National Agency for the Control of AIDS

The COVID-19 pandemic posed a major public health challenge with varying devastating effects on the global community. Vaccination is the most effective measure in combating this pandemic. A major challenge, especially in resource-limited settings, was the shortage of the vaccines. However, evidence by WHO in the use of fractionated doses in combating yellow fever prompted the evaluation of the safety and immunogenicity of fractionated doses of COVID-19 vaccines (ChAd0x1, AD26.COV2.S, and BNT162B2) among Nigerian adults (18-65years). This is a multi-center, non-inferiority randomized, triple-blind trial involving 1812 COVID-19 vaccine naïve participants. Six hundred four eligible participants will be randomized into each of the three vaccine arms of ChAd0x1, AD26.COV2.S, and BNT162B2 COVID-19 vaccine. 151 participants will be randomized each into the 25% and 50% fractionated dose and 300 in the standard full dose arm for the ChAd0x1 and AD26.COV2.S group. In the BNT162B2 group, 201 participants will be randomized into the 50% fractionated dose and 403 into the standard dose arms. The efficacy (immunogenicity) will be evaluated by collecting blood samples at baseline (day 0) and day 28 after immunization to determine the geometric mean fold rise (GMFR) of ≥ 2.5 within the range of 20% non-inferiority to the standard dose of anti-SARS-CoV-2 S antibody response detected by ELISA termed as seroconversion. Safety and adverse events will be evaluated through active evaluation during the first 72h of vaccine administration and on days 14 and 28 of clinic visits. The trial will also assess secondary immunogenicity variables of 50% plaque plaalite reduction neutralization by antibodies against SARS-CoV-2 variants (α, δ, and κ) and cytokines production (IFNα, γ, and IL-2 producing CD4 and CD8 T lymphocytes). The proposed trial will allow for a comprehensive understanding of the immunologic responses and safety profile of fractional doses compared to full doses of COVID-19 vaccines among Nigerian adults. In addition, this will guide policy implementation for prompt vaccination of the population to maximize access to the limited vaccines available during the COVID-19 pandemic or future epidemics/pandemics. The study is registered at the Pan African Clinical Trials Registry (PACTR), a primary registry in the WHO International Clinical Trial Platforms. PACTR202206754734018. Registered on June 1, 2022, Accessible at: https://pactr.samrc.ac.za/ Trial Sponsor: Open Philanthropy.

This study investigates heavy metal contamination in rice from Gashua, Yobe State, Nigeria—an important rice-producing area potentially affected by environmental pollution. Given the widespread consumption of rice as a dietary staple and the rising prevalence of kidney-related diseases in the region, the research aimed to quantify the concentrations of arsenic (As), cadmium (Cd), lead (Pb), and chromium (Cr) in rice and assess their associated health risks. Using a simple random sampling technique, 120 rice samples were collected, consisting of 90 paddy rice from four farms and 30 parboiled rice from Gashua Market. Samples were digested and analyzed using Microwave Plasma–Atomic Emission Spectrometry (MP-AES), and data were evaluated through one-way analysis of variance (ANOVA). The results showed a significant (P<0.05) variation in heavy metal concentrations among samples. Parboiled rice from Gashua Market contained the highest arsenic level (0.383 mg/kg), exceeding WHO and USEPA limits. Cadmium (0.0242 mg/kg) and lead (0.102 mg/kg) also surpassed permissible limits of 0.001 mg/kg and 0.0035 mg/kg, respectively. Hazard Quotient (HQ) values for children indicated low risk, with all values below the threshold of 1. However, in adults, the HQ value for chromium at Gashua Market (2.162) exceeded the safe limit, suggesting potential health risks. The Hazard Index (HI) for both adults and children was greater than 1, primarily due to elevated concentrations of arsenic and chromium, signaling possible non-carcinogenic effects. Incremental Lifetime Cancer Risk (ILCR) analysis further indicated an increased risk of cancer from prolonged exposure. In conclusion, rice grown and sold in Gashua is contaminated with heavy metals at levels posing both carcinogenic and non-carcinogenic health risks. These findings underscore the urgent need for continuous monitoring, stricter regulatory enforcement by agencies such as NAFDAC, and proactive public health interventions to ensure food safety and protect community health.

Malaria remains a major global health challenge due to its high morbidity and mortality, further complicated by growing antimalarial drug resistance. Natural products are being increasingly explored as potential sources of new therapies, with malarial proteases emerging as promising targets due to their essential roles in parasite development, invasion, egress, and hemoglobin degradation. This study evaluates the inhibitory potential of five compounds, quercetrin (DG1), dihydrostilbene (DG2), 4′-methoxy-isoliquiritigenin (DG3), stigmasterol (DG4), and quercetin (DG5), isolated from Globimetula oreophila leaves, using in silico docking against Plasmodium falciparum enzymes. Targets included falcipain-2 and falcipain-3 (cysteine proteases), SERA5 (hemoglobin-processing enzyme), PfDHFR-TS (bifunctional enzyme), and PfCDPK2 (kinase). Docking revealed strong binding affinities through hydrogen bonds, van der Waals forces, and hydrophobic interactions. DG4 showed a high affinity for PfDHFR (-10.3 kcal/mol), comparable to cycloguanil (-10.7 kcal/mol), while DG1 bound firmly to falcipain-2 (-7.9 kcal/mol), falcipain-3 (-7.5 kcal/mol), and PfCDPK2 (-9.0 kcal/mol). Binding to SERA5 ranged from -6.0 to -6.8 kcal/mol. These findings suggest that the tested compounds may act as inhibitors of vital P. falciparum enzymes, holding promise for the development of antimalarial drugs.

