study was carried out from January 1 to December 31, 2007 involving children from 0 to15 years of age, admitted for plasmodium falciparum malaria with positive thick drop examination, meeting at least one of the WHO 2000 malaria severity criteria. Acidosis was not studied.

Outcome

The rate of severe malaria cases in our hospital was 6.4%. The sex ratio was 1.4 and the median age of patients at 91 months. A peak was observed during the 4th trimester (75.5%). Convulsions (52.5%) and obtundation (49.4%) were the most common signs of clinical severity while hyperparasitemia and severe anemia ranged at 27.2% and 21.6%, respectively. Lethality was 11.1 % and the main death risk factors were young age (p = 0.025), coma (p = 0.007), respiratory distress (p = 0.04), or hypoglycemia (p = 0.001).

Conclusion

Reducing malaria hospital mortality in Senegal may be obtained by proper management of poor prognostic factors such as coma, respiratory distress, and hypoglycemia.     

Term pregnancy with intraperitoneal levonorgestrel intrauterine system: a case report and review of the literature

Background

The risk of adverse effects of fetal exposure to the levonorgestrel intrauterine system (LNG-IUS) has not been established.

Study Design

In this case report and literature review, we describe a pregnant patient with an intraperitoneal LNG-IUS and the subsequent maternal and neonatal outcomes. A systematic literature search was performed to identify similar clinical reports. The MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, CENTRAL, Web of Science and Scopus databases were searched from inception through March 2007.

Results

The pregnancy progressed uneventfully and culminated in the elective cesarean delivery of a full-term healthy boy. Of the 35 pregnancies identified in the literature review (34 pregnancies with intrauterine LNG-IUS and 1 term delivery with intraperitoneal LNG-IUS), congenital anomalies were reported in 2 infants (6%).

Conclusions

Fetal exposure to LNG-IUS is associated with a low frequency of congenital anomalies.     

Vitamin C provision improves mood in acutely hospitalized patients

Objective

Hypovitaminosis C and D are highly prevalent in acutely hospitalized patients, but the clinical significance of these biochemical abnormalities is not known. Because deficiencies of vitamin C and D have been linked to psychologic abnormalities, vitamin C or D provision could improve the mood state of acutely hospitalized patients.

Methods

Double-blind clinical trial of the effect of vitamin C (500 mg twice daily) or vitamin D (1000 IU twice daily) on mood, as assessed with a validated instrument, the Profile of Mood States.

Results

Vitamin C therapy increased plasma (P < 0.0001) and mononuclear leukocyte (P = 0.014) vitamin C concentrations and was associated with a 34% reduction in mood disturbance (P = 0.013). Vitamin D therapy increased plasma 25-hydroxyvitamin D concentrations (P = 0.0004), but had no significant effect on mood.

Conclusions

Treatment of hypovitaminosis C improves the mood state of acutely hospitalized patients.     

Residential fungal growth and incidence of acute respiratory illness during the first two years of life

Background

Whether or not indoor mold growth causes acute childhood respiratory illness is controversial.

Objective

To determine the influence of indoor fungus on the incidence of acute respiratory illness episodes during the first two years of life.

Methods

Fungal indicators were measured in homes of children followed by daily symptom diaries and twice monthly telephone contact up to two years.

Participants

357 children born in Prince Edward Island, Canada.

Results

Generally, fungal contamination was not excessive with a geometric mean mold surface area (MSA) of 1012 cm² (geometric standard deviation (GSD) 24.2). The annual mean illness episodes per child were 6.85 (Standard Deviation (SD) 2.80). The incidence of respiratory illness episodes was not significantly related to any of the mold indicators: Analysis of variance (ANOVA) derived F-statistic (p values) was 0.14 (0.7090) for mold surface area.

Conclusions

In homes not selected by degree of fungal contamination, fungal burden was generally not excessive and was not found to be a risk factor for acute respiratory illness episodes during the first two years of life.     

Menstrual blood loss in women using the frameless FibroPlant LNG-IUS

Background

This study was conducted to report on a menstrual blood loss (MBL) study and iron stores in women with and without heavy menstrual bleeding using the frameless FibroPlant^® levonorgestrel-releasing intrauterine system (LNG-IUS) for contraception.

Study design

An open, prospective, noncomparative MBL study, using FibroPlant^® releasing 14 mcg of LNG/day for contraception. MBL was assessed by the quantitative alkaline hematin (QAH) technique.

Results

The MBL study was conducted in 40 heavy and normally menstruating Brazilian women seeking contraception. MBL was reduced from a mean baseline menstrual volume of 29.7 mL to a mean volume of 1.5 mL after 24 months, while ferritin values increased from a mean value of 31.1 ng/mL (at baseline) to a mean level of 72.5 ng/mL (after 24 months of use). Differences were highly significant (p<.0005). There were no significant differences between those who had normal menstrual bleeding and the heavy bleeders. The heavy bleeders had comparable MBL to the normal bleeders 3 months after insertion, and by 24 months post-insertion, their ferritin levels were comparable to those of the normal bleeders. Amenorrhea occurred in 80% of women out of 40 after 24 months of use. No pregnancies were recorded.

Conclusion

The LNG-IUS is effective in reducing MBL in normally menstruating women as well as in women with heavy menstrual bleeding. The authors agree with the recommendations by the UK National Institute for Clinical Effectiveness and the new Finnish guidelines for heavy menstrual bleeding that the LNG-IUS should be positioned as first-line treatment prior to endometrial ablation or hysterectomy.     

