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Rubella is an acute illness caused by rubella virus and characterised by fever and rash. Although rubella is a clinically mild illness, primary rubella virus infection in early pregnancy can result in congenital rubella syndrome, which has serious medical and public health consequences. WHO estimates that approximately 100 000 congenital rubella syndrome cases occur per year. Rubella virus is transmitted through respiratory droplets and direct contact. 25–50% of people infected with rubella virus are asymptomatic. Clinical disease often results in mild, self-limited illness characterised by fever, a generalised erythematous maculopapular rash, and lymphadenopathy. Complications include arthralgia, arthritis, thrombocytopenic purpura, and encephalitis. Common presenting signs and symptoms of congenital rubella syndrome include cataracts, sensorineural hearing impairment, congenital heart disease, jaundice, purpura, hepatosplenomegaly, and microcephaly. Rubella and congenital rubella syndrome can be prevented by rubella-containing vaccines, which are commonly administered in combination with measles vaccine. Although global rubella vaccine coverage reached only 70% in 2020 global rubella eradiation remains an ambitious but achievable goal.

India aims to eliminate rubella and congenital rubella syndrome (CRS) by 2023. We conducted serosurveys among pregnant women to monitor the trend of rubella immunity and estimate the CRS burden in India following a nationwide measles and rubella vaccination campaign. We surveyed pregnant women at 13 sentinel sites across India from Aug to Oct 2022 to estimate seroprevalence of rubella IgG antibodies. Using age-specific seroprevalence data from serosurveys conducted during 2017/2019 (prior to and during the vaccination campaign) and 2022 surveys (after the vaccination campaign), we developed force of infection (FOI) models and estimated incidence and burden of CRS. In 2022, rubella seroprevalence was 85.2% (95% CI: 84.0, 86.2). Among 10 sites which participated in both rounds of serosurveys, the seroprevalence was not different between the two periods (pooled prevalence during 2017/2019: 83.5%, 95% CI: 82.1, 84.8; prevalence during 2022: 85.1%, 95% CI: 83.8, 86.3). The estimated annual incidence of CRS during 2017/2019 in India was 218.3 (95% CI: 209.7, 226.5) per 100, 000 livebirths, resulting in 47,120 (95% CI: 45,260, 48,875) cases of CRS every year. After measles-rubella (MR) vaccination campaign, the estimated incidence of CRS declined to 5.3 (95% CI: 0, 21.2) per 100,000 livebirths, resulting in 1141 (95% CI: 0, 4,569) cases of CRS during the post MR-vaccination campaign period. The incidence of CRS in India has substantially decreased following the nationwide MR vaccination campaign. About 15% of women in childbearing age in India lack immunity to rubella and hence susceptible to rubella infection. Since there are no routine rubella vaccination opportunities for this age group under the national immunization program, it is imperative to maintain high rates of rubella vaccination among children to prevent rubella virus exposure among women of childbearing age susceptible for rubella.

Since 1814, when rubella was first described, the origins of the disease and its causative agent, rubella virus ( Matonaviridae : Rubivirus ), have remained unclear 1 . Here we describe ruhugu virus and rustrela virus in Africa and Europe, respectively, which are, to our knowledge, the first known relatives of rubella virus. Ruhugu virus, which is the closest relative of rubella virus, was found in apparently healthy cyclops leaf-nosed bats ( Hipposideros cyclops ) in Uganda. Rustrela virus, which is an outgroup to the clade that comprises rubella and ruhugu viruses, was found in acutely encephalitic placental and marsupial animals at a zoo in Germany and in wild yellow-necked field mice ( Apodemus flavicollis ) at and near the zoo. Ruhugu and rustrela viruses share an identical genomic architecture with rubella virus 2 , 3 . The amino acid sequences of four putative B cell epitopes in the fusion (E1) protein of the rubella, ruhugu and rustrela viruses and two putative T cell epitopes in the capsid protein of the rubella and ruhugu viruses are moderately to highly conserved 4 – 6 . Modelling of E1 homotrimers in the post-fusion state predicts that ruhugu and rubella viruses have a similar capacity for fusion with the host-cell membrane 5 . Together, these findings show that some members of the family Matonaviridae can cross substantial barriers between host species and that rubella virus probably has a zoonotic origin. Our findings raise concerns about future zoonotic transmission of rubella-like viruses, but will facilitate comparative studies and animal models of rubella and congenital rubella syndrome. Ruhugu virus and rustrela virus are the first close relatives of rubella virus, providing insights into the zoonotic origin of rubella virus and the epidemiology and evolution of all three viruses.

