Immunogenicity and safety of measles-mumps-rubella vaccine delivered by disposable-syringe jet injector in India: A randomized, parallel group, non-inferiority trial

Bavdekar, Ashish; Oswal, Jitendra; Ramanan, Padmasani Venkat; Aundhkar, Chandrashekhar; Sriram, Damal Kandadai; Kapse, Dhananjay; Miller, Tara; McGray, Sarah; Zehrung, Darin; Kulkarni, Prasad S.; Ramaganeshan, D.; Sapru, Amita; Pandit, Anand; Kawade, Anand; Lalwani, Sanjay; Palkar, Sonali; Hanumante, N M; Malshe, Nandini; Krishna, Vidya; Ingale, S.Y.; Gunale, Bhagwat; Chaudhari, Amol; Saganic, Laura; Jarrahian, Courtney

doi:10.1016/j.vaccine.2018.01.006

Cited by 16 publications

(8 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The strong immunogenicity of the SL/B tissue, which is often regarded as a site for immune tolerance induction 6,43 , suggests the adjuvant activity of MVA-HIV and dmLT effectively overcomes the tolerogenic nature of the oral tissue to generate vaccine-specific T and B cell responses. The concept of needle-free delivery of vaccines is not new as recent studies examined needle-free injection through the skin as a method of vaccination in humans 10,11,44–46 . However, to our knowledge this method of vaccination has not been explored for SL/B route in humans or non-human primates and thus our study represents the first demonstration that needle-free SL/B immunization as an attractive approach for mucosal vaccination with protective potential against HIV, warranting further studies to characterize this route for HIV/SIV and other mucosal pathogens.…”

Section: Discussionmentioning

confidence: 99%

HIV-1 vaccination by needle-free oral injection induces strong mucosal immunity and protects against SHIV challenge

et al. 2019

View full text Add to dashboard Cite

The oral mucosa is an attractive site for mucosal vaccination, however the thick squamous epithelium limits antigen uptake. Here we utilize a modified needle-free injector to deliver immunizations to the sublingual and buccal (SL/B) tissue of rhesus macaques. Needle-free SL/B vaccination with modified vaccinia Ankara (MVA) and a recombinant trimeric gp120 protein generates strong vaccine-specific IgG responses in serum as well as vaginal, rectal and salivary secretions. Vaccine-induced IgG responses show a remarkable breadth against gp70-V1V2 sequences from multiple clades of HIV-1. In contrast, topical SL/B immunizations generates minimal IgG responses. Following six intrarectal pathogenic SHIV-SF162P3 challenges, needle-free but not topical immunization results in a significant delay of acquisition of infection. Delay of infection correlates with non-neutralizing antibody effector function, Env-specific CD4+ T-cell responses, and gp120 V2 loop specific antibodies. These results demonstrate needle-free MVA/gp120 oral vaccination as a practical and effective route to induce protective immunity against HIV-1.

show abstract

Section: Discussionmentioning

confidence: 99%

HIV-1 vaccination by needle-free oral injection induces strong mucosal immunity and protects against SHIV challenge

et al. 2019

View full text Add to dashboard Cite

show abstract

“…A similar clinical study was conducted in tandem with this one, at the same study sites, comparing immunogenicity and safety of measles-mumps-rubella (MMR) vaccine administered with either the DSJI or N-S [ 9 ]. That study was completed per the protocol, and concluded that MMR vaccination via DSJI met all non-inferiority criteria; it was as immunogenic and safe as vaccination by N-S.…”

Section: Discussionmentioning

confidence: 99%

Clinical study of safety and immunogenicity of pentavalent DTP-HB-Hib vaccine administered by disposable-syringe jet injector in India

Bavdekar¹,

Malshe

Ravichandran

et al. 2019

Contemporary Clinical Trials Communications

Self Cite

View full text Add to dashboard Cite

Introduction We conducted a randomized, observer-blind, non-inferiority, parallel-group clinical study of diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b conjugate (pentavalent) vaccination of infants in India. Goals were to determine whether the seropositivity rate after vaccination via disposable-syringe jet injector (DSJI) was non-inferior to that via needle and syringe (N-S), and to compare the safety of vaccination by the two methods. Methods Healthy children received a three-dose series of vaccine intramuscularly by DSJI or N-S beginning at 6–8 weeks of age. Immunoglobulin G antibody levels were measured by ELISA at 4–6 weeks after the third dose. The main secondary endpoint was safety, measured as injection site and systemic reactions. Discussion The study was stopped early out of caution beyond that specified in the protocol stopping criteria, after the Data Safety Committee noted a higher frequency of injection site reactions, especially moderate and severe, in the DSJI group. As a result, 128 subjects—DSJI group 61; N-S group 67—completed the study, rather than the 340 planned, and the study was not sufficiently powered to compare immunogenicity endpoints for the groups. Descriptive statistics indicate that seropositivity induced by vaccination with the DSJI was similar to that of N-S for all five antigens. Pentavalent vaccine includes whole-cell pertussis vaccine and an aluminum adjuvant, which may have contributed to the higher number of local reactions with the DSJI. The reactions caused no serious or long-term sequelae, and may be more acceptable in other populations or circumstances. US National Institutes of Health clinical trials identifier: NCT02409095.

show abstract

“…The Injex30 provided comparable antibody titres to subcutaneous N&S injection in a study with mice vaccinated against hepatitis B surface antigen [ 163 ]. A pyro-drive jet injector (Actranza™, DAICEL Corporation, Osaka, Japan) has been shown to allow for the adjustment of injection depth and has demonstrated potential to induce antibodies in rats [ 177 ].…”

Section: Vaccination Into the Dermal Compartment Without Needle Anmentioning

confidence: 99%

Vaccination into the Dermal Compartment: Techniques, Challenges, and Prospects

Hettinga

Carlisle

2020

Vaccines

View full text Add to dashboard Cite

In 2019, an ‘influenza pandemic’ and ‘vaccine hesitancy’ were listed as two of the top 10 challenges to global health by the WHO. The skin is a unique vaccination site, due to its immune-rich milieu, which is evolutionarily primed to respond to challenge, and its ability to induce both humoral and cellular immunity. Vaccination into this dermal compartment offers a way of addressing both of the challenges presented by the WHO, as well as opening up avenues for novel vaccine formulation and dose-sparing strategies to enter the clinic. This review will provide an overview of the diverse range of vaccination techniques available to target the dermal compartment, as well as their current state, challenges, and prospects, and touch upon the formulations that have been developed to maximally benefit from these new techniques. These include needle and syringe techniques, microneedles, DNA tattooing, jet and ballistic delivery, and skin permeabilization techniques, including thermal ablation, chemical enhancers, ablation, electroporation, iontophoresis, and sonophoresis.

show abstract

Immunogenicity and safety of measles-mumps-rubella vaccine delivered by disposable-syringe jet injector in India: A randomized, parallel group, non-inferiority trial

Cited by 16 publications

References 5 publications

HIV-1 vaccination by needle-free oral injection induces strong mucosal immunity and protects against SHIV challenge

HIV-1 vaccination by needle-free oral injection induces strong mucosal immunity and protects against SHIV challenge

Clinical study of safety and immunogenicity of pentavalent DTP-HB-Hib vaccine administered by disposable-syringe jet injector in India

Vaccination into the Dermal Compartment: Techniques, Challenges, and Prospects

Contact Info

Product

Resources

About