Effect of depot medroxyprogesterone acetate on postpartum depression

Background

Depot medroxyprogesterone acetate (DMPA) is commonly prescribed to women immediately postpartum due to its efficacy, convenience and lack of estrogen. It is unclear whether administering a progestin injection can affect the course of postpartum depression (PPD), which some suspect to be influenced by hormonal changes. In this retrospective study, the objective was to determine whether DMPA administered immediately postpartum influences the development of PPD.

Study Design

A retrospective review of a total of 404 charts was conducted of clinic patients who were scheduled for 6-week postpartum visits at a major medical center, where all patients are routinely asked to complete the Edinburgh Postnatal Depression Scale (EPDS). The average scores on the EPDS at these visits were compared between patients who had received DMPA prior to postpartum discharge from the hospital and patients who had not received any hormonal contraception by using an unpaired t test. In addition, the proportions of women diagnosed with PPD via the scale were compared via contingency tables.

Results

Fifty-five women who had received immediate DMPA were compared with 192 women with no hormonal contraception after delivery. The groups were similar in parity, race, mode of delivery and weight, but women receiving DMPA were significantly younger (24.2 vs. 26.2 years, p=.03). Mean EPDS scores at 6 weeks postpartum were not statistically significant between the groups (5.02 vs. 6.17, p=.16). Six patients (10.9%) who received immediate DMPA were diagnosed with PPD based on EPDS scores greater than or equal to 13, while 27 (14.1%) in the comparison group had PPD (p=.88).

Conclusion

Administration of DMPA in the immediate postpartum period does not appear to predispose women to PPD.     

A randomized, double-blind, placebo-controlled, phase 1/2a study of the safety and immunogenicity of a live, attenuated human parainfluenza virus type 3 vaccine in healthy infants

Objective

To evaluate the safety, tolerability, immunogenicity, and viral shedding profiles of a recombinant, live, attenuated human parainfluenza virus type 3 (HPIV3) vaccine, rHPIV3cp45, in healthy HPIV3-seronegative infants 6 to <12 months of age.

Methods

In this double-blind, multicenter study, subjects were randomized 2:1 to receive a 10⁵ TCID₅₀ dose of rHPIV3cp45 (n = 20) or placebo (n = 10) at enrollment and at 2 and 4 months after the first dose. Blood for evaluation of antibody to HPIV3 was collected at baseline and approximately 1 month after each dose. Solicited adverse events (SEs) and unsolicited adverse events (AEs) were collected on days 0-28 after each dose. Nasal wash samples for vaccine virus shedding were collected 3 times after each dose (7-10, 12-18, and 28-34 days post dose) and at unscheduled illness visits. Subjects were followed for 180 days after the last dose.

Results

Vaccine virus was shed by 85% of vaccine recipients after dose 1, by 1 subject after dose 2, and was not shed by any subject after dose 3. The highest titer of shed virus was detected on day 7 after dose 1. The attenuation phenotype and the genotype of the vaccine virus were stable in shed virus. Seroresponse (≥4-fold rise in HPIV3 antibody from baseline) occurred in 61% of subjects after dose 1 and in 77% after dose 3. Either seroresponse or shedding occurred in 95% of vaccine subjects. Adverse events were similar in vaccine and placebo recipients.

Conclusion

The safety, shedding, and immunogenicity profiles of rHPIV3cp45 in HPIV3-seronegative infants 6 to <12 months of age support further development of this vaccine.ClinicalTrials.gov Identifier: NCT00508651.     

A comparative study to evaluate the safety and immunogenicity of two lots of Haemophilus influenzae type-B conjugate vaccine manufactured at different scales

Objective

To compare the immunogenicity and safety of two different lots of SII Haemophilus influenzae type-B-tetanus toxoid conjugate (SII HibP_RO) vaccine manufactured at different scales when given in 3-dose schedule.

Design

Phase IV, open label, comparative, randomized parallel group study.

Setting

Shirdi Sai Baba Hospital, Vadu Budruk, Pune and Pediatrics Department of King Edward Memorial Hospital Research Centre, Pune.

Subjects

204 normal healthy infants of age 6-8 weeks at the time of first vaccination.

Methods

The eligible subjects received 3 doses of 0.5 ml of SII HibP_RO vaccine of either lot depending upon randomization number, intramuscularly in right thigh in the EPI schedule of 6, 10 and 14 weeks. They also received concomitantly DTP-HB vaccine intramuscularly on left thigh and Oral Polio vaccine (OPV). Solicited reactions were captured for 7 days following each vaccination; the events beyond 7 days till day 28 were captured as unsolicited adverse events. Serious Adverse Events (SAEs) were looked for throughout the subject participation. Blood samples were collected at baseline (before the first dose) and one month after the third dose for anti-PRP (polyribosylribitol phosphate) antibodies.

Results

In both groups, more than 98% subjects achieved short-term seroprotection (anti-PRP ≥ 0.15 μg/ml) after 3 doses. The long-term seroprotection (anti-PRP ≥ 1 μg/ml) was 87% and 80% in infants receiving lot manufactured at industrial scale and small scale respectively. Short and long term seroprotection and GMTs increased significantly as compared to baseline in both the groups. Overall local pain (52% and 58%), redness (30% and 41%), swelling (34% and 44%), fever (6% and 6%) and irritability (52% and 50%) were reported in infants receiving lot manufactured at industrial scale and small scale respectively. Majority of the reactions were mild and resoled without any sequelae. Four SAEs, none of them causally related to the study vaccine, occurred during study.

Conclusion

SII HibP_RO vaccines manufactured in small and industrial scale are equally immunogenic, safe and confer adequate seroprotection to infants of 6-14 weeks of age. Scaling up production process has not affected the safety and immune response in the target population.