The World Health Organization's Immunization and Vaccines-related Implementation Research Advisory Committee (IVIR-AC) serves to independently review and evaluate vaccine-related research to maximize the potential impact of vaccination programs. From 28 June – 1 July 2024, IVIR-AC was convened for an ad hoc meeting to discuss new evidence on criteria for rubella vaccine introduction and the risk of congenital rubella syndrome. This report summarizes background information on rubella virus transmission and the burden of congenital rubella syndrome, meeting structure and presentations, proceedings, and recommendations.

Rubella remains an important pathogen worldwide, with roughly 100 000 cases of congenital rubella syndrome estimated to occur every year. Rubella-containing vaccine is highly effective and safe and, as a result, endemic rubella transmission has been interrupted in the Americas since 2009. Incomplete rubella vaccination programmes result in continued disease transmission, as evidenced by recent large outbreaks in Japan and elsewhere. In this Seminar, we provide present results regarding rubella control, elimination, and eradication policies, and a brief review of new laboratory diagnostics. Additionally, we provide novel information about rubella-containing vaccine immunogenetics and review the emerging evidence of interindividual variability in humoral and cell-mediated innate and adaptive immune responses to rubella-containing vaccine and their association with haplotypes and single-nucleotide polymorphisms across the human genome.

•Highly-resolved serosurvey reveals subnational variation in rubella transmission.•Model projections reveal rubella vaccine introduction risk varies across Nigeria.•Paired campaigns and routine immunisation improvements prevents increase in CRS.•Subnational approach to rubella vaccine program design can accelerate introduction. Rubella infection during pregnancy can result in miscarriage or infants with a constellation of birth defects known as congenital rubella syndrome (CRS). When coverage is inadequate, rubella vaccination can increase CRS cases by increasing the average age of infection. Thus, the World Health Organisation recommends that countries introducing rubella vaccine be able to vaccinate at least 80% of each birth cohort. Previous studies have focused on national-level analyses and have overlooked sub-national variation in introduction risk. We characterised the sub-national heterogeneity in rubella transmission within Nigeria and modelled local rubella vaccine introduction under different scenarios to refine the set of conditions and strategies required for safe rubella vaccine use. Across Nigeria, the basic reproduction number ranged from 2.6 to 6.2. Consequently, the conditions for safe vaccination varied across states with low-risk areas requiring coverage levels well below 80 %. In high-risk settings, inadequate routine coverage needed to be supplemented by campaigns that allowed for gradual improvements in vaccination coverage over time. Understanding local heterogeneities in both short-term and long-term epidemic dynamics can permit earlier nationwide introduction of rubella vaccination and identify sub-national areas suitable for program monitoring, program improvement and campaign support.

Background Rubella is considered as a benign childhood infection. Congenital rubella syndrome (CRS) can result from the virus’s teratogenic potential, making the infection dangerous for pregnant women, particularly in the first trimester. Immunization is the only effective prevention against rubella and CRS in the absence of specific treatment. Since 2005, the rubella vaccine has been available in Tunisia. This study aimed to assess, eighteen years after the implementation of the program’s vaccination in the country, its effect on rubella seroprevalence in women of reproductive age. Methods This retrospective cross-sectional study was performed from January 2021 to December 2023 at Aziza Othmana Hospital (Tunis), which has one of the biggest obstetrical and assisted medical procreation units in Tunisia. Each woman consulting in one of these two units was screened for rubella-IgG antibodies by electrochemiluminescence assay using the Elecsys Rubella IgG Kit and the Cobas e411 analyzer (Roche Diagnostics ® , Mannhein). Woman was considered immunized when titer of IgG was ≥ 10 UI/mL. All samples with titers over 500 UI/mL were tested for specific IgM by the same method. Results During the study period, 1652 women were enrolled; their age ranged from 18 to 46 years old (33.4 ± 5.3 years). Overall, the proportion of women who were protected against rubella was 93.9%; it was significantly higher among those who were part of the immunization programs (96.6% vs. 93.2%; p  = 0.01). The median level of Rubella IgG in this first group was 175 ± 159 IU/mL. Women, who were not caught up by the strategy of vaccination, were seronegative in 6.8% of cases. Rubella IgM antibodies were negative in all the 143 cases tested excluding recent infection. Conclusion These findings demonstrate the effectiveness of the rubella vaccine, which is administered systematically as part of the national immunization schedule in all one-year-old infants. Nonetheless, the persistent vulnerability for rubellain susceptible women in their reproductive years highlights the importance of their vaccination during the pre-conception or in early postpartum phases. Clinical trial Not applicable, as this study is not a clinical trial.

