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Objective: To investigate whether the incidence of HIV infection is higher among sexually active women using depot medroxyprogesterone acetate (DMPA) or noresthisterone enanthate (NET-EN) injections for contraception than among women using nonhormonal or no contraception.Methods: Five hundred and fifty-one initially HIV-negative women were followed up for a total of 491 person-years. Participants were interviewed, counselled, examined, tested for HIV and other STIs, and treated, at three monthly intervals for 1 year.Results: There was no significant association between progestin contraceptive use and HIV infection (rate ratio 1.1, 95% CI 0.5 to 2.8; log-rank test, p=.73). In proportional hazards regression, the only significant hazard ratios for HIV acquisition were prevalent Neisseria gonorrhoea (5.2; 95% CI 1.1 to 23.7, p=.035) and Trichomonas vaginalis (4.8; 95% CI 1.0 to 22.8, p=.049); bacterial vaginosis was marginally significant (2.8; 95% CI 1.0 to 8.3, p=.057). The adjusted hazard ratios for NET-EN and DMPA were 1.76 (95% CI 0.64 to 4.84) and 0.46 (95% CI 0.06 to 3.79), respectively, relative to nonuse. Five hundred and twelve of 551 women had one or more confirmed STIs during the study.Conclusions: There is no evidence of an association between HIV infection and injectable contraceptives. Due to the limited power of this study and because similar studies have not included young women using NET-EN, we recommend that further research be carried out to focus on the use of NET-EN and HIV acquisition in high risk groups. [ABSTRACT FROM AUTHOR]

Background Nonoxynol-9 (rINN, nonoxinol-9) is an over-the-counter spermicide that has in-vitro anti-HIV-1 activity. Results of studies of its effectiveness in prevention of HIV-1 infection in women have been inconclusive. We aimed to assess effectiveness of this vaginal gel.Methods We did a randomised, placebo-controlled, triple-blinded, phase 2/3 trial with COL-1492, a nonoxynol-9 vaginal gel, in 892 female sex workers in four countries: Benin, Coˆte d'Ivoire, South Africa, and Thailand. 449 women were randomly allocated nonoxynol-9 and 443 placebo. Primary endpoint was incident HIV-1 infection. Secondary endpoints included Neisseria gonorrhoeae and Chlamydia trachomatis infections. Analysis was by intention to treat.Findings 765 women were included in the primary analysis. HIV-1 frequency in nonoxynol-9 users was 59 (16%) of 376 compared with 104 (27%) of 389 in placebo users (402·5 vs 435·0 woman-years; hazard ratio adjusted for centre 1·5; 95% CI 1·0–2·2; p=0·047). 239 (32%) women reported use of a mean of more than 3·5 applicators per working day, and in these women, risk of HIV-1 infection in nonoxynol-9 users was almost twice that in placebo users (hazard ratio 1·8; 95% CI 1·0–3·2). 516 (68%) women used the gel less frequently than 3·5 times a day, and in these, risk did not differ between the two treatments. No significant effect of nonoxynol-9 on N gonorrhoeae (1·2; 0·9–1·6) or C trachomatis (1·2; 0·8–1·6) infections was reported.Interpretation This study did not show a protective effect of COL-1492 on HIV-1 transmission in high-risk women. Multiple use of nonoxynol-9 could cause toxic effects enhancing HIV-1 infection. This drug can no longer be deemed a potential HIV-1-prevention method. Assessment of other microbicides should continue. [Copyright &y& Elsevier]

