Human vaccines & immunotherapeutics
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Hum Vaccin Immunother · Jul 2021
Randomized Controlled TrialThe effect of screening for vaccine hesitancy on the subsequent development of hesitancy: a randomized controlled trial, Houston, TX.
Vaccine hesitancy remains a global health threat. Addressing parental vaccine hesitancy is essential to maintaining high vaccine coverage levels and preventing disease outbreaks; however, it is unknown if administering a vaccine hesitancy screening tool negatively impacts parental vaccine beliefs. We conducted a stratified randomized controlled trial in pediatric primary care practices. ⋯ The proportion of hesitant parents at 6 months did not differ between PACV and placebo groups (6.6% vs. 6.1%; p = .78) and the odds of hesitancy among PACV group participants was not higher than those in the placebo group (OR = 1.10; 95% CI: 0.63-1.93; p = .743). Race was the only characteristic significantly associated with vaccine hesitancy at 6-month follow up (p = .003). Overall, administration of the PACV did not trigger vaccine hesitancy in this study population.
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Hum Vaccin Immunother · May 2021
Randomized Controlled TrialA phase 1, randomized, placebo-controlled study to evaluate the safety and immunogenicity of an mRNA-based RSV prefusion F protein vaccine in healthy younger and older adults.
Respiratory Syncytial Virus (RSV) causes lower respiratory tract infections that can be severe and sometimes fatal. The risk for severe RSV infection is highest in infants and older adults. A safe and effective RSV vaccine for older adults represents a serious unmet medical need due to higher morbidity and mortality in this age group. ⋯ Primary objectives were safety and tolerability and secondary objectives included humoral and cell-mediated immunogenicity. All dose levels of mRNA-1777 (V171) were generally well tolerated and no serious adverse events related to the vaccine were reported. Immunization with mRNA-1777 (V171) elicited a humoral immune response as measured by increases in RSV neutralizing antibody titers, serum antibody titers to RSV prefusion F protein, D25 competing antibody titers to RSV prefusion F protein, and cell-mediated immune responses to RSV-F peptides.
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Hum Vaccin Immunother · Jan 2019
Randomized Controlled TrialLong-term immunogenicity and safety of tetravalent dengue vaccine (CYD-TDV) in healthy populations in Singapore and Vietnam: 4-year follow-up of randomized, controlled, phase II trials.
Dengue is prevalent in the Asia-Pacific region. Participants of two immunogenicity and safety phase II studies conducted in Singapore and Vietnam (NCT0088089 and NCT00875524, respectively) were followed for up to four years after third vaccine dose of a recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV). Participants (2-45 years) received three doses of CYD-TDV or control at 0, 6, and 12 months. ⋯ Seropositivity rates were higher at year four in participants who were seropositive vs. seronegative at baseline in both studies. No safety concerns were identified. CYD-TDV demonstrated long-term immunogenicity and was well-tolerated for four years after the third vaccine dose.
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Hum Vaccin Immunother · Feb 2018
Randomized Controlled Trial Multicenter StudyMF59-adjuvanted influenza vaccine (FLUAD®) elicits higher immune responses than a non-adjuvanted influenza vaccine (Fluzone®): A randomized, multicenter, Phase III pediatric trial in Mexico.
The poor immune response elicited by trivalent influenza vaccines (TIVs) in children can be enhanced by the addition of adjuvants. This observer-blind, randomized Phase III trial assessed the immunogenicity and safety of the MF59-adjuvanted trivalent influenza vaccine FLUAD® (aTIV) and a non-adjuvanted TIV, in healthy children (aged 6 to <72 months) from 3 centers in Mexico, during the 2014-2015 season. The primary objectives were to assess the non-inferiority of aTIV to TIV, measured by geometric mean titers (GMTs), and the safety of aTIV and TIV. ⋯ No deaths, serious AEs, or AEs leading to premature withdrawal were reported. Overall, aTIV was highly immunogenic and was well tolerated in healthy children 6 to <72 months of age. These results indicate that aTIV may be a beneficial addition to national pediatric vaccination programs.
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Hum Vaccin Immunother · Jan 2018
Randomized Controlled TrialSerological responses to rotavirus NSP2 following administration of RV3-BB human neonatal rotavirus vaccine.
Serum rotavirus IgA responses are an imperfect non-mechanistic correlate of protection, and the lack of an accurate serological marker is a challenge to the development of new rotavirus vaccines. Serological responses to rotavirus NSP2 occur following wild-type infection; however, it is unknown if serological responses to NSP2 occur following administration of rotavirus vaccines. The phase IIa immunogenicity trial of RV3-BB provided an opportunity to investigate the serological responses to NSP2 following vaccination. ⋯ Despite significant serum IgA response against total RV3-BB, we were unable to demonstrate a significant serological response to NSP2 in participants receiving RV3-BB when compared to placebo. Heterotypic antibodies against multiple NSP2 genotypes were detected following RV3-BB vaccination. Our data demonstrates that while serological responses to NSP2 were detectable in a subset of participants, it is a less useful marker when compared to total rotavirus serum IgA response.