Comparison of the immunogenicity and safety of Euvichol-Plus with Shanchol in healthy Indian adults and children: an open-label, randomised, multicentre, non-inferiority, parallel-group, phase 3 trial.

Background: Considering the cholera menace in India and to seek licensure of the oral cholera vaccine (OCV), Euvichol-Plus, we conducted a clinical trial to compare the immunogenicity and safety of Euvichol-Plus with Shanchol in healthy Indian adults and children. Methods: This phase 3, open-label, multicentre, randomised, non-inferiority, parallel-group, comparative study was conducted at seven sites across India involving 416 healthy adults (aged ≥18-60 years) and children (aged ≥1 to <18 years). Healthy individuals who agreed to participate through a voluntary written informed consent form along with oral or written assent (for children aged 7-18 years) were included. No assent was required for those <7 years, as consent was given by the legally acceptable representatives (LAR). Participants were randomised 1:1 to receive two doses of either Euvichol-Plus or Shanchol orally, 14 days apart. The first dose (1.5 ml) was administered on visit 1, and the second dose at 2 weeks after the first dose during visit 2. Participants were followed up telephonically for 3 consecutive days after each visit and returned for final assessment at 2 weeks after the second dose (visit 3). Blood samples were collected for immunogenicity assessment, and safety analyses were done during all the visits. The primary immunogenicity endpoint was the percentage of participants with ≥4-fold increase in anti-Vibrio cholerae (V. cholerae) O1 Ogawa and O1 Inaba (vibriocidal) antibody titres at 2 weeks after the second dose as compared to baseline titres prior to dosing. The secondary immunogenicity endpoints included the percentage of participants with ≥4-fold increase in anti-V. cholerae O139 antibody titres at 2 weeks after the second dose as compared to baseline titres, and geometric mean titres (GMT) and geometric mean ratios (GMR) as measured by anti-V. cholerae O1 Ogawa, O1 Inaba, and O139 antibody titres at 2 weeks after the second dose as compared to baseline titres. The safety endpoints included assessment of solicited, unsolicited adverse events (AEs), and serious adverse events (SAEs). The clinical trial was registered with the Clinical Trials Registry of India (CTRI/2021/08/035344). Findings: The study was performed in two age cohorts: cohort 1 (aged ≥18-60 years, 208 participants [104 in Euvichol-Plus group and 104 in Shanchol group]), and cohort 2 (aged ≥1 to <18 years, 208 participants [104 in Euvichol-Plus group and 104 in Shanchol group]). A total of 414 participants (Euvichol-Plus: 206 and Shanchol: 208) who completed the study (intention-to-treat and per-protocol set) were analysed to compare the vibriocidal titre as an index for immunogenicity. At 2 weeks after the second dose, the percentage of participants in the Euvichol-Plus group who reported a ≥4-fold increase in anti-V. cholerae antibody titres were 68.93% (O1 Ogawa) [95% CI 62.13%-75.18%], 66.02% (O1 Inaba) [95% CI 59.11%-72.46%], and 59.71% (O139) [95% CI 52.67%-66.47%] as compared to 63.94% (O1 Ogawa) [95% CI 57.01%-70.47%], 65.87% (O1 Inaba) [95% CI 58.99%-72.28%], and 56.25% (O139) [95% CI 49.22%-63.10%] in the Shanchol group. The lower limit of 95% CI for treatment difference for all the antibody titres was ≥10% (non-inferiority margin), demonstrating that Euvichol-Plus was non-inferior to Shanchol. The post-vaccination GMT (Day 14 and 28) were more than the pre-vaccination GMT for all three serotypes in both groups. The GMR obtained for Euvichol-Plus over Shanchol for O1 Ogawa, O1 Inaba, and O139 serotypes was >1, indicating non-inferiority of Euvichol-Plus to Shanchol. The safety cohort included 416 participants. Headache was the most common solicited AE, whereas cold and cough were the most common unsolicited AEs in both groups. Interpretation: Euvichol-Plus appears to be non-inferior to Shanchol in terms of immunogenicity and safety in healthy Indian adults and children. Funding: Techinvention Lifecare Private Limited, Mumbai, India.