JVC-001 is a new live attenuated measles–mumps–rubella vaccine (measles AIK-C, mumps RIT4385, and rubella Takahashi strains). Two phase 3 studies were conducted, one to verify the non-inferior immunogenicity of JVC-001 versus the approved mumps and measles–rubella vaccines (J301 study) and another to compare the immunogenicity and safety of different titers (J302 study). Both studies were multicenter, randomized, observer-blinded, phase 3 studies. J301 compared the immunogenicity elicited with a single dose of JVC-001 or control vaccines (measles–rubella vaccine + mumps vaccine [Hoshino strain]). J302 was a titer-confirmation study of a single dose of a low- or high-titer formulation of JVC-001. Both studies enrolled healthy Japanese children (aged 1 year) and had a primary efficacy endpoint of seropositive rate on Day 43. Overall, 861 participants completed J301 (JVC-001, n = 429; control, n = 432) and 100 participants completed J302 (low-titer, n = 48; high-titer, n = 52). For measles and rubella virus antibody titer, non-inferiority of JVC-001 was demonstrated: seropositive rates were ≥ 99.5 %. For mumps virus genotype D antibody titer, seropositive rates were 80.6 % (95 % confidence interval 76.5 % to 84.4 %) with JVC-001 and 88.1 % (84.6 % to 91.0 %) with control vaccination. Thus, non-inferiority for mumps virus genotype D antibody titer was not confirmed. Seropositive rates were similar in the low- and high-titer groups. There were no events leading to discontinuation, or cases of aseptic meningitis in either study. Although the non-inferiority of JVC-001 to currently approved vaccines was not demonstrated for the mumps component, clinical significance and consistent efficacy were indicated. Vaccine titer did not affect immunogenicity. JVC-001 is expected to have a lower risk of aseptic meningitis to currently approved vaccines and raised no new safety signals emerged. •JVC-001 is a new MMR vaccine (measles: AIK-C, mumps: RIT4385, rubella: Takahashi).•Comparative clinical trial of JVC-001 was conducted using MR and mumps vaccines.•Non-inferiority of immunogenicity was not demonstrated only against mumps virus.•However, clinical significance and consistent efficacy were indicated for JVC-001.•Different virus doses of JVC-001 did not affect immunogenicity and safety profile.

•The safety of inadvertent rubella vaccination in pregnancy is assessed.•Evidence is limited, often with no unvaccinated comparison group in registers.•No vaccine associated congenital rubella syndrome cases were identified but rubella infection does occur.•No change to policy to avoid pregnancy for one month after vaccination is suggested.•Inadvertent rubella vaccination in pregnancy is not an indication for abortion. Data on the safety of inadvertent rubella vaccination in pregnancy is important for rubella vaccination programs aimed at preventing congenital rubella syndrome. The association between monovalent rubella or combination vaccinations in or shortly before pregnancy and potential harm to the foetus was examined by conducting a systematic review and meta-analysis using fixed effect methods and simulation. Four cohort studies of inadvertently vaccinated and unvaccinated women were found, 15 cohorts of pregnant women who were rubella susceptible at time of inadvertent vaccination and 9 cohort studies with no information on susceptibility and case series. No case of vaccine associated congenital rubella syndrome (CRS) was identified. Cohort studies with an unvaccinated comparison group were limited in number and size, and based on these only a theoretical additional risk of 6 or more cases of CRS per 1000 vaccinated women (0% observed, upper 95% CI 0.6%) could be excluded. Based on cohorts of vaccinated rubella susceptible pregnant women a maximum theoretical risk of 1 CRS case in 1008 vaccinated women (0% observed, upper 95% CI 0.099%) was estimated. Asymptomatic rubella vaccine virus infection of the neonate was also noted (fixed effects estimate of risk overall 1.74%, 95% CI 1.21, 2.28). There is no evidence that CRS is caused by rubella-containing vaccines but transplacental vaccine virus infection can occur. CRS is effectively prevented by vaccination, thus the risk/benefit balance is unequivocally in favour of vaccination. The data confirm previous recommendations that inadvertent vaccination during pregnancy is not an indication for termination of pregnancy.