In 2014, South Africa implemented a national two-dose HPV vaccination programme using the bivalent vaccine for girls aged 9 years and older attending Grade 4 at public schools. We assessed HPV prevalence and risk factors among South African adolescent girls and young women (AGYW) aged 17–18 years who were ineligible for vaccination. From June to December 2019, we surveyed AGYW aged 17–18 years attending primary care clinics in four South African provinces. Consenting participants completed a questionnaire, underwent HIV counselling and testing, and self-collected a vaginal swab for HPV testing. Samples were tested by Seegene AnyPlex™ II HPV28. We used summary statistics to describe the population characteristics and logistic regression to examine the association between risk factors and high-risk HPV detection. 910 participants were screened, 900 enrolled, 896 had valid HPV results, and 819 were unvaccinated and included in this study. Of these, 248 (30.3 %) were living with HIV and 597 (72.9 %) reported ever having vaginal sex. Overall, 463 (56.5 %) had at least one high-risk HPV detected, and 177 (21.6 %) had HPV16/18 detected. AGYW living with HIV had a higher prevalence of any high-risk HPV (65.3 % vs 52.7 %, p < 0.001) and HPV 16/18 (29.4 % vs 18.2 %, p < 0.001) compared to those without HIV. Multiple infections were also more common in participants living with HIV, with three or more high-risk HPV types detected in 32.3 % compared with 15.4 % of those without HIV (p < 0.001). In multivariate analyses, HIV status (p < 0.001) and higher number of lifetime sexual partners (p-trend<0.001) were associated with high-risk HPV detection. High-risk HPV was very common in unvaccinated South Africa AGYW, especially among those living with HIV, highlighting the importance of HPV vaccination in settings with high HIV prevalence. • HPV detection was very common in unvaccinated South African girls aged 17–18 years. • More than half (57 %) had high-risk HPV, and nearly a quarter (22 %) had HPV16/18. • Higher HPV prevalence was observed in adolescent girls living with HIV • HIV status was an independent risk factor for HPV after adjusting for sexual behaviour. • Results highlight the importance of HPV vaccines and early initiation of antiretroviral therapy. [ABSTRACT FROM AUTHOR]

The past two decades have seen important progress in access to timely, reliable, affordable, and quality-assured supplies of vaccines of global public health importance. The new vaccines developed are powerful tools to fight killers such as pneumonia, diarrhea, and cervical cancer. Global and regional financing and pooled procurement have shortened the lag between access in high- and lower-income countries. The COVID-19 pandemic has shown that by addressing shortcomings and seizing opportunities, we can do even more. In response to COVID-19, vaccine development and access shifted from a sequential, risk-averse paradigm to a rapid approach with maximum compression of time to market while ensuring quality. Vast public investments and innovative technologies were key facilitators. The pandemic has shown that governments play a crucial role in investing in new vaccines and manufacturing capacity and sharing risks with industry. Despite impressive progress, equity in access remains elusive with important moral, economic, and health-related consequences. Global leaders are working on a new International Treaty for Pandemic Prevention, Preparedness, and Response. To apply the lessons of COVID-19, that treaty should include a new paradigm for access to vaccines in which governments agree to: (1) establish early sharing of information about emerging outbreaks and early, evidence-informed strategic goals and leadership that serve the collective global health interest. (2) shoulder risks and invest aggressively to address the needs of today and prepare for future emergencies. (3) strengthen market preparedness by investing in new vaccine technologies, regional research, development and manufacturing hubs, and insurance; by enabling regulatory harmonization; by driving market transparency and oversight; and by ensuring that where public funds are invested there is a contractual obligation to ensure access. (4) define principles and operational details for collaboration in times of scarcity that enable countries to protect their own citizens while ensuring that no country is left behind. This would ensure that COVID-19 catalyzes a shift toward greater access for all under Immunization Agenda 2030. [ABSTRACT FROM AUTHOR]

Abstract: Purpose: To compare the sexual behaviors of young people in South Africa (SA) and the United States (US) with the aim to better understand the potential role of sexual behavior in HIV transmission in these two countries that have strikingly different HIV epidemics. Methods: Nationally representative, population-based surveys of young people aged 18–24 years from SA (n = 7,548) and the US (n = 13,451) were used for the present study. Results: The prevalence of HIV was 10.2% in SA and <1% in the US. Young women and men in the US reported an earlier age of first sex than those in SA (mean age of coital debut for women: US [16.5], SA [17.4]; for men: US [16.4], SA [16.7]). The median number of lifetime partners is higher in the US than in SA: women: US (4), SA (2); men: US (4), SA (3). The use of condom at last sex is reported to be lower in the US than in SA: women: US (36.1%), SA (45.4%); men: US (48%), SA (58%). On average, young women in SA report greater age differences with their sex partners than young women in the US. Conclusion: Young people in the US report riskier sexual behaviors than young people in SA, despite the much higher prevalence of HIV infection in SA. Factors above and beyond sexual behavior likely play a key role in the ongoing transmission of HIV in South African youth, and thus should be urgently uncovered to develop maximally effective prevention strategies. [Copyright &y& Elsevier]

