The Lancet Infectious Diseases

BackgroundThis COVID-19 pandemic has caused unprecedented morbidity, mortality, and global economic instability. Several approved vaccines demonstrated to be effective prevention against COVID-19. We aimed to evaluate the safety and immunogenicity of the PIKA-adjuvanted recombinant SARS-C0V-2 Spike (S) protein subunit vaccine in adults as a primary immunization and as a booster dose against SARS-C0V-2 infection. MethodsThis was a Phase I, open label, dose-escalation study of 3 dose levels of th...

BackgroundThe number and timing of pneumococcal conjugate vaccine (PCV) primary doses can impact infant immune responses. This descriptive post hoc analysis evaluates the immunogenicity of the 20-valent PCV (PCV20) by vaccination timing in healthy infants in 2 key phase 3 trials. MethodsImmunogenicity endpoints from study B7471012 comparing PCV20 to 13-valent PCV (PCV13) in a 2+1 schedule were examined by timing of vaccination subgroup; the 2,4m subgroup (participants vaccinated at 2, 4, and 11...

This study investigated whole-cell oral cholera vaccine (kOCV) single-dose effectiveness and transmission dynamics of Vibrio cholerae through 4 years of epidemiological and genomic surveillance in Democratic Republic of the Congo (DRC). Whole genome sequencing was performed on clinical and water V. cholerae strains from 200 patient households and found annual bimodal peaks of V. cholerae clade AFR10e. 1154 diarrhea patients were enrolled with 342 culture confirmed cholera patients. A large clona...

Although over 12 billion COVID-19 vaccine doses have been administered globally, the important issue of whether the optimal doses are being used has been relatively neglected. To address this question, we reviewed the reports of early-phase dose-finding trials of the nine COVID-19 vaccines approved by World Health Organization (and one additional vaccine which showed partial clinical efficacy), extracting information on study design and findings on reactogenicity and early humoral immune respons...

In this randomized, observer-blinded, phase 2/3 study, S-268019-b (n=101), a recombinant spike protein vaccine, was analyzed for noninferiority versus tozinameran (n=103), when given as a booster [≥]6 months after 2-dose tozinameran regimen in Japanese adults without prior COVID-19 infection. Interim results showed noninferiority of S-268019-b versus tozinameran in co-primary endpoints for neutralizing antibodies on day 29: geometric mean titer (GMT) (124.97 versus 109.70; adjusted-GMT ratio ...

Cholera is a critical global health threat with significant morbidity and mortality, particularly in low- and middle-income countries and populations without access to safe water and sanitation. Clinical surveillance is typically based on non-specific and microbiological diagnostics that are only moderately sensitive. Therefore, identifying cases and understanding the true burden is difficult. Measurements of antibodies can help inform interpretation of cross-sectional sero-epidemiological studi...

BackgroundMVC-COV1901 is a subunit SARS-CoV-2 vaccine based on the prefusion spike protein S-2P and adjuvanted with CpG 1018 and aluminum hydroxide. Although MVC-COV1901 has been licensed for emergency use for adults in Taiwan, the safety and immunogenicity of MVC-COV1901 in adolescents remained unknown. As young people play an important role in SARS-CoV-2 transmission and epidemiology, a vaccine approved for adolescents and eventually, children, will be important in mitigating the COVID-19 pand...

BackgroundImproved seasonal influenza vaccines for older adults are urgently needed, which can induce broadly cross-reactive antibodies and enhanced T-cell responses, particularly against A(H3N2) viruses, while avoiding egg-adaptive antigenic changes. MethodsWe randomized 2654 clinically-stable, community-dwelling adults [≥]65 years of age 1:1 to receive a single intramuscular dose of either Matrix-M-adjuvanted quadrivalent nanoparticle influenza vaccine (qNIV) or a licensed inactivated infl...

In sub-Saharan Africa, non-typhoidal Salmonella (NTS) and Salmonella Typhi are leading causes of invasive disease among young children. Trivalent Salmonella Conjugate Vaccine (TSCV) consists of Vi capsule polysaccharide conjugated to tetanus toxoid and core-plus-O-polysaccharides from the two most prevalent invasive non-typhoidal serovars (Typhimurium, Enteritidis) conjugated to serovar- homologous flagellin subunits. We conducted a first-in-human, randomized, placebo-controlled, stepwise-dose-e...

BackgroundCurrent whole-cell killed oral cholera vaccines have utility but require multiple doses and have limited efficacy in young children. PanChol is a single-dose live-attenuated cholera vaccine derived from the current seventh pandemic Vibrio cholerae O1 strain. It co-expresses Inaba and Ogawa antigens, over-expresses the non-toxic cholera toxin B subunit, and is designed to minimize reactogenicity and prevent toxigenic reversion. We assessed safety and immunogenicity in a first-in-human t...