People living with HIV (PLHIV) who fail first-line ART have a higher risk of failing subsequent ART. We examined viral suppression (VS) among adolescents and youths (AY) failing PI ART in Tanzania. We conducted a retrospective study nested within a national third-line cohort of PLHIV. We analysed data of 147 AY (aged 10-24 years) with failure of PI-based ART between 2020 and 2022 who were followed for 12 months to assess for VS. Descriptive statistics were summarized by demographics and clinical characteristics, and we used logistic regression to assess factors associated with virological failure (VF) and drug resistance mutations (DRMs). More than 40% of 147 participants had HIV subtype A, 52% (76/147) harboured major PI DRMs and 35% had NRTI mutations. A PI regimen at ART initiation was associated with a major PI DRM adjusted relative risk (aRR) of 1.66 (95% CI: 1.13-2.44; P = 0.010). Among participants with major PI DRMs, 12.2% had intermediate to high levels of resistance to lopinavir and atazanavir, and 2.1% to darunavir, respectively. V82A was the most frequent PI DRM; NRTI mutations included thymidine analogue mutations and absent K65R. VS occurred in 65% of AY who had PI DRMs compared with 45% of those without DRMs; this difference was not statistically significant. More than half of AY who had PI DRMs had a higher proportion of early VS (65%) compared with those without DRMs (45%). Optimal viral load monitoring, adherence intensification and routine drug resistance testing are key strategies to improve VS.

Abstract The shortage of COVID-19 vaccines posed a significant challenge in optimal response to the COVID-19 pandemic. Fractional doses of vaccine with adequate immunogenic response and proven safety profile emerged as potential strategy to extend the limited vaccine doses. This study was aimed to evaluate the immunogenicity and safety of fractional doses of the ChadOx1, Ad26.COV2.S, and BNT162B2 vaccines among healthy Nigerian adults. A non-inferiority multi-site triple-blind clinical trial was undertaken in Nigeria. Healthy Nigerian adults (18-65 years) who met the inclusion criteria were enrolled in the study. Participants were block-randomized into three vaccine arms (ChadOx1 quarter, half, and full dose; Ad26.COV2.S: quarter, half and full dose; and BNT162B2: half and full dose) . Participants, clinical staff (clinicians and nurses) and laboratory personnel were blinded. The primary objective of the study was to evaluate non-inferiority in seroconversion rates, defined as geometric mean fold rise (GMFR) ≥ 2.5 in serum anti-spike IgG titre at 28 days post-vaccination by ELISA. Immunogenicity analysis included use of serum neutralization assays using pseudotyped virus bearing spike from Wu-1 and Omicron variants. A total of 1891 participants were enrolled between June 21, 2022, and January 25, 2023. 320 participants in the fractional dose group and 220 in the standard dose group completed follow-up and were included in the analysis. SARS-CoV-2 seropositivity at baseline was high, at 68% (365/539). Seroconversion (geometric mean fold rise) was comparable between standard and fractional doses. For ChAdOx1, 31% achieved ≥ 2.5 fold change increase in serum binding antibody in the standard dose arm (16/52), 28% in half dose (15/53), and 34% in quarter dose (18/53). For Ad26.COV2.S, the proportions were 27% (28/105) in standard dose, 32% (22/68) in half dose, and 30% (21/71) in quarter dose arms respectively. For BNT162N2, the proportions were 43% (27/63) in standard dose and 39% (29/75) in half dose. Subset analysis of binding and neutralization responses in (n=64) participants demonstrated high degree of of prior exposure to SARS-CoV-2 ancestral and Omicron lineage variants prior to vaccination. Serum neutralization responses showed ≥2-fold response to both full and fractional doses indicating immunogenic responses to the vaccine dosing regimens. There was no report of serious adverse events. Fractional vaccine doses showed potential to generate non-inferior immune responses compared to standard doses in the context of a population with high rate of previous exposure to SARS-CoV-2 infection. The three vaccines are safe and well tolerated. Fractional dose should be considered to boost herd immunity and prevent outbreaks of SARS-COV-2.

