Multicenter, open-label, randomized phase II controlled trial of an investigational recombinant Meningococcal serogroup B vaccine with and without outer membrane vesicles, administered in infancy.

BACKGROUND: In the absence of an efficacious broadly protective vaccine, serogroup B Neisseria meningitidis (MenB) is the leading cause of bacterial meningitis and septicemia in many industrialized countries. An investigational recombinant vaccine that contains 3 central proteins; Neisserial adhesin A (NadA), factor H binding protein (fHBP) and Neisserial heparin binding antigen (NHBA) has been developed. These antigens have been formulated with and without outer membrane vesicles (rMenB+OMV and rMenB, respectively) from the New Zealand epidemic strain (B:4:P1.7-2,4). In this trial, we assessed the immunogenicity of these formulations in infants, who are at greatest risk of contracting MenB disease. METHODS: A total of 147 infants from the United Kingdom were enrolled and randomly assigned to receive rMenB or rMenB+OMV at 2, 4, 6, and 12 months of age or a single dose at 12 months of age. Serum samples taken before and after vaccination were assayed in a standardized serum bactericidal antibody assay against 7 MenB strains. Local and systemic reactogenicity were recorded for 7 days after each vaccination. Analysis was according to protocol. RESULTS: After 3 doses, both vaccines were immunogenic against strains expressing homologous or related NadA and fHBP. rMenB+OMV demonstrated greater immunogenicity than did rMenB and was immunogenic against strains expressing homologous PorA. Both vaccines elicited anamnestic responses after the fourth dose. For both vaccines, responses were lower against strains expressing heterologous fHBP variants and after a single dose at 12 months. CONCLUSIONS: The rMenB+OMV vaccine has the potential to protect infants from MenB disease, although the breadth of protection afforded to heterologous antigens requires additional investigation.

Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life: a randomized comparative trial.

BACKGROUND: An investigational vaccine against serogroup B meningococcal (MenB) disease containing 3 main recombinant proteins (factor H-binding protein, Neisserial adhesion A, and Neisserial heparin-binding antigen) has been developed. We evaluated the immunogenicity and reactogenicity of a 3-dose course of this vaccine administered alone (recombinant MenB [rMenB]) or combined with the outer membrane vesicle (OMV) component of the vaccine used in New Zealand (rMenB+OMV). METHODS: A randomized, single-blind, comparative study of 60 healthy infants enrolled at 6 to 8 months of age and immunized with rMenB or rMenB+OMV at day 0, day 60, and at age 12 months. Blood samples obtained at baseline and 1 month following the second and third doses of vaccine were analyzed for serum bactericidal antibody (SBA) using human complement (hSBA) against 7 MenB strains. The putative correlate of protection was an hSBA titer of ≥4. RESULTS: The per-protocol analysis included 24 of 30 participants randomized to each group. After 3 doses of rMenB+OMV, 90% or more of participants had an hSBA titer ≥4 for 5 MenB strains, with 70% of participants having an hSBA titer ≥4 for a sixth strain. rMenB alone was immunogenic for only 3 strains. Both vaccines were well tolerated. CONCLUSIONS: Three doses of rMenB+OMV in the second half of infancy induce bactericidal antibodies against strains expressing vaccine antigens, demonstrating the potential for broader vaccine prevention of MenB disease. This vaccine is now in phase III clinical trials.

Healthy eating champions award for elementary schools.

PURPOSE: The Healthy Eating Champions Award for Elementary Schools (HEC) is a public health initiative that recognizes and rewards schools for their outstanding commitment to the promotion of nutrition, for nutrition education, and for making healthy foods and beverages available. This process evaluation assessed HEC implementation, identified benefits and barriers, and solicited suggestions for program improvement. METHODS: In-person interviews with principals or their designates from 28 HEC participating schools were conducted in fall 2006. RESULTS: Participants had positive feelings about the HEC program and shared many success stories. Perceived program benefits included increased student awareness about healthy eating, more student involvement in healthy eating initiatives, the creation of opportunities for goal setting and spirit boosting, and improved hygiene practices. The challenge of getting parents and teachers involved and the significant financial needs of schools in low-income areas were identified as challenges. CONCLUSIONS: Participants view the HEC program as having a positive impact on the healthy eating environment in schools.

Barriers to breastfeeding in a Vietnamese community: a qualitative exploration.

PURPOSE: Vietnamese women's breastfeeding experience and challenges were explored, as were their families' needs for prenatal and postpartum health professional programs and services. METHODS: A qualitative study was conducted in Middlesex-London, Ontario, using in-depth, semi-structured interviews in a heterogeneous sample of 11 Vietnamese mothers of children younger than two years. Diverse subject characteristics were sought in terms of parity, maternal age, infant age, marital status, education, employment, and breastfeeding initiation and duration. The 45- to 60-minute interviews were audiotaped and transcribed verbatim. Research team members independently reviewed interview transcripts at several stages during data collection. Qualitative analysis was sequential, and involved a combination of editing and template organizing styles. RESULTS: Lack of knowledge and misinformation were major barriers to breastfeeding. Inability to communicate in English and a lack of effective transportation were key obstacles to the women's ability to access mainstream prenatal and postpartum health programs and services. Standard nursing prenatal and postpartum services appear not to have reached this group of mothers effectively. CONCLUSIONS: Culturally and linguistically sensitive breastfeeding promotion and postpartum support services are needed for this Vietnamese community.

Are parents aware that their children are overweight or obese? Do they care?

OBJECTIVE: To compare children's actual weight status with their parents' perceptions of their weight status. DESIGN: Cross-sectional study, including a self-administered questionnaire. SETTING: Seven elementary schools in Middlesex-London, Ont. PARTICIPANTS: A convenience sample of pupils in grades 4 to 6 and their parents. Of the 770 child-parent pairs targeted, 355 pairs participated in the study. MAIN OUTCOME MEASURES: Children's weight, height, and body mass index (BMI). Parents' perceptions of their children's weight status, family demographics, and parents' self-reported body weight and height. The United States Centers for Disease Control's BMI-for-age references were used to define children's weight status (underweight, overweight, or obese). RESULTS: Response rate was 46%. Children's actual weight status (ie, 29.9% overweight or obese and 1.4% underweight) was different from their parents' perceptions of their weight status (ie, 18.3% overweight or obese and 17.2% slightly underweight or underweight). Factors such as children's sex and ethnicity and mothers' weight influenced parents' ability to recognize their children's weight status. Parents' misperceptions of their children's weight status seemed to be unrelated to their levels of education, their family income, or their children's ages. CONCLUSION: A large proportion of parents did not recognize that their children were overweight or obese. Effective public health strategies to increase parents' awareness of their children's weight status could be the first key steps in an effort to prevent childhood obesity.

Acute atypical type-A thoracic aortic dissection with intramural hematoma: the importance of patient symptoms and the transthoracic echocardiographic examination.

This report demonstrates how transthoracic echocardiography, in conjunction with the sonographer's attention to patient symptomatology, heightened the clinical suspicion of an atypical aortic dissection, leading to further investigation and confirmation. Although initially undiagnosed by computed tomography, a structure suggestive of aortic dissection was subsequently found by transthoracic echocardiography. Transesophageal echocardiography and a second computed tomography examination validated the transthoracic findings. An atypical type A aortic dissection with intramural hematoma was confirmed at operation.