A quadrivalent split influenza vaccine IIV4-W against both influenza A and B viruses is urgently needed.To evaluate the safety and immunogenicity of IIV4-W in people aged 3–60 years, 2400 participa...

Affordable HPV vaccines are needed to accelerate elimination of cervical cancer. We evaluated the efficacy, safety, and immunogenicity of a recombinant biv

Influenza vaccines for children aged 6-35 months are typically low-dose (0.25 mL, 7.5 μg hemagglutinin per strain). However, studies have shown that high-dose influenza vaccines (0.5 mL, 15 μg hemagglutinin per strain) can enhance protective efficacy without increasing the risk of adverse reactions. We conducted a randomized, double-blind clinical study in children aged 6-35 months in China. A total of 3,000 participants were randomized (1:1:1) to receive two doses of either an investigational high-dose quadrivalent influenza vaccine (H-QIV), an investigational low-dose quadrivalent influenza vaccine (LQIV-01) or a commercially available low-dose quadrivalent influenza vaccine (LQIV-02). Hemagglutination inhibition (HI) antibody titers 30 d post-vaccination were measured and vaccine safety and tolerability within 6 months post-vaccination were evaluated in these participants. The primary objectives were to demonstrate the non-inferiority of investigational vaccines to the commercially available vaccine in immunogenicity and to compare the H-QIV to L-QIVs. Both investigational vaccines demonstrated non-inferiority, with their seroprotection rates (SPRs), seroconversion rates (SCRs) and geometric mean titers (GMTs) meeting immunogenicity criteria. The H-QIV exhibited >11-fold increases in GMTs against H1N1, H3N2, B/Yamagata and B/Victoria strains compared to pre-vaccination levels, with SPRs exceeding 95% and SCRs exceeding 89%. The H-QIV was superior to both L-QIVs as it induced a stronger immune response to influenza viruses. All vaccines showed comparable safety profiles. The H-QIV can provide greater protection and benefits to this high-risk population.

Background: The Sabin strain-based inactivated poliovirus vaccine (sIPV) assists in completely eradicating poliovirus transmission, especially in developing countries. Sera from sIPV-immunized individuals can neutralize wild poliovirus strains, primarily indicating its protective potential, though clinical efficacy data are required for confirmation. In the present trial, which used 2-month-old infants as study subjects, we aimed to assess the cross-neutralization capacity of test-sIPV (Wuhan Institute of Biological Products) against a panel of epidemiologically relevant poliovirus strains. Methods: We performed a double-blind, randomized, positive-controlled trial including 300 healthy infants who fell into three groups (1:1:1) in a random manner. These subjects received the test-sIPV, control-sIPV, or control-wIPV when they were 2, 3, or 4 months old, respectively. The neutralizing ability of serum samples collected before the 1st dose and 28 days after the 3rd dose of vaccination against 10 individual polio strains, including Sabin, Salk, and recently circulating poliovirus strains, was evaluated. We noted the solicited systematic and local reactions within 7 days and the unsolicited adverse events (AEs) within 28 days following each vaccination and monitored the serious adverse events (SAEs) up to 6 months after the 3rd vaccination. Results: A total of 282 infants who finished the entire vaccination process and provided blood samples before and after immunization within the time window underwent immunogenicity analysis after being included in the pre-protocol population. The seroconversion rates induced by the test-sIPV group, control-sIPV group, and control-wIPV against the 10 poliovirus strains were 91.58–100.0%, 87.23–98.94%, and 94.62–100.0%, respectively. Moreover, the geometric mean antibody titers (GMTs) against the 10 polioviruses were 40.24–2876.29, 25.85–1658.58, and 116.2–958.12, respectively. The test-sIPV, control-sIPV, and control-wIPV systems showed acceptable safety. Fever was the most common systemic solicited reaction, followed by irritation. Pain at the injection site was a representative local solicited AE with the test-sIPV. Conclusions: Our findings suggest that the test-sIPV effectively induces neutralizing antibody response against the Sabin and wild poliovirus strains, with seroconversion rates exceeding 90%.GMTs against most wild-type strains were higher than those of control-sIPV but lower than those of control-wIPV for several strains. Safety profile was acceptable, with no vaccine-related serious adverse events, although the test-sIPV group experienced a higher incidence of mild-to-moderate adverse reactions compared with both control groups, which are already registered for sale. The broad cross-neutralization capacity and favorable safety profile of test-sIPV suggest that it could play a valuable role in global polio eradication strategies, particularly in developing countries transitioning from OPV to affordable IPV-based immunization schedules. Trial registration: Clinical trial number: CTR20211257, registered on 7 June 2021 in the China Drug Clinical Trial Registration and Information Disclosure Platform. http://www.chinadrugtrials.org.cn .

This randomized, double-blind, phase IV study (NCT05731115) assessed the lot-to-lot consistency, immunogenicity, and safety of three manufacturing lots of a 23-valent pneumococcal polysaccharide vaccine (PPV23) in 1800 healthy Chinese adults aged 40-65 y. The participants were enrolled and randomized into three groups at a 1:1:1 ratio, with each group receiving one dose of PPV23 from one of three manufacturing lots. Blood samples were collected pre-vaccination and at 30 d post-vaccination for serotype-specific IgG antibody testing. The primary objective was to demonstrate lot-to-lot consistency via equivalence evaluation in 40-65 y old Chinese adults, assessed by geometric mean concentration (GMC) of IgG antibodies at 30 d post-vaccination. Safety data were collected for up to 30 d after vaccination. The results showed that GMC ratio 95% confidence intervals (CIs) in all 23 serotypes were within the predefined equivalence criteria of (0.5, 2). Although the incidence of adverse reactions (AR) may have varied among the three lots, the clinical impact is likely minimal, given that the vast majority (93.2%) were mild in severity. No serious adverse events (SAEs) related to vaccination were reported during the study. This study confirmed that the three manufacturing lots of PPV23 (Sinovac Biotech Co. Ltd.) demonstrated manufacturing consistency and can elicit satisfactory immune responses for all 23 serotypes and no safety concerns were identified.Trial registration: ClinicalTrial.gov identifier: NCT05731115.