Female sex workers (FSWs) face a significant and persistent risk of contracting HIV. While evidence indicates high rates of pregnancy among FSWs in sub-Saharan Africa, studies on the coverage of HIV testing during pregnancy among them are sparse. The objective of this study was to estimate the prevalence of prenatal HIV testing and determine the associated factors among FSWs in Nigeria. This study was a secondary data analysis of the 2020 Integrated Biological & Behavioural Surveillance Survey (IBBSS) among key populations in Nigeria. We performed weighted descriptive statistics and multivariable binary logistic regression to assess the associations between prenatal HIV testing and sociodemographic characteristics, risk behaviours, HIV knowledge and risk awareness, stigma, and access to healthcare. Of the 1598 FSWs included in the study, 71.0% (95%CI = 68.7%-73.1%) had HIV testing during their last pregnancy. In the regression model, tertiary education (aOR = 2.98, 95%CI = 1.48-6.01), consistent condom use (aOR = 1.95, 95%CI = 1.39-2.75), and receipt of antenatal care (aOR = 35.52, 95%CI = 23.40-53.92) were associated with higher odds of prenatal HIV testing. Compared with the South South geopolitical zone, FSW residing in South East (aOR = 3.38, 95%CI = 1.80-6.35), South West (aOR = 2.97, 95%CI = 1.88-4.68), North Central (aOR = 4.43, 95%CI = 2.80-7.01), North East (aOR = 4.22, 95%CI = 1.64-10.34), North West (aOR = 4.40, 95%CI = 2.59-7.48) had higher odds of reporting prenatal HIV testing. However, being a non-brothel-based FSW (aOR = 0.66, 95%CI = 0.47-0.92), and engaging in sex work during pregnancy (aOR = 0.45, 95%CI = 0.31-0.66) were significantly associated with lower odds of prenatal HIV testing. The prenatal HIV testing among FSWs in this study was suboptimal. The results highlight the need to improve access to antenatal care and implement regional and typology-specific interventions to bridge the gap in prenatal HIV testing among FSWs.

HIV testing remains an entry point into HIV care and treatment services. In 2007, Nigeria adopted and implemented a two-test rapid HIV testing algorithm of three HIV rapid test kits, following the sequence: Alere Determine (first test), UnigoldTM (second test), and STAT-PAK® as the tie-breaker. Sub-analysis of the 2018 Nigeria HIV/AIDS Indicator and Impact Survey data showed significant discordance between the first and second tests, necessitating an evaluation of the algorithm. This manuscript highlights lessons learnt from that evaluation. A two-phased evaluation method was employed, including abstraction and analysis of retrospective HIV testing data from January 2017 to December 2019 from 24 selected sites supported by the United States President's Emergency Plan for AIDS Relief programme. A prospective evaluation of HIV testing was done among 2895 consecutively enrolled and consented adults, aged 15-64 years, accessing HIV testing services from three selected sites per state across the six geopolitical zones of Nigeria between July 2020 and September 2020. The prospective evaluation was performed both in the field and at the National Reference Laboratory under controlled laboratory conditions. Stakeholder engagements, strategic selection and training of study personnel, and integrated supportive supervision were employed to assure the quality of evaluation procedures and outcomes. The algorithm showed higher sensitivity and specificity in the National Reference Laboratory compared with the field. The approaches to quality assurance were integral to the high-quality study outcomes. We recommend comparison of testing algorithms under evaluation against a gold standard. This study provides context-specific considerations in using World Health Organization recommendations to evaluate the Nigerian national HIV rapid testing algorithm.

IntroductionNigeria is committed to reducing industrial trans-fatty acids (iTFA) from the food supply, but the potential health gains, costs and cost-effectiveness are unknown.MethodsThe effect on ischaemic heart disease (IHD) burden, costs and cost-effectiveness of a mandatory iTFA limit (≤2% of all fats) for foods in Nigeria were estimated using Markov cohort models. Data on demographics, IHD epidemiology and trans-fatty acid intake were derived from the 2019 Global Burden of Disease Study. Avoided IHD events and deaths; health-adjusted life years (HALYs) gained; and healthcare, policy implementation and net costs were estimated over 10 years and the population’s lifetime. Incremental cost-effectiveness ratios using net costs and HALYs gained (both discounted at 3%) were used to assess cost-effectiveness.ResultsOver the first 10 years, a mandatory iTFA limit (assumed to eliminate iTFA intake) was estimated to prevent 9996 (95% uncertainty interval: 8870 to 11 118) IHD deaths and 66 569 (58 862 to 74 083) IHD events, and to save US$90 million (78 to 102) in healthcare costs. The corresponding lifetime estimates were 259 934 (228 736 to 290 191), 479 308 (95% UI 420 472 to 538 177) and 518 (450 to 587). Policy implementation costs were estimated at US$17 million (11 to 23) over the first 10 years, and US$26 million USD (19 to 33) over the population’s lifetime. The intervention was estimated to be cost-saving, and findings were robust across several deterministic sensitivity analyses.ConclusionOur findings support mandating a limit of iTFAs as a cost-saving strategy to reduce the IHD burden in Nigeria.