Prevalence of anemia among toddlers (12-36 months) in urban area of district Rohtak, Haryana.

Background: Children are considered as an important asset for any country and their health as one of the important indicators of a healthy country. There are several factors affecting children's health and anemia is one of them. Globally around 1.62 billion people are affected by it, which corresponds to 24.8% of the population, with the highest prevalence of anemia (47.4%) among preschool-aged children. Aim: The present study was conducted to estimate the prevalence of anemia among toddlers (12-36 months) and to determine the associated factors. Materials and Methods: A cross-sectional study was carried out among toddlers (12-36 months) in the urban field practice area of Pt. B.D. Sharma PGIMS, Rohtak. A total of 170 toddlers were enrolled in the study and their mothers were interviewed using a semi-structured pretested questionnaire. Hb was estimated by Sahli's acid hematin method. The data were analyzed using SPSS software version 20. Results: In the present study, more than half (55.9%) participants were girls and 44.1% were boys. The overall prevalence of anemia was found to be 62.4%, with mild, moderate, and severe anemia being 41.8%, 17.7%, and 2.9%, respectively. The children with regular intake of iron supplementation were found to be 6.625 times likely to be nonanemic as compared to those with no supplementation. Conclusion: Every endeavor should be made to combat the anemia in children through multisectoral and multipronged approach such as nutritional education of mothers, growth monitoring, nutritional supplementation, etc.

Association of psychosocial factors with aggression among school going rural adolescents in Haryana.

BACKGROUND: Adolescents are being involved in aggressive activities nowadays. Sometimes, involvement in aggressive activities may be fatal for the victim as well as for the doer. It is a matter of great concern for all including parents, teachers, psychologists, social reformers, and others. A momentary expression of anger sometimes may spoil the future life of the adolescents. AIM AND OBJECTIVES: To determine the prevalence of aggression and to identify the psychosocial risk factors associated with aggression among school-going adolescents. METHODOLOGY: The study recruited 480 school-going rural adolescents from eight government senior secondary schools in the rural block of Beri, district Jhajjar (Haryana). OBSERVATIONS: The mean age of the adolescents was 14.11 ± 1.12 years; 49.4% of the adolescents were found to be aggressive. After applying binary logistic regression, there was a statistically significant relation between aggression and determinants like class, gender, occupation of the father. CONCLUSION AND RECOMMENDATIONS: The study concluded that determinants like age, class of students, gender of the subject, occupation of father found a significant association with aggression. To solve this current situation, parents must give love, attention to their children and must act in an appropriate way in front of them and be role models.

Association between the socioeconomic determinants and soil-transmitted helminthiasis among school-going children in a rural area of Haryana.

BACKGROUND: WHO indicates that India has the highest burden of soil-transmitted helminthiasis (STH) in the world, contributing to 25% of the total global cases, with 220 million children aged 1-14 estimated to be at risk. AIM AND OBJECTIVE: To study the association between the socioeconomic factors and STHs among primary school children in a rural area of Haryana. METHODOLOGY: The study was conducted among children aged 6-10 years studying in the rural government primary schools in the rural areas of Haryana. A total of 300 children were enrolled from government school. RESULTS: The study found that the prevalence of helminthiasis was 28.7% (86/300) and of these 14.0% children were infected with Ascaris lumbricoides and sex wise association with Helminthic infection was observed as statistically nonsignificant. One third of the (31.39%; 27/86) children were pallor and 5.81% subjects were having Bitot's spot while 13.95% children were having constitutional symptoms such as weakness, 6.97% subjects have fatigue, and 5.81% children have body ache. DISCUSSION: The morbidity can be reduced with appropriate inputs to improve the environmental factors. This may need investment for sanitary latrines, food hygiene, and safe drinking water, anti-helminthic drugs, and health education. CONCLUSION AND RECOMMENDATIONS: The results of the study concluded and recommended that proper implementation of national deworming day and other long-term strategies like sanitation, clean drinking water, adequate sanitation, and also improvement in nutritional status through various nutritional health programmes.