Broadly protective coronavirus vaccines are an important tool for protecting against future SARS-CoV-2 variants and could play a critical role in mitigating the impact of future outbreaks or pandemics caused by novel coronaviruses. The Coronavirus Vaccines Research and Development (R&D) Roadmap (CVR) is aimed at promoting the development of such vaccines. The CVR, funded by the Bill & Melinda Gates Foundation and The Rockefeller Foundation, was generated through a collaborative and iterative process, which was led by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota and involved 50 international subject matter experts and recognized leaders in the field. This report summarizes the major issues and areas of research outlined in the CVR and identifies high-priority milestones. The CVR covers a 6-year timeframe and is organized into five topic areas: virology, immunology, vaccinology, animal and human infection models, and policy and finance. Included in each topic area are key barriers, gaps, strategic goals, milestones, and additional R&D priorities. The roadmap includes 20 goals and 86 R&D milestones, 26 of which are ranked as high priority. By identifying key issues, and milestones for addressing them, the CVR provides a framework to guide funding and research campaigns that promote the development of broadly protective coronavirus vaccines. [ABSTRACT FROM AUTHOR]

• A SARS-CoV-2 seroprevalence study was conducted after the second wave of COVID infections. • The study included pregnant women in two urban antenatal clinics in inner-city Johannesburg. • A total of 64% of pregnant women were SARS-CoV-2 seropositive; most (96.6%) were asymptomatic. • No association between HIV status and SARS-CoV-2 seropositivity was found. • Only 60% of pregnant women reported being willing to vaccinate. After South Africa's second wave of COVID-19, this study estimated the SARS-CoV-2 seroprevalence among pregnant women in inner-city Johannesburg, South Africa. In this cross-sectional survey, 500 pregnant women who were non-COVID-19-vaccinated (aged ≥12 years) were enrolled, and demographic and clinical data were collected. Serum samples were tested using the Wantai SARS-CoV-2 spike antibody enzyme-linked immunosorbent assay and Roche Elecsys® anti-SARS-CoV-2 nucleocapsid antibody assays. Seropositivity was defined as SARS-CoV-2 antibodies on either (primary) or both (secondary) assays. Univariate Poisson regression assessed risk factors associated with seropositivity. The median age was 27.4 years, and HIV prevalence was 26.7%. SARS-CoV-2 seroprevalence was 64.0% (95% confidence interval [CI]: 59.6-68.2%) on the primary and 54% (95% CI: 49.5-58.4%) on the secondary measure. Most (96.6%) women who were SARS-CoV-2-seropositive reported no symptoms. On the Roche assay, we detected lower seroprevalence among women living with HIV than women without HIV (48.9% vs 61.7%, P -value = 0.018), and especially low levels among women living with HIV with a clusters of differentiation 4 <350 cells/ml compared with women without immune suppression (22.2% vs 56.4%, prevalence rate ratio = 0.4; 95% CI: 0.2-0.9; P -value = 0.046). Pregnant women attending routine antenatal care had a high SARS-CoV-2 seroprevalence after the second wave in South Africa, and most had asymptomatic infections. Seroprevalence surveys in pregnant women present a feasible method of monitoring the course of the pandemic over time. [ABSTRACT FROM AUTHOR]

Summary: Background: Hormonal contraceptives are used widely but their effects on HIV-1 risk are unclear. We aimed to assess the association between hormonal contraceptive use and risk of HIV-1 acquisition by women and HIV-1 transmission from HIV-1-infected women to their male partners. Methods: In this prospective study, we followed up 3790 heterosexual HIV-1-serodiscordant couples participating in two longitudinal studies of HIV-1 incidence in seven African countries. Among injectable and oral hormonal contraceptive users and non-users, we compared rates of HIV-1 acquisition by women and HIV-1 transmission from women to men. The primary outcome measure was HIV-1 seroconversion. We used Cox proportional hazards regression and marginal structural modelling to assess the effect of contraceptive use on HIV-1 risk. Findings: Among 1314 couples in which the HIV-1-seronegative partner was female (median follow-up 18·0 [IQR 12·6–24·2] months), rates of HIV-1 acquisition were 6·61 per 100 person-years in women who used hormonal contraception and 3·78 per 100 person-years in those who did not (adjusted hazard ratio 1·98, 95% CI 1·06–3·68, p=0·03). Among 2476 couples in which the HIV-1-seronegative partner was male (median follow-up 18·7 [IQR 12·8–24·2] months), rates of HIV-1 transmission from women to men were 2·61 per 100 person-years in couples in which women used hormonal contraception and 1·51 per 100 person-years in couples in which women did not use hormonal contraception (adjusted hazard ratio 1·97, 95% CI 1·12–3·45, p=0·02). Marginal structural model analyses generated much the same results to the Cox proportional hazards regression. Interpretation: Women should be counselled about potentially increased risk of HIV-1 acquisition and transmission with hormonal contraception, especially injectable methods, and about the importance of dual protection with condoms to decrease HIV-1 risk. Non-hormonal or low-dose hormonal contraceptive methods should be considered for women with or at-risk for HIV-1. Funding: US National Institutes of Health and the Bill & Melinda Gates Foundation. [ABSTRACT FROM AUTHOR]

