Janssen Vaccines & Prevention BV, National Institutes of Health, Ragon Institute of MGH, MIT and Harvard, Henry M Jackson Foundation for the Advancement of Military Medicine, US Department of Defense, and International AIDS Vaccine Initiative.

Quadrivalent influenza vaccines (QIVs), which include both B lineage strains, are expected to provide broader protection than trivalent influenza vaccines (TIVs). The non-inferiority, immunogenicity, and safety of a cell culture-based investigational QIVc and 2 TIVs (TIV1c, TIV2c), in adults (≥18 y), were evaluated in this Phase III, double-blind, multicenter study. A total of 2680 age-stratified subjects were randomized (2:1:1) to receive 1 dose of QIVc (n = 1335), TIV1c (n = 676), or TIV2c (n = 669). TIV1c (B/Yamagata) and TIV2c (B/Victoria) differed only in B strain lineage. The primary objective was to demonstrate non-inferiority of the hemagglutinin-inhibition antibody responses of QIVc against TIVc, 22 d post-vaccination. Secondary objectives included the evaluation of immunogenicity of QIVc and TIVc in younger (≥18 – <65 y) and older (≥65 y) adults. Hemagglutinin inhibition assays were performed at days 1 and 22. Solicited local and systemic adverse events (AEs) were monitored for 7 d post-vaccination, and unsolicited AEs and serious AEs until day 181. QIVc met the non-inferiority criteria for all 4 vaccine strains and demonstrated superiority for both influenza B strains over the unmatched B strain included in the TIV1c and TIV2c, when geometric mean titers and seroconversion rates with TIVc were compared at day 22. Between 48%–52% of subjects experienced ≥1 solicited AE, the most common being injection-site pain and headache. Serious AEs were reported by ≤1% of subjects, none were vaccine-related. The results indicate that QIVc is immunogenic and well tolerated in both younger and older adults. The immunogenicity and safety profiles of QIVc and TIVc were comparable at all ages evaluated.

A potentially deadly A/H7N9 avian-origin influenza virus is currently the cause of an ongoing outbreak in China. Preparedness plans have thus been initiated to preempt the spread of this virus, which appears to have substantial pandemic potential. To effectively prevent a pandemic from unfolding, rapid production of an immunogenic vaccine with an acceptable safety profile is critical. Given the significance to public health, we are reporting immunogenicity and safety results from a phase 1 study in healthy adults administered one of four inactivated A/H7N9 vaccine formulations. Three formulations contained increasing quantities of antigen and of an oil-in-water adjuvant, MF59, and one formulation contained only the maximum dose of antigen without adjuvant. All vaccine formulations were derived using a synthetic virus seed technology in combination with a cell culture approach; together, these techniques have been shown to expedite vaccine production compared to conventional methods. Higher responses were seen with the MF59-adjuvanted versus the nonadjuvanted A/H7N9 vaccine, with significant and potentially protective immune responses after two doses in most subjects with no preexisting immunity to the H7N9 virus. Further, despite increased injection site pain and other mild effects with MF59, all formulations were well tolerated. These encouraging immunogenicity and safety data on the A/H7N9 vaccine provide a strong rationale for further clinical development. By also using synthetic seed/cell culture technology, we are now one step closer to being able to rapidly and reliably respond to a potential H7N9 pandemic using a clinically tested A/H7N9 vaccine.

The safety and immunogenicity results from this study support inclusion of the GLA-SE adjuvant in this RSV vaccine for older adults and also support assessment of the efficacy of the vaccine in a larger clinical trial. Clinicaltrials.gov NCT02115815.

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Background This phase 1 placebo-controlled study assessed safety and immunogenicity of two-dose regimens of Ad26.ZEBOV (Ad26) and MVA-BN-Filo (MVA) vaccines with booster vaccination at Day 360. Methods Healthy US adults (N = 164) randomized into 10 groups received saline placebo, standard or high doses of Ad26 or MVA in two-dose regimens in 7-, 14-, 28-, or 56-day intervals; eight groups received booster Ad26 or MVA vaccinations on Day 360. Participants reported solicited and unsolicited reactogenicity; we measured IgG binding, neutralizing antibodies and cellular immune responses to Ebolavirus (EBOV) glycoprotein. Results All regimens were well tolerated with no serious vaccine-related adverse events. Heterologous (Ad26,MVA or MVA,Ad26) and homologous Ad26,Ad26 regimens induced humoral and cellular immune responses 21 days post-dose 2; responses were higher following heterologous regimens. Booster vaccination elicited anamnestic responses in all participants. Conclusions Both heterologous and homologous Ad26,MVA Ebola vaccine regimens are well tolerated in healthy adults, regardless of interval or dose level. Heterologous two-dose Ad26,MVA regimens containing an EBOV insert induce strong, durable humoral and cellular immune responses. Immunological memory was rapidly recalled by booster vaccination, suggesting Ad26 booster doses could be considered for individuals at risk of Ebola infection, who previously received the two-dose regimen.

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to affected families. With strong political commitment and precise response, the outbreak was brought under control within 10 days of confirmation of first case.Results: Epidemiological investigation by multidisciplinary rapid response team confirmed the index case, the first death, which went un noticed. Source of infection identified as possible exposure to a small forest having fruit bats in large numbers, in which the presence of Nipah virus was subsequently confirmed. person to person transmission on close contact with respiratory secretions was confirmed as mode of spread. Intensive surveillance and contact tracking identified 324 close contacts, and subjected to labortory test. 18 cases confirmed as per standard guidelines, of which 16 died in subsequent days (CFR 88.8%). Three hospitals were identified as the possible points of infection transmission. 3000+ persons were tracked for 21 days to rule out NiV infection. Last case reported on 26.5.18 and outbreak closed on 7.7.18, after intensified surveillance for 42 days. Two survivors are being monitored for any long term consequences. Conclusion:The first ever Nipah virus outbreak reported from Kerala state was responded with clinical precision, aided by strong political commitment, excellent adminsitrative back up and profound community participation.