Pattern and determinants of soil-transmitted helminthiasis in a rural area of Haryana: A school-based study.

BACKGROUND: In the world, helminthiasis is the major public health problem in school-age children. More than 60 million school-age children live in intensively transmitted areas and they need immediate treatment and preventive interventions. METHODOLOGY: The study was conducted in the rural government schools of Block Beri, District Jhajjar (Haryana), India, and the study was descriptive and cross-sectional in design. The study recruited 300 school-going children in the age group of 6-10 years. RESULTS: In this study, the mean age of subjects was 7.68 ± 1.467 years and prevalence of soil-transmitted helminths was 28.7%. The association between practice of hand washing and practice of washing fruits and vegetables with helminthic children were found statistically significant. CONCLUSION AND RECOMMENDATION: Impart health education among community through primary care physician about wash hands before eating food and after defecation, washed thoroughly raw and uncooked food before eating.

Study of Domestic Violence among Currently Married Females of Haryana, India.

BACKGROUND: No nation is untouched by domestic violence, and it is well-known that domestic violence has serious impact on women's health and well-being. The present study aimed to assess the prevalence and characteristics of domestic violence and injuries owing to domestic violence among currently married women. MATERIALS AND METHODS: This was a community-based, cross-sectional study conducted in the rural and urban areas of Haryana. In total, 880 currently married females of the reproductive age group were interviewed using the Women's Questionnaire (used in National Family Health Survey-3) which is according to the Modified Conflict Tactics Scale. RESULTS: Totally, 37% of the females had ever experienced domestic violence and 28.9% currently experienced domestic violence. All types of violence (except sexual violence) were significantly more common in the rural area than the urban area. Injuries owing to domestic violence were reported by more than half (55.4%) of the women. Among spousal violence, emotional violence was the most common type of violence followed by physical violence. Only 0.1% and 4.5% of females had ever initiated physical and emotional violence respectively, against their husbands, and in rest of the cases, it was the husband who initiated violence. CONCLUSION: Awareness regarding domestic violence needs to be made, and law enforcement regarding it needs to be made stringent. Rehabilitation of victims of domestic/spousal violence should also be considered on priority.

Community perception about swine flu in an urban slum of Haryana: A cross-sectional study.

BACKGROUND: Swine flu caused by influenza virus and it's a respiratory disease of pigs. The people like farmers and pork processors working in close proximity with pigs are at higher risk of getting swine flu. In India, a total of 117 deaths and 1,154 cases have been reported in the first two months of year 2018. OBJECTIVES: To assess the community perception about Swine flu among adults in an urban slum of District Rohtak. METHODOLOGY: The study was a community based epidemiological study with cross-sectional design and carried out by visiting house to house. The study recruited 500 adults of age 18-60 years. RESULTS: The study found that there was no significant difference between gender and age with heard of swine flu while education wise (p= 0.002) and caste wise (p=0.011) awareness of swine flu was found to be statistically significant. CONCLUSION AND RECOMMENDATION: The study concluded that the majority of subjects heard about swine flu and majority of subjects said that swine flu spread after coughing or sneezing. The study recommends that health care functionaries should spread awareness about signs and symptoms of swine flu.

Hepatitis C, a silent threat to the community of Haryana, India: a community-based study.

BACKGROUND: Hepatitis C is a global public health problem. As many as 12 million people may be chronically infected in India and most are unaware of it. AIMS: To determine the incidence of hepatitis C in the Ratia block of the Fatehabad district, Haryana, India. METHOD: This cross-sectional study was carried out by house-tohouse visits over 2 weeks. After obtaining written consent, a blood sample was drawn from suspected cases by a laboratory technician maintaining all necessary safety precautions and sterilization. RESULTS: Of the samples, 1,630 (22.3 per cent) were found to be positive for hepatitis C by ELISA, 253 (15.5 per cent) patients were previously hepatitis C positive, and adults (21-60 years) were affected maximally (70.0 per cent). CONCLUSION: The study emphasises the need for public awareness campaigns at various levels and prevention of HCV infection. It also suggests the need to develop and strengthen evaluation methodology for the Integrated Disease Surveillance Project (IDSP).