Currently, no formal mechanisms or systematic approaches exist to inform developers of new vaccines of the evidence anticipated to facilitate global policy recommendations, before a vaccine candidate approaches regulatory approval at the end of pre-licensure efficacy studies. Consequently, significant delays may result in vaccine introduction and uptake, while post-licensure data are generated to support a definitive policy decision. To address the uncertainties of the evidence-to-recommendation data needs and to mitigate the risk of delays between vaccine recommendation and use, WHO is evaluating the need for and value of a new strategic alignment tool: Evidence Considerations for Vaccine Policy (ECVP). EVCPs aim to fill a critical current gap by providing early (pre-phase 3 study design) information on the anticipated clinical trial and observational data or evidence that could support WHO and/or policy decision making for new vaccines in priority disease areas. The intent of ECVPs is to inform vaccine developers, funders, and other key stakeholders, facilitating stakeholder alignment in their strategic planning for late stage vaccine development. While ECVPs are envisaged as a tool to support dialogue on evidence needs between regulators and policy makers at the national, regional and global level, development of an ECVP will not preclude or supersede the independent WHO's Strategic Advisory Group of Experts on Immunization (SAGE) evidence to recommendation (EtR) process that is required for all vaccines seeking WHO policy recommendation. Tuberculosis (TB) vaccine candidates intended for use in the adolescent and adult target populations comprise a portfolio of priority vaccines in late-stage clinical development. As such, TB vaccines intended for use in this target population provide a 'test case' to further develop the ECVP concept, and develop the first WHO ECVP considerations guidance. [ABSTRACT FROM AUTHOR]

Very little is known about the characteristics of mesothelial tumours in the paediatric population. In adults with malignant mesothelioma, the pemetrexed-based regimen with cytoreductive surgery (CRS) is a standard of care in limited tumours, but long-term survival is uncommon. The European Cooperative Study Group on Pediatric Rare Tumors (EXPeRT) retrospectively reviewed children, adolescents and young adults (≤21 year) diagnosed with mesothelial tumours treated between 1987 and 2018. Thirty-three patients were identified, 15 male and 18 female patients. One patient's exposure to asbestos was documented. Primary tumour was mainly in the peritoneum (23 patients). Histology was multicystic mesothelioma of the peritoneum (MCM) (six patients) or malignant mesothelioma (MM) (27 patients). Among MM, the first-line treatment comprised preoperative chemotherapy (14 cases), surgery only (three cases), chemotherapy only (five cases), adjuvant chemotherapy (three cases) or palliative treatment (two cases). The response rate to cisplatin–pemetrexed was 50% (6/12 cases). CRS with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) was performed in 19 patients (upfront in three, after neoadjuvant therapy in 12, or after tumour progression in six patients, including three twice). After a median follow-up of 6.7 years (range, 0–20), five-year overall and event-free survivals were 82.3% (95% CI, confidential interval ((CI), 67.8–99.9) and 45.1% (95% CI, 28.4–71.7), respectively. All patients with MCM are alive after surgery (five patients) and CRS-HIPEC (one patient). Paediatric mesothelioma is exceptional and seems to be different from its adult counterpart with few asbestos exposures, more peritoneal primary, and a better outcome. The cisplatin–pemetrexed regimen showed promising efficacy. Relapses could be salvaged with active therapy including CRS-HIPEC. • Large retrospective international study of European pediatric mesothelioma. • Pediatric malignant mesothelioma mainly occurs in adolescents. • Few asbestos exposures in pediatric patients and frequent metastasis. • Possible efficacy of pemetrexed-cisplatinum regimen. • Favorable outcome, particularly in peritoneal primary. [ABSTRACT FROM AUTHOR]

