recombinant FSH (FostiRel)

The Impact of Bilateral Salpingectomy on Ovarian Reserve: A Prospective Analysis of Hormonal, Ultrasound and Clinical Correlations.

Radu Teodora T, Mar Matyas M, Gliga Marius M, Marginean Claudiu C

Background: Opportunistic salpingectomy is widely used in gynecological surgery as a preventive measure against ovarian carcinoma. Questions have been raised about the potential impact of salpingectomy on ovarian function, given the possibility of ovarian vascularity disruption through the utero-ovarian arch located in the mesosalpinx. The aim of this study was to evaluate the short-term effects of bilateral salpingectomy on ovarian reserve. Methods: This prospective cohort study included forty premenopausal women, aged 34-50 years, who underwent hysterectomy with bilateral salpingectomy and ovarian preservation for benign uterine conditions. Ovarian reserve was evaluated before surgery and three months postoperatively, using serum anti-Müllerian hormone (AMH), follicle-stimulating hormone (FSH) and antral follicle count (AFC). Health-related quality of life was assessed using the Women's Health Questionnaire (WHQ). Results: Serum FSH levels increased significantly after surgery, while AMH levels decreased significantly (both p < 0.05). No significant postoperative changes were observed in AFC. The overall WHQ score increased significantly, indicating a mild deterioration in health-related quality of life. The greatest postoperative changes were observed in the depressive, somatic and sexual domains, where menstrual symptoms improved following surgery. No significant correlation was found between WHQ scores and hormonal or ultrasonographic markers of ovarian reserve. Conclusions: Bilateral salpingectomy performed during hysterectomy was associated with significant short-term hormonal changes, while AFC remained stable. Although patient-reported quality of life slightly worsened after surgery, these changes were not correlated with hormonal or ultrasonographic markers of ovarian reserve. Larger controlled studies with longer follow-up are required to determine the long-term clinical significance of these findings.

Recombinant EHV-1 Vector Expressing Immunodominant Hemagglutinin Protein of Equine Influenza Virus H3N8 (Sub-Lineage Florida Clade 2).

Bera Bidhan Chandra BC, Bernela Manju M, Madhwal Aashwina A, Pradhan Stephanie S SS et al.

Equine herpesvirus type 1 (EHV-1) and equine influenza virus (EIV) are major respiratory pathogens in horses, causing significant economic losses in domesticated horses. Bacterial Artificial Chromosome (BAC) technology can be used to precisely manipulate the EHV-1 genome for the development of live-attenuated vector vaccines. Earlier, our group developed a live-attenuated EHV-1 vaccine by deleting virulence-associated genes using this technology and the mutant EHV-1 has been exploited for expressing foreign gene in the current study. Specifically, in this study, a mutant EHV-1 virus expressing the hemagglutinin (HA) gene of H3N8 EIV (sub-lineage: Florida clade 2) was generated and characterized in vitro. The HA gene of EIV (Florida clade 2) was used for antigen gene cloning. The expression cassette for the HA gene was commercially synthesized and inserted into the backbone of EHV1∆IR6 BAC using an En passant mutagenesis strategy. Recombinant clones were selected using antibiotic selection, PCR, and RFLP. Further, the recombinant virus was regenerated in RK-13 cells via transfection and characterized in vitro for plaque size, growth kinetics and immunofluorescence antibody test (IFAT). PCR and RFLP confirmed the successful insertion of the HA gene into pEHV1∆IR6/gE BAC. The recombinant virus, vEHV1∆IR6/gE-HA(FC2), was successfully rescued in RK13 cells and demonstrated expression of the EIV haemagglutinin proteins by immunofluorescence assay. Although plaque size was reduced in the generated mutant virus in comparison to parental virus, the growth kinetics of the recombinant viruses were comparable to those of vEHV1∆IR6/gE. These findings demonstrate the successful expression of immunodominant hemagglutinin protein of EIV by recombinant EHV-1 and indicate the potential suitability of EHV-1 BAC as a vector platform for foreign gene expression.

Methodological Considerations in the Bioequivalence Assessment of Recombinant Human Serum Albumin [Letter].

Chang Peng P, Shen Danfeng D

Immunogenicity of a Candidate Hepatitis C Vaccine Based on Non-Structural DNA-Protein Sequences and a Novel Complex Adjuvant.

Masalova Olga V OV, Lesnova Ekaterina I EI, Kozlov Vyacheslav V VV, Valuev-Elliston Vladimir T VT et al.

Global elimination of hepatitis C virus (HCV) infection requires not only direct-acting antivirals (DAAs) but also the development of a highly effective prophylactic and/or therapeutic vaccine. Background/Objectives: Our aim was to optimize the composition of the candidate vaccine against HCV by combining recombinant non-structural proteins and a DNA construct with a complex adjuvant. Methods: C57BL/6 and DBA/2J mice were immunized three times at 2-week intervals using different schemes. The viral antigens consisted of a mixture of NS3, NS5A, and NS5B proteins and/or recombinant DNA expressing NS3-NS5B polyprotein. As adjuvants, a complex adjuvant, a mixture of Polymuramil® and Pyrogenalum® (NOD1/NOD2 and TLR-4 agonists), or a CpG ODN adjuvant (TLR-9 agonist) were used. Results: The most efficient regimen was three subcutaneous administrations of the combined DNA, recombinant protein components, and a new complex adjuvant. This scheme elicited a robust immune response, characterized by high antibody titers, enhanced antigen-specific lymphocyte proliferation, and significant interferon-gamma (IFN-γ) secretion in both mouse lines. Furthermore, the complex adjuvant outperformed CpG ODN in stimulating both humoral and cellular immunity against the HCV antigens. The vaccine composition stimulated the formation of CD4+ memory T cells and decreased the relative frequences of suppressive Treg and MDSCs. Conclusions: The presented candidate vaccine induces a strong immune response to HCV proteins. The next step would be to validate the protective effect in cell culture and animal models. This would one the path to preclinical studies of this vaccine composition.