BackgroundNanocovax is a recombinant severe acute respiratory syndrome coronavirus 2 subunit vaccine composed of full-length prefusion stabilized recombinant SARS-CoV-2 spike glycoproteins (S-2P) and aluminum hydroxide adjuvant. In a Phase 1 and 2 studies, (NCT04683484) the vaccine was found to be safe and induce a robust immune response in healthy adult participants. MethodsWe conducted a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, immunogenicity, an...

BACKGROUND The ongoing coronavirus disease (COVID)-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) might be controlled by an efficacious vaccine. Multiple vaccines are in development, but no efficacious vaccine is currently available. METHODS We designed a multi-center phase 1/2a randomized, double-blinded, placebo-controlled clinical study to assesses the safety, reactogenicity and immunogenicity of Ad26.COV2.S, a non-replicating adenovirus 26 based vector exp...

BackgroundMeasles seroprevalence data has potential to be a useful tool for understanding transmission dynamics and for decision making efforts to strengthen immunization programs. In this study, we conducted a systematic review and bias assessment of all primary data on measles seroprevalence in low- and middle-income countries published from 1962 to 2021. MethodsOn March 9, 2022, we searched PubMed for all available data. We included studies containing primary data on measles seroprevalence a...

BackgroundImprovements in malaria control have stalled recently and new tools are needed. The R21 vaccine is comprised of the malaria circumsporozoite protein fused to hepatitis B surface antigen (HBsAg). It forms particles that lack the excess HBsAg in the frequently tested malaria vaccine candidate, RTS,S/AS01B. MethodsWe conducted an open-label, first-in-human, Phase Ia study evaluating safety and immunogenicity of R21 administered alone and with the saponin-based adjuvant, Matrix-M (MM). Tw...

BackgroundData from previous studies of the MVC-COV1901 vaccine, a subunit vaccine against SARS-CoV-2 based on the stable prefusion spike protein (S-2P) adjuvanted with CpG 1018 adjuvant and aluminum hydroxide, suggest that the vaccine is generally safe and elicits a good immune response in healthy adults and adolescents. By comparing with AZD1222, this study adds to the findings from previous trials and further evaluates the breadth of protection offered by MVC-COV1901. MethodsIn this phase 3,...

BackgroundThe ReCOV is a recombinant trimeric two-component SARS-CoV-2 subunit vaccine adjuvanted with BFA03. We report the preliminary safety and immunogenicity results for the ReCOV. MethodsThis first in human, randomized, double-blind, placebo-controlled phase I study, was conducted at 2 study sites in New Zealand. Subjects were stratified into two age cohorts (18-55 years and 56-80 years old) and then randomly assigned in a 4:1 ratio to receive two 0.5 mL intramuscular doses of the ReCOV va...

BackgroundThe only licensed malaria vaccine, RTS,S/AS01E, confers moderate protection against symptomatic disease. Because many malaria infections are asymptomatic, we conducted a large-scale longitudinal parasite genotyping study of samples from a clinical trial exploring how vaccine dosing regimen affects vaccine efficacy (VE). Methods1,500 children aged 5-17 months were randomized to receive four different RTS,S/AS01E regimens or a rabies control vaccine in a phase 2b clinical trial in Ghana...

BackgroundRapid spread of SARS-CoV-2 in Wuhan prompted heightened surveillance in Shenzhen and elsewhere in China. The resulting data provide a rare opportunity to measure key metrics of disease course, transmission, and the impact of control. MethodsThe Shenzhen CDC identified 391 SARS-CoV-2 cases from January 14 to February 12, 2020 and 1286 close contacts. We compare cases identified through symptomatic surveillance and contact tracing, and estimate the time from symptom onset to confirmatio...

BackgroundDue to severe outcomes, elderly adults 60 years or older are prioritized for COVID-19 vaccination but accumulated SARS-CoV-2 infection and vaccination likely modifies their risk. We estimated vaccine effectiveness against omicron-associated hospitalisation among elderly adults, by number of doses, prior infection history and time since last immunological event. MethodsWe conducted a test-negative case-control study among symptomatic elderly adults tested for SARS-CoV-2 in Quebec, Cana...

Background: To understand current and mitigate future measles mortality burden, it is critical to have robust estimates of measles case fatality. Estimates of measles case fatality ratios (CFR) that are age-, location-, and time-specific are essential to capture variation in underlying population-level factors--such as vaccination coverage and measles incidence--that contribute systematically to increases or decreases in case fatality. In this study, we updated estimates of measles CFR by expand...