• GVAP provided a comprehensive and coherent global framework for immunization. • Much progress was achieved under GVAP, although most GVAP goals will not be met. • GVAP was perceived as top-down, with too little consideration of country context. • GVAP was only partially implemented, and it had limited levers to influence country actions. • Many targets were seen as unrealistic, particularly in the absence of additional funding. • Lessons learned from GVAP can inform the Immunization Agenda 2030. The Global Vaccine Action Plan 2011–2020 (GVAP) was developed to realize the ambitions of the Decade of Vaccines – that all individuals and communities enjoy lives free from vaccine-preventable diseases. It included a comprehensive monitoring and evaluation/accountability framework to assess progress towards global targets with recommendations for corrective actions. While many of the GVAP targets are very unlikely to be met by the end of 2020, substantial progress has nevertheless been made, establishing a strong foundation for a successor global immunization strategy, the Immunization Agenda 2030 (IA2030). The Strategic Advisory Group of Experts on immunization has made a series of recommendations to ensure that the lessons learned from GVAP inform the development and implementation of IA2030. [ABSTRACT FROM AUTHOR]

Abstract Background RV144 is to date the only HIV vaccine trial to demonstrate efficacy, albeit rapidly waning over time. The HVTN 702 trial is currently evaluating in South Africa a similar vaccine formulation to that of RV144 for subtype C HIV with additional boosters (pox-protein regimen). Using a detailed stochastic individual-based network model of disease transmission calibrated to the HIV epidemic, we investigate population-level impact and maximum cost of an HIV vaccine to remain cost-effective. Methods Consistent with the original pox-protein regimen, we model a primary series of five vaccinations meeting the goal of 50% cumulative efficacy 24 months after the first dose and include two-yearly boosters that maintain durable efficacy over 10 years. We simulate vaccination programs in South Africa starting in 2027 under various vaccine targeting and HIV treatment and prevention assumptions. Results Our analysis shows that this partially effective vaccine could prevent, at catch-up vaccination with 60% coverage, up to 941,000 (15.6%) new infections between 2027 and 2047 assuming current trends of antiretroviral treatment. An impact of up to 697,000 (11.5%) infections prevented could be achieved by targeting age cohorts of highest incidence. Economic evaluation indicates that, if treatment scale-up was achieved, vaccination could be cost-effective at a total cost of less than $385 and $62 per 10-year series (cost-effectiveness thresholds of $5,691 and $750). Conclusions While a partially effective, rapidly waning vaccine could help to prevent HIV infections, it will not eliminate HIV as a public health priority in sub-Saharan Africa. Vaccination is expected to be most effective under targeted delivery to age groups of highest HIV incidence. Awaiting results of trial, the introduction of vaccination should go in parallel with continued innovation in HIV prevention, including studies to determine the costs of delivery and feasibility and further research into products with greater efficacy and durability. [ABSTRACT FROM AUTHOR]

Background Women in sub-Saharan Africa have high dual burden of HPV and HIV infections, which can interact to increase cervical cancer (CC) risk. The 9-valent HPV (9vHPV) vaccine has high demonstrated effectiveness against HPV types causing 90% of CC. Additionally, one dose of the 9vHPV vaccine has the potential to achieve greater coverage at lower costs than a two-dose schedule. However, the potential impact of single-dose 9vHPV vaccine accounting for HPV-HIV interactions has not been estimated. Methods We adapted a dynamic HIV transmission model to include HPV acquisition and CC pathogenesis and projected the impact of a single dose 9vHPV preadolescent vaccination in KwaZulu-Natal, South Africa. We report health impacts of HPV vaccination separately for HIV-positive women stratified by HIV treatment and CD4 count and HIV-negative women. Results At 90% coverage of females age 9 years with 80% lifelong vaccine efficacy, single dose HPV vaccination was projected to reduce CC incidence by 74% and mortality by 71% in the general female population at 70 years after the start of the vaccination program. Age-standardized CC incidence and mortality reductions were comparable among HIV-negative women, HIV-positive women, and HIV-positive women on ART. Health benefits were reduced when assuming waning protection at 10, 15 and 20 years after vaccination. Discussion Single dose 9vHPV vaccination is projected to avert substantial CC burden in South Africa and similar high HIV prevalence settings. Health benefits were comparable across all female subpopulations stratified by HIV status, CD4 count, and ART status. [ABSTRACT FROM AUTHOR]

