Comparative study of ovarian development in wild and captive-reared long-whiskered Sperata aor (Hamilton, 1822).

Long-whiskered catfish Sperata aor is a freshwater catfish known for its supreme flesh quality and fast growth, whose captive-reared broodstock denotes a difficult challenge for aquaculture. The reproductive dysfunctions in long-whiskered catfish raised in tank conditions were observed by comparing tissue biochemical composition and ovarian histology of wild female broodstock. Sixty (60) female broodstocks were used in the current study, consisting of 30 reared at sandy-muddy soil tank bottoms in captive conditions and 30 wild individuals collected from the haor basin during the breeding season. The fish reproductive state was investigated using the biometric and reproductive parameters, biochemical composition and levels of amino acids in the different tissues, and histological analysis of ovarian development. Results revealed that the biometrical parameters of wild and captive female broodstocks exhibited no remarkable difference (p > 0.05). Nevertheless, the wild fish had remarkably higher (p < 0.05) GSI (8.73%), oocyte weight (0.45 mg/egg), and ripeness (27.08%) in comparison with captive-reared broodstock. The total length and body weight, body weight and ovary weight, ovipositor diameter and ovary weight, and GSI and HSI displayed a positive relationship with R2 = 1, R2 = 1, R2 = 0.993, and R2 = 0.973, respectively, for wild broodstock, while R2 = 0.994, R2 = 0.806, R2 = 0.804, and R2 = 0.896, respectively, for captive broodstock. Additionally, the proximate composition in oocytes and liver tissues in both broodstocks did not differ significantly (p > 0.05). However, two essential amino acids (EAA), i.e., lysine and phenylalanine, and two non-essential amino acids, i.e., glutamic acid and glycine, were highly significant differences (p < 0.05) in the oocytes and liver of wild broodstock compared to the captive-reared broodstock. On the other hand, the EAA, e.g., isoleucine, threonine, leucine, and arginine, were highly dominated in both wild and captive female brood oocytes and liver. The ovarian histological slides from each fish group showed three oocytes developmental stages that indicated the asynchronous-reproductive ovarian oocytes of this fish. This study may be useful to fully understand the factors affecting the spawning and reproduction of S. aor broodstock, crucial for management in captive conditions as well as conservation and protection for sustainable aquaculture management of S. aor.

HEV study protocol : design of a cluster-randomised, blinded trial to assess the safety, immunogenicity and effectiveness of the hepatitis E vaccine HEV 239 (Hecolin) in women of childbearing age in rural Bangladesh.

INTRODUCTION: Hepatitis E virus (HEV) is a leading cause of acute viral hepatitis in the developing world and is a public health problem, in particular among pregnant women, where it may lead to severe or fatal complications. A recombinant HEV vaccine, 239 (Hecolin; Xiamen Innovax Biotech, Xiamen, China), is licensed in China, but WHO calls for further studies to evaluate the safety and immunogenicity of this vaccine in vulnerable populations, and to evaluate protection in pregnancy. We are therefore conducting a phase IV trial to assess the effectiveness, safety and immunogenicity of the HEV 239 vaccine when given in women of childbearing age in rural Bangladesh, where HEV infection is endemic. METHODS AND ANALYSIS: Enrolment of a target of approximately 20 000 non-pregnant women, aged 16-39 years, started on 2 October 2017 in Matlab, Bangladesh. Sixty-seven villages were randomised by village at a 1:1 ratio to receive either the HEV vaccine or the control vaccine (hepatitis B vaccine). A 3-dose vaccination series at 0, 1 and 6 months is ongoing, and women are followed up for 24 months. The primary outcome is confirmed HEV disease among pregnant women. After vaccination, participants are requested to report information about clinical hepatitis symptoms. Participants who become pregnant are visited at their homes every 2 weeks to collect information about pregnancy outcome and to screen for clinical hepatitis. All suspected hepatitis cases undergo laboratory testing for diagnostic evaluation. The incidence of confirmed HEV disease among pregnant and non-pregnant women will be compared between the HEV vaccinated and control groups, safety and immunogenicity of the vaccine will also be evaluated. ETHICS AND DISSEMINATION: The protocol was reviewed and approved by the International Centre for Diarrhoeal Disease Research, Bangladesh Research Review Committee and Ethical Review Committee, and the Directorate General of Drug Administration in Bangladesh, and by the Regional Ethics Committee in Norway. This article is based on the protocol version 2.2 dated 29 June 2017. We will present the results through peer-reviewed publications and at international conferences. TRIAL REGISTRATION NUMBER: The trial is registered at clinicaltrials.gov with the registry name "Effectiveness Trial to Evaluate Protection of Pregnant Women by Hepatitis E Vaccine in Bangladesh" and the identifier NCT02759991.

A randomized Phase I/II study to evaluate safety and reactogenicity of a heat-stable rotavirus vaccine in healthy adults followed by evaluation of the safety, reactogenicity, and immunogenicity in infants.

Objectives: To assess the safety and reactogenicity of single oral dose of heat-stable rotavirus vaccine (HSRV) in healthy adults aged 18-45 years followed by assessment of safety, reactogenicity, and immunogenicity of three doses of HSRV in healthy infants aged 6-8 weeks at enrollment.Trial Design: Single-center randomized controlled, sequential, blinded (adults) and open-label (infants).Setting: Single site at International Center for Diarrheal Disease Research, Bangladesh (icddr,b).Participants: Fifty eligible adults randomized in 1:1 ratio (HSRV: Placebo) followed by 50 eligible infants randomized in 1:1 ratio (HSRV: Comparator (RotaTeq®, pentavalent human-bovine (WC3) reassortant live-attenuated, rotavirus vaccine)).Intervention: Adults received either a single dose of HSRV or placebo and followed for 14 days. Infants received three doses of either HSRV or comparator with a follow-up for 28 days after each dose.Main Outcome Measures: Solicited and unsolicited adverse events (AEs) along with any serious adverse events (SAEs) were part of the safety and reactogenicity assessment in adults and infants whereas serum anti-rotavirus IgA response rates were part of immunogenicity assessment in infants only. Post-vaccination fecal shedding of vaccine-virus rotavirus strains was also determined in adults and infants.Results: In this study, HSRV, when compared with placebo, did not result in increase in solicited adverse events (solicited AEs) in adults. In infants, HSRV had a safety profile similar to comparator vis-à-vis solicited AEs. In infants, fecal shedding of vaccine-virus strains was not detected in HSRV recipients but was observed in two comparator recipients. Percentage of infants exhibiting threefold rise in serum anti-rotavirus IgA titers from baseline to 1-month post-dose 3 in HSRV group was 88% (22/25) and 84% (21/25) in comparator group.Conclusion: HSRV was found to be generally well-tolerated in both adults and infants and immunogenic in infants.