Objectives: Studies that rely on self-report to investigate the relationship between hormonal contraceptive use and HIV acquisition and transmission, as well as other health outcomes, could have compromised results due to misreporting. We determined the frequency of misreported hormonal contraceptive use among African women with and at risk for HIV.Study Design: We tested 1102 archived serum samples from 664 African women who had participated in prospective HIV prevention studies. Using a novel high-performance liquid chromatography-mass spectrometry assay, we quantified exogenous hormones for injectables (medroxyprogesterone acetate or norethisterone), oral contraceptives (OC) (levonorgestrel or ethinyl estradiol) and implants (levonorgestrel or etonogestrel) and compared them to self-reported use.Results: Among women reporting hormonal contraceptive use, 258/358 (72%) of samples were fully concordant with self-report, as were 642/744 (86%) of samples from women reporting no hormonal contraceptive use. However, 42/253 (17%) of samples from women reporting injectable use, 41/66 (62%) of samples from self-reported OC users and 3/39 (8%) of samples from self-reported implant users had no quantifiable hormones. Among self-reported nonusers, 102/744 (14%) had ≥1 hormone present. Concordance between self-reported method and exogenous hormones did not differ by HIV status.Conclusion: Among African women with and at risk for HIV, testing of exogenous hormones revealed agreement with self-reported contraceptive use for most women. However, unexpected exogenous hormones were identified among self-reported hormonal contraceptive users and nonusers, and an important fraction of women reporting hormonal contraceptive use had no hormones detected; absence of oral contraceptive hormones could be due, at least in part, to samples taken during the hormone-free interval. Misreporting of hormonal contraceptive use could lead to biased results in observational studies of the relationship between contraceptive use and health outcomes.Implications: Research studies investigating associations between hormonal contraceptive use and HIV should consider validating self-reported use by objective measures; because both overreporting and underreporting of use occur, potential misclassification based on self-report could lead to biased results in directions that cannot be easily predicted. [ABSTRACT FROM AUTHOR]

In 2014, the World Health Organization, the US National Institutes of Health, and global technical partners published a comprehensive roadmap for development of new vaccines against sexually transmitted infections (STIs). Since its publication, progress has been made in several roadmap activities: obtaining better epidemiologic data to establish the public health rationale for STI vaccines, modeling the theoretical impact of future vaccines, advancing basic science research, defining preferred product characteristics for first-generation vaccines, and encouraging investment in STI vaccine development. This article reviews these overarching roadmap activities, provides updates on research and development of individual vaccines against herpes simplex virus, Chlamydia trachomatis , Neisseria gonorrhoeae , and Treponema pallidum , and discusses important next steps to advance the global roadmap for STI vaccine development. [ABSTRACT FROM AUTHOR]

Global initiatives such as the Millennium Development Goals have led to major improvements in the health of women and children, and significant reductions in childhood mortality. Worldwide, maternal mortality has decreased by 45% and under-five mortality has fallen by over 50% over the past two decades [1] . However, improvements have not been achieved evenly across all ages; since 1990, under-five mortality has declined by ∼5% annually, but the average decrease in neonatal mortality is only ∼3% per year. Against this background, the Bill and Melinda Gates Foundation (BMGF) convened a meeting in Berlin on January 29–30, 2015 of global health stakeholders, representing funders, academia, regulatory agencies, non-governmental organizations, vaccine manufacturers, and Ministries of Health from Africa and Asia. The topic of discussion was the potential of maternal immunization (MI) to achieve further improvements in under-five morbidity and mortality rates in children, and particularly neonates and young infants, through targeting infectious diseases that are not preventable by other interventions in these age groups. The meeting focused on effective and appropriately priced MI vaccines against influenza, pertussis, and tetanus, as well as against respiratory syncytial virus, and the group B Streptococcus , for which no licensed vaccines currently exist. The primary goals of the BMGF 2015 convening were to bring together the global stakeholders in vaccine development, policy and delivery together with the Maternal, Newborn and Child Health (MNCH) community, to get recognition that MI is a strategy shared between these groups and so encourage increased collaboration, and obtain alignment on the next steps toward achieving a significant health impact through implementation of a MI program. [ABSTRACT FROM AUTHOR]

Abstract: In a context of high rates of intimate partner violence (IPV), trials of female-controlled technologies for HIV prevention such as microbicides may increase the possibility of social harms. Seeking to explore the relationship between IPV and microbicide use further, this paper documents women's narratives of participating in the Microbicide Development Program (MDP) trial in Johannesburg, South Africa, and experiences of partner violence and conflict. A social science sub-study, nested within the trial, was conducted between September 2005 and August 2009, and 401 serial in-depth-interviews were undertaken with 150 women. Using coded interview transcripts, we describe the distribution of IPV and the possible association thereof with microbicide gel use and trial participation. More than a third of these 150 women reported IPV, of which half the cases were related to involvement in the trial. In their narratives, those women reporting IPV cast their partners as authoritarian, controlling and suspicious and reported verbal abuse, abandonment, and in some cases, beatings. Shared experiences of everyday violence shaped women's feelings of unease about revealing their participation in the trial to intimate partners and attempted concealment further contributed to strains and conflict within relationships. Our findings point to the role of social scientific enquiry in identifying the less obvious, hidden negative impacts of participation in a clinical trial therefore exposing limitations in the biomedical construction of ‘social harms’, as well as the implications thereof for potential future use outside the clinical trial setting. [Copyright &y& Elsevier]

Highlights: [•] Cervical cancer is an important public health problem worldwide. [•] Two efficacious and safe prophylactic HPV vaccines are available. [•] Development and testing of a nine-valent HPV vaccine is being undertaken. [•] Other research include development of prophylactic L2 and therapeutic vaccine. [Copyright &y& Elsevier]

Abstract: Objective: This study was conducted to determine the association between the use of injectable progestin contraception (IPC) and the risk of infection with Neisseria gonorrhoeae (GC), Chlamydia trachomatis (CT), bacterial vaginosis (BV) and Trichomonas vaginalis (TV) among women in South Africa. Methods: From August 1999 through May 2001, 643 HIV-1-negative women were recruited from family planning clinics in Orange Farm, South Africa. IPC [norethisterone enanthate (NET-EN) and depot medroxyprogesterone acetate (DMPA)] users and nonhormonal contraception users were recruited in approximately equal numbers. Eligible participants were seen at enrolment and on four follow-up visits over a 12-month period; 567 returned for at least one follow-up visit. Multivariable Poisson regression models with generalized estimating equations were used to compute the incidence rate ratios (IRRs) for infections with GC, CT, BV and TV by use of NET-EN or DMPA relative to nonuse during follow-up. Results: In multivariable models, the use of DMPA slightly increased the risk of infection with CT [IRR=1.24; 95% confidence interval (95% CI)=0.80–1.94] and GC (IRR=1.30; 95% CI=0.58–2.98), although these associations were not statistically significant. In contrast, DMPA appeared to be protective for TV (IRR=0.35; 95% CI=0.12–1.01), although this estimate was very imprecise. The use of both DMPA and NET-EN was associated with a decreased risk of BV. Conclusions: The use of DMPA among women in this study population was associated with an increased — but not statistically significant — risk of cervical infection with chlamydia and gonorrhea, and a decreased risk of TV and BV. Given the inconsistencies and limitations of the data describing an increased risk of CT and GC with IPC use, the potential risk of sexually transmitted infections (STIs) must be balanced against the risk of unintended pregnancy and its health consequences, especially in developing countries. Women opting to use IPC should be counseled to use condoms to protect against STIs and HIV. [Copyright &y& Elsevier]

Background: Use of depot-medroxyprogesterone acetate (DMPA), norethisterone enanthate (NET-EN) and low-dose combined oral contraceptives (COCs) has been associated with loss of bone mineral density (BMD) in adolescents. However, the effect of using a combination of these methods over time in this age group is limited. The aim of this cross-sectional study was to investigate BMD in young women (aged 19-24 years) with a history of mixed hormonal contraceptive use.Study Design: BMD was measured at the spine, hip and femoral neck using dual X-ray absorptiometry. Women were classified into three groups: (1) injectable users (DMPA, NET-EN or both) (n=40), (2) mixed COC and injectable users (n=13) and (3) non-user control (n=41).Results: Women in the injectables-only user group were found to have lower BMDs compared to the non-user group at all three sites, and there was evidence of a difference in BMD between these two groups at the spine after adjusting for body mass index (p=.042), hip (p=.025) and femoral neck (p=.023). The mixed COC/injectable user group BMD values were lower than those for controls; however, there was no evidence of a significant difference between this group and the non-user group at any of the three sites.Conclusion: This study suggests that BMD is lower in long-term injectable users but not when women have mixed injectable and COC use. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: Dual contraceptive method use is advocated for adolescent women to prevent pregnancy, sexually transmitted diseases and HIV. Methods: We examined data from a nationally representative sample of South African women aged 15–24 years to establish factors associated with dual method use. Results: Only 7% of current contraceptive users reported using dual methods, although this percentage increased to 28.1% when women reporting hormonal contraception and condom use at last sex were included. In multivariate analyses, having talked about condoms with a partner was most strongly associated with dual method use (adjusted odds ratio (AOR), 12.3; 95% confidence interval (CI), 6.1–25.1) and suggests that communication skills might be the most effective way of increasing dual method use. Difficulty in accessing condoms was associated with lower odds of dual method use (AOR, 0.5; 95% CI, 0.2–1.0). Conclusion: We conclude with recommendations to increase male involvement and encourage communication between partners for the integration of HIV prevention and other reproductive health care services. [Copyright &y& Elsevier]

The objective of this study was to investigate whether follicle-stimulating hormone (FSH) levels can be used reliably to indicate approaching menopause in older (aged 40–49), long-term users of depomedroxyprogesterone acetate (DMPA) and norethisterone enanthate (NET-EN). One-hundred and seventeen women using DMPA, 60 NET-EN users and 161 nonusers of contraception were recruited. At recruitment, serum FSH levels were measured and questions were asked regarding menopausal symptoms, menstrual cycle and date of last injection. Results of the recruitment blood test showed that 32% of the nonusers had FSH levels in the menopausal range >25.8 mIU/mL compared to 28% of the DMPA users and 9% of the NET-EN group. After adjusting for age, there was no significant difference between the 3 groups (p = 0.13). An increase of 1 year in age increased the FSH level by 3 mIU/mL (p < 0.001). All the hormonal contraceptive users were between 1 day and 12 weeks of their injection interval. Many had been using the injectable contraceptive method for over 10 years and almost all were amenorrheic at the time of recruitment. The data show that a raised FSH level can be detected during use of DMPA and NET-EN and could be used as a menopausal indicator without interrupting method use in this group of contraceptive users. [Copyright &y& Elsevier]

Delegates at the first International African Vaccinology Conference noted, with dismay, that many African children have limited access to existing and new vaccines as a consequence of weak immunisation programmes, lack of political will, and high vaccine prices. This inequality is a denial of the African child her basic right to a healthy life, and jeopardises long term economic growth on the continent. In addition, there is insufficient emphasis in Africa on adolescent and adult immunisation. The delegates documented various concerns and made various commitments; contained in this Cape Town Declaration on Vaccines, adopted on 11 November 2012. Finally, delegates confirmed their agreement with the goals and strategic objectives of the Global Vaccine Action Plan, and committed to hold African leaders accountable for its implementation during the Decade of Vaccines. The full list of registered conference delegates is provided as supplementary data to this manuscript. [ABSTRACT FROM AUTHOR]

Increasing reliance on antibiotics of last resort to treat the rising numbers of multidrug-resistant bacterial infections in people has focused attention on how shared-use antibiotics are managed and regulated across human and animal health. Discussions at international and national levels have intensified since the identification of new plasmid-mediated genes for colistin resistance in 2016, first in China and subsequently in many other countries, removing the last line of defense against multidrug-resistant Gram-negative bacterial infections with carbapenem resistance. South Africa has reacted to this threat by doing a situational analysis and review of the existing legislation concerning colistin use in animals and people, to inform which course of action to take. The experiences shared in this Personal View outline the process, institution of governance with widespread stakeholder engagement, surveillance, and interventions that South Africa has taken towards optimising the shared use of colistin. The instigation of stewardship guided by the principles of the One Health concept for shared-use antibiotics at the country level is a crucial component of any action plan to combat antibiotic resistance, and is as relevant to other existing antibiotics and new chemical entities that will be forthcoming from an invigorated antibiotic pipeline as it is to colistin. [ABSTRACT FROM AUTHOR]